ACUMED SUTURE ANCHOR by ACUMED, INC.

The provided text is a 510(k) summary for the Acumed Suture Anchor, a medical device. This type of regulatory submission focuses on demonstrating "substantial equivalence" to existing, legally marketed predicate devices, rather than establishing de novo performance criteria through a study with specific acceptance criteria as would be done for novel devices or those undergoing extensive clinical trials.

Therefore, the document does not contain information regarding a study designed to establish acceptance criteria and prove the device meets them in the way described in the request. Instead, the core argument for clearance is based on the similarity to predicate devices.

Here's how to address the requested information based on the provided text, and where it falls short:

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

Information Not Found: The document does not define specific performance acceptance criteria (e.g., tensile strength, pull-out force) for the Acumed Suture Anchor, nor does it report specific performance values from a dedicated study against such criteria. The submission relies on the assumption that its performance will be "similar" to predicate devices.

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

Information Not Found: No test set sample size or data provenance is mentioned because no performance study, in the sense of testing against acceptance criteria, is described for the Acumed Suture Anchor. The "data on file at Acumed" regarding sterilization mentions an SAL, but this is a process validation, not a device performance study.

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

Information Not Found: This information is not applicable as no test set or expert-established ground truth is described for the device's functional performance.

4. Adjudication method for the test set

Information Not Found: This is not applicable.

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

Information Not Found: This is not applicable. The device is a physical bone anchor, not an AI-assisted diagnostic tool.

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

Information Not Found: This is not applicable. The device is a physical bone anchor, not an algorithm.

7. The type of ground truth used

Information Not Found: This is not applicable to a device clearance based on substantial equivalence to predicate devices for its functional performance. The "ground truth" here is essentially the regulatory acceptance of the predicate devices.

8. The sample size for the training set

Information Not Found: This is not applicable. There is no mention of a "training set" as this is not a machine learning or diagnostic device.

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

Information Not Found: This is not applicable.

Summary of Device Acceptance Criteria and Study as per the Provided Text:

The Acumed Suture Anchor's acceptance and market clearance are not based on meeting new, device-specific performance acceptance criteria established through a dedicated study. Instead, its acceptance is based on demonstrating substantial equivalence to existing predicate devices.

The arguments for substantial equivalence are:

Identical Indications For Use: "This device is identical in indication to the Mitek GII and SuperAnchor (K953877), the Zimmer Statak (K926384), and the Linvatec Revo (K941691)." Specifically, "This device is intended for anchoring soft tissue to bone in rotator cuff repairs of the shoulder and soft tissue repair of the foot and ankle."
Similar Design and Manufacturing Material: "This device is most similar in design to the Zimmer Statak and the Linvatec Revo devices in that all three are based on screw designs and are manufactured from titanium alloys. The Acumed Suture Anchor is manufactured from titanium 6AL 4V ELI per ASTM F 136."
Similar Surgical Techniques: "The Acumed Suture Anchor and the Mitek GII Anchor and SuperAnchor have similar surgical techniques."
Sterilization Validation: Acumed has identified process parameters for steam sterilization providing an SAL of 10^-6, "as validated by data on file at Acumed." (This is a process validation, not a performance study of the anchor itself).

In essence, the "study" demonstrating this device meets "acceptance criteria" is the comprehensive review by the FDA (K980103) concluding that the Acumed Suture Anchor is substantially equivalent to legally marketed predicate devices, thereby assuming similar safety and effectiveness. No specific performance study to quantify device performance (e.g., pull-out strength in tissue) against predefined numerical acceptance criteria is detailed in this 510(k) summary.

Summary

{0}------------------------------------------------

Quality Orthopaedic Instruments and Implants

CHILLER

Appendix F - 510(k) Summary

MAR 1 6 1998

SAROIC 1 of 1

Classification Name: Common Name: Proprietary Name: Proposed Regulatory Class: Device Product Code: Manufacturing Facility:

Establishment Registration No .: Contact: Labeling/Promotional Materials: Substantial Equivalence:

Bone Anchor Bone Anchor Acumed Suture Anchor Class II JDR, MBI Acumed, Inc. 10950 SW 5th Street, Suite 170 Beaverton, OR 97005 U.S.A. 3025141 Shari Jeffers See Appendix D

This device is identical in indication to the Mitek GII and SuperAnchor (K953877), the Zimmer Statak (K926384), and the Linvatec Revo (K941691). This device is most similar in design to the Zimmer Statak and the Linvatec Revo devices in that all three are based on screw designs and are manufactured from titanium alloys. Literature on Mitek and Linvatec and substantial equivalence information are included in Appendix E.

This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.93.

The Acumed Suture Anchor is a single use implantable device used with non-absorbable, non-coated white or green #2 or #0 braided polyester suture to anchor soft tissue to bone in rotator cuff repairs and soft tissue repairs of the foot and ankle. The suture anchor is manufactured from titanium 6AL 4V ELI per ASTM F 136 and is provided non-sterile. Acumed has identified a set of process parameters for steam sterilization which provide an SAL of 10-6 as validated by data on file at Acumed. Information regarding labeling has been provided.

Predicate devices that are substantially equivalent to the Acumed Suture Anchor are the Mitek GII Anchor and SuperAnchor, the Linvatec Revo, and the Zimmer Statak. All the devices mentioned above have the same indications and are manufactured from titanium. The design of the Acumed Suture Anchor is screw based and is similar to the Linvatec Revo and the Zimmer Statak. The Acumed Suture Anchor and the Mitek GII Anchor and SuperAnchor have similar surgical techniques. Based on the similarities between the Acumed Suture Anchor and the predicate devices studied, the safety and effectiveness of the Acumed Suture Anchor is expected to be similar to the predicate devices mentioned above.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized image of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 6 1998

Ms. Shari Jeffers Regulatory Affairs Manager Acumed, Inc 10950 Sw 5th Street, Suite 170 Beaverton, Oregon 97005

K980103 Re: Acumed Suture Anchor Trade Name: Regulatory Class: II Product Code: MBI Dated: January 5, 1998 Received: January 12, 1998

Dear Ms. Jeffers:

We have reviewed your Section 510(k) 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 nearour books in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with, the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

{2}------------------------------------------------

Page 2 - Ms. Shari Jeffers

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

{3}------------------------------------------------

510(k) Number (if known): K980103

Acumed Suture Anchor Device Name:

Indications For Use: This device is intended for anchoring soft tissue to bone in rotator cuff repairs of the shoulder and soft tissue repair of the foot and ankle.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hicouda
(Division Sign-Off)

Division of General Restorative Devices
510(k) Number K980103

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.