(29 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 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 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 document is a 510(k) Premarket Notification from the FDA for the GEM™ Flow COUPLER™ Device and System. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics of a new device.
Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, ground truth establishment, and expert involvement are not explicitly present in the provided text. The document states that the modified Flow Coupler device is considered substantially equivalent to its own predicate (K142609), which is the GEM Flow COUPLER Device and System.
Here's an attempt to answer the questions based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with quantitative acceptance criteria and reported device performance in the way a clinical study or performance verification study for a new device might. Instead, it states that "functional specifications were not affected by the line extension" for the 4.0mm Flow COUPLER. The acceptance criteria would broadly be that the modified device performs equivalently to the predicate device across the listed tests.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional specifications not affected by size range extension | "functional specifications were not affected by the line extension" (for 4.0mm Flow COUPLER) |
| Shock and vibration performance maintained | Testing included: "shock and vibration" (implies performance was acceptable/equivalent to predicate) |
| Pin alignment maintained | Testing included: "pin alignment" (implies performance was acceptable/equivalent to predicate) |
| Ring retention maintained | Testing included: "ring retention" (implies performance was acceptable/equivalent to predicate) |
| Probe signal maintained | Testing included: "probe signal" (implies performance was acceptable/equivalent to predicate) |
| Ring separation maintained | Testing included: "ring separation" (implies performance was acceptable/equivalent to predicate) |
| Probe to COUPLER separation force maintained | Testing included: "probe to COUPLER separation force" (implies performance was acceptable/equivalent to predicate) |
| Device is substantially equivalent to predicate device | "The risk assessment and bench testing of this device demonstrate that the device is substantially equivalent to the predicate device." |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "bench testing on the 4.0mm Flow COUPLER line extension," but it does not specify the sample size for any of these tests. The data provenance is not mentioned, but given it's a submission to the US FDA and the company is based in the US, it's highly likely the testing was conducted in the US. The nature of "bench testing" implies it's a prospective series of tests performed on physical devices.
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)
This information is not provided in the document. For bench testing of physical properties, "experts" in the clinical sense are typically not involved; rather, engineering and quality assurance personnel conduct the tests against specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are highly relevant for clinical studies or studies involving human interpretation. For bench testing of functional specifications, the results are usually objective measurements against predefined engineering tolerances.
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
There is no mention of an MRMC study or AI assistance in this document. The device is a mechanical coupler with an ultrasonic Doppler probe, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is not an algorithm, but a physical medical device. It has a "standalone" function in the sense that the Doppler probe detects blood flow independently, but it is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench tests, the "ground truth" would be the engineering specifications and established functional parameters of the predicate device or industry standards for similar devices. For example, for "ring retention" or "probe signal," there would be quantifiable metrics and tolerances that the device must meet.
8. The sample size for the training set
There is no mention of a training set. This type of test is for a physical device, not a machine learning model.
9. How the ground truth for the training set was established
This is not applicable as there is no training set mentioned.
§ 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.