Extra-capsular repairs;
a. medial collateral ligament
b. lateral collateral ligament
c. posterior oblique ligament
Iliotibial band tenodesis
Patellar realignment and tendon repairs, including vastus medialis obliquous advancement

Device Description

The Smith & Nephew Phoenix 5.0 Allograft Anchor Kit composed of machined cortical bone. The anchor is of a threaded design with two (2) evelets, to which braided #2 USP suture is attached (one per eyelet). The proximal end of the anchor accepts a disposable driver, which is used as the insertion device. The anchor requires a tapping procedure prior to implantation. Following the implantation of the anchor, the free ends of the suture are used to reattach soft tissue to bone.

AI/ML Overview

The provided text is a 510(k) summary for the Smith & Nephew Phoenix 5.0 Allograft Anchor Kit. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study or performance testing that generated quantitative performance metrics against pre-defined thresholds.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be extracted from the provided document.

The document states: "Performance testing has been performed to support substantial equivalence." However, it does not detail these performance tests, their acceptance criteria, or the specific results. It primarily compares the new device to predicate devices based on design, function, intended use, and materials.

Based on the provided text, the following aspects cannot be answered:

1. A table of acceptance criteria and the reported device performance: No specific quantitative acceptance criteria or performance metrics are reported.
2. Sample sized used for the test set and the data provenance: No information on a test set sample size or data provenance is provided. The performance testing mentioned is likely mechanical/bench testing to support equivalence rather than a clinical study with a "test set" in the context of AI/diagnostic devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a test set requiring expert ground truth for performance evaluation in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for diagnostic or AI-assisted devices, not for a surgical anchor.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. This device is not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of what can be inferred from the document regarding "proof of meeting acceptance criteria":

The "proof" in this 510(k) is the demonstration of substantial equivalence to existing legally marketed predicate devices, not the meeting of quantitative performance acceptance criteria in a clinical study.

Predicate Devices: Smith & Nephew Preloaded PRC5 5.0 mm Polyacetal Suture Anchor (K982963) and Multitak SS Bone Anchor (K993115).
Basis for Equivalence: "The Smith & Nephew Phoenix 5.0 Allograft Anchor Kit is substantially equivalent in design, function and intended use to the Smith & Nephew PRC5 Polyacetal Anchor. Performance testing has been performed to support substantial equivalance. It is substantially equivalent in its materials and use to the Mutlitak SS Bone Anchor."
"Study" (Implied): Performance testing (likely mechanical/bench testing) was conducted to demonstrate that the new allograft anchor performs comparably to the predicate polyacetal anchor in terms of design, function, and intended use characteristics. The specific methodology or results of this testing are not detailed in this summary. The material equivalence is drawn from comparison to the Multitak SS Bone Anchor.

Summary

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011985 p 1/2

NOV 0 2 2001

510(k) Summary Smith & Nephew Phoenix 5.0 Allograft Anchor Kit Revision Date: September 24, 2001

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

A. Submitter

Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover, MA 01810

B. Company Contact

Tim Crabtree Regulatory Affairs Specialist

C. Device Name

Trade Name: Smith & Nephew Phoenix 5.0 Allograft Anchor Kit Common Name; Soft Tissue Suture Anchor Classification Name: Unclassified

D. Predicate Devices

Smith & Nephew Preloaded PRC5 5.0 mm Polyacetal Suture Anchor (K982963) Multitak SS Bone Anchor (K993115)

E. Description of Device

F. Intended Use

The Smith & Nephew Phoenix 5.0 Allograft Anchor Kit is intended for use only for the fixation of soft tissue to bone for the following indications:

Shoulder:

1. Bankart lesion repairs
1. SLAP lesion repairs

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K011985 p²/2

1. Acromioclavicular separation repairs
1. Rotator cuff tear repairs
1. Capsular shift or capsulolabral reconstructions
1. Biceps tenodesis
1. Deltoid repairs

Foot and Ankle:

1. Hallux valgus repairs
1. Medial or lateral instability repairs/reconstructions
1. Achilles tendon repairs/reconstructions
1. Midfoot reconstructions
1. Metatarsal ligament/tendon repairs/reconstructions

Elbow, Wrist, and Hand:

1. Scapholunate ligament reconstructions
1. Ulnar or radial collateral ligament reconstructions
1. Lateral epicondylitis repair
1. Biceps tendon reattachment

Knee:

1. Extra-capsular repairs;
- a. medial collateral ligament
- b. lateral collateral ligament
- c. posterior oblique ligament
1. Iliotibial band tenodesis

Patellar realignment and tendon repairs, including vastus medialis obliquous advancement

G. Comparison of Technological Characteristics

The Smith & Nephew Phoenix 5.0 Allograft Anchor Kit is substantially equivalent in design, function and intended use to the Smith & Nephew PRC5 Polyacetal Anchor. Performance testing has been performed to support substantial equivalance. It is substantially equivalent in its materials and use to the Mutlitak SS Bone Anchor.

Tm Cobb

Tim Crabtree Regulatory Affairs Specialist

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

Image /page/2/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wing segments, symbolizing health, hope, and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 2 2001

Mr. Tim Crabtree Regulatory Affairs Specialist Smith & Nephew, Inc. 160 Dascomb Road Andover, Massachusetts 01810

Re: K011985

Trade/Device Name: Smith & Nephew Phoenix 5.0 Allograft Anchor Kit Regulation Number: 21 CFR 888.3040 and 878.5000 Regulation Name: Smooth or threaded metallic bone fixation fastener and nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: MAI, JDW, BAS Dated: June 19, 2001 Received: June 26, 2001

Dear Mr. Crabtree:

We have reviewed your Section 510(k) premarket notification of intent to market the device wfo nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfal the encreaters of to 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 r ou may , ateres, mains of the Act include requirements for annual registration, listing of general controls proficious 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 If your device is elassince (soo as 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 r reaso or action and intermination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must corply 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 orth 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.

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

Page 2 - Mr. Tim Crabtree

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,

for Marli N-Mellman

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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K011985

NOV 0 2 2001 510(k) Number :

Device Name : The Smith & Nephew Phoenix 5.0 Allograft Kit

Indications for Use :

The Smith & Nephew Phoenix 5.0 Allograft Anchor Kit is intended for use only for the fixation of soft tissue to bone for the following indications:

Shoulder:

1. Bankart lesion repairs
1. SLAP lesion repairs
1. Acromioclavicular separation repairs
1. Rotator cuff tear repairs
1. Capsular shift or capsulolabral reconstructions
1. Biceps tenodesis
1. Deltoid repairs

Foot and Ankle:

1. Hallux valgus repairs
1. Medial or lateral instability repairs/reconstructions
1. Achilles tendon repairs/reconstructions
1. Midfoot reconstructions
1. Metatarsal ligament/tendon repairs/reconstructions

Elbow, Wrist, and Hand:

1. Scapholunate ligament reconstructions
1. Ulnar or radial collateral ligament reconstructions
1. Lateral epicondylitis repair
1. Biceps tendon reattachment

Knee:

1. Extra-capsular repairs:
- a. medial collateral ligament
- b. lateral collateral ligament
- c. posterior oblique ligament
1. Iliotibial band tenodesis
1. Patellar realignment and tendon repairs, including vastus medialis obliquous advancement

fo Mark N Milliman

storative 011985

510(k) Number

Smith & Nephew Phoenix5.0 Allograft Anchor Kit Page 19 of 64

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.