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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.

Device Description

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.

AI/ML Overview

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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K Number

K143387

Device Name

GE333 Blood Glucose Monitoring System

Manufacturer

Bionime Coporation

Date Cleared

2015-06-03

(189 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K092052

Intended Use

The GE Blood Glucose Monitoring System 333 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE Blood Glucose Monitoring System 333 is intended to be used by a single person and should not be shared.

The GE Blood Glucose Monitoring System 333 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE Blood Glucose Monitoring System 333 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The GE Blood Glucose Test Strips 33 are for use with the GE Blood Glucose Meter 333 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

Device Description

The GE Blood Glucose Monitoring System 333 consists of the following devices: GE Blood Glucose Meter 333, GE Blood Glucose Test Strip 333, and Rightest Control Solution GC550. The GE333 Blood Glucose Meter and GE Blood Glucose Test Strips 333 are manufactured by BIONIME Corporation. The GE Blood Glucose Meter 333, when used with the GE Blood Glucose Test Strips 333, quantitatively measures glucose in fresh capillary whole blood. The performance of the GE Blood Glucose Monitoring System 333 is verified by the Rightest Control Solution GC550.

The Rightest Control Solution GC550 has been previously been cleared (K092052) and is being repackage for use with the GE Blood Glucose Monitoring System 333.

GE Blood Glucose Test Strip 333 paired with GE Blood Glucose Meter 333 that utilizes electrical characteristic technology for measuring the glucose level in human blood. A relatively small drop of blood (minimum requirement of only 0.75 µL) is placed on the disposable GE Test Strip 333 coated with Glucose Oxidase which interacts with the GE Blood Glucose Meter 333. Within 5 seconds after testing, the blood glucose level is indicated on the meter's digital display screen.

AI/ML Overview

This document describes K143387, for the GE Blood Glucose Monitoring System 333, which is substantially equivalent to the Rightest Blood Glucose Monitoring System GM550.

Here's an analysis of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

The document frequently refers to "acceptance criteria" but does not explicitly list them in a single table with associated performance statistics. Instead, the performance is reported against implicit or general criteria (e.g., "falls within the acceptance criteria," "within the criteria of ±15%," "met the acceptance criteria").

Below is a table summarizing the performance evaluation where acceptance criteria are discernable from the text:

Study/Test	Acceptance Criteria (Implied)	Reported Device Performance
Linearity	Linear regression mean slopes above 0.99, R2 values above 0.99	Linear regression between device and reference method shows mean slopes above 0.9912 and R2 values above 0.999. Glucose assay is linear from 20-600 mg/dL.
Precision (Repeatability)	Falling within defined acceptance criteria (not explicitly stated numerically)	Repeatability evaluation results demonstrate that repeatability falls within the acceptance criteria.
Precision (Intermediate)	Falling within defined acceptance criteria (not explicitly stated numerically)	Intermediate precision evaluation results demonstrate that intermediate precision falls within the acceptance criteria.
Sample Volume (Minimum)	Less than 0.60 µL should display an error message (Er4); other volumes within ±10% bias compared to reference	When sample volumes were less than 0.60 µL, meter displayed error message (Er4). At all other sample volumes (greater than 0.65 µL), the results were within the accepted criteria of ±10% bias compared to reference. Minimum sample volume determined to be 0.75 µL.
Interference	Percentage of interference within ±10% bias (as implied by the report)	Ascorbic acid (≥ 5 mg/dL), cholesterol (600 mg/dL), and uric acid (≥ 10 mg/dL) indicated percentage of interference over ±10% bias in high glucose concentration (leading to limitations statement). The remaining 16 interference substances were within the criteria for normal and high glucose concentrations.
Hematocrit	Stability compared to reference method within ±15% of reference value	Stability compared to the reference method during various HCT ranges were all within the criteria of ±15% of reference value. The acceptable HCT range is 20-60%.
System Accuracy	Meets acceptance criteria and EGA (Error Grid Analysis) for clinical performance, no significant difference in slope, intercept, and correlation coefficient between subject device and comparative meter/reference lab instrument.	The accuracy of subject device met the acceptance criteria, and there was no significant difference in slope, intercept, and correlation coefficient between the comparative meter or reference lab instrument.
User Performance	Achieves accurate results such that it is substantially equivalent to predicate device	The study result shows substantial equivalence to predicate device used in finger, palm and forearm position for accurate results by lay users.

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

Linearity: 15 levels of glucose concentrations. (Specific number of samples per level not stated). Data provenance is likely internal lab testing ("Venous blood samples spiked").
Precision (Repeatability): 1500 test strips used (over 10 days, 5 glucose concentrations, 10 meters, 3 lots). Data provenance is internal lab testing ("venous blood sample results").
Precision (Intermediate): 900 test strips used (over 10 days, 3 glucose concentrations, 10 meters, 3 lots). Data provenance is internal lab testing ("venous blood sample results").
Sample Volume: 9 sample volumes (ranging from 0.60 to 3.0 µL), 3 lots of strips, 3 glucose concentration levels. Data provenance is internal lab testing ("Venous blood").
Interference Study: 3 lots of test strips, 2 glucose concentration levels, 19 interference substances. Data provenance is internal lab testing ("venous blood samples").
Hematocrit Study: 3 lots of blood glucose test strips, 6 glucose concentration levels, tested in 5 replicates. Data provenance is internal lab testing ("venous blood samples").
System Accuracy Study: 103 patients participated. Data provenance is clinical study ("capillary whole blood obtained from fingertip, palm, and/or forearm"). The location (country) is not specified, but typically these studies are either internal to the company's location (Taiwan) or a contract research organization. It does not state if it was retrospective or prospective, but clinical accuracy studies are generally prospective.
User Performance Study: 160 laypersons in multiple sites. Data provenance is a clinical study ("capillary whole blood from fingertip, palm and forearm sample sites"). The location (country) is not specified. It does not state if it was retrospective or prospective, but user performance studies are generally prospective.

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

For the non-clinical studies (Linearity, Precision, Sample Volume, Interference, Hematocrit), the ground truth was established by the YSI 2300 Plus Glucose Analyzer (or YSI 2300 Analyzer), which is a laboratory reference method. Therefore, human experts were not directly establishing the ground truth for these measurements; rather, it was established by a recognized gold standard instrument. Expert qualifications for operating and maintaining such instruments are implied but not stated.

For the System Accuracy Study, the ground truth was established by the YSI 2300 Plus Glucose Analyzer. A comparative effectiveness was also done against a reference device, the Roche ACCU-CHEK Performa. Human experts were involved in collecting samples and running the analyzers but not in establishing the ground truth value itself, which came from the YSI machine.

For the User Performance Study, the primary ground truth reference is the subject device's own performance against its predicate (implying the predicate device's established accuracy as a baseline for "accurate results"). However, in clinical studies like this, a lab reference method (like YSI) would typically be used to compare both the user's results and potentially results from trained personnel. The document does not explicitly state how ground truth was established for the user performance aspect, beyond showing substantial equivalence to the predicate.

4. Adjudication Method for the Test Set

Not applicable. For the analytical studies, the ground truth was established by an automated laboratory reference instrument (YSI 2300 Plus Glucose Analyzer). For the clinical studies, no "adjudication" between multiple human readers is mentioned, as the primary ground truth was instrumental or comparison to a predicate.

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

No, an MRMC comparative effectiveness study in the context of human readers improving with AI vs. without AI assistance was not performed. This device is a blood glucose monitoring system, not an AI-powered diagnostic imaging tool requiring human interpretation.

A System Accuracy Study was performed comparing the device to a reference method (YSI 2300 Plus Glucose Analyzer) and a comparative meter (Roche ACCU-CHEK Performa). This is a comparative study but not an MRMC study involving human readers and AI assistance.

A User Performance Study involved lay users, effectively acting as "multiple readers" for the device, but it was to demonstrate the device's usability and accuracy by laypersons, not to assess an AI's impact on human reader performance.

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

Yes, the analytical performance studies (Linearity, Precision, Sample Volume, Interference, Hematocrit) and the System Accuracy Study are essentially standalone performance evaluations of the device (meter and test strips) against a laboratory reference standard. These studies assess the algorithm's ability to accurately measure glucose without direct human interpretive intervention beyond operating the device and reference method. The device itself is an algorithm-driven measurement tool.

7. The Type of Ground Truth Used

For non-clinical analytical studies (Linearity, Precision, Sample Volume, Interference, Hematocrit) and the System Accuracy Study, the ground truth was established by a laboratory reference method: YSI 2300 Plus Glucose Analyzer.

For the User Performance Study, the ground truth was implied by the established accuracy of the predicate device and the reference method used in other studies, to determine if lay users could obtain "accurate results."

8. The Sample Size for the Training Set

The document does not specify a training set size. Blood glucose monitoring systems typically do not involve machine learning models that require distinct "training sets" in the same way AI/ML algorithms for image analysis do. Instead, the device's design, calibration, and internal algorithms are developed and validated using extensive lab testing and engineering principles. The studies described are primarily for verification and validation of the final product's performance and accuracy.

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

As no specific training set for a machine learning model is mentioned, this question is not directly applicable. The device's underlying technology relies on electrochemical reactions and calibration curves established through rigorous laboratory testing using reference methods like the YSI 2300 Plus Glucose Analyzer, rather than a "training set" in the context of AI.

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K Number

K133522

Device Name

RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM

Manufacturer

BIONIME COPORATION

Date Cleared

2014-04-17

(153 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K062567,K123008,K113007

Intended Use

The Bionime Rightest Diabetes Management System is an over-the-counter software system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. User(s) can transfer blood glucose readings from the following glucose meters: Rightest Blood Glucose Monitoring System GM550 and GM250 with Rightest PC Link Adaptor (GP550), Rightest Blood Glucose Monitoring System GM700 with Rightest PC Link Adaptor (GP550) or Rightest Bluetooth PC Link (GP700), Rightest Blood Glucose Monitoring System GM650 with Rightest PC Link Adaptor for GM650 (GP650), and Rightest Blood Glucose Monitoring System GM300 with Rightest PC Link Adaptor for GM300 (GP300) to a personal computer for the purpose of viewing, analyzing and printing the blood glucose readings, as well as to backup and to recover users' profile and data.

The Bionime Rightest Diabetes Management System is not intended to provide treatment decisions, nor should it substitute professional opinion. All medical diagnoses and treatment plans should be performed by a licensed healthcare professional.

The GE Diabetes Management System is an over-the-counter software system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. User(s) can transfer blood glucose readings from the following glucose meters: GE100 Blood Glucose Monitoring System with GE PC Link Adaptor (GE GP550), GE300 Talking Blood Glucose Monitoring System with GE PC Link Adaptor for GE300 (GE GP300) or GE200 Blood Glucose Monitoring System with GE PC Link Adaptor (GE GP5500 and GE Bluetooth PC Link (GE GP700) to a personal computer for the purpose of viewing, analyzing and printing the blood glucose readings, as well as to backup and to recover users' profile and data.

The GE Diabetes Management System is not intended to provide treatment decisions. nor should it substitute professional opinion. All medical diagnoses and treatment plans should be performed by a licensed health care professional.

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 glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

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 Rightest Blood Glucose Monitoring System GM300 is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or diabetes at home to measure the glucose concentration for aiding diabetes management. The glucose concentration is measured with quantitative capillary whole blood from the fingertip, palm, and forearm by using Rightest Blood Glucose Monitoring System GM300. This device is not intended for testing neonate blood samples.

Special conditions for use statement(s): Rightest System provides plasma equivalent results.

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 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 Blood Glucose Test Strip is 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.

Device Description

Rightest Blood Glucose Monitoring System GM700 consists of 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, 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.

Rightest Blood Glucose Monitoring System GM650 consists of 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, 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.

Rightest Blood Glucose Monitoring System GM300 consists of following devices: Rightest Blood Glucose Meter GM300, Rightest Blood Glucose Test Strip GS300, Rightest Control Solution GC300, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM300, when used with the Rightest Blood Glucose Test Strips GS300, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM300 is verified by the Rightest Control Solution GC300.

GE200 Blood Glucose Monitoring System consists of following devices: GE200 Blood Glucose Meter, GE200 Blood Glucose Test Strip, GE200 Control Solution, lancing device and steriled lancets. 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

GE300 Talking Blood Glucose Monitoring System consists of 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, 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.

The Bionime Rightest Diabetes Management System allows the transfer of blood glucose readings from a compatible Rightest Glucose meter to a PC via PC link adapter (through USB and wireless connection). The Data analysis features enable the user(s) to view and analyze blood glucose readings from different meal time periods. Other features including data tables, trend charts, pie charts, and printed reports are available for viewing and analyzing these readings within the different time slots.

The revised system includes: 1) Installation CD with setup files for Rightest GP200 Diabetes Management Software and Rightest PC Link Adapter Driver, 2) One or multiple Rightest Adapters: GP550, GP700, GP650 and GP300 Compatible Meters include: GM250, GM550, GM700, GM650 and GM300.

The GE Diabetes Management System allows the transfer of blood glucose readings from a compatible GE Glucose meter to a PC via PC link adapter (through USB and wireless connection). The Data analysis features enable the user(s) to view and analyze blood glucose readings from different meal time periods. Other features including data tables, trend charts, pie charts, and printed reports are available for viewing and analyzing these readings within the different time slots.

The revised system includes: 1) Installation CD with setup files for GE GP200 Diabetes Management Software and GE PC Link Adapter Driver, 2) One or multiple GE Adapters: GE GP550, GE GP700 and GE GP300. Compatible Meters include: GE100, GE200 and GE300.

AI/ML Overview

The provided text describes the submission of a 510(k) premarket notification for several blood glucose monitoring systems and associated diabetes management software (BIONIME CORPORATION, K133522). The submission aims to add additional compatible meters and adapters to existing cleared systems. The studies primarily focus on the functional verification of data transfer and system usability for the diabetes management software, rather than the analytical performance of the blood glucose meters themselves (which are largely established through predicate devices).

Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied functional requirements and satisfactory user performance.

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Data Transmission Accuracy	Full set of data (up to the meter's memory capacity) transferred from meter to software must be accurately downloaded.	Passed: Full set of data (1000 records for GM700, 500 for GM650/GE300, 300 for GM300, 1000 for GE200) transferred from meter to software was accurately downloaded for all tested meter/adapter combinations (Rightest GM700/GP550, Rightest GM700/GP700, Rightest GM650/GP650, Rightest GM300/GP300, GE200/GEGP550, GE200/GEGP700, GE300/GEGP300).
Memory Data Rollover	Meter memory data rollover must be accurately transmitted to the Diabetes Management System with additional new data.	Passed: Meter memory data rollover accurately transmitted to Rightest/GE DMS with additional new data for all tested meter/adapter combinations that have rollover (implied for all, explicitly stated for GM700, GM300, GE200, GE300).
User Performance	English-speaking laypersons must be able to follow user instructions for PC link adapters and software user manual to successfully connect the adapters/meters to a PC and import data to the GP200 Diabetes Management Software.	Passed: The study demonstrates that English-speaking laypersons are able to follow user instructions to successfully connect PC Link Adapters and paired meters to a PC and import data to the GP200 Diabetes Management Software.
Electromagnetic Compatibility (EMC)	PC Link Adapters (GP300, GP650, GP700) must meet performance criteria indicated by relevant safety standards for electrical equipment.	Passed: EMC reports confirmed that each PC Adapter met performance criteria indicated by the standards.
Readability Assessment	PC Adapter Guides and PC Adapter User Manuals for both Rightest BDMS and GE DMS Software must achieve a Flesch-Kincaid Grade Level indicating comprehension by an average eighth-grade student (implied acceptance score based on reported results).	Passed: Assessments ranged from 6.2 to 7.4 Flesch-Kincaid Grade Level, indicating each text is expected to be understood by an average student in the eighth grade, thus meeting the criteria.

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

Data Transmission Memory Rollover Synchronization Verification: The test set used "3 meters per adapter." The data provenance is not explicitly stated (e.g., country of origin) but would be prospective controlled testing performed by the manufacturer.
User Performance Evaluation: 45 participants were used for the test set. The study was conducted from October to December 2013. Data provenance is implied to be prospective testing conducted under controlled conditions, likely in Taiwan (country of the submitter, BIONIME CORPORATION).
Electromagnetic Compatibility (EMC): The sample size isn't specified but typically involves a single unit or a small number of units of each adapter type (GP300, GP650, GP700) for testing. This would be prospective testing.
Readability Assessment: The "sample size" here refers to the documents themselves (PC Adapter Guides and PC Adapter User Manuals). This is analysis of existing documentation.

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

For the Data Transmission and EMC tests, "ground truth" is established by direct observation and comparison against expected functional behavior and established engineering standards. No human experts are explicitly mentioned for establishing ground truth in the sense of clinical interpretation.
For the User Performance Evaluation, the "ground truth" of successful operation is determined by the layperson participants' ability to complete the tasks as instructed. There were no "experts" establishing a ground truth for individual performance, but rather the study design aimed to assess the usability by the target user group (laypersons).
For the Readability Assessment, the Flesch-Kincaid Grade Level score is an algorithmic measure of readability, so no human experts were involved in establishing the "ground truth" of readability other than the developers of the readability index itself.

4. Adjudication Method for the Test Set

For Data Transmission and EMC, the "adjudication" is based on direct verification against defined functional requirements and technical standards. There isn't an adjudication method like 2+1 or 3+1 typically used in image interpretation studies. It's a pass/fail determination based on objective criteria.
For User Performance Evaluation, the method of judging success by the 45 participants is not detailed, but it's presumed to be direct observation of task completion. No mention of an adjudication panel.
For Readability Assessment, the Flesch-Kincaid algorithm provides the score, not human adjudication.

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

There was no MRMC comparative effectiveness study done. The devices covered in this submission are blood glucose monitoring systems and their associated data management software. These are not AI-based diagnostic image interpretation systems or similar devices where MRMC studies with human readers and AI assistance would typically be conducted. The tests performed are for functional performance and user interface/usability of data logging and transfer.

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

While the blood glucose meters themselves operate "standalone" in their measurement function, the studies reported here are primarily focused on the data management software. The data transmission and rollover verification tests are essentially "standalone" evaluations of the software's ability to accurately receive and store data from the meters without human intervention influencing the data transfer accuracy. The user performance study, however, explicitly involves a human-in-the-loop to evaluate usability.

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

Data Transmission Accuracy and Memory Rollover: The ground truth is the "expected" or "correct" transfer and storage of data, which is objectively verifiable. This is a functional ground truth, not a clinical one.
User Performance Evaluation: The ground truth is the successful completion of tasks by laypersons following instructions. This is a usability/human factors ground truth.
EMC: The ground truth is compliance with international safety and electromagnetic compatibility standards. This is a regulatory/engineering ground truth.
Readability Assessment: The ground truth is the calculated Flesch-Kincaid Grade Level score, an objective linguistic measure.

8. The Sample Size for the Training Set

This submission does not discuss AI algorithms that require training sets in the conventional sense. The "systems" being evaluated are hardware (meters, adapters) and software for data management, not machine learning models. Therefore, there is no mention of a training set of data for any AI algorithm.

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

Since there is no training set mentioned in the context of AI/machine learning, this question is not applicable to the provided document. The functional evaluations performed, such as data transmission, are verified against the design specifications and expected behavior, not against a "ground truth" derived from a separate training process.

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