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The UniStrip1™ Generic Blood Glucose Test Strips are used with the OneTouch® Ultra®2, OneTouch®, UltraMini® and OneTouch®, UltraSmart® meters purchased before April 2016, set at calibration code 49, for measuring glucose (sugar) in whole capillary blood. The strips are meant for self-testing of blood glucose as an aid to monitor the effectiveness of diabetes control.

They are for single patient use only and should not be shared.

They are used to quantitatively measure glucose in fresh capillary whole blood samples taken from the finger, palm, or forearm. Testing is done outside the body (in vitro diagnostic use).

They are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.

Not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The UniStrip1™ Generic Blood Glucose Test Strips allow alternate site testing (AST) from the fingertip, palm and/or the forearm. (Use of palm AST is not to be done with OneTouch®, Ultra® meter). Alternative site testing should only be done during steady-state times (when glucose is not changing rapidly).

Device Description

The UniStripl Generic Blood Glucose Test Strips are used with the OneTouch® Ultra, OneTouch® Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® meters. The UniStrip1 Generic Blood Glucose Test Strips are intended for use outside the body (in vitro diagnostic use) by people with diabetes using the OneTouch® Ultra®, OneTouch® Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® blood glucose monitoring systems as an aid to monitor the effectiveness of diabetes control. The UniStrip1 Generic Blood Glucose Test Strips allow alternate site testing (AST) from the fingertip, palm and/or the forearm. (Use of palm AST is not to be done with OneTouch* Ultra* meter). The UniStrip1 Generic Blood Glucose Test Strips can only be used with the OneTouch® Ultra®, OneTouch Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® meters purchased before April 2016. UniStripl Generic Blood Glucose Test Strips are only for use with calibration code 49.

AI/ML Overview

The provided text details various studies and their acceptance criteria for the UniStrip1™ Generic Blood Glucose Test Strips. This device is intended for self-testing of blood glucose with several OneTouch® Ultra® meters.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Study/Test	Acceptance Criteria	Reported Device Performance
Altitude Study	Individual bias within ±10% at altitudes from 298 feet (91 meters) to 11,161 feet (3,402 meters). SD < 5.0 mg/dL for glucose < 100 mg/dL, and CV < 5.0% for glucose ≥ 100 mg/dL.	Individual bias fell within ±10% from 298 feet (91 meters) to 11,161 feet (3,402 meters). SD < 5.0 mg/dL and CV < 5.0% for specified glucose concentrations. Claimed usability up to 10,000 ft.
Hematocrit Study	(1) All SD and CV < 5 mg/dL and 5% respectively. (2) All individual bias of glucose measurement vs YSI mean < 15%. (3) Mean Bias% to YSI for each sample < 10%. (4) Difference % between mean glucose bias and mean bias of mid-level sample (Hct: 42%) < 10%.	(1) All SD and CV were less than 5 mg/dL and 5% respectively. (2) All individual bias of glucose measurement vs YSI mean was less than 15%. (3) Mean Bias% to YSI for each sample < 10%. (4) Difference % between mean glucose bias and mean bias of mid-level sample (Hct: 42%) < 10%. Results met criteria for HCT 30% to 55%.
Interference Study	All bias of test results within the tested range ≤ 10% compared with controlled pool measurements. Concentration limits of interfering substances higher than therapeutic or physiological levels.	All bias of test results within the range were ≤ 10% compared with controlled pool. No obvious interference observed at therapeutic or physiological levels for interfering substances at two blood glucose levels.
Linearity Study	Correlation coefficient > 0.95. 100% of individual glucose results bias within ±10 mg/dL for glucose < 100 mg/dL, and ±10% for glucose ≥ 100 mg/dL, compared with YSI 2300.	Correlation coefficients were 0.9994 (Lot I), 0.99925 (Lot II), and 0.99955 (Lot III), all > 0.95. 100% of individual glucose results bias fell within ±10 mg/dL (glucose < 100 mg/dL) and ±10% (glucose ≥ 100 mg/dL) compared with YSI 2300. Linearity established from 20 to 600 mg/dL.
Operation Condition	Individual bias within ±10 mg/dL for glucose < 100 mg/dL and within ±10% for glucose ≥ 100 mg/dL. SD < 5.0 mg/dL for glucose < 100 mg/dL, and CV < 5.0% for glucose ≥ 100 mg/dL.	Individual bias was within ±10 mg/dL (glucose < 100 mg/dL) and within ±10% (glucose ≥ 100 mg/dL). SD < 5.0 mg/dL (glucose < 100 mg/dL) and CV < 5.0% (glucose ≥ 100 mg/dL). Operated normally in conditions 42-111°F (6-44°C), 10-90% R.H.
Precision Study	Pooled and maximum SD < 5.0 mg/dL for glucose < 75 mg/dL. Pooled and maximum CV < 5.0% for glucose ≥ 75 mg/dL. Maximum individual bias < 10% compared with glucose analyzer YSI 2300.	Pooled and maximum SD were < 5.0 mg/dL for glucose < 75 mg/dL. Pooled and maximum CV were < 5.0% for glucose ≥ 75 mg/dL. Maximum bias for all levels was between -5.3% and 3.7%. Repeatability CVs were primarily between 1.8% and 3.5%. Intermediate Precision CVs between 3.6% and 3.9%.
Shelf-Life Study	All data meet acceptance criteria.	Unopened vials stable for 24 months. Opened vials stable for 90 days.
User Performance	(Lay users): Correlation values R' > 0.98. Populations of individual bias: ≥95% users within ±15 mg/dL for glucose < 75 mg/dL, and ≥95% users within ±15% for glucose ≥ 75 mg/dL, compared with YSI 2300.	R' values were 0.9827 (Lot I), 0.9816 (Lot II), 0.9876 (Lot III), all > 0.98. For glucose < 75 mg/dL: 100% within ±15 mg/dL for fingertip and forearm. For glucose ≥ 75 mg/dL: 100% within ±15% for fingertip and forearm.
Satisfactory Evaluation	More than 85% of volunteers agree that labels and user guide provide enough product information. More than 95% of volunteers' scores > 80 points.	More than 85% of volunteers agreed labels and user guide provided enough information. More than 95% of scores were > 80 points.
Sample Volume Study	Required at least 1.0 µL to obtain normal test results.	The sample volume of UniStrip1 Generic Blood Glucose Test Strips with OneTouch® Ultra® Meters was required at least 1.0 µL to obtain the normal testing results. Measured glucose results using sample volumes from 1.0 to 1.5 µL.
Error Message Verification	Error messages displayed correctly at given conditions.	Error messages of OneTouch® Ultra® Meters displayed correctly at given condition of procedures.

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

Altitude Study: Not explicitly stated, but implies sufficient samples to demonstrate individual bias and precision metrics over the specified altitude range.
Hematocrit Study: Not explicitly stated, but samples with HCT from 30% to 55% were used.
Interference Study: Not explicitly stated, but samples with various interfering substances at different glucose levels were used.
Linearity Study: Not explicitly stated, but implies sufficient samples to establish linearity across 20 to 600 mg/dL for three strip lots.
Operation Condition Study: Not explicitly stated, but implies sufficient samples for evaluation in normal and extreme environments.
Precision Study:
- Repeatability: 100 tests per lot at each of 5 glucose levels (Total: 3 lots x 5 levels x 100 tests = 1500 tests).
- Intermediate Precision: Not explicitly stated, but likely multiple tests per lot at each of 3 glucose levels over several days for each of 3 lots.
Shelf-Life Study: Not explicitly stated.
User Performance (Lay users) Evaluation:
- Glucose < 75 mg/dL: 20 capillary blood samples for fingertip, 20 for forearm.
- Glucose ≥ 75 mg/dL: 80 capillary blood samples for fingertip, 80 for forearm.
- Linearity Analysis: Implies sufficient samples collected by lay users to generate linearity equations for 3 strip lots.
Satisfactory Evaluation: "More than 85% of volunteers" and "more than 95% of volunteers" imply a volunteer sample size, but the exact number isn't specified.
Sample Volume Study: Not explicitly stated, but involved measuring glucose with sample volumes from 1.0 to 1.5 µL.
Error Message Verification Study: Not explicitly stated.

Data Provenance: The studies were conducted by OK Biotech Co., Ltd. in Taiwan. The description does not specify if the data was retrospective or prospective, but clinical performance studies using human samples imply prospective collection for tests like user performance. Other tests (e.g., altitude, hematocrit, linearity, precision) likely used controlled laboratory samples.

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

The document primarily refers to the YSI 2300 Glucose Analyzer as the reference method for establishing ground truth for glucose measurements. The YSI 2300 is a laboratory-grade analyzer, considered a gold standard for glucose measurement; therefore, specific human experts for ground truth adjudication are not typically used in this context.

4. Adjudication Method for the Test Set

Adjudication in the traditional sense (e.g., 2+1 expert consensus) is not applicable here as the ground truth for glucose concentration is established by a reference laboratory instrument (YSI 2300). The device's performance is directly compared to the results from the YSI 2300.

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

No MRMC comparative effectiveness study was done. This device is a blood glucose test strip system, not an AI-assisted diagnostic imaging device or similar system where human reader performance would be a primary endpoint. The "User Performance" study evaluates lay users' ability to operate the device correctly and obtain accurate readings, which is a different type of assessment.

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

This is a standalone device in the sense that the test strip and meter system provide a direct glucose reading. There isn't an "algorithm only" component separate from the integrated device. The performance data presented (linearity, precision, interference, etc.) represent the standalone performance of the test strip system. The "User Performance" study specifically assesses human-in-the-loop performance by lay users but is focused on correct operation and result accuracy, not on assistance with an AI algorithm.

7. The Type of Ground Truth Used

The primary ground truth used is reference measurement by a Glucose Analyzer, specifically the YSI 2300. This is considered a highly accurate laboratory method for quantitative glucose determination.

8. The Sample Size for the Training Set

The document describes performance studies and evaluation against established methods (YSI 2300).
No explicit training set or development set size is mentioned. This type of medical device (blood glucose test strips) typically undergoes analytical and clinical validation studies without a "training set" in the machine learning sense. The device's chemical and electrical components are designed and optimized, and then validated through these performance studies.

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

Since no explicit training set for a machine learning model is mentioned, the concept of establishing ground truth for a training set in that context does not apply directly. The "ground truth" for evaluating the performance of the device design and manufacturing process is consistently the YSI 2300 Glucose Analyzer, as mentioned above.

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