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The Dexcom Pro Q Continuous Glucose Monitoring System (Dexcom Pro Q System) is a factory calibrated continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 years and older under the supervision of a healthcare professional. The Dexcom Pro Q System collects and processes data for aiding in the management of a disease or condition related to glycemic control.

Interpretation of the data recorded by the Dexcom Pro Q System results should be made only by a qualified healthcare professional based on glucose trends and several sequential readings over time. The Dexcom Pro Q System aids in detecting glucose excursions facilitating care plan adjustments. The Dexcom Pro Q System is also intended to interface with digitally connected devices.

The Dexcom Pro Q Continuous Glucose Monitoring System (Dexcom Pro Q System) is a continuous glucose monitor that offers an altered feature set versus the predicate Dexcom G6 CGM System.

The Dexcom Pro Q System consists of two main components: sensor/applicator delivery system, and a transmitter. The sensor is a small and flexible wire inserted into subcutaneous tissue where it converts glucose into electrical current. The transmitter is connected to the sensor and is worn on the body. It samples the electrical current produced by the sensor and converts these measurements into glucose readings using an onboard algorithm. The transmitter logs estimated glucose values every 5 minutes during the sensor wear period (up to 10 days).

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

The provided document is a 510(k) summary for the Dexcom Pro Q Continuous Glucose Monitoring System, comparing it to the Dexcom G6 CGM System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting extensive new clinical studies for efficacy. Therefore, a traditional "study that proves the device meets the acceptance criteria" in the sense of a novel clinical trial with specific performance endpoints outlined in detail isn't fully present in this document. Instead, it relies on the predicate's established performance and verifies that the new device performs similarly.

Based on the available information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative "acceptance criteria" in a typical table format for a clinical study. Instead, it claims substantial equivalence to the predicate device (Dexcom G6), which implies that its performance should be comparable. The relevant performance claims are related to its function as a continuous glucose recording device for retrospective analysis.

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

The document does not provide details on the sample size for a test set for the Dexcom Pro Q, nor does it specify data provenance (country of origin, retrospective/prospective). This is typical for a 510(k) submission not requiring new clinical trials, as it relies on the predicate's established performance and the new device's verification against its own specifications. The "performance testing" mentioned is likely internal validation and verification processes rather than a new clinical study with a distinct test set.

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

This information is not provided. Given the nature of a 510(k) submission based on substantial equivalence and typical device verification/validation, a panel of experts for ground truth establishment in a clinical context isn't a stated component of the testing summarized here. Ground truth would be based on reference glucose measurements if any clinical data was collected, but details are absent.

4. Adjudication Method for the Test Set

No information is provided regarding an adjudication method.

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

No, an MRMC comparative effectiveness study was not done or at least not described in this 510(k) summary. This type of study is more common for diagnostic imaging devices where human interpretation is a critical factor. For a CGM device, the primary "output" is a glucose value, not an interpretation by a reader.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document heavily implies standalone algorithm performance as a core component of its functioning. The "transmitter samples the electrical current... and converts these measurements into glucose readings using an onboard algorithm" (Page 4). The "performance testing" mentioned in Section 5.7 would have verified the accuracy of this algorithm against specified targets, although the specifics of the test protocol are not provided in this summary.

7. The Type of Ground Truth Used

The type of ground truth is not explicitly stated in this summary. For CGM devices, the ground truth for glucose values would typically be obtained from a highly accurate laboratory reference method (e.g., YSI glucose analyzer) applied to blood samples taken simultaneously with CGM readings. This would be part of the predicate device's original clinical validation. For the Dexcom Pro Q, if any new clinical data were collected, similar reference methods would be used.

8. The Sample Size for the Training Set

The document does not provide information about the training set size for the algorithm. It states the Dexcom Pro Q System uses an "onboard algorithm" but doesn't detail its development or training.

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

This information is not provided. Similar to point 8, the document is a 510(k) summary focused on substantial equivalence rather than a detailed algorithm development document.

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