The provided text is a 510(k) premarket notification for a medical device called the "Opus Magnum™ Bone Anchor with Inserter." This document establishes substantial equivalence to an existing device rather than presenting a study to prove acceptance criteria for a novel device. Therefore, the information typically found in such a study (like detailed performance metrics, sample sizes for test and training sets, expert qualifications, or adjudication methods) is not present in the provided text.

The core of this 510(k) is a claim of substantial equivalence to a previously cleared device. This means the manufacturer is asserting that the modified device is as safe and effective as the predicate device, not that it has independently met specific performance criteria through a new clinical or laboratory study in the way a novel device might.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not describe acceptance criteria for a new device's performance, nor does it report specific performance metrics from a study designed to meet those criteria. The submission is based on substantial equivalence.

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

Not applicable. No "test set" in the context of device performance evaluation (e.g., a cohort of patients or a set of images) is mentioned because this is a substantial equivalence submission, not a de novo study.

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

Not applicable. No ground truth establishment by experts is described as there is no performance study presented.

4. Adjudication Method

Not applicable. No adjudication method is described.

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

Not applicable. No MRMC study is mentioned. The device is a bone anchor, not an AI or imaging device that would typically undergo an MRMC study.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a physical bone anchor and inserter, not an algorithm.

7. Type of Ground Truth Used

Not applicable. No ground truth is described.

8. Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set or ground truth established for training.

Summary of Provided Information Relevant to Substantial Equivalence:

Device Name: Opus Magnum™ Bone Anchor with Inserter
Manufacturer: Opus Medical, Inc.
Predicate Device: Opus Magnum™ Anchor with Inserter (cleared under 510(k) K012125)
Reason for 510(k): Proposed modification to the Magnum™ Bone Anchor.
Claim of Equivalence: The modified Opus Magnum™ is substantially equivalent to the original, with the same intended use, indications for use, and technology.
Indications for Use: Fixation of soft tissue to bone for rotator cuff repair.

In essence, this 510(k) notification is a regulatory submission for a minor modification to an already approved device, asserting that the change does not alter its safety or effectiveness compared to the previous version. It does not contain the kind of detailed performance study data you would request for a novel device.

Summary

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

Opus Medical, Inc.
--------------------

510(k) Notification

Magnum™ Bone Anchor and Instrument Set Page 9 of 35

NOV 1 2 2004

Section 4: 510(k) Summary

K04 2914

510(k) Number:

page 1 of 1

Substantial Equivalence

In accordance with the requirements of 21 CFR 807.93, this summary is formatted with the Agency's final rule, " ... 510(k) Summaries and 510(k) Statements ... " and can be used to provide equivalence summary to anyone requesting it from the Agency.

Manufacturer:	Opus Medical, 27127 Calle Arroyo, Suite 1924San Juan Capistrano, CA. 92675
Contact Person:	Laura Kasperowicz, Ph: (949) 234-0400, Fax: 234-0493E-Mail: Lkasperowicz@opusmedical.com
Date Prepared:	October 19, 2004

Device Information

Trade Name:	Opus Magnum™ Anchor with Inserter
Common Name:	Bone Anchor, Fastener, Fixation, Soft Tissue
Classification Name:	Fastener, Fixation, Non-degradable, Soft Tissue
Classification:	Class II per 21 CFR 888.3040; Product Code: HTY

Substantial Equivalence

The Opus Magnum™ Anchor with Inserter is substantially equivalent to the existing Opus Magnum™ Anchor with Inserter cleared by the Food and Drug Administration.

Indications For Use

The Opus Magnum™ bone anchor with inserter is indicated for use in fixation of soft tissue to bone for rotator cuff repair.

Executive Summary and Reason for 510(k) Notification

The purpose of this 510(k) is to notify the FDA of a proposed modification to the Magnum™ Bone Anchor. The modified Opus Magnum™ is substantially equivalent to the Opus Magnum™ Anchor originally cleared under 510(k) 012125. The intended use, indications for use, and technology of the modified Magnum Anchor are the same as the original Magnum Anchor.

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

NOV 1 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Laura Kasperowicz Regulatory Affairs Opus Medical, Inc. 27127 Calle Arroyo, Suite 1924 San Juan Capistrano, California 92675

Re: K042914

Trade/Device Name: Opus Magnum™ Bone Anchor with Inserter Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI, HTY Dated: October 19, 2004 Received: October 21, 2004

Dear Ms. Kasperowicz:

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.

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

Page 2 -- Ms. Laura Kasperowicz

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Millman

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

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

Opus Medical, Inc.

510(k) Notification

SECTION 3: STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): Kort 2914

Device Name: Opus Magnum™ Bone Anchor with Inserter

Indications for Use:

The Opus Magnum™ bone anchor with inserter is indicated for use in fixation of soft tissue to bone for rotator cuff repair.

Prescription Use X (Per CFR 801.109)

Over-The-Counter Use __

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mash A. Mikkelson

. Restorative, Division of Ger and Neurological Devices

510(k) Number K042914

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.