The Smith & Nephew BIORAPTOR 2.9 and TwinFix Ti 2.8 & 3.5 suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder, Foot and Ankle, Elbow, Knee, Hip.

Device Description

BioRaptor: Preloaded 2.9 mm suture anchor manufactured from PLA (Poly(L-Lactide)) incorporating either ultra high molecular weight polyethelene suture or polyester suture on a stainless steel inserter.
TwinFix: 2.8 and 3.5mm titanium suture anchor incorporating either ultra high molecular weight polyethylene or polyester suture. TwinFix anchors are available preloaded on a stainless steel inserter shaft or unassembled. TwinFix anchors are available with or a stammess stool inserter shaft is available in two lengths, regular and XL.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the TwinFix Ti and BioRaptor 2.9 suture anchors:

No acceptance criteria or study details are provided in the given text.

The document is a 510(k) summary of safety and effectiveness information, specifically regarding an indication expansion for existing devices (TwinFix Ti 2.8 & 3.5 and BioRaptor 2.9) to include hip labral repair.

Here's a breakdown of why the requested information cannot be extracted from this document:

Acceptance Criteria and Reported Device Performance (Table 1): The document states: "The performance testing conducted includes bench and cadaver testing that demonstrates substantial equivalence for the indication of hip labral to soft tissue repair in other joints." However, it does not specify any numerical acceptance criteria (e.g., minimum pull-out strength, maximum displacement) or the actual results obtained from these tests. It only makes a general statement of "substantial equivalence."
Sample Size and Data Provenance (2): No information is provided regarding the specific sample sizes used for bench or cadaver testing. Data provenance (country, retrospective/prospective) is also not mentioned.
Number of Experts and Qualifications (3): The document mentions "cadaver testing" but does not indicate the involvement of experts in establishing ground truth for a test set, which would typically be relevant for imaging or diagnostic devices.
Adjudication Method (4): Not applicable, as no expert review process or test-set ground truth establishment is described.
MRMC Comparative Effectiveness Study (5): This type of study is usually conducted for diagnostic aids or AI-assisted interpretation, where human readers' performance is evaluated with and without AI. This document is about a physical medical device (suture anchors), so an MRMC study is not relevant here.
Standalone Performance (6): "Standalone performance" usually refers to the algorithm's performance without human intervention, again relevant for AI or diagnostic software. This is not applicable to a physical suture anchor device.
Type of Ground Truth (7): For mechanical devices like suture anchors, "ground truth" often refers to the actual mechanical properties measured (e.g., maximum load at failure) or direct observation during cadaveric procedures. The document does not detail how "ground truth" was established for the performance testing beyond stating "bench and cadaver testing."
Training Set Sample Size (8) and Ground Truth Establishment (9): These concepts are primarily relevant for AI/machine learning models that require training data. A physical device like a suture anchor does not have a "training set" in this context. Its development involves engineering design, material science, and mechanical testing.

Summary of what the document does state regarding performance data:

Type of Testing: Bench testing and cadaver testing.
Purpose: To demonstrate substantial equivalence for hip labral repair to soft tissue repair in other joints, comparing it to predicate devices (Smith & Nephew TwinFix Ti 2.8 & 3.5 (K972326) and BioRaptor 2.9 (K031683)).
Conclusion: The testing "demonstrates substantial equivalence."

In conclusion, while the document acknowledges that performance testing was conducted, it does not provide the specific details required in your request regarding acceptance criteria, sample sizes, expert involvement, or adjudication methods for that testing. This is common in 510(k) summaries, which often provide only high-level statements about testing results rather than detailed raw data or criteria.

Summary

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K053344 Page 1 of 4

FEB 2 3 2006

SECTION IV SECTION IV

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

STOR SOMMERS OF OF 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

Indication Expansion -- TwinFix Ti 2.8 & 3.5/BioRaptor 2.9

Date Prepared: December 1, 2005

A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover MA, 01810

B. Company Contact

Deana Boushell Principle Regulatory Affairs Specialist (508) 337-4036 Phone: (508) 261-3620 FAX:

C. Device Name

Trade Name:	TwinFix Ti 2.8 & 3.5	BioRaptor 2.9
Common Name:	Suture Anchor	Suture Anchor
Classification Name:	Fastener, Fixation,non-degradable, soft tissue	Fastener, Fixation,degradable, soft tissue

D. Predicate Devices

The indication of hip labral repair is substantially equivalent to the currently Fire multications for use of the following legally marketed devices in marketed indications for ass of the Smith & Nephew TwinFix Ti 2.8 & 3.5 (K972326) BioRaptor 2.9 (K031683).

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Kc1-3344 P62-12

E. Description of Device

BioRaptor

Preloaded 2.9 mm suture anchor manufactured from PLA (Poly(L-Lactide)) incorporating either ultra high molecular weight polyethelene suture or polyester suture on a stainless steel inserter.

TwinFix

2.8 and 3.5mm titanium suture anchor incorporating either ultra high molecular weight polyethylene or polyester suture. TwinFix anchors are available preloaded on a stainless steel inserter shaft or unassembled. TwinFix anchors are available with or a stammess stool inserter shaft is available in two lengths, regular and XL.

Intended Use F.

The intended use of the currently available suture anchors remains unchanged. The suture anchors are intended for the fixation of soft tissue to bone.

G. Comparison of Technological Characteristics

There are no changes to the existing devices. Technological Characteristics remain the same.

H. Summary Performance Data

The performance testing conducted includes bench and cadaver testing that demonstrates substantial equivalence for the indication of hip labral to soft tissue repair in other joints.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 2006

Ms. Deana Boushell Principle Regulatory Affairs specialist Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Road Andover, MA 01810

K053344 Re:

Trade/Device Name: TwinFix 2.8mm, 3.5mm and BioRaptor 2.9mm Suture Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI, JDR, MAI Dated: January 27, 2006 Received: January 30, 2006

Dear Ms. Boushell:

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

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Page 2 - Ms. Deana Boushell

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. product indiation of to begin marketing your device as described in your Section 510(k) I mis letter will and in yourse organ finding of substantial equivalence of your device to a legally premailed notificated on "ce 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 If you dealer of Compliance at (301) 594-4639. 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 Oixor general 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. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

05354

Device Name: BioRaptor and TwinFix Ti 2.8 & 3.5 Suture Anchors

Indications For Use.

The Smith & Nephew BIORAPTOR 2.9 and TwinFix Ti 2.8 & 3.5 suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder

Capsular Stabilization Bankhart Repair Anterior Shoulder Instability Repair SLAP lesion repairs Capsular Shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid Repairs Rotator Cuff tear repairs Biceps tenodesis

Foot and Ankle Hallux valgus repairs Medial or lateral instablility repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy

Elbow Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

Knee

Extra-capsular repairs: medial collateral ligament lateral collateral ligament posterior oblique ligament Patellar realignment and tendon repairs: vastus medialis obliquous advancement Iliotibial band tenodesis

Hip

Capsular repair Acetabular labral repair

Prescription Use ____x

(Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use No

FR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

510(k) Number_

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.