ADHOC CLAW by FUTURE MEDICAL SYSTEMS, INC.

The provided text is a 510(k) summary for the ADHOC® CLAW soft tissue fixator. It does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices (MITEK GII and ACUFEX MICROSURGICAL) based on similar intended use and design, rather than on performance metrics or clinical study results demonstrating new acceptance criteria.

Therefore, I cannot provide the requested information. The sections below indicate why each point cannot be addressed from the given text:

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

Not applicable. The document does not define any specific acceptance criteria for performance (e.g., tensile strength, fixation force, biocompatibility thresholds) nor does it report device performance against such criteria. The basis for clearance is substantial equivalence to legally marketed predicate devices, not meeting novel performance benchmarks.

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

Not applicable. No test set or study data are mentioned explicitly in the provided summary.

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. No ground truth establishment or expert involvement in a test set is described.

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

Not applicable. No test set or adjudication method is mentioned.

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. This device is a medical implant (soft tissue fixator), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

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

Not applicable. As stated above, this is an implant, not an algorithm, so standalone performance in that context is not relevant.

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

Not applicable. No ground truth for performance evaluation is mentioned. The "ground truth" for clearance in this context is the safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not an AI/ML device.

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

Not applicable. No training set or ground truth for it is mentioned.

Summary

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510(k) SUMMARY FOR SOFT TISSUE FIXATOR

510k #: K023963

Owner / Operator:	Future Medical Systems, SA.	510K #: K023963
Address:	265 Route de la Baronne, ST. Jeannet 06640 France	MAY 0 5 2003
Phone:	011-33-4-92-12-32-56
Fax:	011-33-4-92-12-04-75
Contact:	Patrick Janin (US Native/ English speaker)
Official correspondent:
Company:	Future Medical Systems, Inc.
Address:	504 McCormick Drive, Glen Burnie, MD 21061
Phone:	410 761 9411 ext. 11
Fax:	410 760 9422
Contact:	Mr. Steve Janin
Date of submission:	November 26th 2002
Name of device:	ADHOC® CLAW
Common name:	Soft tissue fixator
Classification:	87 MBI, Class II, 21 CFR 888.3040

Predicate device:

K953877: MITEK GII (Mitek Surgical Products now Ethicon J&J) K884565: ACUFEX MICROSURGICAL (now SMITH & NEPHEW). K896310: ACUFEX MICROSURGICAL (now SMITH & NEPHEW).

Device intended use, description and substantial equivalence:

The ADHOC® CLAW is an implant used for rotator cuff repair in shoulder surgery. The ADHOC® CLAW is made of 316L stainless steel.

The ADHOC® CLAW and the predicate devices have the same final function. In addition, the small differences in design do not affect the use, safety and effectiveness, between the device and the predicate devices.

Based on these similarities and equivalences we believe the ADHOC® CLAW is substantially equivalent to the MITEK GII and the Acufex Fixation Button.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing the wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0 5 2003

Mr. Steven Janin Future Medical System, Inc. 504 McCormick Drive, Suite T Glen Burnie, MD 21061

Re: K023963

Trade/Device Name: ADHOC® CLAW Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: March 25, 2003 Received: March 28, 2003

Dear Mr. Janin:

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 (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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Part 2 - Mr. Steven Janin

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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Mark A. Millenn

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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510 K Number: K023963

Page 1 of 1

Device name: ADHOC® CLAW soft tissue fixator

INDICATIONS FOR USE:

The ADHOC® CLAW is an implant used for rotator cuff repair in shoulder surgery.

Mark N. Melhus

(Division Sign-Off) Division of General. Restorative and Neurological Devices 023963

510(k) Number ________________________________________________________________________________________________________________________________________________________________

(Please do not write below this Line-Continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter-Use (Optional Format 1)

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.