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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 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 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 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 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 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.

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.

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.

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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