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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. The system is intended to be used by a single patient and should not be shared.
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 is not to be used for the diagnosis of or screening of diabetes or for neonatal use.
The OneTouch® Verio® Test Strips are for use with the OneTouch® Verio® Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.

The OneTouch® Verio® Blood Glucose Monitoring System consists of the OneTouch® Verio® Sync Blood Glucose Meter, OneTouch® Verio® Test Strips, OneTouch® Verio® Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch® Verio® Blood Glucose Monitoring 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.

Here's a breakdown of the acceptance criteria and study information for the OneTouch Verio Blood Glucose Monitoring System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document specifically refers to ISO 15197:2003(E) as the standard for performance testing. While ISO 15197:2003(E) has specific accuracy criteria (e.g., a certain percentage of results within ±X mg/dL or ±Y%), the summary text reports the device's performance against those criteria rather than explicitly stating the criteria as acceptance thresholds separate from the results. However, we can infer the acceptance criteria from the reported performance, as reaching 100% within certain thresholds implies these were the targets.

Note: While the results are high, the table does not explicitly state 100% for these user performance categories, so we cannot infer 100% as the acceptance criterion from the provided text for user performance.

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

• System Accuracy Test Set Sample Sizes:
  • Glucose < 75 mg/dL: 69 samples
  • Glucose ≥ 75 mg/dL: 231 samples
• User Performance Evaluation Test Set Sample Sizes:
  • Glucose < 75 mg/dL: 20 samples
  • Glucose ≥ 75 mg/dL: 169 samples
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective as they were conducted as part of design verification and validation testing for the 510(k) submission.

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

• The document mentions comparison to a "laboratory reference method, the Yellow Springs Instrument (YSI)". This indicates that the ground truth was established by a validated laboratory method, not by human experts. Therefore, the concept of "number of experts" and "qualifications of those experts" does not apply in this context.

4. Adjudication Method for the Test Set:

• Not applicable, as the ground truth was established by a laboratory reference instrument (YSI), which provides a quantitative measurement, not a subjective interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not conducted with human readers improving with AI vs without AI assistance. This device is a blood glucose meter, and its performance is evaluated against a reference laboratory method, not against human interpretation of images or data.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance:

• Yes, the "System Accuracy" section reports the performance of the device (meter) directly against the laboratory reference method, which is a standalone assessment of the algorithm/device. The "User Performance Evaluation" also assesses the device, but in the hands of intended users, which is slightly different but still focuses on the device's accuracy.

7. Type of Ground Truth Used:

• The type of ground truth used was a laboratory reference method (Yellow Springs Instrument - YSI). This is a quantitative, highly accurate measurement system often considered the gold standard for glucose concentration.

8. Sample Size for the Training Set:

• The document does not explicitly state a separate "training set" sample size. For in vitro diagnostic devices like blood glucose meters, the development and calibration typically involve extensive data, but the 510(k) summary focuses on the performance verification using a distinct test set. The precision data (Within Run Precision with 300 venous blood tests per glucose level, and Total Precision with 600 control solution tests at each level) could be considered part of the data used for device development and characterization, but not explicitly as a "training set" in the machine learning sense.

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

• As a dedicated "training set" is not explicitly mentioned in the context of machine learning model training, this question is not directly applicable. However, the overall development and calibration of the glucose meter would rely on a robust ground truth established by laboratory reference methods (like the YSI) to ensure accurate measurements across various glucose concentrations, similar to how the test set ground truth was established.

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The OneTouch Verio Sync Blood Glucose Monitoring System (BGMS) is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The system is intended to be used by a single person and should not be shared.

The OneTouch Verio Sync BGMS 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 Sync BGMS should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The OneTouch Verio Test Strips are for use with the OneTouch Verio Sync Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

The OneTouch® Verio™ Sync Blood Glucose Monitoring System consists of the OneTouch® Verio™ Sync Blood Glucose Meter, OneTouch® Verio™ Test Strips, OneTouch® Verio™ Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch® Verio™ Sync Blood Glucose Monitoring 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.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for OneTouch Verio Sync Blood Glucose Monitoring System

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against the requirements of ISO 15197:2003(E) for system accuracy. The provided text details two levels of accuracy checks: against a laboratory reference method (YSI) and a user performance evaluation with fingertip blood samples.

System Accuracy (Against Laboratory Reference - YSI)

Total Precision (Based on Control Solution Tests)

User Performance Evaluation (Subject Fingertip Results)

Note: The document states that the testing was performed in accordance with ISO 15197:2003(E). While the specific acceptance thresholds (e.g., "95% of results within...") are not explicitly listed in the provided text as "acceptance criteria," they are inherent to meeting the ISO standard. The reported performance values demonstrate that the device met or exceeded these implicit acceptance criteria.

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

• Test Set Sample Size for System Accuracy (Against Lab Reference):
  • Glucose <75 mg/dL: 57 samples
  • Glucose ≥75 mg/dL: 243 samples
  • Total for System Accuracy: 300 samples (57 + 243)
• Test Set Sample Size for User Performance Evaluation:
  • Glucose <75 mg/dL: 23 samples
  • Glucose ≥75 mg/dL: 250 samples
  • Total for User Performance: 273 samples (23 + 250)
• Test Set Sample Size for Total Precision: 600 control solution tests.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for a medical device cleared in the US (FDA), it is highly probable that the studies were conducted in accordance with good clinical practice and likely involved prospective data collection.

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

• Number of Experts: Not applicable in the context of this device. The ground truth for glucose measurements is established by a laboratory reference method, specifically the Yellow Springs Instrument (YSI).
• Qualifications of Experts: Not applicable. The YSI is a highly accurate and standardized laboratory instrument used for reference glucose measurements.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth is established by a quantitative laboratory reference method (YSI), which does not typically involve human expert adjudication for determining values. The comparison is directly between the device's reading and the YSI's reading.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human readers interpret images. For a blood glucose monitoring system, the focus is on the accuracy and precision of the numerical measurement provided by the device, both in a lab setting and by a single lay user. The "user performance evaluation" assesses accuracy and usability, not reader improvement with AI assistance.
• Effect size of human readers improve with AI vs without AI assistance: Not applicable as it wasn't an MRMC study with AI.

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

• Yes, a standalone performance study was done. The "System Accuracy" section (Page 4) directly compares the OneTouch® Verio™ Sync Blood Glucose Monitoring System's results to a laboratory reference method (YSI). This is a standalone assessment of the device's (meter, strips, and control solutions) accuracy without direct human interpretation influencing the measurement itself, beyond applying the blood sample and following test procedure.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for glucose concentrations was established using a laboratory reference method, specifically the Yellow Springs Instrument (YSI). This is a highly accurate and precise method for determining glucose levels in blood samples.

8. The Sample Size for the Training Set

• The document does not explicitly state a separate sample size for a training set. For a blood glucose monitoring system, particularly one cleared via 510(k) as "substantially equivalent," the focus is on verification and validation testing rather than large-scale training of an artificial intelligence algorithm in the way a machine learning device would require. The system's underlying electrochemical reaction and algorithms are inherent to its design and calibrated during manufacturing. Therefore, there isn't a "training set" in the sense of a dataset used to train a machine learning model.

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

• As mentioned in point 8, a distinct "training set" for a machine learning algorithm is not detailed or implied in the submission. The device's operational principles are based on established electrochemical sensing technology. Any internal calibration or algorithm development would have relied on highly controlled glucose standards and reference methods during the device's engineering and design phases. The "ground truth" for the device's development and calibration would similarly be laboratory reference methods, but the specific details and dataset sizes for this are not provided in the 510(k) summary.

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

OneTouch® Verio" IQ 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" "IQ Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes, neonatal use.

The OneTouch® Verio" Test Strips are for use with the OneTouch® Verio" IQ Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.

The OneTouch® Verio" Verio" IQ Blood Glucose Monitoring System consists of the OneTouch Verio" " Q Blood Glucose Meter, OneTouch® Verio" Test Strips, OneTouch® Verio" Mid and High Control Solutions, Lancing Device, Sterile Lancets and Alternative Site testing Kit (available separately). The Alternative Site Testing Kit comprises the OneTouch® Lancing Device, OneTouch® UltraSoft" Sterile Lancets, OneTouch®, Clear Cap and Instructions for Use. The OneTouch® Verio" IQ Blood Glucose Monitoring 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.

The OneTouch® Verio™ IQ Blood Glucose Monitoring System was tested in accordance with ISO 15197:2003(E) to demonstrate its performance characteristics.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for system accuracy are generally defined in ISO 15197:2003(E). While the document doesn't explicitly state the "acceptance criteria" alongside the results, the provided performance data demonstrates adherence to typical standards for blood glucose meters. Often, for glucose concentrations <75 mg/dL, the results should be within ±15 mg/dL, and for concentrations ≥75 mg/dL, within ±15% or ±20%.

2. Sample sizes used for the test set and the data provenance

• System Accuracy Test Set:

  • Number of Subjects: 100
  • Number of Tests: 600 (each subject tested 6 times, likely in duplicate for three test strip lots).
  • Data Provenance: Not explicitly stated, but the study "was tested in accordance with ISO 15197:2003(E)" which is an international standard. Given the sponsor is "LifeScan Europe, a Div. of Cilag GmbH International, Zug, Switzerland," and the correspondent is in the UK, it is highly likely the data is from Europe/UK. It appears to be a prospective study for regulatory submission.

• User Performance Evaluation Test Set:

  • Number of Subjects: Not explicitly stated as a single number, but there are "Subject" (intended users) results totalling 276 measurements (<75 mg/dL: 31, ≥75 mg/dL: 245) and "HCP" results totalling 276 measurements (<75 mg/dL: 31, ≥75 mg/dL: 245). This implies at least 31 data points for glucose <75 mg/dL and 245 for glucose ≥75 mg/dL for both subject and HCP users.
  • Data Provenance: Not explicitly stated, but likely from the same geographical region as the system accuracy study. It is a prospective user study.

• Alternate Site Testing (AST) Test Set:

  • Palm Site: 8 measurements (<75 mg/dL), 154 measurements (≥75 mg/dL).
  • Forearm Site: 7 measurements (<75 mg/dL), 144 measurements (≥75 mg/dL).
  • Data Provenance: Not explicitly stated, but likely from the same geographical region as the system accuracy study. It is a prospective user study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states that the device was compared to a "laboratory reference method, the Yellow Springs Instrument (YSI)." This is a laboratory-grade analyzer, highly accurate and commonly used as a gold standard for blood glucose measurement. The ground truth is established by this instrument, not by human experts. Therefore, the number and qualifications of experts in this context are not applicable.

4. Adjudication method for the test set

Not applicable. The ground truth is a direct measurement from a YSI laboratory analyzer, which is a quantitative and objective measurement. There is no human interpretation or adjudication involved in establishing the ground truth for glucose values.

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

Not applicable. This is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device with human readers. The device performs a direct measurement of glucose.

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

Yes, the "System Accuracy" section represents the standalone performance of the device (meter and strips) compared against the YSI laboratory reference method. The "User Performance Evaluation" sections then assess the performance when humans (subjects/HCPs) use the device, which includes the human-in-the-loop aspect of sample collection and meter operation.

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

The ground truth used for system accuracy and user performance evaluation is the Yellow Springs Instrument (YSI), which is a highly accurate and established laboratory reference method for glucose measurement. This falls under a "reference standard" or "gold standard" laboratory method.

8. The sample size for the training set

The document does not explicitly state the sample size for a "training set." This device is a blood glucose meter, and its performance is based on electrochemical principles and calibration. While the device would undergo internal calibration and development, the concept of a "training set" as understood in machine learning is not directly applicable or reported in this type of regulatory submission for a traditional in-vitro diagnostic device. Analytical and clinical performance studies are typically validation sets.

9. How the ground truth for the training set was established

As there is no distinct "training set" reported in the machine learning sense, this question is not fully applicable. However, for the underlying calibration and development of the device, similar reference methods (like YSI) would be used to ensure the meter's accuracy across various glucose concentrations, ensuring it correctly translates electrochemical signals into glucose readings.

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