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The CONTOUR® NEXT GEN Blood Glucose Monitoring System consists of the CONTOUR® NEXT GEN meter, CONTOUR® NEXT blood glucose test strips and the CONTOUR® Diabetes app.

The CONTOUR® NEXT GEN Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The CONTOUR® NEXT GEN Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® NEXT GEN 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 in monitoring the effectiveness of a diabetes control program.

The CONTOUR® NEXT GEN Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use.

The system is intended for in vitro diagnostic use only.

The CONTOUR® PLUS BLUE Blood Glucose Monitoring System consists of the CONTOUR® PLUS BLUE meter, the CONTOUR® PLUS blood qlucose test strips, and the CONTOUR® Diabetes app.

The CONTOUR® PLUS BLUE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® PLUS BLUE 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 in monitoring the effectiveness of a diabetes control program.

The CONTOUR® PLUS BLUE Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The CONTOUR® PLUS blood glucose test strips are for use with the CONTOUR® PLUS BLUE meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips.

The system is intended for in vitro diagnostic use only.

CONTOUR® NEXT GEN and CONTOUR® PLUS BLUE Blood Glucose Meters have Bluetooth Low Energy technology built in so that the meters can communicate wirelessly to smart phones and tablets. The CONTOUR® NEXT GEN meter uses the CONTOUR® NEXT blood glucose test strips and CONTOUR® NEXT control solution and CONTOUR® PLUS BLUE meter uses CONTOUR® PLUS blood glucose test strips and CONTOUR® PLUS control solution respectively. The meters can be connected to the CONTOUR® Diabetes app. Both the meters use two replaceable coin cell batteries. Both the meters' shape is a traditional oval form factor. The CONTOUR® NEXT GEN and CONTOUR® PLUS BLUE meters have smartLIGHT® and smartCOLOR® indicator features respectively to see if a glucose result is above, within, or below target range.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CONTOUR® PLUS BLUE and CONTOUR® NEXT GEN Blood Glucose Monitoring Systems.

It's important to note that the provided FDA 510(k) clearance letter and summary primarily focus on demonstrating substantial equivalence to a predicate device, specifically for a minor modification (change in Bluetooth Low Energy microprocessor). As such, the documentation does not contain exhaustive details about the initial validation studies that established the device's fundamental accuracy and performance. Instead, it leverages previous clearances and focuses on showing that the change doesn't negatively impact performance.

Therefore, for several points requested in the prompt, the information is not available in the provided text, as the submission is for a modification rather than an entirely new device's initial clearance.

Acceptance Criteria and Device Performance

The document states that "Bench testing showed that the CONTOUR® NEXT GEN Blood Glucose Monitoring System and CONTOUR® PLUS BLUE Blood Glucose Monitoring System performed as intended and met the relevant standards (ANSI IEEE C63.27-2021, IEEE UL Std 2621.2-2022, IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION), performance testing and software testing applicable to this change."

While specific numerical acceptance criteria (e.g., accuracy percentages) and detailed reported performance metrics are not explicitly listed in this 510(k) summary, the mention of "relevant standards" and "performance testing" implies that the device met the established performance requirements for blood glucose monitoring systems. For the purpose of this specific modification submission, the critical acceptance criterion was demonstrating that the measurement function was not impacted by the change.

Given the nature of the submission (a change in microprocessor), the primary 'acceptance criteria' in this context are:

Note: For a full, initial clearance of a blood glucose meter, specific accuracy criteria (e.g., ISO 15197) would be provided, often specifying percentages of readings within a certain deviation from a reference method (e.g., laboratory analyzer) for different glucose ranges. These details are not in the provided modification summary.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified for this particular submission's testing. The document states "Bench testing including reliability testing, software verification and validation, and confirmation of no impacts to BGM measurement was conducted." This type of testing typically involves a set number of meters and strips, and controlled blood samples, but the exact quantities are not detailed in this summary.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The testing described is "bench testing," implying laboratory-based evaluation. The document also states "The modified devices also relied on previously conducted analytical testing to support substantial equivalence." This suggests some data would be retrospective from prior clearances. The "clinical testing was leveraged from the previous clearances," meaning no new clinical trials were conducted for this specific modification.

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

   • Not Applicable / Not Specified. For a blood glucose meter, "ground truth" for accuracy is typically established by comparative measurements against a laboratory reference method (e.g., a YSI Glucose Analyzer) using blood samples with known glucose concentrations, not by expert consensus on visual review as might be the case for imaging devices. The document does not describe the specific ground truth establishment method for the bench testing beyond stating "confirmation of no impacts to BGM measurement." For the leveraged clinical testing (from previous submissions), the ground truth would have been established using a laboratory reference method, but the details are not provided here.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation of data (e.g., radiology reads) to resolve discrepancies. This document describes bench testing for a physical/electrical device modification and leveraging prior clinical data, neither of which involves such adjudication processes.

4. 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. This is a blood glucose monitoring system, not an AI-powered image analysis or diagnostic tool involving human readers. Therefore, an MRMC study is not relevant or performed for this device.

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

   • Partially Applicable. Blood glucose meters are essentially standalone algorithms (or systems) that provide a numerical output. The "bench testing" and "confirmation of no impacts to BGM measurement" assessed the device's performance directly, independent of a human "in the loop" for the measurement itself, beyond the act of sampling. The focus was on the performance of the meter and strips, and the impact of the new microprocessor on that performance.

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

   • Analytical Reference Method. For blood glucose meters, the ground truth for accuracy is established by a highly accurate laboratory reference method (e.g., YSI Glucose Analyzer) that measures glucose concentration in blood samples. This is a scientific, analytical measurement, not based on expert consensus or pathology. While not explicitly detailed for this submission's testing, it would have been the ground truth for the "previously conducted analytical testing" and "clinical testing leveraged from the previous clearances."

7. The sample size for the training set:

   • Not Applicable / Not Specified. This document describes a modification to an existing, cleared device, not the development of a new device or an AI/machine learning model that would have a traditional "training set." The performance assessments are validation efforts, not model training.

8. How the ground truth for the training set was established:

   • Not Applicable. See point 7.

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The CONTOUR® PLUS BLUE Blood Glucose Monitoring System consists of the CONTOUR® PLUS BLUE meter, the CONTOUR® PLUS blood glucose test strips and the Contour® Diabetes app.

The CONTOUR® PLUS BLUE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® PLUS BLUE 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 in monitoring the effectiveness of a diabetes control program.

The CONTOUR® PLUS BLUE Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The CONTOUR® PLUS blood glucose test strips are for use with the CONTOUR® PLUS BLUE meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips.

The system is intended for in vitro diagnostic use only.

CONTOUR® PLUS BLUE Blood Glucose Monitoring System is a blood glucose monitoring system with Bluetooth Low Energy technology built in so that the meter can communicate wirelessly to smart phones and tablets. The meter uses the CONTOUR® PLUS blood glucose test strips and CONTOUR® PLUS control solution. The meter can be connected to the Contour® Diabetes app. It utilizes a similar algorithm as the one used in the CONTOUR® NEXT GEN Blood Glucose Monitoring System. It uses two replaceable coin cell batteries. The meter's shape is a traditional oval form factor and it includes an on-screen arrow that points to the color indicating if a glucose result is above, within, or below target range.

This document describes the CONTOUR® PLUS BLUE Blood Glucose Monitoring System, a medical device for quantitative measurement of glucose in fresh capillary whole blood. The submission aims to demonstrate substantial equivalence to a predicate device (CONTOUR® NEXT GEN Blood Glucose Monitoring System (K193407)).

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided text generally states that the device "met the system specifications" and "performed as intended." However, it does not provide specific numerical acceptance criteria or detailed performance data in a tabular format as requested. Therefore, the table below provides what can be inferred from the text, but lacks the specific quantitative details typically found in such a table.

Important Note: The current document lacks the detailed numerical acceptance criteria (e.g., specific accuracy ranges, precision limits, interference limits) and the corresponding measured performance data. For a complete answer, this information would be required from a more detailed study report.

2. Sample Size and Data Provenance

The document states that "clinical testing showed that the CONTOUR® PLUS BLUE Blood Glucose Monitoring System performed as intended and met the system specifications." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study).

3. Number of Experts and Qualifications for Ground Truth

The document does not provide any information regarding the number of experts used to establish the ground truth for the test set or their qualifications. This information is typically relevant for studies involving human interpretation (e.g., interpretation of medical images), which is not directly applicable to a blood glucose monitoring system that provides a quantitative reading. The "ground truth" for a device measuring glucose would likely be a highly accurate laboratory reference method.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method. This is usually relevant in studies where multiple human readers or experts are involved in assessing data, and their disagreements need to be resolved. For a blood glucose monitoring system, the "adjudication" would refer to the process by which the reference method's result is established, which is typically a standardized laboratory procedure rather than expert consensus on interpretation.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to a blood glucose monitoring system. This type of study evaluates the effect of AI assistance on human reader performance, typically in diagnostic imaging. The CONTOUR® PLUS BLUE system directly measures glucose and provides a reading, without human interpretation in the same way an imaging study would require. Therefore, no such study was performed or needed.

6. Standalone Performance (Algorithm Only)

The document focuses on the overall system performance, which includes the meter, test strips, and app. It states that the system "met the system specifications." While the device uses "a similar algorithm as the one used in the CONTOUR® NEXT GEN Blood Glucose Monitoring System," the document does not provide separate standalone (algorithm-only) performance data. The performance described encompasses the integrated device.

7. Type of Ground Truth Used

While not explicitly stated, for a blood glucose monitoring system, the ground truth is typically established using a highly accurate laboratory reference method for glucose measurement (e.g., a YSI analyzer, or a certified clinical laboratory method). This is the gold standard against which the device's measurements are compared. The document states "clinical testing showed that the CONTOUR® PLUS BLUE Blood Glucose Monitoring System performed as intended and met the system specifications," implying comparison to a reference.

8. Sample Size for the Training Set

The document does not provide any information about the sample size for the training set. The device utilizes "a similar algorithm as the one used in the CONTOUR® NEXT GEN Blood Glucose Monitoring System," which suggests that the core algorithm may have been trained previously, and this submission focuses on validating the integrated system.

9. How Ground Truth for Training Set Was Established

The document does not provide any information on how the ground truth for the training set was established. Given it states the algorithm is "similar" to a previously approved device, it's possible the training data and ground truth protocols for the original algorithm are foundational, but the specific details are not present in this submission summary. As with the test set, it would expectedly involve comparison to a laboratory reference method.

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