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.

Device Description

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.

AI/ML Overview

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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 16, 2014

Synovis Micro Companies Alliance Incorporated A Subsidiary of Synovis Life Technology Incorporated Mr. Troy Thome Regulatory Affairs Specialist 2575 University Avenue West. Suite 180 Saint Paul, Minnesota 55114

Re: K142309

Trade/Device Name: GEM™ Flow COUPLER™ Device and System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: MVR, DPW Dated: August 18, 2014 Received: August 19, 2014

Dear Mr. Thome:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known) K142309

Device Name GEM Flow COUPLER Device and System

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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2.0 510(K) SUMMARY

Submitted by	Synovis Micro Companies Alliance, Inc.A Subsidiary of Synovis Life Technologies, Inc.439 Industrial LaneBirmingham, AL 35211-4464
	FDA Registration #1062741
	Tel: 205-941-0111Fax: 205-941-1522
Contact Person	Troy ThomeSynovis Micro Companies Alliance, Inc.,A Subsidiary of Synovis Life Technologies, Inc.2575 University Avenue WestSt. Paul, MN 55114-1024
	Tel: 651-796-7550Fax: 651-603-5211
Date Prepared	August 11, 2014
Device Trade Name	GEM™ Flow COUPLER™ Device and System
Common Name	• Microvascular Anastomotic Coupler• Cardiovascular Blood Flowmeter
Classification Name	Microvascular Anastomotic CouplerRegulation Number: 21CFR § 878.4300Regulation Name: Implantable ClipRegulatory Class: IIProduct Code: MVR, DPW
Predicate Device(s)	GEM Flow COUPLER Device and System: K132727GEM Flow COUPLER Device and System: K093310

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Device Description	The Flow COUPLER System consists of a Flow COUPLER Deviceand a Flow COUPLER Monitor. The Flow COUPLER Device is asterile, single-use implantable pair of rings molded out of highdensity polyethylene with stainless steel pins on each ring. TheFlow COUPLER Device is designed to serve as a mechanical,sutureless device for connecting veins or arteries. A probe-holderfeature is molded on one Flow COUPLER ring and serves as thepress-fit point of attachment for a pre-attached 20 MHz Dopplerprobe. The Doppler probe connects to the Flow COUPLERMonitor unit, via the external lead.The Flow COUPLER Monitor and Doppler probe is a pulsedDoppler ultrasound system designed for the detection of blood flowin vessels. An audible ultrasonic signal is produced when theDoppler probe detects blood flow.The Flow COUPLER Device and System has been specificallydesigned for use in end-to-end anastomosis of blood vessels and thedetection of blood flow at the anastomotic site. On an as neededbasis, blood flow can be detected for up to 7 days. The FlowCOUPLER rings are intended to be a permanent implant. The FlowCOUPLER probe is not intended to be a permanent implant; theprobe should be removed, by gentle traction on the external lead,3 to 14 days post-operatively.
Statement ofIntended use	The Flow COUPLER Device and System is intended to be used inthe anastomosis of veins and arteries normally encountered inmicrovascular and vascular reconstructive procedures and in thedetection of blood flow and confirmation of vessel patency followingend-to-end anastomosis of vessels.
TechnologicalComparisons	The Flow Coupler Device and System is acting as its own predicate and is therefore substantially equivalent having the same technological characteristics including:
	Intended use Indications for use Device functionality Device method of operation Device finished specifications Doppler probe (wire material, wire diameter, and insulation material)Power supply requirements Device monitor Packaging Sterilization method Shelf life
	The modified Flow Coupler device has the following differences as compared to the predicate device:
	Device size range Device dimensions Additional stainless steel pins (2)
Technology/DeviceTesting	A risk assessment of the size range extension in the form of a Design FMEA and Health Hazard Analysis has been conducted in accordance with EN ISO 14971: 2012.
	Bench testing on the 3.5mm Flow COUPLER line extension was performed to validate that the functional specifications were not affected by the line extension. Testing included: shock and vibration, pin alignment (visual), ring retention, probe signal, ring separation, and probe to COUPLER separation force.
	The risk assessment and bench testing of this device demonstrate that the device is substantially equivalent to the predicate device.
Summary	The device is substantially equivalent to the predicate device with respect to biocompatibility, manufacturing process, product performance, indications, sterilization, shelf life, packaging, and safety and efficacy.

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Regulation Number and Section

§ 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.