ACUMED SUTURE ANCHOR by ACUMED, INC.

This document is a 510(k) summary for the Acumed Suture Anchor, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the way one would for a novel AI/software medical device.

Therefore, many of the requested categories for AI/software device evaluation are not applicable or cannot be extracted from the provided text. The document describes a traditional hardware medical device (suture anchor), not a software or AI-driven device.

Here's an analysis based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This document is a 510(k) summary for a hardware device, not a performance study for an AI/software device. It doesn't present performance metrics like sensitivity, specificity, or accuracy against a defined acceptance criterion.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. There is no "test set" in the context of evaluating an AI or software device. The document mentions "data on file at Acumed" regarding steam sterilization validation, but this is a manufacturing process validation, not clinical performance data for a diagnostic or therapeutic AI.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth, as understood in AI/software device evaluation, is not established or discussed for this hardware device.

4. Adjudication Method

Not applicable. There is no adjudication process described for a study evaluating AI or software performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. An MRMC study is relevant for evaluating the impact of AI on human readers, which is not the subject of this 510(k).

6. Standalone (Algorithm Only) Performance Study

Not applicable. The Acumed Suture Anchor is a physical implant, not an algorithm.

7. Type of Ground Truth Used

Not applicable. There is no "ground truth" established in the sense of clinical diagnoses or outcomes to validate an algorithm. The 510(k) process for this device relies on demonstrating substantial equivalence to existing legally marketed predicate devices in terms of indications for use, technological characteristics, and safety/effectiveness profiles.

8. Sample Size for the Training Set

Not applicable. There is no "training set" for a hardware medical device like this suture anchor.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set mentioned or relevant for this type of device submission.

Summary of Relevant Information from the Provided Text for a Hardware Medical Device:

The document focuses on demonstrating Substantial Equivalence to legally marketed predicate devices, which is the primary "study" for a 510(k) submission of this nature.

Acceptance Criteria: The implicit acceptance criterion for a 510(k) is that the new device is "substantially equivalent" to predicate devices in terms of:
- Indications for use.
- Technological characteristics (e.g., material, design, sterilization).
- Safety and effectiveness.
Study That Proves Device Meets Acceptance Criteria (in this context): The "study" is the comparison to predicate devices.
- Predicate Devices: Mitek GII Anchor, SuperAnchor, Linvatec Revo, and Zimmer Statak.
- Demonstration of Equivalence:
  - Indications: The Acumed Suture Anchor has the "same indications" as the predicates (anchoring soft tissue to bone in rotator cuff repairs, and soft tissue repairs of the foot and ankle).
  - Materials: Manufactured from titanium 6AL 4V ELI per ASTM F136, similar to predicates.
  - Design: Screw-based design is "similar to the Linvatec Revo and the Zimmer Statak."
  - Surgical Techniques: "Similar surgical techniques" to the Mitek GII Anchor and SuperAnchor.
  - Sterilization: The document mentions "Acumed has identified a set of process parameters for steam sterilization which provide an SAL of 10 as validated by data on file at Acumed." This is a validation of the sterilization process itself, not a comparative performance study in a clinical setting.
- Conclusion: "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."

Essentially, the "study" for this 510(k) is a detailed comparison and justification, rather than a clinical trial or a performance evaluation against specific numerical thresholds in a test set. This is typical for Class II hardware devices seeking market clearance via the 510(k) pathway.

Summary

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acumen®

Quality Orthopaedic Instruments and Implants

Appendix F - 510 (k) Summary

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, noncoated white or green #2 or #0 braided polyester suture to anchor soft tissue to bone in rotator cuff repairs as cleared by 510(k) submission K980103 and soft tissue repairs of the foot and ankle. The suture anchor is manufactured from titanium 6AL 4V ELI per ASTM F136 and is provided non-sterile. Acumed has identified a set of process parameters for steam sterilization which provide an SAL of 10 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.

Acumed, Inc. � 10950 S.W. 50 € Beaverton, OR 97005 � (503) 627-9957 ◆ Fax (503) 520-9618 C1998, Acumed, Inc. Appendix F

ടലമപ 00. 341 SS STREET & 1388558825355 14:44 0002/70/10

K993657

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2000

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

Re: K993657 Trade Name: Acumed Suture Anchor Regulatory Class: II Product Code: MBI Dated: October 18, 1999 Received: October 28, 1999

Dear Ms. Shari 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 reclassified 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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: 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 regulations.

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

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Page 2 - Ms. Shari Jeffers

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) 594-4595. 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,

Russell W. Rogers

& James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_ K 993657

Device Name: Acumed Suture Anchor

Indications For Use:

This device is intended foranchoring soft tissue to bone in soft tissue repair of the foot and ankle and rotator cuff repair.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Plunell Sawyer teriz.

Division Sign-Off Division of General Restorative Devices 510(k) Number

Prescription Use
X
(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.