The indications for the SURETAC III are rotator cuff repair, repair of recurrent anterior shoulder dislocation and subluxaton, and repair of acute/primary anterior shoulder dislocation and subluxation.

Device Description

The SURETAC® III is a bioabsorable fixator utilized for soft tissue to bone approximation.

AI/ML Overview

The provided document is a 510(k) summary for the SURETAC® III device, a bioabsorbable fixator for soft tissue to bone approximation. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain information about specific acceptance criteria, detailed study designs, or performance metrics in the way a clinical study report would.

Therefore, I cannot provide the requested table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The document does not describe a standalone algorithm performance study.

Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Applicable: This document does not specify quantitative acceptance criteria or report performance metrics from a study designed to meet such criteria. The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance data against pre-defined acceptance criteria for a new clinical study.

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

Not Applicable: The document does not refer to a test set in the context of device performance evaluation in a clinical study. The 510(k) submission is based on demonstrating substantial equivalence through comparison of technological characteristics to predicate devices and adherence to regulatory requirements.
Data Provenance: Not specified as no performance data from a dedicated test set is presented.

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

Not Applicable: No test set or related ground truth establishment is described.

4. Adjudication method for the test set:

Not Applicable: No test set or related 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:

No: This document does not describe an MRMC comparative effectiveness study. The device is a physical bioabsorbable fixator, not an AI-assisted diagnostic or therapeutic tool for which such a study would typically be conducted.

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

No: This document does not describe a standalone algorithm performance study. The device is not an algorithm.

7. The type of ground truth used:

Not Applicable: As no specific performance study against a ground truth is reported in this document, this information is not available.

8. The sample size for the training set:

Not Applicable: The concept of a "training set" is not relevant to this 510(k) submission for a physical medical device. This term is typically used for machine learning or AI models.

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

Not Applicable: See point 8.

Summary

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Image /page/0/Picture/0 description: The image shows handwritten text on a white background. The text includes the alphanumeric string "K023417" on the top line. Below that, the phrase "page 1 of 2" is written in a cursive style. The handwriting appears to be done with a dark ink or marker, creating a clear contrast against the white background.

Endoscopy Division

Smith & Nephew, Inc. 160 Dascomb Road, Andover, MA 01810 U.S.A. Telephone: (978) 749-1000 Toll Free: 1-800-343-8386 Fax: (978) 749-1599

Smith<}Nephew

SECTION V 510(k) Summary

? 2002 NOV

SURETAC® III

Date Prepared: October 09, 2002

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

A. Submitter

Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover, MA 01810 508. 261.3699

B. Company Contact

Jason Bilobram Regulatory Specialist

C. Device Name

Trade Name:	SURETAC ® III
Common Name:	SURETAC ® Fixation Device
Classification Name:	Class II, Smooth or Threaded Metallic bone fixation fastenerProduct Code JDR (prior classification)Class II, Fastener, Fixation, Biodegradable, Soft TissueProduct Code MAI (current classification)

D. Predicate Devices

	SURETAC ® Fixation Device (K911837)SURETAC ® Expanded Indication (K931519)
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SURETAC® Expanded Indication II (K020948)

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K023417
page 2 of 2

E. Description of Device

The SURETAC® III is a bioabsorable fixator utilized for soft tissue to bone approximation.

F. Intended Use

SURETAC III is intended for soft tissue to bone approximation.

G. Comparison of Technological Characteristics

Both the SURETAC Fixation Device and the SURETAC III are intended for approximation of soft tissue to bone.

Jason Bilobran

Jasón Bilobram Regulatory Specialist

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 7 2002

Mr. Jason Bilobram Regulatory Affairs Specialist Endoscopy Division Smith & Nephew, Inc. 160 Dascomb Road Andover, Massachusetts 01810

Re: K023417

Trade/Device Name: SURETAC® III Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: JDR Dated: October 10, 2002 Received: October 11, 2002

Dear Mr. Bilobram:

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 (OS) 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. Jason Bilobram

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,

Muriam C. Provost

forCelia 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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Page 1 of 1

510(k) Number :

Device Name: SURETAC® III

Indications for Use :

The SURETAC III is indicated for rotator cuff repair of recurrent anterior shoulder dislocation and subluxaton, and repair of acute/primary anterior shoulder dislocation and subluxation.

(PLEASE DO 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)

Over-the-Counter U0

(Optional Format 1-2-96)

Muriam C. Provost
(Division Sign Off)

(Division Sign-6 Division of General. Restorative and Neurological Devices

510(k) Number Kc 23417

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.