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RIGHTEST Blood Glucose Monitoring System Max Tel is intended to the quantitative measurement of glucose (sugar) in fresh capillary whole drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.

RIGHTEST Blood Glucose Monitoring System Max Tel is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to montor the effectiveness of diabetes control. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The RIGHTEST Blood Glucose Monitoring System Max Tel is comprised of the RIGHTEST Meter Max Tel and the RIGHTEST Blood Glucose Test Strip Max.

RIGHTEST Blood glucose monitoring System Max Tel consists of the following devices: Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, Lancing Device and Sterile Lancets. The Blood Glucose Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation.

RIGHTEST Blood Glucose Meter Max Tel, when used with the RIGHTEST Blood Glucose Test Strips Max, quantitatively measure glucose in fresh whole blood samples from capillary. The performance of RIGHTEST Blood Glucose Monitoring System Max Tel is verified by the RIGHTEST Control Solution GC700.

The glucose measurement is achieved by using the amperometric detection meth test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with FAD-glucose dehydrogenase and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed.

The provided FDA 510(k) summary for the RIGHTEST Blood Glucose Monitoring System Max Tel focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed clinical study results typical of a de novo or PMA submission. Therefore, much of the requested information regarding a comprehensive study proving acceptance criteria for an AI/device for diagnostic purposes (e.g., number of experts, MRMC studies, ground truth establishment for a training set) is not directly present in this document because it is not an AI/Software as a Medical Device (SaMD) submission for a diagnostic algorithm.

This document describes a glucose monitoring system, which is a medical device rather than an AI-powered diagnostic system that typically involves image analysis or complex algorithmic interpretations of patient data for diagnosis. The "Software Safety Analysis" refers to enabling LTE functionality and adjusting the measurement range, alongside cybersecurity considerations, not the performance of a diagnostic AI.

However, I can extract the acceptance criteria and performance as described in the document for this specific device:

Device: RIGHTEST Blood Glucose Monitoring System Max Tel
Intended Use: Quantitative measurement of glucose (sugar) in fresh capillary whole blood samples for self-testing by people with diabetes at home, as an aid to monitor the effectiveness of diabetes control.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the "Discussion of Non-Clinical Tests Performed for Determination of Substantiability" (Section 8) and the "Comparison to Predicate Devices" (Section 7), the acceptance criteria are generally implied by the successful completion and compliance with relevant FDA guidelines for glucose monitoring systems. The performance is reported in terms of demonstrating compliance.

Overall Conclusion: "Results of performance evaluation of RIGHTEST Blood Glucose Monitoring System Max Tel that had no impacts to BGM measurement was conducted to support substantially equivalent to the predicate device..." |
| Measurement Range: Correct display of "Hi" or "Lo" for out-of-range results. | Hi Lo Display: "The measurement range has been adjusted, and the system displayed a notification indicating 'Hi' or 'Lo'—for results that fall outside the established range." The specific numerical range is 20 - 600 mg/dL (1.1 - 33.3 mmol/L). |
| Software Functionality and Safety:

• Successful implementation and validation of LTE functionality.
• Compliance with FCC testing.
• Compliance with FDA's cybersecurity guidance. | Software Safety Analysis: "Software adjustments were made to enable LTE functionality and adjusted the measurement range. The LTE function was validated through both FCC compliance testing and laboratory testing. As LTE functionality introduced cybersecurity considerations, we ensured compliance with the FDA's guidance on the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." |
  | Interference: Performance maintained in the presence of specified interferents. | Interference Data Points: Ascorbic Acid ≥ 3 mg/dL, Conjugated Bilirubin ≥ 30 mg/dL, Uric Acid ≥ 12 mg/dL, Xylose ≥ 8 mg/dL. (Implies performance within specification despite these levels, though the exact outcome of the testing is not described beyond listing the tested interferents) |
  | Other Functional Parameters: Measurement technology, sample type, minimum sample volume, test time, control solution compatibility, operating conditions, storage conditions, shelf life, reagent composition, power saving, coding, monitor, backlight, color, power supply, memory capacity, meter dimension, LCD display area, meter weight, data transmission. | All these parameters are listed as characteristics of the new device, implicitly meeting the predicate device's standards or being deemed acceptable (e.g., LTE network for data transmission is a new feature). |
  | General Acceptance: All laboratory studies met acceptance criteria. | "All laboratory studies that the acceptance criteria were met. Therefore, the performances from these laboratory studies were acceptable." |

Regarding the other requested points (relevant for AI/SaMD):

• 2. Sample sized used for the test set and the data provenance: Not specified in the provided document. The reference to "natural and modified blood samples" in "The Extreme Glucose Study" suggests lab-based testing, but no specific sample size or provenance is given.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/diagnostic imaging device requiring expert ground truth for interpretation. Ground truth for a glucose meter is typically established by laboratory reference methods (e.g., YSI analyzer).
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This type of adjudication is usually for subjective interpretations by multiple human readers, not for a highly objective measurement device like a glucose meter.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI system assisting human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a "standalone" measurement device. Its performance is measured directly against laboratory reference standards, but there is no "algorithm only" in the sense of an AI interpreting complex data that a human would usually interpret.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For glucose meters, the ground truth is typically a laboratory reference method (e.g., a YSI analyzer), rather than expert consensus or pathology, as the measurement is quantitative. This is implied by the nature of the device, although not explicitly stated as "YSI" in the document.
• 8. The sample size for the training set: Not applicable. This device does not use machine learning with a distinct training set in the typical sense of an AI/ML algorithm. Its functionality is based on established electrochemical principles, not pattern recognition learned from a dataset.
• 9. How the ground truth for the training set was established: Not applicable, for the same reason as point 8.

In summary, the provided document is a 510(k) summary for a blood glucose monitoring system, emphasizing its substantial equivalence to a predicate device and compliance with general FDA guidelines for such devices. It does not contain the detailed study results and AI-specific ground truth methodologies that would be found in a submission for an AI-powered diagnostic device.

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RIGHTEST Blood Glucose Monitoring System Max Tel is intended to the quantitative measurement of glucose (sugar) in fresh capillary whole drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.

RIGHTEST Blood Glucose Monitoring System Max Tel is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to montor the effectiveness of diabetes control. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The RIGHTEST Blood Glucose Monitoring System Max Tel is comprised of the RIGHTEST Meter Max Tel and the RIGHTEST Blood Glucose Test Strip Max.

RIGHTEST Blood glucose monitoring System Max Tel consists of the following devices: Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, Lancing Device and Sterile Lancets. The RIGHTEST Blood Glucose Test Strip Max is the same as Test Strip Max cleared in K173638.The Blood Glucose Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation.

RIGHTEST Blood Glucose Meter Max Tel, when used with the RIGHTEST Blood Glucose Test Strips Max, quantitatively measure glucose in fresh whole blood samples from capillary. The performance of RIGHTEST Blood Glucose Monitoring System Max Tel is verified by the RIGHTEST Control Solution GC700.

The glucose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with FAD-glucose dehydrogenase and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed.

The provided document pertains to the 510(k) premarket notification for the "RIGHTEST Blood Glucose Monitoring System Max Tel." It primarily focuses on demonstrating substantial equivalence to a predicate device through various non-clinical and clinical tests, particularly outlining the system's accuracy.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document presents system accuracy results, which serve as the primary performance metrics for the clinical study. The acceptance criteria are implicitly based on the FDA SMBG OTC guidance 2020 (mentioned in the interference section but generally applicable to system accuracy for OTC glucose meters), which typically specifies percentages of results within certain accuracy ranges compared to a reference method.

Table of Acceptance Criteria and Reported Device Performance:

Note: For glucose meters, the acceptance criteria often involve percentages of results within +/-15 mg/dL for glucose concentrations = 100 mg/dL. The document simplifies this to overall percentages within +/-15%, +/-10%, and +/-5% of a reference bias, and mentions 100% within +/-20%. This implies meeting the standard accuracy requirements for blood glucose meters.

Study Details: User Performance Study

1. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: 370 participants for the User Performance Study.
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, user performance studies for regulatory submissions are typically prospective clinical trials. Given the manufacturer (Bionime Corporation) is based in Taiwan and the regulatory consultant is in the US, it's possible the study was conducted in Taiwan or the US, or both.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• The document describes a "User Performance Study" where lay users measure glucose. The "System accuracy" section compares these results to a "reference bias" or "comparison method."
• No information is provided about experts establishing ground truth in the way one might for an AI-powered diagnostic image analysis system requiring expert annotation. For a blood glucose monitoring system, the "ground truth" or reference method is typically established by laboratory-grade glucose analyzers, often using a method like hexokinase or glucose oxidase with a highly accurate spectrophotometer. These are standardized laboratory procedures, not dependent on expert interpretation. The document mentions "reference bias," further suggesting a comparison to a precise laboratory method.

3. Adjudication Method for the Test Set:

• Not applicable in the context of a blood glucose monitoring system's accuracy study. Adjudication typically refers to resolving discrepancies among human readers or between human readers and an AI output in diagnostic imaging studies. Here, the comparison is between the device's reading and a precise laboratory reference method.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC study was not done. This type of study is relevant for diagnostic imaging systems where multiple human readers assess cases with and without AI assistance to determine the AI's impact on human performance. For a blood glucose meter, the evaluation is direct device performance against a reference standard, not an improvement in human reader performance.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• This concept isn't directly applicable in the same way it would be for an AI algorithm. The device itself (the meter and strips) is the "standalone" entity that produces a measurement. The "User Performance Study" assesses the "human-in-the-loop" aspect by having lay users operate the device and measure their own blood samples. The system accuracy results directly report the device's performance as used by humans.

6. The Type of Ground Truth Used:

• The ground truth (or reference method) for this blood glucose monitoring system study is implied to be highly accurate laboratory-based glucose measurements, against which the device's readings are compared. The term "reference bias" supports this. For blood glucose meters, this reference is typically a carefully calibrated laboratory instrument, not expert consensus or pathology, which are common for AI-based image analysis.

7. The Sample Size for the Training Set:

• Not applicable. This document describes the validation of a blood glucose monitoring system, not an AI or machine learning model that requires a "training set." The system's underlying technology is an electrochemical sensor, not a learned algorithm in the AI sense.

8. How the Ground Truth for the Training Set was established:

• Not applicable. As no training set for an AI model is mentioned, there's no ground truth establishment for a training set.

In summary, the document details a traditional validation approach for a medical device (blood glucose monitor) focusing on its accuracy and performance under various conditions, including lay user operation. It does not involve the complex AI-specific testing methodologies (such as MRMC, training sets, or expert adjudication for ground truth) that would be pertinent to AI/ML-driven diagnostic devices.

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The Rightest Blood Glucose Monitoring System GM700S consists of the Rightest Blood Glucose Monitoring Meter GM700S and the Rightest Blood Glucose Test Strips GS700. The Rightest Blood Glucose Monitoring System GM700S is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM700S is intended for self-testing outside the body (in-vitro diagnostic use), by individuals with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended to be used by a single person and should not be shared. The systems should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The Rightest Blood Glucose Monitoring System GM700SB consists of the Rightest Blood Glucose Monitoring Meter GM700SB and the Rightest Blood Glucose Test Strips GS700. The Rightest Blood Glucose Monitoring System GM700SB is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM700SB is intended for self-testing outside the body (in-vitro diagnostic use), by individuals with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended to be used by a single person and should not be shared. The systems should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

Rightest Blood Glucose Monitoring System GM700S and Rightest Blood Glucose Monitoring System GM700SB, consist of the following devices: Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, Lancing device and Sterile lancets. The Blood Glucose Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation. Rightest Meter GM700S and Rightest Meter GM700SB (with Bluetooth), when used with the Rightest Test Strips GM700S, quantitatively measure glucose in fresh whole blood samples from capillary. The performance of Rightest Blood Glucose Monitoring System GM700S and Rightest Blood Glucose Monitoring System GM700SB (with Bluetooth) are verified by the Rightest Control Solution GC700.

Here's a breakdown of the acceptance criteria and study information for the Rightest Blood Glucose Monitoring System GM700S and GM700SB, based on the provided document:

Acceptance Criteria and Device Performance

The document summarizes the performance tests conducted, but does not explicitly state "acceptance criteria" in a separate section. Based on the provided performance characteristics and the conclusion of "substantial equivalence," the implicit acceptance criteria would be that the device performs comparably to the predicate device and meets established standards for blood glucose monitoring systems.

Table of Acceptance Criteria (Implicit) and Reported Device Performance

Study Details

The document describes one clinical study: a User Performance Study.

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: A total of 354 patients participated.
   • Data Provenance: The document does not explicitly state the country of origin. It also does not specify if the study was retrospective or prospective, but "user performance study" typically implies a prospective collection of data from real users.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the user performance study. In blood glucose monitoring studies, ground truth is usually established by a laboratory reference method, not by expert consensus on the device's readings. The study's aim was to show that lay users could obtain accurate results, meaning the comparison would be against a known accurate measurement.

3. Adjudication Method for the Test Set:

   • The document does not describe an adjudication method. For performance studies of blood glucose meters, the standard is typically comparison to a laboratory reference method, not an adjudication process among experts looking at the device results.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. This device is a blood glucose monitoring system, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data with and without AI.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, performance evaluations for the device itself (what could be considered the "algorithm only" in a different context) were conducted. The document mentions "precision, linearity, interference, sample volume, hematocrit, and operated environment" evaluations, which are standalone tests of the device's technical performance characteristics. The user performance study then assessed the human-in-the-loop aspect.

6. The type of ground truth used:

   • For the user performance study, the ground truth would have been established by a laboratory reference method for blood glucose measurement (e.g., a YSI analyzer), to which the device's readings are compared. The document doesn't explicitly name the reference method, but this is the standard for such studies.

7. The sample size for the training set:

   • The document does not mention a training set sample size. Blood glucose meters do not typically involve "training sets" in the same way machine learning models do. Their calibration is usually established during manufacturing based on known glucose concentrations.

8. How the ground truth for the training set was established:

   • N/A, as there is no explicitly mentioned "training set" for an algorithm in the machine learning sense. The device's calibration and performance parameters are established through rigorous engineering and testing processes using samples with known glucose concentrations, typically traced to a reference method, during development and manufacturing.

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Rightest Blood Glucose Monitoring System Max is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.

Rightest Blood Glucose Monitoring System Max is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The Rightest Blood Glucose Monitoring System Max is comprised of the Rightest Blood Glucose Test Strip Max and the Rightest Meter Max.

Rightest Blood Glucose Monitoring System Max Plus with Bluetooth function is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.

Rightest Blood Glucose Monitoring System Max Plus with Bluetooth function is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The Rightest Blood Glucose Monitoring System Max Plus is comprised of the Rightest Blood Glucose Test Strip Max and the Rightest Meter Max Plus.

GE Blood Glucose Monitoring System Max is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.

GE Blood Glucose Monitoring System Max is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The GE Blood Glucose Monitoring System Max is comprised of the GE Blood Glucose Test Strip Max and the GE Meter Max.

GE Blood Glucose Monitoring System Max Plus with Bluetooth function is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.

GE Blood Glucose Monitoring System Max Plus with Bluetooth function is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The GE Blood Glucose Monitoring System Max Plus is comprised of the GE Blood Glucose Test Strip Max and the GE Meter Max Plus.

For Over-the-Counter Setting:

Rightest Blood Glucose Monitoring System Max and Rightest Blood Glucose Monitoring System Max Plus, consist of the following devices:

Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, lancing device and sterile lancets. The Blood Glucose Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation.

Rightest Meter Max and Rightest Meter Max Plus, when used with the Rightest Test Strips Max, quantitatively measure glucose in fresh whole blood samples from capillary. The performance of Rightest Blood Glucose Monitoring System Max and Rightest Blood Glucose Monitoring System Max Plus are verified by the Rightest Control Solution GC700.

GE Blood Glucose Monitoring System Max and GE Blood Glucose Monitoring System Max Plus, consist of the following devices:

Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, lancing device and sterile lancets. The Blood Glucose Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation.

GE Meter Max and GE Meter Max Plus, when used with the GE Test Strips Max, quantitatively measure glucose in fresh whole blood samples from capillary. The performance of GE Blood glucose monitoring System Max and GE Blood glucose monitoring System Max Plus are verified by the Rightest Control Solution GC700.

The provided text pertains to a 510(k) premarket notification for a blood glucose monitoring system, not an AI model. Therefore, direct answers to questions regarding acceptance criteria for an AI device, sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone AI performance, or ground truth establishment for AI are not applicable.

However, I can extract information related to the performance of the blood glucose monitoring system and present it in a format that mirrors the requested table, as well as address the aspects of the study that were performed.

Here's a breakdown of the information available and how it relates to your questions:

Device: Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus. These are glucose test systems (NBW, Class II, 21 CFR 862.1345).

Study Type: This is a premarket notification (510(k)) seeking substantial equivalence to a predicate device (Rightest Blood Glucose Monitoring System GM720, K140210). The studies described are for the performance of a blood glucose meter, not an AI algorithm.

Information applicable to the prompt (adapted for a glucose meter):

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabulated format for distinct performance metrics but rather presents various technical specifications and study results to demonstrate substantial equivalence. The provided information focuses on the technical specifications and a lay user performance study.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: A "User performance study with 357 participants" was performed.
• Data Provenance: The document does not specify the country of origin. It indicates the manufacturer is Bionime Corporation in Taichung City, Taiwan, and the consultant is in San Juan Capistrano, CA, USA. The study type is for a medical device performance validation, which typically involves prospective data collection. It is implied to be prospective as it's a performance study with participants.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the document describes a study for a blood glucose meter, not an AI interpretation model. The "ground truth" for a blood glucose meter is typically established by comparing its readings to a laboratory reference method (e.g., a central lab analyzer's measurement of glucose in the same blood sample), not by expert consensus on image interpretation.

4. Adjudication Method for the Test Set

This section is not applicable for a blood glucose meter performance study. Adjudication methods are relevant for subjective interpretations, often in imaging or clinical diagnoses.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This section is not applicable. An MRMC study is relevant for evaluating the impact of AI systems on human reader performance, typically in diagnostic imaging. This document describes the performance of a blood glucose meter itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This section is not applicable as the device is a blood glucose meter. Its performance is inherent to the device's measurement capabilities. The "Lay User Performance Study" evaluates the device's accuracy when used by its intended users (individuals with diabetes at home), which includes a human "user-in-the-loop" aspect, but this is about device usability and accuracy, not AI algorithm standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for blood glucose measurements in such studies is typically comparison to a laboratory reference method. The document states that the "study result shows substantial equivalence to comparison method," implying that the device's readings were compared against a highly accurate laboratory standard.

8. The Sample Size for the Training Set

This section is not applicable. Blood glucose meters are not "trained" in the way AI models are. Their performance is based on their electrochemical design and calibration.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable as blood glucose meters do not have a "training set" or "ground truth" established for it in the context of machine learning. Their calibration and performance are validated through rigorous lab testing against reference standards.

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Rightest Blood Glucose Monitoring System Wiz is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.

Rightest Blood Glucose Monitoring System Wiz is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

Rightest Blood Glucose Test Strip Wiz is used with Rightest Blood Glucose Meter Wiz for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm.

Rightest Blood Glucose Monitoring System Wiz Plus is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.

Rightest Blood Glucose Monitoring System Wiz Plus is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

Rightest Blood Glucose Test Strip Wiz is used with Rightest Blood Glucose Meter Wiz Plus for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm.

Rightest Blood Glucose Monitoring System Wiz and Wiz Plus are identical with the exception of Bluetooth function for Rightest Blood Glucose Monitoring System Wiz Plus, which allows for wireless information transfer.

Rightest Blood Glucose Monitoring System Wiz and Wiz Plus consists of the following devices: Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, Lancing Device, and Sterile Lancets. The Blood Glucose Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation.

The provided text describes the 510(k) premarket notification for the Rightest Blood Glucose Monitoring System Wiz and Wiz Plus. It includes details about the device, its intended use, comparison to a predicate device, and summaries of non-clinical and clinical tests performed.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance (Implicit)

The document heavily relies on demonstrating "substantial equivalence" to a predicate device (Rightest GM280 Blood Glucose Monitoring System, K170143). While explicit numerical acceptance criteria for accuracy are not provided in the summary sections, the discussion of non-clinical and clinical tests implies that the device performance must be comparable to or within acceptable limits relative to the predicate device and established standards for glucose monitoring systems. Key performance aspects tested, which would imply related acceptance criteria, include:

Study Details

Based solely on the provided text, the information is limited, especially regarding detailed methodologies and numerical study outcomes beyond general statements of equivalence.

1. A table of acceptance criteria and the reported device performance: See the table above. Explicit numerical acceptance criteria are not provided in this summary. The performance is summarized as demonstrating "substantial equivalence" to the predicate.

2. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated for any of the non-clinical or clinical tests. For the User Performance Study, it mentions "capillary whole blood from fingertip, palm and forearm sample sites" but does not give a number of participants or samples.
   • Data Provenance: Not explicitly stated. Given the submitter's address (Taiwan), the studies were likely conducted in Taiwan, but this is not confirmed. It is a premarket notification, thus the data would be prospective for the purpose of this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned in the provided text. The ground truth method for the "User Performance Study" is implied to be a comparison against the predicate device, but the details of the "true" glucose reference method (e.g., lab analyzer) are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned in the provided text.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is for a Blood Glucose Monitoring System, which is an in-vitro diagnostic device, not an imaging AI device that involves human reader interpretation. No human reader involvement or AI assistance is described for this type of device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • For the non-clinical tests (precision, linearity, interference, sample volume, hematocrit), these would inherently be standalone performance evaluations of the device's measurement capabilities.
   • The "User Performance Study" evaluates the accuracy when used by lay users, which is a human-in-the-loop performance, but the 'algorithm' (the device's internal measurement system) itself is performing the measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For the non-clinical tests (precision, linearity, interference, sample volume, hematocrit), the ground truth would typically be established using a traceable, highly accurate laboratory reference method (e.g., a YSI analyzer for glucose). This is not explicitly stated but is standard for such evaluations.
   • For the User Performance Study, the ground truth is implied to be a reference method (likely a lab analyzer) against which both the new device and the predicate device's readings are compared for equivalence.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a "training set" in the traditional sense of machine learning. It's a glucose monitoring system whose performance is established through empirical testing rather than a learned model.

9. How the ground truth for the training set was established: Not applicable, as there is no "training set" for this type of device.

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The Rightest Blood Glucose Monitoring System GM280B is intended to the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM280B is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM280B intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Rightest Blood Glucose Test Strip GS280 is used with Rightest meter GM280B for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The GE Blood Glucose Monitoring System 182 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE Blood Glucose Monitoring System 182 is intended to be used by a single person and should not be shared.

The GE Blood Glucose Monitoring System 182 intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE Blood Glucose Monitoring System 182 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The GE Blood Glucose Strip 180 is used with GE Blood Glucose Monitoring Meter 182 for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The Rightest Blood Glucose Monitoring System GM280 is intended to the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM280 is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM280 intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Rightest Blood Glucose Test Strip GS280 is used with Rightest meter GM280 for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The GE Blood Glucose Monitoring System 180 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE Blood Glucose Monitoring System 180 is intended to be used by a single person and should not be shared.

The GE Blood Glucose Monitoring System 180 intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE Blood Glucose Monitoring System 180 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The GE Blood Glucose Strip 180 is used with GE Blood Glucose Monitoring Meter 180 for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The Rightest and GE Blood Glucose Monitoring System series consists of the following devices: Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, lancing device and sterile lancets. The Blood Glucose Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation.

The Rightest Blood Glucose Meter GM280 and Rightest Blood Glucose Meter GM280B, when used with the Rightest Blood Glucose Test Strips GS280, quantitatively measure glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM280 and Rightest Blood Glucose Monitoring System GM280B are verified by the Rightest Control Solution GC550.

The GE Blood Glucose Meter 180 and GE Blood Glucose Meter 182, when used with the GE Blood Glucose Test Strips 180, quantitatively measure glucose in fresh capillary whole blood. The performance of the GE Blood Glucose Monitoring System 180 and GE Blood Glucose Monitoring System 182 are verified by the Rightest Control Solution GC550.

The provided text describes the acceptance criteria and the study conducted for the GE Blood Glucose Monitoring System series.

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The main criterion for a glucose monitoring system's accuracy is typically measured against a laboratory reference method. For this device, the acceptance criteria relates to the accuracy of the blood glucose measurements compared to the YSI 2300 Plus Glucose Analyzer.

Acceptance Criteria and Reported Device Performance (System Accuracy Study)

Note: The exact numerical acceptance criteria for system accuracy (e.g., percentage of readings within a certain deviation from the reference) are not explicitly stated in the provided documents but are implied to have been met. For such devices, commonly, the ISO 15197 standard for blood glucose monitoring systems is referenced, which specifies accuracy requirements (e.g., 95% of results must be within ±15 mg/dL for glucose concentrations

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The GE200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The GE200 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE200 Blood Glucose Monitoring System should not be used for the diagnosis of , or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). The GE200 Blood Glucose Test Strips are for use with the GE200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The GE300 Talking Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE300 Talking Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The GE300 Talking Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by diabetic individuals at home as an aid to monitor the effectiveness of diabetes control. Only limited audible information is available, not intended as an aid for the visually impaired. The GE300 Talking Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The GE300 Talking Blood Glucose Test Strips are for use with the GE300 Talking Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE300 Series Control Solution are for use with the GE300 Talking Blood Glucose Meter and the GE300 Talking Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

The Rightest Blood Glucose Monitoring System GM650 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Monitoring System GM650 is intended to be used by a single person and should not be shared. The Rightest Blood Glucose Monitoring System GM650 is intended for self testing outside the body (in vitro diagnostic use) by diabetic individuals at home as an aid to monitor the effectiveness of diabetes control. Only limited and ble, is available, not intended as an aid for the visually impaired. The Rightest Blood Glucose Monitoring System GM650 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The Rightest Blood Glucose Test Strips GS650 are for use with the Rightest Blood Glucose Meter GM650 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Control Solutions GC650 are for use with the Rightest Blood Glucose Meter GM650 and the Rightest Blood Glucose Test Strip GS650 to check that the meter and test strips are working together properly and that the test is performing correctly.

The Rightest Blood Glucose Monitoring System GM700 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Monitoring System GM700 is intended to be used by a single person and should not be shared. The Rightest Blood Glucose Monitoring System GM700 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System GM700 should not be used for the diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The Rightest Blood Glucose Test Strips GS700 are for use with the Rightest Blood Glucose Meter GM700 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The GE200 Blood Glucose Monitoring System consists of the GE200 Blood Glucose Meter, GE200 Blood Glucose Test Strip, and GE200 Control Solution. The GE200 Blood Glucose Meter, when used with the GE200 Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance is verified by the GE200 Control Solution.

The GE300 Talking Blood Glucose Monitoring System consists of the GE300 Talking Blood Glucose Meter, GE300 Talking Blood Glucose Test Strip, and GE300 Series Control Solution. The GE300 Talking Blood Glucose Meter, when used with the GE300 Talking Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance is verified by the GE300 Series Control Solution.

The Rightest Blood Glucose Monitoring System GM650 consists of the Rightest Blood Glucose Meter GM650, Rightest Blood Glucose Test Strip GS650, and Rightest Control Solution GC650. The Rightest Blood Glucose Meter GM650, when used with the Rightest Blood Glucose Test Strips GS650, quantitatively measures glucose in fresh capillary whole blood. The performance is verified by the Rightest Control Solution GC650.

The Rightest Blood Glucose Monitoring System GM700 consists of the Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strip GS700, and Rightest Control Solution GC700. The Rightest Blood Glucose Meter GM700, when used with the Rightest Blood Glucose Test Strips GS700, quantitatively measures glucose in fresh capillary whole blood. The performance is verified by the Rightest Control Solution GC700.

The provided document describes the non-clinical and clinical studies performed for the BIONIME Righhtest Blood Glucose Monitoring System (GM700, GM650) and GE Blood Glucose Monitoring System (GE200, GE300) to demonstrate their substantial equivalence. The primary change for these systems is a revised hematocrit (HCT) range for the test strips (GS700/GS650/GS750 for Rightest brand and identical strips for GE200/GE300).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to adherence to ISO 15197:2003 for precision and references other CLSI guidelines for interference studies, but it doesn't explicitly state specific numerical acceptance criteria for each test (e.g., specific bias percentages for linearity or accuracy). However, it consistently states that "the results fall within the acceptance criteria" or "meet the acceptance criteria."

However, for accuracy, the general standard for blood glucose meters within ISO 15197:2003 (which was referenced) is typically:

• **For glucose concentrations ±10% bias at certain concentrations (noted as limitations). |
  | Altitude Effect | Stability of bias compared to reference during various operated altitudes within criteria. | Stability of bias compared to REF during various operated altitude were all within the criteria. |
  | Operating Temperature/Humidity | Stability of bias compared to reference during various operated temperature and humidity within criteria. | Stability of bias compared to REF during various operated temperature and humidity were all within the criteria. |
  | Hematocrit Range | Stability compared to reference during various HCT ranges within criteria. | Stability compared to REF during various HCT ranges were all within the criteria. Acceptable HCT range is 20-65%. |
  | Lay User Performance | Lay users could obtain accurate results (implies meeting accuracy standards). | Showed substantial equivalence to predicate device in finger, palm, and forearm positions. |

2. Sample sizes used for the test set and the data provenance:

• Linearity Study Data Provenance: Not explicitly stated, but given it evaluates venous blood samples, it's likely a controlled lab study, probably prospective.
• Precision Study Sample Size:
  • Within-day: 500 test strips (across 3 lots)
  • Between-day: 300 test strips (across 3 lots)
  • Data Provenance: Not explicitly stated, implied controlled lab study, probably prospective.
• Specimen Volume Study Data Provenance: Not explicitly stated, likely a controlled lab study, probably prospective.
• Interference Study Data Provenance: Not explicitly stated, likely a controlled lab study, probably prospective.
• Altitude Study Data Provenance: Not explicitly stated, likely a controlled lab study, probably prospective.
• Operating Temperature and Humidity Study Data Provenance: Not explicitly stated, likely a controlled lab study, probably prospective.
• Hematocrit Study Data Provenance: Not explicitly stated, likely a controlled lab study, probably prospective.
• System Accuracy Study (Whole Blood) Sample Size: A total of 120 patients participated.
  • Data Provenance: Not explicitly stated (e.g., country of origin), but it's a clinical study on patients, which would typically be prospective for this type of accuracy assessment.
• Lay User Study Sample Size: A total of 100 laypersons.
  • Data Provenance: Not explicitly stated (e.g., country of origin), but it's a clinical study on lay users, which would typically be prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• For all the non-clinical studies (Linearity, Precision, Specimen Volume, Interference, Altitude, Operating Temperature/Humidity, Hematocrit), the ground truth was established by a reference method, specifically the YSI 2300 Analyzer. This is an automated laboratory instrument, not human experts.
• For the clinical System Accuracy Study, the comparison was made against "plasma glucose values on reference lab instrument," which is the YSI 2300 Analyzer. No human experts are explicitly mentioned as establishing this ground truth for the test.
• For the Lay User Study, the evaluation method is comparing the lay users' results to a "predicate device." The ground truth for direct accuracy is again, by implication from other studies, the YSI 2300 Analyzer. No explicit mention of human experts establishing ground truth for the test sets in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• No adjudication method by human experts is described in the document for any of the test sets. The ground truth for all quantitative measurements relies on comparison to a reference laboratory instrument (YSI 2300 Analyzer).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• This is not applicable as the device is a blood glucose monitoring system, not an AI diagnostic tool that human readers would interpret. There are no "human readers" in the context of interpreting results from this device; patients or healthcare professionals read the numerical glucose value displayed by the meter.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, the performance of the device (meter and test strip) is inherently standalone as it provides a direct numerical result. The non-clinical studies (Linearity, Precision, Interference, etc.) and the System Accuracy study report on the algorithm's (device's) performance compared to a reference standard without human interpretation as an intermediate step. The "Lay User Study" evaluates the user's ability to operate the device and obtain accurate results, not their interpretation of an algorithm's output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• The ground truth used for all quantitative performance analyses (linearity, precision, interference, system accuracy, etc.) was a reference laboratory instrument, specifically the YSI 2300 Analyzer, which provides plasma glucose values. This is an objective, instrumental reference method.

8. The sample size for the training set:

• This document is a 510(k) summary for a medical device (blood glucose monitoring system), not an AI/machine learning model. Therefore, the concept of a "training set" in the context of AI is not applicable. The device's operational parameters and calibration are established through engineering and analytical studies, not typically by training a model on a large dataset in the way AI systems are trained.

9. How the ground truth for the training set was established:

• As mentioned above, the concept of a "training set" for an AI model is not applicable to this device. For the calibration and internal algorithms of the blood glucose meter, the ground truth would be established through a rigorous process involving samples with known glucose concentrations, validated by a reference method like the YSI 2300 Analyzer during the device's development and manufacturing.

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The Rightest Professional Blood Glucose Monitoring System GM720 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm and in venous and arterial whole blood. The Rightest Professional Blood Glucose Monitoring System GM720 is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The Rightest Professional Blood Glucose Monitoring System GM720 should not be used for the diagnosis of, or screening for testing neonate blood samples. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Rightest Professional Blood Glucose Test Strips GS720 are for use with the Rightest Professional Blood Glucose Meter GM720 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm and in venous and arterial whole blood samples.

The Rightest Blood Glucose Monitoring System GM720 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM720 is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM720 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System GM720 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Rightest Blood Glucose Test Strips GS720 are for use with the Rightest Blood Glucose Meter GM720 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The Rightest Blood Glucose Monitoring System GM720 consists of the following devices: Rightest Blood Glucose Meter GM720, Rightest Blood Glucose Test Strip GS720, Rightest Control Solution GC700, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM720, Rightest Blood Glucose Test Strips GS720, and Lancing Device are manufactured by BIONIME Corporation.

The Rightest Professional Blood Glucose Monitoring System GM720 consists of the following devices: Rightest Professional Blood Glucose Meter GM720, Rightest Professional Blood Glucose Test Strip GS720, and Rightest Control Solution GC700. This system should only be used with auto-disabling, single-use lancing devices and sterile lancets. The Rightest Professional Blood Glucose Meter GM720 and Rightest Professional Blood Glucose Test Strips GS720 are manufactured by BIONIME Corporation.

Biomine's Rightest™ GM720 system is an electronic device that utilizes the electrical characteristic technology for measuring the glucose level in human blood. A relatively small drop of blood is placed on a disposable test strip coated with FAD-glucose Dehydrogenase (FAD-GDH). Within five seconds, the level of blood glucose will be shown on the digital display screen.

Rightest™ Blood Glucose Monitoring System GM720, with an auto-coding feature, requires only minimum of 0.75 microliter of blood for the testing, therefore it reduces the time and effort required for testing and improves the compliance of diabetic people to their testing regimens.

Device Name: Bionime Rightest™ Blood Glucose Monitoring System GM720, Bionime Rightest™ Professional Blood Glucose Monitoring System GM720

This response describes the acceptance criteria and the study that proves the device meets those criteria, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state the numerical acceptance criteria for the system accuracy study in a clear, tabulated format. However, it states that "The accuracy study... demonstrates that the accuracy of Rightest Blood Glucose Monitoring System GM720 met the acceptance criteria." This implies that predefined criteria were used and successfully met.

Based on the general context of blood glucose monitoring systems, acceptance criteria typically align with standards like ISO 15197 for accuracy. Common criteria are usually expressed as a percentage of measurements falling within a certain deviation from a reference method, particularly at different glucose concentration ranges. Without the specific numerical thresholds, it's impossible to create a precise table.

However, the reported performance is implicitly that the device did meet these unstated acceptance criteria.

Note: The document only states that the device "met the acceptance criteria" without providing the specific numerical targets for accuracy (e.g., % within ±15 mg/dL or ±15%). For a comprehensive answer, these numerical criteria would be needed.

2. Sample Sizes Used for the Test Set and Data Provenance

• System Accuracy Study (Test Set):

  • Sample Size: 121 patients were recruited.
  • Data Provenance: Not specified in the provided text (e.g., country of origin). The study involved "whole blood (plasma equivalent) glucose values" and "plasma glucose values on a lab instrument," suggesting a clinical setting.
  • Retrospective/Prospective: Not explicitly stated, though the recruitment of "patients" for a study generally implies a prospective collection of data for the purpose of the study.

• User Performance Study (Test Set):

  • Sample Size: 165 laypersons.
  • Data Provenance: Not specified (e.g., country of origin).
  • Retrospective/Prospective: Not explicitly stated, but recruiting "laypersons" to demonstrate they "could obtain accurate results using the subject device" strongly suggests a prospective study design.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document mentions "plasma glucose values on a lab instrument" as the comparator for the System Accuracy Study.

• Number of Experts: Not explicitly stated. The ground truth would typically be established by laboratory technicians or medical professionals operating the reference laboratory instrument.
• Qualifications of Experts: Not explicitly stated. However, personnel operating a "lab instrument" for plasma glucose measurements are expected to be trained and qualified in clinical laboratory procedures.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for either the System Accuracy Study or the User Performance Study. The System Accuracy Study directly compared the device's readings to a lab instrument's plasma glucose values, implying a direct comparison rather than an adjudication process involving multiple interpretations of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study, comparing human readers with AI assistance versus without AI assistance, was not conducted or reported in the provided text. This device is a blood glucose monitoring system, which directly measures glucose levels and does not involve human interpretation or AI assistance in the reading of results in the way a medical imaging AI would.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was done. The "System Accuracy Study" evaluated the "Rightest Blood Glucose Monitoring System GM720" by comparing its glucose values directly with a reference lab instrument. This represents the standalone performance of the device itself, without human intervention in the result generation or interpretation beyond the standard operation of the device.

7. Type of Ground Truth Used

• For System Accuracy Study: The ground truth was established using plasma glucose values on a lab instrument. This is a highly accurate and standardized method typically used as a reference in clinical laboratories for glucose measurement.
• For User Performance Study: The ground truth was implicitly the same (laboratory reference method), as the study aimed to demonstrate that lay users could obtain "accurate results" comparable to the performance already established by the system accuracy study.

8. Sample Size for the Training Set

The provided document does not mention a training set. This is typical for a medical device like a blood glucose meter, which relies on electrochemical measurement principles rather than machine learning algorithms that require extensive training data. The device's performance is based on its hardware and firmware design, not a learning algorithm developed using a "training set."

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned or applicable for this type of device, this question is not relevant.

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The Rightest Blood Glucose Monitoring System GM700 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM700 is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM700 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System GM700 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Rightest Blood Glucose Test Strips GS700 are for use with the Rightest Blood Glucose Meter GM700 to quantitatively measure alucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm,

The GE200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The GE200 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE200 Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The GE200 Blood Glucose Test Strips are for use with the GE200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The Rightest Blood Glucose Monitoring System GM650 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM650 is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM650 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System GM650 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Rightest Blood Glucose Test Strips GS650 are for use with the Rightest Blood Glucose Meter GM650 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The GE300 Talking Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE300 Talking Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The GE300 Talking Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE300 Talking Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The GE300 Talking Blood Glucose Test Strips are for use with the GE300 Talking Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

Our Rightest Blood Glucose Monitoring System GM700 consists of the following devices: Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strip GS700, Rightest Control Solution GC700, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strips GS700, and Lancing Device are manufactured by BIONIME Corporation. The Rightest Blood Glucose Meter GM700, when used with the Rightest Blood Glucose Test Strips GS700, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM700 is verified by the Rightest Control Solution GC700.

Our GE200 Blood Glucose Monitoring System consists of the following devices: GE200 Blood Glucose Meter, GE200 Blood Glucose Test Strip, GE200 Control Solution, lancing device and sterile lancets. The GE200 Blood Glucose Meter, GE200 Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation. The GE200 Blood Glucose Meter, when used with the GE200 Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the GE200 Blood Glucose Monitoring System is verified by the GE200 Control Solution.

Our Rightest Blood Glucose Monitoring System GM650 consists of the following devices: Rightest Blood Glucose Meter GM650, Rightest Blood Glucose Test Strip GS650, Rightest Control Solution GC650, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM650. Rightest Blood Glucose Test Strips GS650, and Lancing Device are manufactured by BIONIME Corporation. The Rightest Blood Glucose Meter GM650, when used with the Rightest Blood Glucose Test Strips GS650, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM650 is verified by the Rightest Control Solution GC650.

Our GE300 Talking Blood Glucose Monitoring System consists of the following devices: GE300 Talking Blood Glucose Meter, GE300 Talking Blood Glucose Test Strip, GE300 Series Control Solution, lancing device and sterile lancets. The GE300 Talking Blood Glucose Meter. GE300 Talking Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation. The GE300 Talking Blood Glucose Meter, when used with the GE300 Talking Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the GE300 Talking Blood Glucose Monitoring System is verified by the GE300 Series Control Solution.

Here's a breakdown of the acceptance criteria and study information for the BIONIME Blood Glucose Monitoring Systems, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a numerical or percentage format for accuracy or other performance metrics. Instead, it relies on demonstrating "substantial equivalence" to predicate devices through various tests.

The comparison tables (Exhibit #1, pages 4-5) primarily focus on the specifications of the new devices (GM700, GE200, GM650, GE300) against their respective predicate devices (K110737, K120423). These specifications represent the design parameters and functional characteristics rather than direct acceptance criteria for clinical accuracy.

However, the "Discussion of Non-Clinical Tests Performed" (Exhibit #1, page 6) mentions that the evaluation included:

• Precision
• Linearity
• Interference
• Sample volume
• Hematocrit

The acceptance criteria for these tests are implied to be met if the results demonstrate substantial equivalence to the predicate devices and support the intended use. Without direct numerical targets for these (e.g., specific CV% for precision, correlation coefficient for linearity), a detailed "reported device performance" against stated acceptance criteria cannot be fully populated from this document.

Implied Acceptance Criteria and Performance (Based on Substantial Equivalence):

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the verification and validation tests (precision, linearity, interference, sample volume, hematocrit).

The data provenance (e.g., country of origin, retrospective/prospective) is also not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For blood glucose monitoring systems, ground truth is typically established using a laboratory reference method, not expert consensus in the same way as image analysis.

4. Adjudication Method for the Test Set

This information is not provided. As noted above, ground truth for blood glucose measurements often relies on comparative analysis with a reference method, rather than expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned and is generally not applicable to the evaluation of point-of-care blood glucose monitoring systems, which are objective measurement devices rather than diagnostic interpretation tools for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This refers to the performance of the device itself (the meter and test strip) without human interpretative intervention, which is precisely what the non-clinical tests (precision, linearity, interference, etc.) are designed to evaluate. So, yes, standalone performance was assessed through these verification and validation tests. The results of the meter measuring glucose in blood samples are inherently "standalone."

7. The Type of Ground Truth Used

For a blood glucose monitoring system, the ground truth is typically established by laboratory reference methods. While not explicitly stated, the comparison would have been against a highly accurate laboratory glucose analyzer. The document implies this by stating that the devices "quantitatively measures glucose in fresh capillary whole blood" and that performance was evaluated for "precision, linearity, interference, sample volume and hematocrit," which are all usually assessed against a known standard or reference method.

8. The Sample Size for the Training Set

This document describes a 510(k) submission for conventional medical devices (blood glucose meters) which are based on electrochemical sensing technology, not machine learning or AI models that require "training sets." Therefore, the concept of a "training set" in the context of AI/ML is not applicable here.

9. How the Ground Truth for the Training Set was Established

As explained above, the concept of a "training set" is not applicable to this type of device.

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The Rightest Blood Glucose Monitoring System, Model GM650 is intended for in vitro diagnostic use (outside of body). It is indicated to be used by a single user at home to measure the glucose concentration as an aid to monitor the effectiveness of diabetes control. The glucose concentration is measured with quantitative capillary whole blood (from the fingertip, palm, and forearm), by using Rightest Blood Glucose Monitoring System, GM650.

This device is not intended for testing neonate blood samples and is not intended for the diagnosis of or screening for diabetes mellitus. And this device should not be used for testing multiple patients. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

Rightest Blood Glucose Test Strips GS650 are intended for use with the Rightest Blood Glucose meter GM650 in the quantitative measurement of glucose in capillary whole blood from the fingertip, palm and forearm.

Rightest Control Solutions GC650 are intended for use with the Rightest Blood Glucose Monitoring System. Model GM650 to check that both the glucose meters and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.

The Rightest Blood Glucose Monitoring System GM650 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole samples drawn from the fingertips, palm and forearm. The Rightest Blood Glucose Monitoring System GM650 is intended for single patient use only.

The Rightest Blood Glucose Monitoring System GM650 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System GM650 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Rightest Blood Glucose Test Strip GS650 is for use with the Rightest Blood Glucose meter GM650 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm or forearm.

The Rightest Control Solution Set GC650 is for use with the Rightest Blood Glucose meter GM650 and Rightest Blood Glucose Test Strips GS650 to check that the meters and test strip are working together properly and that the test is performing correctly.

The GE talking blood glucose monitoring system Model GE300 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole samples drawn from the fingertips, palm and forearm. The GE talking blood glucose monitoring system Model GE300 is intended for single patient use only.

The GE talking blood glucose monitoring system Model GE300 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE talking blood glucose monitoring system Model GE300 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The GE300 Blood Glucose Test Strip is for use with the GE talking blood glucose monitoring system Model GE300 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm or forearm.

The GE300 Control Solution Set is for use with the GE talking blood glucose monitoring system Model GE300 and GE300 Blood Glucose Test Strips to check that the meters and test strip are working together properly and that the test is performing correctly.

Our Blood Glucose Monitoring System consists of a Meter, Blood Glucose Test Strips, Three Control Solutions, Lancing Device and Lancets.

The Rightest Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation. The Rightest Meter, when used with the Rightest Test Strips Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System is verified by the Control Solution.

Bionime's Rightest™ GM650 system is an electronic device that utilizes the electrical characteristic technology for measuring the glucose level in human blood. A relatively small drop of blood is placed on a disposable test strip coated with FAD-glucose Dehydrogenase (FAD-GDH) which interacts with the software driven digital talking meter. Within five seconds, the level of blood glucose will be shown on the digital display screen.

Rightest™ Blood Glucose Monitoring System, with an auto-coding feature, requires only minimum of I microliter of blood for the testing, therefore it reduces the time and effort required for testing and improves the compliance of diabetic people to their testing regimens.

Here's an analysis of the acceptance criteria and study details for the Bionime Rightest Blood Glucose Monitoring System, Model GM650, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary states that the Rightest Blood Glucose Monitoring System Model GM650 "met the acceptance criteria" for its accuracy study. However, it does not explicitly list the quantitative acceptance criteria for blood glucose monitoring systems (e.g., specific percentages within certain glucose ranges). Without those specific criteria, a table comparing them to reported performance cannot be fully constructed.

What is present:

Study Details:

1. Sample sizes used for the test set and data provenance:

   • System Accuracy Study: 118 patients. The provenance of the data (country of origin, retrospective/prospective) is not specified, but it's implied to be a prospective clinical study involving patient samples.
   • User Performance Study: 161 consumers. The provenance is not specified, but it's implied to be a prospective study involving lay users.

2. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

   • The ground truth for the System Accuracy Study was established by "plasma glucose values on a lab instrument." This implies a reference laboratory method and instrument, not human experts. The qualifications of the operators of the lab instrument are not specified.
   • For the User Performance Study, the ground truth would also be the "lab instrument" readings, as the study aims to show that lay users can obtain accurate results compared to a reference method, not necessarily compared to expert interpretation of the device's output.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • No adjudication method involving multiple experts is described for either the System Accuracy Study or the User Performance Study. The ground truth relies on a single laboratory reference instrument.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC comparative effectiveness study was done or is described in the summary. This type of study is not relevant for a blood glucose monitoring system, which provides a direct quantitative reading rather than images or data requiring interpretation by human readers, or AI-assisted interpretation.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • The "System Accuracy Study" can be considered a standalone performance evaluation of the device (meter + strip) which incorporates the algorithm to generate a glucose reading. It compares the device's output directly to a reference method, without human interpretation of the device's reading as part of the primary outcome. The "User Performance Study" assesses the "human-in-the-loop" aspect by having lay users operate the device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the System Accuracy Study, the ground truth was "plasma glucose values on a lab instrument." This is a laboratory-based reference method, considered highly accurate for glucose measurement.
   • For the User Performance Study, the ground truth would implicitly be the same "plasma glucose values on a lab instrument," serving as the benchmark against which lay user results are compared.

7. The sample size for the training set:

   • The document does not explicitly mention a "training set" or its sample size. This type of device (blood glucose meter with a fixed algorithm) typically undergoes development and internal validation, but a distinct "training set" as understood in machine learning is not usually detailed in such regulatory summaries for these types of devices. The "verification and validation of test results" mentioned generally refers to the internal development and testing processes prior to clinical studies.

8. How the ground truth for the training set was established:

   • Since no training set is explicitly mentioned or detailed, the method for establishing its ground truth is also not provided. The development process would have involved rigorous testing against calibrated reference standards and established laboratory methods.

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