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TeleRPM Gen2 Blood Glucose Monitoring System is comprised of the TeleRPM Gen2 Blood Glucose Meter and the TeleRPM Blood Glucose Test Strips. TeleRPM Gen2 Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

TeleRPM Gen2 Blood Glucose Monitoring System consists of TeleRPM Gen2 Blood Glucose Meter and the TeleRPM Blood Glucose Test Strips.

TeleRPM Control Solution, TeleRPM Lancing Device, TeleRPM Lancets are required for use but not included in meter box or test strips box and should be purchased separately. The TeleRPM Control Solution is for use with the above meter and test strip as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly. TeleRPM Lancing Device and TeleRPM Lancets are used for puncturing fingertip and then user can perform qlucose test with blood sample.

TeleRPM Gen2 Blood Glucose Monitoring System is designed to quantitatively measure the glucose concentration in fresh capillary whole blood from the fingertip. 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 glucose oxidase 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 value is reported in plasma equivalents and is displayed on meter screen.

The provided text primarily focuses on the substantial equivalence determination for the TeleRPM Gen2 Blood Glucose Monitoring System to a predicate device. While it mentions the general types of studies conducted (robustness, precision, linearity, user evaluation, interference, stability, flex studies, software, cybersecurity controls, and a clinical usability study), it does not provide detailed acceptance criteria or numerical performance data as requested for several of your points.

Based on the information available:

1. A table of acceptance criteria and the reported device performance:

The document broadly states that the device "met the FDA SMBG OTC Guidance and industry standards" and that "these devices performed as intended and met associated guidance documents and industry standards." Specific numerical acceptance criteria and reported device performance for each study (precision, linearity, interference, etc.) are not detailed in the provided summary. For the user evaluation (clinical study), it states "the clinical performance met the FDA SMBG OTC Guidance."

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

• User Evaluation (Clinical Study): The document mentions "All participants" were able to understand the labeling, use the system, and interpret results. However, the exact sample size for the clinical usability evaluation is not specified.
• Provenance: Not explicitly stated, but the company is located in Zhongshan, Guangdong, China. The testing location isn't specified, but it's reasonable to infer the studies were conducted by or on behalf of the manufacturer, likely in China or a region where they operate.

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

• This information is not provided in the summary. For a blood glucose monitoring system, the "ground truth" for glucose levels would typically be established by a laboratory reference method, not by experts adjudicating results.
• For the usability evaluation, the "ground truth" is about successful interaction with the device, which is assessed through user performance and observation, not expert consensus on a measurement.

4. Adjudication method for the test set:

• This information is not provided. For analytical performance, laboratory reference methods are used, not typically expert adjudication. For usability, the success of user interaction is observed and recorded.

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 to this device. A "Blood Glucose Monitoring System" measures blood glucose; it is not an AI-assisted diagnostic imaging device that involves "human readers." Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

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

• The device performs a direct measurement of blood glucose. Its core function is a "standalone" algorithmic interpretation of the electrochemical reaction to display a glucose reading. This is its fundamental operation. There isn't a separate "human-in-the-loop" component in the direct glucose measurement process that would necessitate a distinction here.

7. The type of ground truth used:

• For analytical performance (precision, linearity, interference), the ground truth for blood glucose concentration would be established using a laboratory reference method (e.g., YSI analyzer). This is standard for blood glucose meter validation.
• For the usability evaluation, the "ground truth" assesses whether users can successfully operate the device and interpret results, which is based on direct observation and participant feedback.

8. The sample size for the training set:

• This device is a physical blood glucose meter and test strips relying on electrochemical principles, not a machine learning or AI model that requires a "training set" in the computational sense. Therefore, the concept of a training set sample size is not applicable here.

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

• As above, the concept of a training set is not applicable.

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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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The Sejoy Blood Glucose Monitoring System is composed of the Sejoy Blood Glucose Meter and Sejoy Blood Glucose Test Strips. The Sejoy Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood collected from the fingertip. The Sejoy Blood Glucose Monitoring System 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 system should not be used for the diagnosis of, or screening for diabetes or for neonatal use.

The Sejoy Advance Link Blood Glucose Monitoring System is composed of the Sejoy Advance Link Blood Glucose Meter and Sejoy Blood Glucose Test Strips. The Sejoy Advance Link Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The Sejoy Advance Link Blood Glucose Monitoring System 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 system should not be used for the diagnosis of, or screening for diabetes or for neonatal use.

The Sejoy Advance Link Blood Glucose Monitoring System is composed of the Sejoy Advance Link Blood Glucose Meter and Sejoy Blood Glucose Test Strips, and the Sejoy Blood Glucose Monitoring System is composed of the Sejoy Blood Glucose Meter and Sejoy Blood Glucose Test Strips. The Sejoy Blood Glucose Control Solutions, and the Sejoy Lancing Device with Sejoy disposable safety lancets (K222034, manufactured independently by Beijing Ruicheng Medical Supplies Co. Ltd. and cleared under 510(k)) are for use with the system and could sold separately.

The Sejoy Advance Link Blood Glucose Meter and Sejoy Blood Glucose Meter differ only in Bluetooth functionality which is present only in the Sejoy Advance Link Blood Glucose Meter.

The system measures glucose using amperometric technology and features glucose dehydrogenase in the test strip, interacting with glucose in the blood to produce an electrical current. This current is directly proportional to the blood glucose concentration, converted into values by the system software. The result is displayed on the meter's LCD in plasma value equivalence (mg/dL) and is automatically stored.

The provided document describes the Sejoy Blood Glucose Monitoring System and Sejoy Advance Link Blood Glucose Monitoring System and their substantial equivalence to a predicate device. Information relevant to acceptance criteria and study proving performance is extracted below.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for blood glucose monitoring systems are primarily based on accuracy compared to a lab reference method. The document specifies accuracy levels at various percentage tolerances.

| Accuracy Tolerance | Acceptance Criterion (Implicit) | Reported Device Performance (Overall) | Reported Device Performance (Glucose 250 mg/dL) |
|---|---|---|---|---|
| Within ±5% | N/A (Often implies higher percentages) | 56.8% (200/352) | 54.0% (27/50) | 60.0% (30/50) |
| Within ±10% | N/A (Often implies higher percentages) | 90.3% (318/352) | 92.0% (46/50) | 96.0% (48/50) |
| Within ±15% | N/A (Often implies higher percentages) | 98.3% (346/352) | 100.0% (50/50) | 100.0% (50/50) |
| Within ±20% | N/A (Often implies higher percentages) | 100% (352/352) | 100.0% (50/50) | 100.0% (50/50) |

Note: The document states "Sejoy Blood Glucose Monitoring System and Sejoy Advance Link Blood Glucose Monitoring System were designed and tested in accordance with FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (September 2020)." This guidance typically sets specific accuracy criteria (e.g., within ±15% for a certain percentage of samples). While the exact numerical criteria from the FDA guidance are not explicitly stated in the provided text, the reported performance metrics clearly indicate the device's adherence to such guidelines, as implied by the phrase "sufficiently accurate."

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

• Overall Test Set Sample Size: 352 lay persons (for the user evaluation study).
• Extreme Glucose Concentrations Test Set Sample Size: 50 subjects for low blood glucose (250 mg/dL), totaling 100 subjects for this specific sub-study.
• Data Provenance: The document does not explicitly state the country of origin for the data, but it refers to "lay persons representative of the age, gender, education of the intended users in the US," suggesting the study subjects were recruited in the US. The study was a prospective user performance evaluation where subjects self-tested their capillary whole blood.

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

The ground truth was established using a laboratory reference method, the YSI 2300 STAT PLUS glucose analyzer, which is a highly accurate and standardized instrument. There is no mention of experts being used to establish the ground truth for the test set, as the YSI analyzer itself serves as the gold standard.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by a laboratory reference instrument (YSI 2300), not by human readers requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging or interpretation tool. The study involved users operating the device, not interpreting images with or without AI assistance.

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

Yes, analytical performance testing was conducted which can be considered analogous to "standalone" performance for such a device. This included:

• Repeatability
• Intermediate precision
• Hematocrit effect
• Short sample volume
• Perturbation
• Interference
• Linearity testing

These tests evaluate the intrinsic performance of the device's measurement algorithm and hardware components, independent of human operation variability.

7. The Type of Ground Truth Used

The ground truth was established using a laboratory reference method: the Yellow Springs Instrument (YSI 2300 STAT PLUS glucose analyzer). The document specifies "capillary plasma" for the YSI 2300 reference, indicating a highly accurate and controlled measurement.

8. The Sample Size for the Training Set

The document describes performance evaluation studies (user evaluation and extreme glucose concentration studies) which are typically "test set" studies for device clearance. It does not provide information on the sample size used for the training set of the device's internal algorithms, as this detail is generally considered proprietary to the manufacturer and not typically included in a 510(k) summary unless the device heavily relies on a continuously learning AI model that requires explicit training data disclosure in the submission. For a blood glucose meter, the "training" (calibration and optimization) of its algorithms is usually done during the device's development phase rather than through a distinct "training set" in the context of machine learning.

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

Since information about a specific "training set" is not provided, the method for establishing its ground truth is also not detailed. However, for a device like a blood glucose meter, the internal algorithms and calibration are established using highly controlled laboratory experiments and reference methods (like YSI 2300) during the design and development phase to ensure accuracy across the measurement range and various physiological conditions.

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The CONTOUR® NEXT GEN Blood Glucose Monitoring System consists of the CONTOUR® NEXT GEN meter, CONTOUR® NEXT blood glucose test strips and the CONTOUR® Diabetes app.

The CONTOUR® NEXT GEN Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The CONTOUR® NEXT GEN Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® NEXT GEN 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 in monitoring the effectiveness of a diabetes control program.

The CONTOUR® NEXT GEN Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use.

The system is intended for in vitro diagnostic use only.

The CONTOUR® PLUS BLUE Blood Glucose Monitoring System consists of the CONTOUR® PLUS BLUE meter, the CONTOUR® PLUS blood qlucose test strips, and the CONTOUR® Diabetes app.

The CONTOUR® PLUS BLUE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® PLUS BLUE 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 in monitoring the effectiveness of a diabetes control program.

The CONTOUR® PLUS BLUE Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The CONTOUR® PLUS blood glucose test strips are for use with the CONTOUR® PLUS BLUE meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips.

The system is intended for in vitro diagnostic use only.

CONTOUR® NEXT GEN and CONTOUR® PLUS BLUE Blood Glucose Meters have Bluetooth Low Energy technology built in so that the meters can communicate wirelessly to smart phones and tablets. The CONTOUR® NEXT GEN meter uses the CONTOUR® NEXT blood glucose test strips and CONTOUR® NEXT control solution and CONTOUR® PLUS BLUE meter uses CONTOUR® PLUS blood glucose test strips and CONTOUR® PLUS control solution respectively. The meters can be connected to the CONTOUR® Diabetes app. Both the meters use two replaceable coin cell batteries. Both the meters' shape is a traditional oval form factor. The CONTOUR® NEXT GEN and CONTOUR® PLUS BLUE meters have smartLIGHT® and smartCOLOR® indicator features respectively to see if a glucose result is above, within, or below target range.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CONTOUR® PLUS BLUE and CONTOUR® NEXT GEN Blood Glucose Monitoring Systems.

It's important to note that the provided FDA 510(k) clearance letter and summary primarily focus on demonstrating substantial equivalence to a predicate device, specifically for a minor modification (change in Bluetooth Low Energy microprocessor). As such, the documentation does not contain exhaustive details about the initial validation studies that established the device's fundamental accuracy and performance. Instead, it leverages previous clearances and focuses on showing that the change doesn't negatively impact performance.

Therefore, for several points requested in the prompt, the information is not available in the provided text, as the submission is for a modification rather than an entirely new device's initial clearance.

Acceptance Criteria and Device Performance

The document states that "Bench testing showed that the CONTOUR® NEXT GEN Blood Glucose Monitoring System and CONTOUR® PLUS BLUE Blood Glucose Monitoring System performed as intended and met the relevant standards (ANSI IEEE C63.27-2021, IEEE UL Std 2621.2-2022, IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION), performance testing and software testing applicable to this change."

While specific numerical acceptance criteria (e.g., accuracy percentages) and detailed reported performance metrics are not explicitly listed in this 510(k) summary, the mention of "relevant standards" and "performance testing" implies that the device met the established performance requirements for blood glucose monitoring systems. For the purpose of this specific modification submission, the critical acceptance criterion was demonstrating that the measurement function was not impacted by the change.

Given the nature of the submission (a change in microprocessor), the primary 'acceptance criteria' in this context are:

Note: For a full, initial clearance of a blood glucose meter, specific accuracy criteria (e.g., ISO 15197) would be provided, often specifying percentages of readings within a certain deviation from a reference method (e.g., laboratory analyzer) for different glucose ranges. These details are not in the provided modification summary.

Study Details

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

   • Sample Size: Not specified for this particular submission's testing. The document states "Bench testing including reliability testing, software verification and validation, and confirmation of no impacts to BGM measurement was conducted." This type of testing typically involves a set number of meters and strips, and controlled blood samples, but the exact quantities are not detailed in this summary.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The testing described is "bench testing," implying laboratory-based evaluation. The document also states "The modified devices also relied on previously conducted analytical testing to support substantial equivalence." This suggests some data would be retrospective from prior clearances. The "clinical testing was leveraged from the previous clearances," meaning no new clinical trials were conducted for this specific modification.

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

   • Not Applicable / Not Specified. For a blood glucose meter, "ground truth" for accuracy is typically established by comparative measurements against a laboratory reference method (e.g., a YSI Glucose Analyzer) using blood samples with known glucose concentrations, not by expert consensus on visual review as might be the case for imaging devices. The document does not describe the specific ground truth establishment method for the bench testing beyond stating "confirmation of no impacts to BGM measurement." For the leveraged clinical testing (from previous submissions), the ground truth would have been established using a laboratory reference method, but the details are not provided here.

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

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation of data (e.g., radiology reads) to resolve discrepancies. This document describes bench testing for a physical/electrical device modification and leveraging prior clinical data, neither of which involves such adjudication processes.

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. This is a blood glucose monitoring system, not an AI-powered image analysis or diagnostic tool involving human readers. Therefore, an MRMC study is not relevant or performed for this device.

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

   • Partially Applicable. Blood glucose meters are essentially standalone algorithms (or systems) that provide a numerical output. The "bench testing" and "confirmation of no impacts to BGM measurement" assessed the device's performance directly, independent of a human "in the loop" for the measurement itself, beyond the act of sampling. The focus was on the performance of the meter and strips, and the impact of the new microprocessor on that performance.

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

   • Analytical Reference Method. For blood glucose meters, the ground truth for accuracy is established by a highly accurate laboratory reference method (e.g., YSI Glucose Analyzer) that measures glucose concentration in blood samples. This is a scientific, analytical measurement, not based on expert consensus or pathology. While not explicitly detailed for this submission's testing, it would have been the ground truth for the "previously conducted analytical testing" and "clinical testing leveraged from the previous clearances."

7. The sample size for the training set:

   • Not Applicable / Not Specified. This document describes a modification to an existing, cleared device, not the development of a new device or an AI/machine learning model that would have a traditional "training set." The performance assessments are validation efforts, not model training.

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

   • Not Applicable. See point 7.

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VivaChek™ Fad Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

VivaChek™ Fad Smart Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

VivaChek™ Fad Sync Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

VivaChek™ Fad Blood Glucose Monitoring System consists of VivaChek™ Fad Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips. The glucose meter and test strips are packaged separately.

VivaChek™ Fad Smart Blood Glucose Monitoring System consists of VivaChek™ Fad Smart Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips. The glucose meter and test strips are packaged separately.

VivaChek™ Fad Sync Blood Glucose Monitoring System consists of VivaChek™ Fad Sync Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips. The glucose meter and test strips are packaged separately.

VivaChek Fad Control Solution, VivaChek Lancing Device, VivaChek Lancets are required for use but not included in meter box or test strips box and should be purchased separately. The VivaChek Fad Control Solution is for use with the above meter and test strip as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly. VivaChek Lancing Device and VivaChek Lancets are used for puncturing fingertip and then user can perform qlucose test with blood sample.

VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System and VivaChek™ Fad Sync Blood Glucose Monitoring System are designed to quantitatively measure the glucose concentration in fresh capillary whole blood from the fingertip. The ducose 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 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.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions meeting "FDA SMBG OTC Guidance and industry standards" for clinical performance. A specific detailed table of acceptance criteria and reported performance is not explicitly provided in the excerpt. However, based on the context of Blood Glucose Monitoring Systems, the primary acceptance criteria would relate to the accuracy of glucose readings compared to a reference method. The document states that the clinical studies data showed that the clinical performance met the FDA SMBG OTC Guidance, implying the device successfully passed these criteria. Without the specific guidance document referenced, a detailed table cannot be created from this text alone.

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

The document does not explicitly state the numerical sample size used for the test set in the clinical studies. It mentions "non-professional, inexperienced lay persons" were used for user evaluations.

• Data Provenance: The studies were conducted by Vivachek Biotech (Hangzhou) Co., Ltd, located in Zhejiang, China. The document does not explicitly state if the data was retrospective or prospective, but clinical studies (user evaluations) generally imply prospective data collection in a controlled environment.

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, the ground truth is typically established using a laboratory reference method (e.g., YSI analyzer), rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given that the ground truth for blood glucose is typically a laboratory reference measurement, adjudication by experts wouldn't be directly applicable in the same way it would be for image-based diagnostics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable to a Blood Glucose Monitoring System. MRMC studies are relevant for AI in diagnostic imaging where human readers interpret cases. This device is a direct measurement system.

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

The device itself is a standalone system for glucose measurement. The "study" here refers to the overall performance of the device in the hands of the intended users. The clinical studies (user evaluations) assess the device's performance when used by individuals (humans in the loop). The "algorithm only" concept doesn't apply as it's a physical meter and test strip system.

7. The Type of Ground Truth Used

While not explicitly stated for all studies, for blood glucose monitoring systems, the ground truth for accuracy studies is typically established using a laboratory reference method (e.g., YSI Glucose Analyzer) on venous blood samples. The document implies this by stating that clinical performance met FDA SMBG OTC Guidance, which mandates comparison to such reference methods.

8. The Sample Size for the Training Set

This information is not provided. For a physical device like a blood glucose meter, there isn't a "training set" in the same sense as machine learning algorithms. The device's calibration and performance characteristics are established during its design and manufacturing process, and then validated through laboratory and clinical studies.

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

Not applicable as there is no traditional "training set" for an AI algorithm here. The performance is validated against established reference methods and clinical guidelines.

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The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm and/or forearm. Testing is done outside of the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, as an aid to monitor the effectiveness of diabetes control.

The WaveSense Jazz Blood Glucose Monitoring System includes a meter with batteries, compact carrying case, lancing device lancets, control solution and instructions for use. Test Strips are necessary for testing but are sold separately.

The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertips, palm or forearm. The WaveSense Jazz Test Strips are for in vitro diagnostic (outside of the body) use only. The WaveSense Jazz System is not intended for use with neonates.

The provided text describes a 510(k) premarket notification for the WaveSense Jazz Blood Glucose Monitoring System. The document focuses on establishing substantial equivalence to a predicate device (K072413), rather than presenting a de novo clinical study with detailed acceptance criteria and performance data as typically seen for novel devices, especially those incorporating AI.

Therefore, the information required to fully answer the request regarding acceptance criteria and a study proving device performance (especially for an AI/ML context) is largely absent from this specific 510(k) summary. The document primarily discusses the intended use, technological comparison to a predicate, and the modifications made (new colors, new data management feature), implying that much of the performance data would have been established for the original predicate device.

However, I can extract the relevant information that is present and indicate where information is not available from the provided text.

Here's an attempt to answer based on the provided document, acknowledging its limitations for an AI/ML-centric request:

Acceptance Criteria and Device Performance (based on the provided 510(k) Summary for a Glucose Monitoring System)

It's crucial to understand that this 510(k) pertains to a Blood Glucose Monitoring System, which is a hardware-based diagnostic device, not an AI/ML-powered software or imaging device. Therefore, many of the typical questions regarding AI/ML clinical studies (MRMC, expert consensus for ground truth, training set details, etc.) are not applicable to this type of submission.

The "study" referenced in the provided text is primarily focused on verification and validation (V&V) of the modifications made to an existing predicate device, rather than a large-scale clinical trial to establish novel performance.

1. Table of Acceptance Criteria and Reported Device Performance

For a Blood Glucose Monitoring System, acceptance criteria usually relate to accuracy standards (e.g., ISO 15197 for point-of-care testing), precision, and other analytical performance characteristics. The provided 510(k) summary does not explicitly list these numerical acceptance criteria or the specific performance results in a table. It instead states that "verification and validation results" were sufficient to establish substantial equivalence.

However, based on typical FDA requirements for Blood Glucose Monitoring Systems, the implicit acceptance criteria would relate to:

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The CONTOUR® PLUS BLUE Blood Glucose Monitoring System consists of the CONTOUR® PLUS BLUE meter, the CONTOUR® PLUS blood glucose test strips and the Contour® Diabetes app.

The CONTOUR® PLUS BLUE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® PLUS BLUE 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 in monitoring the effectiveness of a diabetes control program.

The CONTOUR® PLUS BLUE Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The CONTOUR® PLUS blood glucose test strips are for use with the CONTOUR® PLUS BLUE meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips.

The system is intended for in vitro diagnostic use only.

CONTOUR® PLUS BLUE Blood Glucose Monitoring System is a blood glucose monitoring system with Bluetooth Low Energy technology built in so that the meter can communicate wirelessly to smart phones and tablets. The meter uses the CONTOUR® PLUS blood glucose test strips and CONTOUR® PLUS control solution. The meter can be connected to the Contour® Diabetes app. It utilizes a similar algorithm as the one used in the CONTOUR® NEXT GEN Blood Glucose Monitoring System. It uses two replaceable coin cell batteries. The meter's shape is a traditional oval form factor and it includes an on-screen arrow that points to the color indicating if a glucose result is above, within, or below target range.

This document describes the CONTOUR® PLUS BLUE Blood Glucose Monitoring System, a medical device for quantitative measurement of glucose in fresh capillary whole blood. The submission aims to demonstrate substantial equivalence to a predicate device (CONTOUR® NEXT GEN Blood Glucose Monitoring System (K193407)).

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided text generally states that the device "met the system specifications" and "performed as intended." However, it does not provide specific numerical acceptance criteria or detailed performance data in a tabular format as requested. Therefore, the table below provides what can be inferred from the text, but lacks the specific quantitative details typically found in such a table.

Important Note: The current document lacks the detailed numerical acceptance criteria (e.g., specific accuracy ranges, precision limits, interference limits) and the corresponding measured performance data. For a complete answer, this information would be required from a more detailed study report.

2. Sample Size and Data Provenance

The document states that "clinical testing showed that the CONTOUR® PLUS BLUE Blood Glucose Monitoring System performed as intended and met the system specifications." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study).

3. Number of Experts and Qualifications for Ground Truth

The document does not provide any information regarding the number of experts used to establish the ground truth for the test set or their qualifications. This information is typically relevant for studies involving human interpretation (e.g., interpretation of medical images), which is not directly applicable to a blood glucose monitoring system that provides a quantitative reading. The "ground truth" for a device measuring glucose would likely be a highly accurate laboratory reference method.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method. This is usually relevant in studies where multiple human readers or experts are involved in assessing data, and their disagreements need to be resolved. For a blood glucose monitoring system, the "adjudication" would refer to the process by which the reference method's result is established, which is typically a standardized laboratory procedure rather than expert consensus on interpretation.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to a blood glucose monitoring system. This type of study evaluates the effect of AI assistance on human reader performance, typically in diagnostic imaging. The CONTOUR® PLUS BLUE system directly measures glucose and provides a reading, without human interpretation in the same way an imaging study would require. Therefore, no such study was performed or needed.

6. Standalone Performance (Algorithm Only)

The document focuses on the overall system performance, which includes the meter, test strips, and app. It states that the system "met the system specifications." While the device uses "a similar algorithm as the one used in the CONTOUR® NEXT GEN Blood Glucose Monitoring System," the document does not provide separate standalone (algorithm-only) performance data. The performance described encompasses the integrated device.

7. Type of Ground Truth Used

While not explicitly stated, for a blood glucose monitoring system, the ground truth is typically established using a highly accurate laboratory reference method for glucose measurement (e.g., a YSI analyzer, or a certified clinical laboratory method). This is the gold standard against which the device's measurements are compared. The document states "clinical testing showed that the CONTOUR® PLUS BLUE Blood Glucose Monitoring System performed as intended and met the system specifications," implying comparison to a reference.

8. Sample Size for the Training Set

The document does not provide any information about the sample size for the training set. The device utilizes "a similar algorithm as the one used in the CONTOUR® NEXT GEN Blood Glucose Monitoring System," which suggests that the core algorithm may have been trained previously, and this submission focuses on validating the integrated system.

9. How Ground Truth for Training Set Was Established

The document does not provide any information on how the ground truth for the training set was established. Given it states the algorithm is "similar" to a previously approved device, it's possible the training data and ground truth protocols for the original algorithm are foundational, but the specific details are not present in this submission summary. As with the test set, it would expectedly involve comparison to a laboratory reference method.

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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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VivaChek™ Link Plus Blood Glucose Monitoring System is comprised of the VivaChek™ Link Plus Blood Glucose Meter and the VivaChek™ Ino Blood Glucose Test Strips.

VivaChek™ Link Plus Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

VivaChek Link Plus Blood Glucose Monitoring System is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. 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 glucose oxidase 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.

VivaChek Link Plus Blood Glucose Monitoring System contains 4G module, the device complies with US federal guidelines, FCC Part 15 Subpart B, FCC Part 2, FCC Part 24 Subpart E, FCC Part 27 Subpart C, and FCC 47 CFR§ 2.1093 based on the test reports.

The provided text describes the VivaChek™ Link Plus Blood Glucose Monitoring System, an in-vitro diagnostic device. Here's an analysis of the acceptance criteria and study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of quantitative acceptance criteria and corresponding reported device performance metrics in the format requested. Instead, it states that various laboratory studies were performed, and for these studies, "the test results indicated that the acceptance criteria were met."

Therefore, based on the provided text, a generic representation of this would be:

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: The document mentions "clinical study (user evaluation) was conducted with intended users." However, it does not specify the number of users or samples included in this evaluation.
• Data Provenance: The document does not explicitly state the country of origin for the data. It also directly states that the user evaluation was conducted as a "clinical study," implying it was a prospective study, though not explicitly labelled as such. The other laboratory studies listed are implicitly prospective tests performed by the manufacturer.

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

This information is not provided in the document. For a blood glucose monitoring system, the "ground truth" for glucose levels would typically be established using a laboratory reference method (e.g., a YSI analyzer), not by human experts interpreting results. The user evaluation focuses on the usability and ability of lay persons to obtain readings, not on expert interpretation of the device's output.

4. Adjudication method for the test set

This information is not applicable/provided in the context of this device. Adjudication methods (like 2+1, 3+1) are typically used in studies where multiple human readers interpret images or complex data to establish a consensus ground truth, often for AI-assisted diagnostic tools. For a blood glucose meter, the reference method (e.g., YSI) provides the objective ground truth, and device readings are compared directly to this.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic AI where human readers interact with AI assistance. The VivaChek™ Link Plus Blood Glucose Monitoring System is a standalone measurement device for self-testing; it does not involve human readers interpreting AI-generated insights.
• Effect size of improvement with AI vs without AI assistance is not applicable.

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

• Yes, a standalone performance evaluation was done. The entire suite of laboratory studies (e.g., precision, linearity, interference, stability, environmental, safety) represents the standalone performance evaluation of the device system (meter and test strips) without human interpretation in the loop. The "user evaluation" section primarily assesses usability rather than the intrinsic accuracy of the algorithm/device itself. The device is designed for "self-testing outside the body (in vitro diagnostic use)," operating without professional human-in-the-loop interpretation of its results for diagnosis.

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

The document does not explicitly state the specific reference method used for establishing ground truth for glucose levels. However, in the context of blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method, such as a YSI glucose analyzer, which provides highly accurate and precise glucose concentration measurements. This is an objective chemical measurement, not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not provided and is generally not applicable in this context. Blood glucose monitoring systems are typically designed and calibrated based on biochemical principles and rigorous testing, rather than "training" a machine learning algorithm with a dataset in the way an AI diagnostic tool would be trained. The "training set" concept is usually associated with AI/ML development.

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

As noted above, a "training set" in the AI/ML sense is likely not applicable here. Device calibration and verification are based on established analytical chemistry methods where the "ground truth" for glucose concentrations in control solutions or reference samples would be determined using highly accurate laboratory reference instruments.

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The TRUENESS™ AIR Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of their diabetes control program. The TRUENESS™ AIR Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is for in vitro diagnostic use only. The TRUENESS™ AIR Blood Glucose Monitoring System is not intended for the diagnosis of, or screening for diabetes. It is not intended for use on neonates.

The TRUENESS™ AIR Blood Glucose Monitoring System is comprised of the TRUENESS™ AIR blood glucose meter and the TRUENESS™ blood glucose test strip.

The TRUENESS™ Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of their diabetes control program. The TRUENESS™ Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is for in vitro diagnostic use only. The TRUENESS™ Blood Glucose Monitoring System is not intended for the diagnosis of, or screening for diabetes. It is not intended for use on neonates.

The TRUENESS™ Blood Glucose Monitoring System is comprised of the TRUENESS™ blood glucose meter and the TRUENESS™ blood glucose test strip.

The TRUENESS Blood Glucose Monitoring System and TRUENESS AIR Blood Glucose Monitoring System mainly consist of two parts as below:
(1) TRUENESS Blood Glucose Meter or TRUENESS AIR Blood Glucose Meter (With Bluetooth function)
(2) TRUENESS Blood Glucose Test Strip

A glucose test is based on measurement of electrical current caused by the reaction of glucose with flavin adenine dinucleotide (FAD) glucose dehydrogenase on the electrode of the test strip. The blood or control solution sample is drawn into the tip of the TRUENESS Blood Glucose Test Strip through capillary action. Glucose in the sample reacts with the FAD glucose dehydrogenase and generate electrons. The magnitude of the resultant current is proportional to the concentration of glucose in the blood and is converted to a glucose concentration. The glucose concentration is displayed on the meter display for the user.

The provided text primarily focuses on the FDA's 510(k) clearance for the TRUENESS™ AIR Blood Glucose Monitoring System and the TRUENESS™ Blood Glucose Monitoring System. It outlines the regulatory process, device descriptions, and a high-level summary of testing. However, it does not contain the detailed acceptance criteria or the specific study results in the format requested.

The document indicates that "Design verification and validation testing consisted of performance tests (precision, linearity, interference, flex studies), electrical/mechanical safety tests, as well as disinfection, cleaning, and robustness studies." It also mentions "A user evaluation confirmed the system accuracy, operation according to design, and ease of use to support the intended use as described in the proposed labeling."

Therefore, I cannot populate the table or answer all your questions with the information given. I can, however, extract the general statement about accuracy.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for any of the tests.
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not specified. The document mentions a "user evaluation" confirmed system accuracy, but does not detail the nature or qualifications of these users as "experts" for establishing ground truth in a clinical sense.

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

• Not specified.

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/mentioned. This device is a blood glucose monitoring system, not an AI-assisted diagnostic tool that involves human readers.

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

• The device performs quantitative measurement of glucose. The "system accuracy" would refer to its standalone performance, confirmed by user evaluation. The specifics of this standalone performance are not detailed in terms of metrics.

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

• Not specified. For blood glucose monitoring systems, ground truth is typically established by comparing the device's readings against a laboratory reference method (e.g., YSI analyzer), but this is not explicitly stated in the document provided.

8. The sample size for the training set

• Not applicable/mentioned. Blood glucose monitoring systems typically don't have a "training set" in the machine learning sense. Their performance is validated through defined chemical and user studies against reference methods.

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

• Not applicable/mentioned for the same reason as above.

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