A clip like device intended to connect internal tissues to aid in healing. These clips are intended to be used in accordance with the many of surgeon judgement.

Device Description

The MSC Ligating Clip is substantially equivalent in function and intended use to the Edward Weck and Company Hemoclip Ligating Clip and the Ethicon Ligaclip. Specifically: the MSC Ligating Clip is exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices mentioned above. The packaging methods and packaging materials are exactly the same, respectively.

AI/ML Overview

This document is a 510(k) premarket notification for the Micro Stamping Corporation (MSC) Ligating Clip. It focuses on establishing substantial equivalence to existing devices rather than presenting detailed performance studies or specific acceptance criteria with numerical performance targets. Therefore, the requested information cannot be fully extracted as it is not present in the provided text.

Here is an attempt to address your request based on the available information, with specific notes on what is not provided:

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

Acceptance Criteria	Reported Device Performance
Functional Design	"exactly similar in functional design" to Edward Weck and Company Hemoclip Ligating Clip and Ethicon Ligaclip.
Function	"performs the same functions" as predicate devices.
Intended Use	"has the same intended use" as predicate devices: to connect internal tissues to aid in healing.
Packaging Methods	"exactly the same" as predicate devices.
Packaging Materials	"exactly the same" as predicate devices.
Indications for Use	"A clip like device intended to connect internal tissues to aid in healing. These clips are A clip like device intended to Conteet internal Lisate of the many of surgeon judgement." (This is presented as an "Indications for Use statement" rather than a performance criterion with a numerical target).
Safety and Effectiveness	"substantially equivalent in function and intended use" to predicate devices.

Missing Information: There are no specific numerical acceptance criteria (e.g., tensile strength, closure force, biocompatibility test results with thresholds) or quantitative performance data presented in the document. The substantial equivalence argument is based on qualitative similarity to predicate devices.

2. Sample size used for the test set and the data provenance

Not provided. This document does not describe a performance study with a test set. The submission is a 510(k) premarket notification claiming substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. As no specific performance study with a test set is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication method for the test set

Not applicable/Not provided. No test set or adjudication method is described.

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

Not applicable/Not provided. This device is a ligating clip, not an AI-based diagnostic or assistive device. Therefore, an MRMC study related to human readers and AI is irrelevant and not mentioned.

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

Not applicable/Not provided. This is a medical device (a ligating clip), not an algorithm or software. "Standalone performance" in this context is not relevant. The device's performance would be assessed through bench testing and potentially animal or human clinical data (though none are detailed in this specific document for the substantial equivalence claim).

7. The type of ground truth used

Not applicable/Not provided. Since this is a 510(k) based on substantial equivalence to predicate devices, the "ground truth" is largely established by stating the similarities to devices already legally marketed and presumed safe and effective. There is no mention of pathology, outcomes data, or expert consensus used as ground truth for a novel performance study.

8. The sample size for the training set

Not applicable/Not provided. This is not an AI/machine learning device, so the concept of a "training set" is not relevant.

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

Not applicable/Not provided. As above, no training set for an algorithm is involved.

Summary of what the document does provide regarding "proof" of meeting criteria:

The "study that proves the device meets the acceptance criteria" in this context is the substantive equivalence comparison detailed in the "Summary of Safety and Effectiveness." The proof is in the assertion that the MSC Ligating Clip is "substantially equivalent in function and intended use" to legally marketed predicate devices like the Edward Weck and Company Hemoclip Ligating Clip and the Ethicon Ligaclip. This equivalence is justified by stating:

"exactly similar in functional design"
"performs the same functions"
"has the same intended use"
"packaging methods and packaging materials are exactly the same"

This type of submission relies on the established safety and effectiveness of the predicate devices as evidence that the new device, being substantially similar, also meets those standards. It does not typically involve new, extensive performance studies with quantitative acceptance criteria detailed within the 510(k) summary itself, unless the differences from the predicate device warrant new data.

Summary

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Micro Stamping Corporation (Pre-market Notification)

Page 14

NOV 2 9 2001

Appendix A (Summary of Safety And Effectiveness)

Submitter:

John Gagliardi. President (contact person) MidWest Process Innovation, LLC 7736 Woodside Court Maineville, OH 45039 513-573-0085 (Telephone and fax) or 513-573-0519 (Telephone and fax) JGAGL777@One.Net

Trade Name: Micro Stamping Corporation (MSC) Ligating Clip

Common Name: Ligating Clip

Classification Name: Implantable Clip (21 CFR, Part 878.4300)

Summary of Safety and Effectiveness:

The MSC Ligating Clip is substantially equivalent in function and intended use to the Edward Weck and Company Hemoclip Ligating Clip (see example of labeling in Appendix E of products presently on the market) and the Ethicon Ligaclip.

Specifically:

the MSC Ligating Clip is exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices mentioned above.

The packaging methods and packaging materials are exactly the same, respectively.

The MSC Ligating Clip is indicated for use as to connect internal tissues to aid in healing. This device is for prescription use only.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern. Inside the circle is a stylized symbol consisting of three curved lines, which is the department's official emblem. The overall design is simple and conveys a sense of authority and professionalism.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 9 2001

Micro Stamping Corporation MidWest Process Innovation, LLC C/o John Gagliardi President 7736 Woodside Court Maineville, Ohio 45039

Re: K013264

Trade/Device Name: MSC Ligating Clip Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP Dated: September 25, 2001 Received: October 1, 2001

Dear Mr. Gagliardi:

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.

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

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(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 807); labelling (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elect forth in the quality systems (QD) rogulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-

This letter will allow you to begin marketing your device as described in your Section 510(k)
The same of the first of the success of section with assisses of your device to I his letter will anow you to begin manxemily of substantial equivalence of your device to a legally premarket notification. The PDA initing of backandary of 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 CFF) Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFN Fall 607.10 for his rate under in the promotion and advertising of Compliance at (301) 594-4037. Thursday, 16 - 410-1463. Also, please note the your device, prease comate and of the reference to premarket notifications be obtained from the Other general information on your responsibilities under the Act may be obtained from the Other general mionnation on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address (800) 056-2041 61 (501) vs (501) vs (400 http://www.fda.gov/cdrh/dsmamain.html

Sincerely yours,

Susan Walker, MD

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

Enclosure

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Image /page/3/Picture/0 description: The image shows the logo for Micro Stamping Corp. The logo is in black and white and features the company name in a bold, sans-serif font. Below the company name is the phrase "the stamp of quality". There is also a handwritten note at the top of the image that says "P. 7 of 12".

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Attachment II

Indications for Use

Re: K013264

Device Name: MSC Ligating Clip

Indications for Use:

Indications for Use:
A clip like device intended to connect internal tissues to aid in healing. These clips are A clip like device intended to contect internal Lisate to the many of surgeon judgement.

(please do not write below this line - continue on another page if needed)

Prescription Use_X (Per 21 CFR, Part 801.109)

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

Susan Walker

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number

Optional Format 1-2-96

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.