The BioAnchor® with Disposable Driver, Preloaded with One #2 Herculine™ Suture is intended for soft tissue repair of the shoulder; specifically, Bankhart and SLAP repair, and capsulolabral reconstruction.

Device Description

The BioAnchor® with Disposable Driver, Preloaded with One #2 Herculine™ Suture is an injection molded PLLA suture anchor implant pre-loaded with a single strand of the absorbable suture, preloaded onto a disposable driver with a stainless steel shaft and ABS handle. The BioAnchor® is supplied sterile and single use. The modification described in this Special 510(K) is to replace the suture in the device with One #2 Herculine™ High Strength polyethylene non-absorbable suture.

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness, which describes a medical device, its intended use, and its predicate device. This type of document is submitted to the FDA for market clearance and does not typically contain detailed information about acceptance criteria or specific study results proving device performance against such criteria. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting raw performance data or a full clinical study report.

Therefore, the requested information, specifically a table of acceptance criteria and reported device performance, sample sizes for test sets and training sets, details about ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness study results, cannot be extracted from the provided text.

Here's what can be inferred or stated based on the text:

A table of acceptance criteria and the reported device performance: Not Applicable (N/A). The document states that the modification (changing the suture material) "does not affect the device's intended use, fundamental scientific technology or performance specifications." This implies that the device is expected to perform as well as its predicate, but no specific performance metrics or acceptance criteria are provided in the document.
Sample size used for the test set and the data provenance: N/A. No specific test sets or study data are presented. The document relies on demonstrating substantial equivalence to a predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. No primary study data requiring ground truth establishment is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. No primary study data is described.
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: N/A. This device is a suture anchor, not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A. This device is a physical medical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A. No primary study data requiring ground truth is described.
The sample size for the training set: N/A. This device is a physical medical implant, and the concept of a "training set" is not applicable in this context.
How the ground truth for the training set was established: N/A. Not applicable given the nature of the device.

In summary: The provided 510(k) summary focuses on demonstrating that a modification to an existing device (BioAnchor® with Disposable Driver) – specifically, replacing the suture with Herculine™ High Strength polyethylene non-absorbable suture – does not alter its fundamental aspects or performance, and thus it remains substantially equivalent to its predicate. It does not provide the detailed performance study results or acceptance criteria typically found in, for example, a clinical trial report for a novel diagnostic device.

Summary

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PROPRIETARY INFORMATION -- LINVATEC CORPORATION

page 1 of 2

October 1, 2004

SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Device Act of 1990
Carperation of the states of the Carperation in horoby submitting the Soecial In accordance with the requirements of the Saveby submitting the Special
and 21 CFR 807.92, Linvates Corporation is hereby submitting the Special and 21 CFR 807.92, Linvate Offportuness for the BioAnchor® with 510(K) Summary of Salety and Enootiveness 71.
Disposable Driver, Preloaded with One #2 Herculine™ Suture 510(K)
Pressure Driver, Preloaded with One #2 Herculine™ Suture 510(K Number Ko42778

Submitter A.

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294

Company Contact B.

Elizabeth Paul Manager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX

C. Device Name

Trade Name:	BioAnchor® with Disposable Driver,Preloaded with One #2 Herculine™ Suture
Common Name:	Suture Anchor
Classification Names:	Screw, Fastener Fixation, Biodegradable, Soft tissue; 21 CFR 888.3040. Suture,Nonabsorbable, Synthetic, Polyethylene; 21 CFR 878.5000
Proposed Class/Device:	Class II
Product Code:	MAI, GAT, HWC

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PROPRIETARY INFORMATION -- LINVATEC CORPORATION

Summary of Safety and Effectiveness

Summary of Sarety and Ellectiveness
BioAnchor® with Disposable Driver, Preloaded with One #2 Herculine™

Suture Suure
510(k) # Ko42778 October 1, 2004

Predicate/Legally Marketed Devices D.

510(k) # K033804 BioAnchor® with Disposable Driver Linvatec Corporation

Device Description E.

The BioAnchor® with Disposable Driver, Preloaded with One #2 The BloAnchor® with Disposable "Diver", "Al-laction -PLLA suture Herculine™ Sulure is an injection moraded with a single strand of the a anchor Implant pre-infeaded while a suture, preloaded onto a absorbable driver with a stainless steel shaft and ABS handle. The disposable driver with a Stamloed store creation with One #2 BloAnchol® - will is supplied sterile and single use.

The modification described in this Special 510(K) is to replace the The modification described in the openal a Herculine™ High Strength polyethylene non-absorbable suture.

This modification does not affect the device's intended use, I his "modification" does" hot "andor" the "here specifications.
fundamental scientific technology or performance specifications.

Intended Use F.

information® with Disposable Driver, Preloaded with One #2 Herculine™ The BloArchol® Will Disposable Briver of the shoulder; specifically,
Suture is intended for soft tissue repair of the shoulder; specifically, Suture is intended for Soft tissue repair thifts and capsulolabral reconstruction.

Substantial Equivalence G.

The BioAnchor® with Disposable Driver, Preloaded with One #2 The BloAnchol® Min Diopoodio Dquivalent in design and intended Herculine … Suture is Substantially equing has been use to the DioAnchor® with Bloging the suture in the device does not conducted to accure transarding safety and effectiveness.

Page 1.3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" written around it. Inside the circle is a stylized symbol that resembles an abstract eagle or bird with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 4 2004

Ms. Elizabeth Paul Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773

Re: K042778

Trade/Device Name: BioAnchor® with Disposable Drive, Preloaded with #2 Herculine™ Suture Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MAI Dated: October 1, 2004 Received: October 6, 2004

Dear Ms. Paul:

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).

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Page 2- Ms. Elizabeth Paul

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 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.

L. Alvah N. Millikan

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

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PROPRIETARY INFORMATION – LINVATEC CORPORATION

Indications for Use

510(k) Number (if known):

Device Name: BioAnchor® with Disposable Driver, Preloaded with One #2 Herculine™ Suture

Indications For Use:

Indications For Sol.
The BioAnchor® with Disposable Driver, Preloaded with One #2 Herculine™ Suture is The BioAnchow with Disposable Diver, i reloaded with Shoulder; specifically, Bankhart and SLAP repair,
intended for soft tissue repair of the shoulder; specifically, Bankhart intended for son tissas report for struction.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Office of Device Evaluation (ODE) Concurrence of CDRH,

Mark A Miller

Division of General, Restorative, and Neurological Devices

510(k) Number K042778 Page 1 of 1

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.