The modified Coalescent Surgical U-CLIP™ is intended for endoscopic and non-endoscopic tissue and prosthetic material approximation/attachment and the creation of anastomoses in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.

Device Description

The modified Coalescent Surgical U-CLIP™ is a single self-closing clip for vascular anastomosis and tissue approximation/attachment applications. The U-CLIP consists of a specially designed vascular clip connected to needles via flexible members. This design allows precise placement of clips prior to closure and facilitation of an interrupted "suture" technique. The device is fabricated from standard medical and implantable grade materials. Accessories include Clip removal devices and vessel retention tools.

AI/ML Overview

The provided text describes a 510(k) summary for the Coalescent Surgical U-CLIP™ and accessories, focusing on its substantial equivalence to a predicate device. This type of regulatory submission primarily relies on demonstration of equivalence rather than extensive de novo clinical trials with predefined acceptance criteria and performance metrics in the way a novel AI algorithm would.

Therefore, the requested information about acceptance criteria, detailed study design, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance is not present in the provided document, as it is not typically required for a 510(k) submission based on substantial equivalence to a predicate device.

However, I can interpret the available information to answer what data was presented and how the device met its 'acceptance criteria' in the context of a 510(k).

Here's how the information relates to your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Functional Characteristics Equivalence (to predicate device)	"In vitro data confirm that functional characteristics are substantially equivalent to the predicate device cited. All data fell well within, both, internal specification requirements, as well as external standard requirements and device performance expectations."
Substantial Equivalence (to predicate device K013664)	The submission states: "The modified Coalescent Surgical U-CLIP™ and accessories is substantially equivalent in intended use, fabrication, design and method of operation to the following predicate device: Coalescent Surgical U-CLIP™ 510(k) K013664." And "Based upon the product technical information, intended use and clinical performance information provided in this pre-market notification, the modified Coalescent Surgical U-CLIP™ and accessories has been shown to be substantially equivalent to a currently marketed predicate device." The FDA concurred with this determination, as indicated by the clearance letter.
Adherence to Internal and External Standards	"All data fell well within, both, internal specification requirements, as well as external standard requirements and device performance expectations."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not specified. The document only mentions "In vitro data" and "product technical information." Clinical data with specific sample sizes for a "test set" in the context of an AI device are not present.
Data provenance: Not specified. The data is described as "In vitro data." No information about country of origin or whether it was retrospective/prospective is provided, as this is not relevant for an in-vitro performance test of a mechanical device.

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/Not specified. This information is relevant for AI algorithms relying on expert annotations for ground truth. This document pertains to a medical device (surgical clip), where "ground truth" would be established through engineering specifications, material testing, and performance against defined physical standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not specified. Adjudication methods are typically used when human experts review and categorize data, often in the context of AI model evaluation or clinical trials with subjective endpoints. This document focuses on a physical device.

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. An MRMC study is completely irrelevant for this type of medical device (surgical clip). MRMC studies are designed to evaluate the impact of medical imaging devices or AI aids on human reader performance, which isn't the function of the U-CLIP.

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

Not applicable. The U-CLIP is a physical surgical device, not an algorithm. Therefore, "standalone algorithm performance" doesn't apply.

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

The "ground truth" for this device would be based on engineering specifications, material properties, and performance benchmarks for mechanical strength, biocompatibility, and functional operation (e.g., clip closure force, material integrity under stress, sealing capability). The document states "internal specification requirements, as well as external standard requirements and device performance expectations." This implies that the device was tested against established physical and material standards.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm, so there is no "training set."

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

Not applicable. As above, there is no "training set" for this physical device.

Summary

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

K021407 510(k) Number:

Applicant Information:

April 2, 2002 Date Prepared:

Name: Coalescent Surgical, Inc. Address: 559 E. Weddell Drive Sunnyvale, CA 94089 408-743-9794

Contact Person:	Michael A. Daniel
Phone Number:	(415) 407-0223
Facsimile Number:	(925) 932-5706

Device Information:

Classification:	Class II Implantable Clips
Trade Name:	Coalescent Surgical U-CLIPTM and Accessories
Common Name:	Implantable Clip, Vascular Clip
Classification Name:	Surgical Devices: Implantable Clip, 79FZP, 21 CFR 878.430

Predicate Devices:

The modified Coalescent Surgical U-CLIP™ and accessories is substantially equivalent in intended use, fabrication, design and method of operation to the following predicate device:

Coalescent Surgical U-CLIP™ 510(k) K013664 ●

Device Description:

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510(k) SUMMARY

(Continued)

Intended Use:

Comparison to Predicate Device(s):

The modified Coalescent Surgical U-CLIP™ and accessories is substantially equivalent to the Coalescent Surgical U-CLIP (K013664).

Test Data:

In vitro data confirm that functional characteristics are substantially equivalent to the predicate device cited. All data fell well within, both, internal specification requirements, as well as external standard requirements and device performance expectations.

Summary:

Based upon the product technical information, intended use and clinical performance information provided in this pre-market notification, the modified Coalescent Surgical U-CLIP™ and accessories has been shown to be substantially equivalent to a currently marketed predicate device.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 2002 JUL

Coalescent Surgical Michael A. Daniel Regulatory and Clinical Affairs 559 East Weddell Drive Sunnyvale, California 94089

Re: K021407

Trade Name: Coalescent Surgical U-Clip™ Regulation Number: 878.4300 Regulation Name: Implantable Clip, Vascular Clip Regulatory Class: II Product Code: FZP Dated: May 1, 2002 Received: May 3, 2002

Dear Mr. Daniel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 - Mr. Michael Daniel

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ney RP Ogle

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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KOZI407 TBD 510(k) Number (if known): ___

Coalescent Surgical U-CLIPTM Device Name:

Indications For Use:

The Coalescent Surgical U-CLIP™ is intended for endoscopic and non-endoscopic tissue and prosthetic material approximation/attachment and the creation of anastomoses in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ARo for Cmu

(Division Sign-Off) Division of General, Restorative and Neurological Devices Over-The-Counter Use OR K021407 510(k) Number

(Optional Format 1-2-96)

Prescription Use
(Per 21 CFR 801.109)

000009

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.