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The FLOW COUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FLOW COUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FLOW COUPLER Device is used in conjunction with the FLOW COUPLER Monitor, the FLOW COUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Post-operatively, blood flow can be detected on an as needed basis for up to 7 days. The FLOW COUPLER Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days post-operatively.

The GEM FLOW COUPLER System is designed for the detection of blood flow in vessels. The GEM FLOW COUPLER System consists of components as described below:

1. FLOW COUPLER Device (Product Code MVR) - single-use implantable rings used to secure anastomosis of small vessels. This includes a 20MHz ultrasonic Doppler transducer (probe) which attaches to one of the FLOW COUPLER rings, and an external lead.
2. FLOW COUPLER Monitor (Product Code DPW) - portable monitor that provides the audible output of the FLOW COUPLER Device's pulsed Doppler ultrasound signal. A varying audible signal is produced when the FLOW COUPLER Device (probe) detects flow.

The medical device in question is the GEM FLOW COUPLER Monitor (GEM1020M-2).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for each specific test set (e.g., how many monitors were tested for cleaning, how many for audio quality). However, the tests described are primarily non-clinical performance tests of the device's hardware, firmware, and cleaning protocols. Therefore, the "data provenance" is typically within a controlled laboratory or manufacturing environment, rather than clinical patient data. There is no information regarding country of origin of data or whether it was retrospective or prospective, as these are not relevant to these types of engineering/performance tests.

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

For the types of tests conducted (e.g., cleaning, design, audio quality, EMC), the "ground truth" is established by industry standards (e.g., IEC 60601-1:2005, IEC 60601-1-2 Edition 4.1: 2020, 47 CFR, Part 15:2022) and the manufacturer's internal design and functional specifications. These are objective measures rather than subjective expert consensus. Therefore, the concept of "experts establishing ground truth" in the manner of medical image interpretation is not directly applicable here. The "experts" would be the engineers and technicians performing the tests and verifying compliance with the established standards and specifications. Their qualifications are implicitly in their ability to perform such tests and interpret the standards.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense for non-clinical performance and engineering tests. The tests are designed with objective acceptance criteria, and the results (e.g., measured values, pass/fail based on a threshold) are typically directly compared against these criteria.

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. This document describes a 510(k) Pre-market Notification for modifications to an existing device, the GEM FLOW COUPLER Monitor. The changes are primarily hardware and firmware updates (power management, power button, audio system, remote monitoring disabling) and labeling updates (cleaning solutions). The device itself (a cardiovascular blood flowmeter) provides audible output to a human user to detect blood flow and confirm vessel patency. It does not involve AI or image interpretation, and therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not applicable.

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

No. This device is a monitor that provides audible output to a human user (surgeon, nurse) for the detection of blood flow. It is intrinsically a "human-in-the-loop" device in its intended use. It does not operate as a standalone algorithm for diagnosis or decision-making.

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

The ground truth for the performance tests is based on:

• International and Federal Standards: e.g., IEC 60601-1, IEC 60601-1-2, 47 CFR Part 15.
• Manufacturer's Design and Functional Specifications: These are internal objective criteria derived from engineering requirements.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm or a diagnostic tool that requires a "training set" in the machine learning sense. The performance tests are for hardware and software functionality, not for training a model.

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

Not applicable, as there is no training set for this device.

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