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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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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 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 GM700 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 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 Strip GS700 is for use with the Rightest Blood Glucose meter GM700 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm or forearm.

The Rightest Control Solution GC700 is for use with the Rightest Blood Glucose meter GM700 and Rightest Blood Glucose Test Strips GS700 to check that the meters and test strip are working together properly and that the test is performing correctly.

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 Rightest Blood Glucose Monitoring System GM700 is verified by the Rightest Control Solution GC700.

A Rightest Blood Glucose Monitoring System GM700 kit box may contain different bundled items.

Here's a summary of the acceptance criteria and study information for the Rightest Blood Glucose Monitoring System GM700, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text only explicitly states that the device "met the acceptance criteria" for the system accuracy study. It does not numerically list the specific acceptance criteria for blood glucose monitoring systems, nor does it provide a direct numerical performance result. In the absence of a detailed table from the source, I will indicate the general finding.

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

• Sample Size for Accuracy Study: 103 patients
• Sample Size for User Performance Study: Not explicitly stated, but implies a sufficient number of lay consumers participated.
• Data Provenance: Not explicitly stated, but the submission is from a Taiwanese company (BIONIME CORPORATION NO 694, RENHUA ROAD, DALI DIST., TAICHUNG CITY, TAIWAN 412), suggesting the studies may have been conducted in Taiwan or a related region. It does not specify if the data was retrospective or prospective, but clinical studies are generally prospective.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. The ground truth for the accuracy study was established by "plasma glucose values on a lab instrument," implying trained laboratory personnel were involved, but their specific qualifications are not detailed.

4. Adjudication Method for the Test Set

• The text does not mention an adjudication method (such as 2+1 or 3+1) for establishing the ground truth. The ground truth was based on a "lab instrument" for plasma glucose values.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is focused on the performance of a medical device (blood glucose monitor), not an AI algorithm assisting human readers.

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

• This question is not applicable as the device is a Blood Glucose Monitoring System, which includes the meter, test strips, and control solution, and is used by a human. The "standalone" concept typically applies to AI algorithms. The system itself is the "standalone" diagnostic tool.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the system accuracy study was established using "plasma glucose values on a lab instrument." This is a reference measurement, often considered a highly accurate and standardized method for glucose determination.

8. The Sample Size for the Training Set

• Blood Glucose Monitoring Systems are typically developed through electrochemical and hardware engineering, and thus do not involve a "training set" in the context of machine learning. Therefore, a sample size for a training set is not applicable to this device.

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

• As the concept of a "training set" is not applicable to the development of this device, the question of how its ground truth was established is not applicable. Device performance is validated against established laboratory reference methods and clinical accuracy standards, rather than "training" an algorithm.

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