The CUFFLOK Anchor is a partially bioabsorbable three-part polymer implant designed for use in shoulder rotator cuff repair and is used to secure soft tissue to bone. The three components of the implant are a tapered tip (PLA with blue dye #6), a sleeve (polypropylene blue) and an inner suture pin (PLA with blue dye #6). The anchor is also provided with ETHIBOND non-absorbable sutures and a stainless steel needle. Similar to the currently marketed CUFFTACK Anchor, the implant is mounted on a stainless steel trocar and placement of the implant is facilitated via use of a Delivery Gun.

AI/ML Overview

Here's an analysis of the provided text regarding the CUFFLOK Anchor's acceptance criteria and studies:

Summary of Device and Approval:

The CUFFLOK Anchor is a partially bioabsorbable three-part polymer implant designed for use in shoulder rotator cuff repair. It is intended to secure soft tissue to bone. The FDA granted substantial equivalence (K031519) to the CUFFTACK Anchor (K003076) based on the information provided.

Acceptance Criteria and Study Details for CUFFLOK Anchor:

The provided document does not contain information about specific acceptance criteria related to a performance study with defined metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical strength values) and subsequent reporting of device performance against these criteria.

Instead, the approval for the CUFFLOK Anchor appears to be based on demonstrating substantial equivalence to a predicate device (CUTTACK Anchor) and confirming biological compatibility.

Below, I've structured the answer based on the questions, indicating where information is present or absent in the provided text.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Biocompatibility: Non-toxic	Demonstrated to be non-toxic (as stated in the "Safety" section).
Biocompatibility: Non-irritating	Demonstrated to be non-irritating (as stated in the "Safety" section).
Biocompatibility: Non-sensitizing	Demonstrated to be non-sensitizing (as stated in the "Safety" section).
Biocompatibility: Non-cytotoxic	Demonstrated to be non-cytotoxic (as stated in the "Safety" section).
Substantial Equivalence: Similar indications for use (shoulder rotator cuff repair)	Met: Indicated for shoulder rotator cuff repair, same as predicate (implied by FDA's substantial equivalence determination).
Substantial Equivalence: Similar technology/design (three-part polymer implant, delivery method via trocar/Delivery Gun)	Met: "Similar to the currently marketed CUFFTACK Anchor, the implant is mounted on a stainless steel trocar and placement of the implant is facilitated via use of a Delivery Gun."
Performance (e.g., mechanical strength, pull-out force, tissue integration, etc.)	Not specified/Explicitly reported in the provided text. The document relies on substantial equivalence to the predicate for assumed performance.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document refers to "biocompatibility studies" but does not detail the sample size or design of these studies. No performance "test set" in the context of an AI/software device is mentioned.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. The document does not describe a process involving human experts to establish ground truth for a test set, as this is a physical medical device, not an AI/software product requiring image interpretation or similar.
Adjudication Method for the Test Set:
- Not applicable. No test set requiring expert adjudication is described.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document makes no mention of an MRMC study. This type of study is typically relevant for interpretative AI devices where human performance with and without AI assistance is evaluated.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No. This is a physical medical device, not an algorithm.
Type of Ground Truth Used:
- The "ground truth" for the CUFFLOK Anchor in the context of this submission appears to be:
  - Biocompatibility test results: Demonstrating non-toxicity, non-irritation, non-sensitization, and non-cytotoxicity.
  - Design and Material Equivalence: Comparison to the predicate device (CUTTACK Anchor) for design, materials (PLA, polypropylene), and intended use. The FDA's substantial equivalence finding validates this comparison.
- No pathology, imaging, or outcomes data used as "ground truth" for performance comparison is described in this document.
Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a training set.
How the Ground Truth for the Training Set Was Established:
- Not applicable. No training set is involved.

Summary

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

JUN - 6 2003

SECTION 2 - 510(k) SUMMARY

CUFFLOK Anchor

Submitter's Name and Address:	Mitek Worldwide a division of ETHICON Inc. a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, MA 02062
Contact Person	Ruth C. Forstadt Senior Regulatory Affairs Associate Mitek Worldwide a division of ETHICON Inc. a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, MA 02062
Telephone:	781-251-3188
Facsimile:	781-278-9578
e-mail:	rcforstad@ethus.jnj.com
Name of Medical Device
Classification Name:	Fastener, Fixation, Biodegradable, Soft Tissue
Common/Usual Name:	Bone Anchor
Proprietary Name:	CUFFLOK Anchor
Substantial Equivalence	CUFFLOK Anchor is substantially equivalent to: CUTTACK Anchor (K003076) manufactured by Mitek Worldwide, a division of Ethicon, Inc., a Johnson & Johnson Company, 249 Vanderbilt Avenue, Norwood, MA 02062.
Device Classification	Bone anchors/screws are classified by FDA as a Class II Medical Devices under the generic category of Single/Multiple Component Metallic Bone Fixation Appliances, Orthopedic Devices Panel (reference 21 CFR §888.3030). Product code MAI.
Device Description	The CUFFLOK Anchor is a partially bioabsorbable three-part polymer implant designed for use in shoulder rotator cuff repair and is used to secure soft tissue to bone. The three components of the implant are a

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

tapered tip (PLA with blue dye #6), a sleeve (polypropylene blue) and an inner suture pin (PLA with blue dye #6). The anchor is also provided with ETHIBOND non-absorbable sutures and a stainless steel needle.

Similar to the currently marketed CUFFTACK Anchor, the implant is mounted on a stainless steel trocar and placement of the implant is facilitated via use of a Delivery Gun.

The CUFFLOK Anchor is indicated for shoulder rotator cuff repair. Indications for Use の 2007年 10月 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時

Safety

Biocompatibility studies have demonstrated the CUFFLOK Anchor to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic.

CONFIDENTIAL

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

JUN - 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ruth C. Forstadt Senior Regulatory Affairs Associate Mitek Worldwide A division of ETHICON Incorporated A Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062

K031519 Re:

Trade Name: CUFFLOK Anchor Regulation Number: 21 CFR 888.3030, 21 CFR 878.5000 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II

Product Code: MAI, GAT Dated: May 14, 2003 Received: May 19, 2003

Dear Ms. Forstadt:

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.

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

Page 2 - Ms. Ruth C. Forstadt

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). 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.

Miriam C. Provost

for 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

{4}------------------------------------------------

INDICATIONS FOR USE

510(k) Number (if known): K 43 3 15 19

Device Name: CUFFLOK Anchor

Indications for Use:

The CUFFLOK Anchor is indicated for shoulder rotator cuff repair.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-the-Counter Use -------

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K03/5/9

CONFIDENTIAL

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.