The Pre-Loaded UltraFix® RC is supplied sterile and consists of an suture anchor with USP#2 non-absorbable polyester suture with cartidge and needles preloaded onto a single from disposable inserter. The Pre-Loaded UltraFix® RC is made from 316(L) stainless steel per ASTM F138-92 or ASTM F138-92 and conforms to ISO 5832-1.

AI/ML Overview

The provided text is a 510(k) summary for the "Pre-Loaded UltraFix® RC" suture anchor. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria for a new device.

Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets those criteria are not present in the provided document. The document primarily attests to a comparative analysis against a legally marketed predicate device rather than independent performance validation against predefined criteria.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the document. The document describes the device and its intended use but does not provide a table of performance metrics with acceptance criteria and corresponding reported values from a study.

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

Sample size for test set: Not specified.
Data provenance: Not specified. The document states "Performance testing has been conducted to demonstrate safety and effectiveness" but does not detail the nature, size, or origin of this testing data. Given the context of a 510(k) summary focused on substantial equivalence, it's highly probable the "testing" involved verification and validation activities rather than a large-scale clinical test set for new performance criteria.

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

Number of experts: Not specified.
Qualifications of experts: Not specified.

4. Adjudication method for the test set

Adjudication method: 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

This is not applicable as the device is a physical suture anchor, not an AI or imaging diagnostic tool.

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

This is not applicable as the device is a physical suture anchor, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of ground truth: Not explicitly stated. For a physical medical device like this, "ground truth" would typically relate to mechanical performance (e.g., tensile strength, pull-out force) or biocompatibility, evaluated against established standards or predicate device performance. The document mentions "Performance testing has been conducted to demonstrate safety and effectiveness" and that the device is "substantially equivalent in design, materials, manufacturing, works of technology and intended use to Linvatec's existing UltraFix® RC Suture Anchor System." This implies performance was compared against the predicate's known characteristics, which would serve as a de facto "ground truth" for equivalence.

8. The sample size for the training set

This is not applicable as the device is a physical suture anchor, not an AI model requiring a training set.

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

This is not applicable for the same reason as above.

Summary of what is present:

Device Name: Pre-Loaded UltraFix® RC
Intended Use: Used for rotator cuff repairs and the site of tendon or ligament to bone reattachment, either arthroscopically or in an open technique.
Predicate Device: K963812 UltraFix® RC from Linvatec.
Substantial Equivalence Claim: The Pre-Loaded UltraFix® RC is substantially equivalent in design, materials, manufacturing, works of technology, and intended use to Linvatec's existing UltraFix® RC Suture Anchor System.
Performance Testing: "Performance testing has been conducted to demonstrate safety and effectiveness." (No details provided on the specific tests, criteria, or results.)

In conclusion, this 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to a previously cleared device. It does not provide the kind of detailed study design, acceptance criteria, and performance metrics typically associated with establishing new performance claims or with AI/diagnostic device validation.

Summary

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

DEC 1 9 2001

October 23, 2001

SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Device Act of In accordance with the requirements of the Sale Medical Donatting the Market Corporation of the Market Corporation of the Pre-Loaded UltraFix in 20
1990 and 21 CFR 807.92, Linvatec Corporation is nereoy addining of the Pre-Loaded UltraFix®
510(k) Summary of Safety and Effectiveness for the Pre-Loaded UltraFix®

RC. RC.
510(k) Number _K013553.

Submitter A.

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

Company Contact B.

Laura D. Seneff, RAC Laurager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX

Device Name C.

Trade Name: Pre-Loaded UltraFix® RC

Common Name: Suture Anchor

Fastener, Fixation, Nondegradable, soft Classification Names: tissue

Proposed Class/Device: Class II, MBI Product Code

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

Summary of Safety and Effectiveness Summary UltraFix® RC Kol3553 510(k) # _ October 23, 2001 Page 2 of 2

Predicate/Legally Marketed Devices

Predicate/Legally Marketed Devices D.

K963812 UltraFix® RC Linvatec

E.

Device Description
The Pre-Loaded UltraFix® RC is supplied sterile and consists of an
the Pre-Loaded UltraFix® with USP#2 non-absorbable polyester The Pre-Loaded UltraFix® RC is supplied stenie and other Hick To suture anchor with USP#2 noreadson onto a single from
suture with cartidge and needles preloaded onto a single from
suture with carting The Bre-Loaded UltraFix® RC is Oltania With carridge and needles preloaded UltraFix® RC is made from
disposable inserter. The Pre-Loaded UltraFix® RC is made from
disposable inserter. The Pre-Loaded UltraF Suture The Fre-Loaded UntraPRS Tre-Loaded UntraPRS TRO-18 The Free States
316(L) stainless steel per ASTM F138-92 or ASTM F138-92 and
316(L) stainless steel per ASTM F138-92 conforms to ISO 5832-1.

r.

Intended Use
The Pre-Loaded UltraFix® RC is intended to be used for rotator cuff
es and the site of be sither arthroscopically or in an open technique. mtendop on

Substantial Equivalence Substantial Equivalence

The Pre-loaded UltraFix® RC is substantially equivalent in design,
The Pre-loaded by total use to Linvateds existing UltraFix® RC G. The Pre-loaded UltraFix® RC is substantially equivalorit works of technology and intended use to Linvated testing has been conducted to
Suture Anchor System. Performance testing has been conduction in toonliness
Suture Anchor System. Performance testing has boon controller in the modeling the modeling the model safety and effectiveness.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles an eagle with three stylized lines representing its wings, and a wavy line below, possibly representing water or a ribbon. The logo is printed in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2001

Ms. Laura Seneff Regulatory Affairs Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908

Re: K013553

K013535
Trade/Device Name: Pre-Loaded UltraFix® RC
Trade/Device Name: Pre-Loaded UltraFix® RC
Coade/Device Name: CAR 2019 2010 Trade/Device rumber: 21 CFR 888.3040 Regulation Number: 21 CFF 888.3040
Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener
T Regulatory Class: Class II Product Code: MBI Dated: October 23, 2001 Received: October 25, 2001

Dear Ms. Seneff:

Dour reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 5 I (K) prematics not incent of the indications
referenced above and have determined the device is substantially equivalent (for the indications referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to legally market device Institute America Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Food, Drug, commerce prior to May 28, 1976, the enactment and of ho received by the Federal Food, Drug,
devices that have been reclassified in accordance with the provisions of the Feder devices that have been reclassified in accordance with the proval online to more of the Act.
and Cosmetic Act (Act) that do not require approval of a premarket approval optiv and Cosmetic Act (Act) that do not require approval or approval or the Act. The
You may, therefore, market the device, subject to the general controls of the Act. The Act You may, therefore, market the device, subject to the general conner provincial controls.
general controls provisions of the Act include requirements for ammanding and general controls provisions of the Act include requirements for allude organism misbranding and adulteration.

at antil is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into either class in (Special Conaction of the country to comments of the can
may be subject to such additional controls. Existing m may be subject to such additional controls. Existing major regalatown a literation, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. be found in the Code of Federal Regulations, Frito 21, Children

please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's ssuance of a substanted activals.ited adverseasing of the Act
that FDA has made a determination that your device complies with other requires. that FDA has made a determination that your are complet Federal agencies. You must
or any Federal statutes and regulations soluncian but not limited to: registration and li or any Federal statutes and regulations administed by out a ugestiration and listing (21
comply with all the Act's requirements, including, but not limited to regultents as s comply with all the Act's requirements, including, but not mines were requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements CFR Part 807); labeling (21 CFR Part 801); godd manufacture; pract and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1f ap forth in the quality systems (QS) regulation (21 CFR Part 22) ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Page 2 - Ms. Laura Seneff

This letter will allow you to begin marketing your device as described in your Section 510(k)
I allegally and the TDA Finding of substantial equivalence of your device to a This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The in a cleasification for your device and thus, premarket notification. The FDA finding of substantial equivalite on 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 If you desire specific advice for your device on our labeling regulation of the Office of
additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the It you are at (201) 594-4659. Additionally, for questions on the promotion and advertising of
Compliance at (301) 594-4659. Additionally, for questions on the promotion and Compliance at (301) 594-4659. Additionally, for questions on and promotes of the one the your device, please contact the Office of Complance at (01) 397 (1) 37 Part 807.97).
regulation entitled, "Misbranding by reference to prematket may be otained from the regulation entitled, "Mishranding by reference to premailer homments" (
Other general information on your responsibilities under the Act may be obtained from the 1984 - 1988 - 1998 - 1998 - 1998 - 1995 - 1995 - 1998 - 1998 - 1998 - 1998 - 1998 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -Division of Small Mianufacturers, Incat its Internet address
(800) 638-2041 or (301) 443-6597 or at its Internet in . ht (800) 638-2041 or (301) 445-6597 or ar le no no no no no http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Divison of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 DGRND D.O. D/t: SWFoster:bxw:12/18/01

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Page 1 of 1

October 23, 2001

510(k) Number (if known): John 3553

Device Name: Pre-Loaded UltraFix® RC

Indications for Use:

The Pre-Loaded UltraFix® RC is intended to be used for rotator cuff repairs in the The FTC-Eoadou Oldar of an open technique.

(Division Sign-Off) Division of Gener Restorative and Neurological ... vices

510(k) Number L

(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE If NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
OR
(Per 21 CFR 801.109)
Over-the-Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

N/A