The Smith & Nephew Osteoraptor OS Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications: Elbow, Wrist, and Hand (Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair), Foot and Ankle (Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy), Hip (Hip capsule repair, Acetabular labrum 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), Shoulder (Capsular stabilization: Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis).

Device Description

The Smith & Nephew OSTEORAPTOR OS Suture Anchor is a fixation device intended to provide secure attachment of soft tissue to bone until healing occurs. The device consists of a resorbable composite suture anchor with attached non-absorbable suture(s) preloaded onto an insertion device. A 24 month ovine bone implantation study demonstrated that 9x10 mm implants typically resorb in approximately two years and are replaced by bone. This device is provided sterile, for single use only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the OSTEORAPTOR OS Suture Anchor. This is a submission to demonstrate substantial equivalence to previously marketed devices, not a study setting specific acceptance criteria and proving performance against them in the way clinical trials for new medical technologies typically do.

Therefore, many of the requested elements (like acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) are not applicable or not detailed in this type of regulatory document, which focuses on demonstrating equivalence rather than establishing novel performance metrics.

However, I can extract the information that is present and indicate where the requested information is not available.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate devices (OSTEORAPTOR Suture Anchors (K082215) and DePuy Mitek LUPINE BR Anchor (K070925)) in intended use, operating principle, and design features.	The OSTEORAPTOR OS Suture Anchor is considered substantially equivalent to the predicate devices. The only noted difference is the anchor material.
Biocompatibility	Biocompatibility studies demonstrated equivalence.
Resorption properties and replacement by bone	A 24-month ovine bone implantation study showed 9x10 mm implants typically resorb in approximately two years and are replaced by bone.
In vitro testing performance	In vitro testing demonstrated equivalence.
Safety and efficacy are not negatively impacted by material change.	The proposed modification to the anchor material does not raise new questions of safety and efficacy.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for the test set: Not explicitly stated as a "test set" in the context of algorithm performance. The ovine implantation study involved an unspecified number of 9x10 mm implants.
Data Provenance:
- Ovine bone implantation study: Performed in animals (ovine). Country of origin not specified. This would be considered a prospective animal study.
- Biocompatibility and in vitro testing: Details on data provenance are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This document is not describing a study that establishes ground truth based on expert review for a test set in the way an AI/algorithm validation would. The ground truth for the animal study would be based on histological and imaging analysis conducted by veterinary pathologists/researchers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This document does not describe a study involving human adjudication of a test set in relation to an algorithm's output.

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

No. This document does not mention any MRMC comparative effectiveness study, nor does it involve AI assistance for human readers.

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

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

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

For the ovine implantation study, the "ground truth" for resorption and bone replacement would be established through pathological examination (histology) and potentially imaging studies of the bone/implant site over time.
For biocompatibility, the ground truth is established through standard biocompatibility testing methods (e.g., cytotoxicity, irritation, sensitization based on ISO 10993 standards).
For in vitro testing, the ground truth is established through mechanical testing specifications and results.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm study that uses a training set.

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

Not applicable.

Summary

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JAN 2 7 2011

SECTION IV 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

OSTEORAPTOR™ OS Suture Anchor

Date Prepared: 10 November 2010

A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover, MA 01810

B. Company Contact

Julie Acker, RAC Senior Regulatory Affairs Specialist Phone: (508) 261-3618 Fax: (508) 261-3620

C. Device Name

Trade Name:	OSTEORAPTOR OS Suture Anchor
Common Name:	Suture Anchor
Classification Name:	Fastener, Fixation, Biodegradable, Soft Tissue
Product Code:	MAI
Regulation Number:	21 CFR § 888.3030

D. Predicate Devices

The Smith & Nephew Osteoraptor OS Suture Anchor is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: Smith & Nephew OSTEORAPTOR Suture Anchors (K082215) and DePuy Mitek LUPINE BR Anchor (K070925).

E. Description of Device

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implants typically resorb in approximately two years and are replaced by bone. This device is provided sterile, for single use only.

Intended Use

The Smith & Nephew Osteoraptor OS Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications:

Elbow, Wrist, and Hand	Knee
Biceps tendon reattachment	Extra-capsular repairs:
Ulnar or radial collateral ligament.reconstructions	– Medial collateral ligament
Lateral epicondylitis repair	– Lateral collateral ligament– Posterior oblique ligament
Foot and Ankle	Patellar realignment and tendon repairs
Hallux valgus repairs	– Vastus medialis obliquous advancement
Medial or lateral instabilityrepairs/reconstructions	Iliotibial band tenodesis
Achilles tendon repairs/reconstructions
Midfoot reconstructions	Shoulder
Metatarsal ligament/tendonrepairs/reconstructions	Capsular stabilization
Bunionectomy	– Bankart repair
	– Anterior shoulder instability
Hip	– SLAP lesion repairs
Hip capsule repair	– Capsular shift or capsulolabralreconstructions
– Acetabular labrum reattachment	Acromioclavicular separation repairsDeltoid repairs
	Rotator cuff tear repairs

F. Comparison of Technological Characteristics

The intended use; operating principle and design features of the Osteoraptor OS Suture Anchors are substantially equivalent to the legally marketed predicate anchors. Osteoraptor OS anchors are identical in design and intended use to the predicate Osteoraptor anchors except for the anchor material.

Biceps tenodesis

G. Summary Performance Data

Results of biocompatibility studies, animal studies, and in vitro testing demonstrate that Osteoraptor OS Anchors are substantially equivalent to predicate devices and the proposed modification to the anchor material does not raise new questions of safety and efficacy for these devices.

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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 representation of an eagle or bird-like figure, with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH &" is vertically oriented on the left side of the logo, and the text "HUMAN SERVICES" is vertically oriented on the right side of the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JAN 2 7 2011

Smith & Nephew, Inc. Endoscopy Division % Julie Acker Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, MA 01810

Re: K101459

Trade/Device Name: OSTEORAPTOR OS Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: January 26, 2011 Received: January 27, 2011

Dear Ms. Acker:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page - 2 – Ms. Julie Acker

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); medical device reporting reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutfDA/CentersOffices/CDRH/CDRHOPffices/ucm11178001/jpn1 for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2116FR Preat 807.97). For questions regarding the reporting of adverse events under the MDR regulting (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Ay B. Rh

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Osteoraptor II Suture Anchors

The Smith & Nephew Osteoraptor II Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications:

KIO1459

Knee Elbow, Wrist, and Hand Biceps tendon reattachment Extra-capsular repairs: - Medial collateral ligament Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair - Lateral collateral ligament - Posterior oblique ligament Foot and Ankle Patellar realignment and tendon repairs Hallux valgus repairs - Vastus medialis obliquous advancement Medial or lateral instability repairs/reconstructions Iliotibial band tenodesis Achilles tendon repairs/reconstructions Shoulder Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Capsular stabilization Bunionectomy - Bankart repair - Anterior shoulder instability Hip - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions Hip capsule repair Acromioclavicular separation repairs - Acetabular labrum reattachment Deltoid repairs Rotator cuff tear repairs Biceps tenodesis

Prescription Use X

AND/OR

Over-The-Counter Use _

(Per 21 CFR 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)

Ar.M.Mulkerson

(Divisiøn Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K10/459

22 of 381

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.