(28 days)
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 intraoperatively 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 Flow COUPLER System consists of a Flow COUPLER Device and a Flow COUPLER Monitor. The Flow COUPLER Device is a sterile, single-use implantable pair of rings molded out of high density polyethylene with stainless steel pins on each ring. The Flow COUPLER Device is designed to serve as a mechanical, sutureless device for connecting veins or arteries. A probe-holder feature is molded on one Flow COUPLER ring and serves as the press-fit point of attachment for a pre-attached 20 MHz Doppler probe. The Doppler probe connects to the Flow COUPLER Monitor unit, via the external lead.
The Flow COUPLER Monitor and Doppler probe is a pulsed Doppler ultrasound system designed for the detection of blood flow in vessels. An audible ultrasonic signal is produced when the Doppler probe detects blood flow.
The Flow COUPLER Device and System has been specifically designed for use in end-to-end anastomosis of blood vessels and the detection of blood flow at the anastomotic site. On an as needed basis, blood flow can be detected for up to 7 days. The Flow COUPLER rings are intended to be a permanent implant. The Flow COUPLER probe is not intended to be a permanent implant; the probe should be removed, by gentle traction on the external lead, 3 to 14 days post-operatively.
The provided text describes the GEM™ Flow COUPLER™ Device and System, which is a medical device for microvascular reconstruction procedures. However, the document is a 510(k) premarket notification decision letter from the FDA, and it focuses on demonstrating substantial equivalence to a predicate device, not on proving that the device meets specific acceptance criteria through a clinical study or AI model performance evaluation.
Therefore, the requested information categories regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, adjudication, and MRMC/standalone studies cannot be fully provided based on the given document.
The document indicates that this device is an update to an existing device (K132727 and K093310). The "acceptance criteria" discussed are largely related to ensuring the new version retains the safety and effectiveness of the previous version and that manufacturing and design changes (like an extended size range) do not negatively impact performance.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported device performance in the context of an AI model or a specific clinical trial outcome (e.g., sensitivity, specificity, AUC). Instead, it discusses the validation of functional specifications for a line extension.
| Acceptance Criteria Category (Implied) | Reported Device Performance/Testing |
|---|---|
| Functional Specifications (3.5mm Flow COUPLER line extension) | Bench testing performed to validate that functional specifications were not affected by the line extension. |
| Shock and Vibration | Tested |
| Pin Alignment (visual) | Tested |
| Ring Retention | Tested |
| Probe Signal | Tested |
| Ring Separation | Tested |
| Probe to COUPLER separation force | Tested |
| Risk Assessment | Design FMEA and Health Hazard Analysis conducted in accordance with EN ISO 14971:2012. |
| Overall Equivalence | Device demonstrated substantial equivalence to the predicate device with respect to biocompatibility, manufacturing process, product performance, indications, sterilization, shelf life, packaging, and safety and efficacy. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document discusses "bench testing" for a device line extension, not a test set for an algorithm or a clinical study. No information on sample size or data provenance in this context is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not a study involving expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving an adjudicated test set.
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 does not mention an MRMC study or AI models. It pertains to a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This document does not discuss an algorithm or standalone performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the bench testing, the "ground truth" would be the engineering specifications and expected performance benchmarks for each test (e.g., a certain force for probe separation, a clear probe signal). For the risk assessment, it would be the identified hazards and their severities. This is not clinical ground truth.
8. The sample size for the training set
Not applicable. This document does not describe a training set for an AI model.
9. How the ground truth for the training set was established
Not applicable. This document does not describe a training set for an AI model.
In summary: The provided text is a regulatory clearance document for a medical device (GEM™ Flow COUPLER™ Device and System) based on substantial equivalence. It details manufacturing, design, and functional testing to support modifications to an existing device, rather than providing the kind of performance data usually associated with acceptance criteria for a new AI-powered diagnostic or prognostic tool.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.