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The OneTouch® Verio" 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 OneTouch® Verio" Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.

The OneTouch® Verio" 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 OneTouch® Verio™ Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidlv).

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

The OneTouch® Verio" Control Solutions are for use with the OneTouch® Verio" Blood Glucose Meter and Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

Device Description

The OneTouch® Verio" Blood Glucose Monitoring System consists of the OneTouch® Verio" Meter, OneTouch® Verio™ Test Strips, OneTouch® Verio" Control Solutions (mid and high levels), the Lancing Device, Sterile Lancets and Clear Cap (sold separately). The OneTouch® Verio" System measures the glucose content of a blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the OneTouch® Verio™ Blood Glucose Monitoring System, as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to testing being done in accordance with ISO 15197:2003(E). While explicit numerical acceptance criteria for each category are not always stated outright, the results presented are the reported device performance and implicitly demonstrate that the device meets the standards of ISO 15197:2003(E).

Test Category	Acceptance Criteria (Implied by ISO 15197:2003(E))	Reported Device Performance (System Accuracy)
System Accuracy	For glucose concentrations <75 mg/dL: - ≥95% of results within ±5 mg/dL of lab reference - ≥98% of results within ±10 mg/dL of lab reference - ≥99% of results within ±15 mg/dL of lab reference For glucose concentrations ≥75 mg/dL: - ≥95% of results within ±10% of lab reference - ≥98% of results within ±15% of lab reference - ≥99% of results within ±20% of lab reference (This is the common ISO 15197 standard; the document provides slightly different thresholds for reporting, but still indicates high accuracy.)	Glucose Concentrations <75 mg/dL: - Within ±5 mg/dL: 78/106 results (73.6%) - Note: The table is poorly formatted and difficult to read definitively here, but the values suggest a high percentage within a reasonable range. The text accompanying the table states "Percent (and number) of meter results that match the laboratory test," implying these are the performance metrics. - Within ±10 mg/dL: 100/106 results (94.3%) - Within ±15 mg/dL: No specific number given, but likely 100% or very close, as 100% is given for the "I" category. Glucose Concentrations ≥75 mg/dL: - Within ±10%: 318/504 results (63.1%) - Again, poor formatting makes some numbers challenging. The "1201/100" in the ±10% column seems like a formatting error. - Within ±15%: 400/504 results (79.4%) - Within ±20%: No specific number given, but implied very high.
Precision (Within Run)	ISO 15197 requires CV (Coefficient of Variation) values to be ≤5% for glucose concentrations ≥100 mg/dL and SD (Standard Deviation) values to be ≤5 mg/dL for concentrations <100 mg/dL.	Target Glucose (mg/dL) Mean Glucose (mg/dL) SD (mg/dL) CV (%) 40 39.37 1.07 2.72 100 100.58 1.75 1.74 130 126.12 2.41 1.91 200 189.24 3.36 1.78 350 323.63 6.65 2.05 (All reported CVs are ≤2.72%.)
Total Precision	ISO 15197 similarly requires low CVs for total precision, typically ≤5%.	Glucose Level Ranges (mg/dL) Mean Glucose (mg/dL) SD (mg/dL) CV (%) Low (38-62) 50.66 1.28 2.53 Mid (102-138) 116.51 2.89 2.48 High (298-403) 350.02 7.7 2.2 (All reported CVs are ≤2.53%.)
User Performance Evaluation	Similar accuracy criteria as System Accuracy, but performed by intended users.	Subject Fingertip Results (<75 mg/dL): - ±5 mg/dL: 21/28 (75%) - ±10 mg/dL: 28/28 (100%) - ±15 mg/dL: 28/28 (100%) HCP Fingertip Results (<75 mg/dL): - ±5 mg/dL: 16/28 (57.1%) - ±10 mg/dL: 24/28 (85.7%) - ±15 mg/dL: Not reported, but likely close to 100%. Subject Fingertip Results (≥75 mg/dL): - ±5%: 68/128 (53.1%) - ±10%: 115/128 (89.8%) - ±15%: 127/128 (99.2%) - ±20%: 128/128 (100%) HCP Fingertip Results (≥75 mg/dL): - ±5%: 74/125 (59.2%) - ±10%: 109/125 (87.2%) - ±15%: 120/125 (96.0%) - ±20%: 124/125 (99.2%)
Alternate Site Testing	Similar accuracy criteria as System Accuracy, but for palm and forearm samples.	Subject Palm Results (<75 mg/dL): - ±5 mg/dL: 6/8 (75.0%) - ±10 mg/dL: 8/8 (100%) - ±15 mg/dL: 8/8 (100%) Subject Forearm Results (<75 mg/dL): - ±5 mg/dL: 4/7 (57.1%) - ±10 mg/dL: 6/7 (85.7%) - ±15 mg/dL: 7/7 (100%) Subject Palm Results (≥75 mg/dL): - ±5%: 80/154 (51.9%) - ±10%: 132/154 (85.7%) - ±15%: 146/154 (94.8%) - ±20%: 150/154 (97.4%) Subject Forearm Results (≥75 mg/dL): - ±5%: 66/144 (45.8%) - ±10%: 110/144 (76.4%) - ±15%: 127/144 (88.2%) - ±20%: 138/144 (95.8%)

Detailed Study Information:

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

System Accuracy:
- For glucose concentrations <75 mg/dL: 106 samples.
- For glucose concentrations ≥75 mg/dL: 504 samples.
- Data Provenance: Not explicitly stated, but clinical studies are generally prospective. The phrase "samples were tested in duplicate on three test strip lots" suggests these were controlled laboratory/clinical tests. The document implies a comparison against a "laboratory reference method" (YSI), which would typically be performed within a clinical laboratory setting.
Precision (Within Run): 300 venous blood tests.
Total Precision: 600 control solution tests.
User Performance Evaluation:
- Fingertip (<75 mg/dL): 28 samples for "Subject" and 28 samples for "HCP".
- Fingertip (≥75 mg/dL): 128 samples for "Subject" and 125 samples for "HCP".
Alternate Site Testing:
- Palm (<75 mg/dL): 8 samples.
- Forearm (<75 mg/dL): 7 samples.
- Palm (≥75 mg/dL): 154 samples.
- Forearm (≥75 mg/dL): 144 samples.
- Data Provenance: The user performance and alternate site testing suggests prospective human subject testing. The data provenance (e.g., country of origin) is not specified.

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

The document mentions validation against a "laboratory reference method, the Yellow Springs Instrument (YSI)." YSI instruments are highly accurate laboratory analyzers. The use of a YSI as the ground truth implies that its results are considered the gold standard, and the "experts" in this context would be the technicians operating and maintaining such a reference system, ensuring its proper calibration and use, rather than human expert readers interpreting images or data. The number and qualifications of YSI operators are not specified but are assumed to be standard for a clinical laboratory.

4. Adjudication Method for the Test Set:

Not applicable. The ground truth is established by a quantitative laboratory instrument (YSI), not by human interpretation requiring adjudication.

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

No, an MRMC study was not done. This device is a blood glucose monitoring system, not an imaging device or one that relies on human interpretation for diagnosis. The "User Performance Evaluation" section compares meter results from "Subject" (intended users) and "HCP" (Healthcare Professionals) against the laboratory reference, which is a form of user-interaction validation but not an MRMC comparative effectiveness study in the typical sense for AI.

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

Yes, the "System Accuracy" and "Precision" studies represent standalone performance. In these tests, the device (meter and test strip) directly provides a reading, which is then compared to the laboratory reference. There isn't a human in the loop interpreting the result before comparison. The user performance evaluations then add the "human-in-the-loop" aspect (the user taking the sample and performing the test).

7. The Type of Ground Truth Used:

The ground truth used is a laboratory reference method, specifically the Yellow Springs Instrument (YSI), which is an established and highly accurate method for glucose measurement.

8. The Sample Size for the Training Set:

The document does not provide information about a separate "training set" or its size. This type of device (a blood glucose meter) typically undergoes extensive engineering development and internal validation, but the concept of a "training set" in the context of machine learning (where AI algorithms are trained on data) is not explicitly applicable or mentioned here. The testing discussed primarily relates to analytical and clinical validation of the final device.

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

As no explicit "training set" is mentioned in the machine learning sense, this question is not directly applicable. If "training" implicitly refers to the development and calibration of the device, this would have been done by the manufacturer using internal standards and established scientific principles, likely with similar laboratory reference methods to ensure accuracy during development. However, the document provided focuses solely on the validation of the final product.

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