The KINSA RC Anchor is a suture anchor manufactured from PEEK polymer. The design incorporates a suture knot within the anchor body and a suture loop with a tension suture extending from the top of the anchor. This design allows the surgeon to implant the anchor, pass the suture loop through the tissue and using the tensioning suture, complete the repair without the need for knot tying.

AI/ML Overview

The provided text describes a 510(k) summary for the Smith & Nephew KINSA RC Suture Anchor. It establishes substantial equivalence by comparing it to a predicate device (Smith & Nephew KINSA Suture Anchor, K061154).

However, the document does not contain the specific information requested regarding acceptance criteria, device performance, or details of a study involving ground truth, expert review, or sample sizes related to AI or algorithm performance.

This document is a regulatory submission for a medical device (suture anchor), and its performance assessment is based on demonstrating substantial equivalence to a previously cleared device, not typically on the kind of clinical study details requested for an AI/algorithm-based device.

Therefore, I cannot populate the table or answer most of the questions based on the provided text.

Here is what can be inferred or explicitly stated from the provided text, recognizing that it does not directly address many of the questions:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
	Comparison to Predicate Device: The performance testing conducted demonstrates substantial equivalence to the Smith & Nephew KINSA Suture Anchor (K061154). The differences in the new device and the predicate device do not raise any new issues of safety and efficacy.

Missing Information: Specific numerical acceptance criteria (e.g., tensile strength thresholds, pull-out force minimums) and corresponding numerical performance data are not provided in this summary. The "performance" here refers to demonstrating equivalence rather than meeting specific quantifiable clinical or engineering thresholds.

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

Sample Size: Not specified.
Data Provenance: Not specified, but generally, such comparison testing would occur internally at Smith & Nephew. The nature of this 510(k) is about device equivalence, generally based on mechanical or animal testing, not human clinical trial data for this type of device.

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

Not applicable/Not specified. The "ground truth" for a mechanical device like a suture anchor is typically based on engineering specifications and mechanical testing standards, not expert clinical consensus in the way an AI diagnostic tool would be evaluated.

4. Adjudication method for the test set:

Not applicable/Not specified.

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 is not an AI-based device, nor is it a diagnostic imaging device that would typically involve human readers.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

The "ground truth" implicitly used for this device's approval is its mechanical and material properties meeting established engineering standards and demonstrating equivalence to a legally marketed predicate device. This would involve physical testing data (e.g., pull-out strength, material composition verification) rather than clinical outcomes or expert consensus on medical images.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a "training set."

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

Not applicable.

Summary based on the provided text:

The Smith & Nephew KINSA RC Suture Anchor gained 510(k) clearance by demonstrating substantial equivalence to a predicate device (Smith & Nephew KINSA Suture Anchor, K061154). The study involved performance testing that showed the new device is substantially equivalent in design, materials, function, and intended use to the predicate and that its differences do not raise new safety or efficacy issues. The type of "ground truth" relied upon for this clearance would be engineering and mechanical testing data confirming the properties and performance of the device against a known standard (the predicate device). Details regarding specific numerical acceptance criteria, test sample sizes, or any human expert review for establishing ground truth are not included in this 510(k) summary, as it's a submission for a mechanical implantable device, not a diagnostic or AI-driven system.

Summary

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SECTION IV 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

Smith & Nephew KINSA RC Suture Anchor

MAY 16 2007

Date Prepared: May 14, 2007

A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover MA, 01810

B. Company Contact

Deana Boushell Regulatory Affairs Specialist (508) 337-4036 Phone: (508) 261-3620 FAX:

C. Device Name

Trade Name:	KINSA RC Suture Anchor
Common Name:	Fastener, fixation, non-degradable, soft tissue
Classification Name:	Fastener, fixation, non-degradable, soft tissue

D. Predicate Devices

The Smith & Nephew KINSA RC Anchor is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: The Smith & Nephew KINSA Suture Anchor (K061154).

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Description of Device isi

Intended Use F.

The Smith & Nephew KINSA RC Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:

Deltoid Repairs Rotator Cuff Tear repairs Biceps tenodesis

G. Comparison of Technological Characteristics

The Smith & Nephew KINSA RC Suture Anchor is substantially equivalent in design, materials, function and intended use to the Smith & Nephew KINSA suture anchor, cleared in K061154. The proposed and the predicate devices both have the same intended use, indications for use, anchor material, suture material, knotless design.

H. Summary Performance Data

The performance testing conducted demonstrates substantial equivalence to the Smith & Nephew KINSA Suture Anchor, cleared in K061154 . The testing also demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy.

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc. % Ms. Deana Boushell Regulatory Affairs Specialist Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810

MAY 16 2007

K070908 Re:

Trade/Device Name: KINSA RC Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: March 29, 2007 Received: April 2, 2007

Dear Ms. Boushell:

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

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Page 2 - Ms. Deana Boushell

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. 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Buchner

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K070908 510(k) Number (if known): Device Name: Smith & Nephew KINSA RC Suture Anchor

Indications For Use:

The Smith & Nephew KINSA RC Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:

Deltoid Repairs Rotator Cuff Tear repairs Biceps tenodesis

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buchner

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

510(k) Number K070908

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.