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

Elbow, Wrist, and Hand
Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicylitis repair

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

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

Device Description

The Smith & Nephew BIORAPTOR Curved 2.3 PK Suture Anchor is nonabsorbable 2.3 mm suture anchor manufactured from PEEK and comes preloaded with non-absorbable ultra high molecular weight braided polyethylene #2 suture preassembled to a flexible stainless steel inserter.

AI/ML Overview

The provided text describes the 510(k) summary for the BIORAPTOR Curved 2.3 PK Suture Anchor. It details the device's intended use and a comparison to a predicate device, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like accuracy, sensitivity, or specificity, which are common for AI/ML devices.

This document pertains to a physical medical device (suture anchor) and focuses on demonstrating substantial equivalence to a predicate device through functional testing (insertion, pull out, suture slide properties). The questions posed are more relevant to the evaluation of AI/ML-based medical devices.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown based on the information available:

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

Acceptance Criteria	Reported Device Performance
Not explicitly stated in terms of quantitative targets.	"The performance testing demonstrates that the insertion, pull out and suture slide properties of the BIORAPTOR Curved 2.3 PK anchors are substantially equivalent to the Smith & Nephew BIORAPTOR 2.3 PK anchors."

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: Not specified for any performance testing.
Data Provenance: Not specified. This typically refers to the source of patient data for AI/ML models, which is not applicable here as it's a physical device.

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)

Number of Experts & Qualifications: Not applicable. Ground truth for physical device performance (like pull-out strength) is typically established through direct measurement and engineering standards, not expert consensus as would be the case for image interpretation or diagnostic AI.

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

Adjudication Method: Not applicable. This concept is relevant for reconciling discrepancies in expert opinions, which is not described for this physical device testing.

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

MRMC Study: No. This type of study is specifically for evaluating the impact of AI on human reader performance, which is not relevant for a suture anchor.

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

Standalone Performance: No. This refers to the performance of an AI algorithm on its own, without human interaction. This is not applicable to a physical suture anchor.

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

Type of Ground Truth: For physical device testing, "ground truth" would be established through direct physical measurements of properties such as insertion force, pull-out strength, and suture slide characteristics using standardized testing methods. The document states "performance testing demonstrates that the insertion, pull out and suture slide properties... are substantially equivalent."

8. The sample size for the training set

Training Set Sample Size: Not applicable. There is no AI/ML algorithm being "trained" for this physical device.

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

Ground Truth for Training Set Establishment: Not applicable. (See answer to #8).

Summary of the Study:

The provided document describes a non-clinical performance study to demonstrate substantial equivalence of the BIORAPTOR Curved 2.3 PK Suture Anchor to its predicate device, the BIORAPTOR 2.3 PK Suture Anchor (K071586).

Acceptance Criteria (Implicit): The implicit acceptance criterion is that the new device's "insertion, pull out and suture slide properties" are "substantially equivalent" to those of the predicate device. This typically means the measured values for these properties fall within acceptable ranges or demonstrate similar statistical distributions compared to the predicate.
Study Design: Performance testing was conducted.
Reported Performance: The testing "demonstrates that the insertion, pull out and suture slide properties of the BIORAPTOR Curved 2.3 PK anchors are substantially equivalent to the Smith & Nephew BIORAPTOR 2.3 PK anchors."
Key takeaway: This is a submission for a physical medical device, not an AI/ML device, hence the lack of information pertaining to AI/ML specific evaluation criteria.

Summary

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< We are smith&nephew

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

978 749 1000 978 749 1599 Fax www.smith-nephew.com

DEC 1 3 2010

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.

BIORAPTOR Curved 2.3 PK Suture Anchor

Date Prepared: September 13, 2010

A. Submitter's Name:

. Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover, MA 01810

B. Company Contact

Kathleen Solomon

Regulatory Affairs Specialist II

Phone: (978) 749-1605

FAX: (978) 749-1443

C. Device Name

Trade Name:	BIORAPTOR Curved 2.3 PK Suture Anchor
Common Name:	Fastener, fixation, non-degradable, soft tissue
Classification Name:	Smooth or threaded metallic bone fixation fastener
Product Code:	MBI
Regulation Number:	21 CFR §888.3040

D. Predicate Device

The Smith & Nephew BIORAPTOR Curved 2.3 PK Suture Anchors are substantially equivalent in Indication for Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: BIORAPTOR 2.3 PK Suture Anchor (K071586).

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E. Description of Device

F. Intended Use

The BIORAPTOR Curved 2.3 PK suture anchors are intended for the fixation of soft tissue to bone in the Hip. Shoulder. Foot, Ankle, Elbow, Wrist, Hand and Knee as follows:

Hip

Hip capsule repair - Acetabular labrum reattachment

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

Foot and Ankle

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

Elbow, Wrist, and Hand

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

Knec

Extra-capsular repairs: - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament Patellar realignment and tendon repairs – Vastus medialis obliquous advancement Iliotibial band tenodesis

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

G. Comparison of Technological Characteristics

The Smith & Nephew BIORAPTOR Curved 2.3 PK Suture Anchors are substantially equivalent in indications for use, technological characteristics, and are as safe and as effective as their currently marketed predicate device, the Smith & Nephew BIORAPTOR 2.3 PK Suture Anchor (K071586).

H. Summary Performance Data

The performance testing demonstrates that the insertion, pull out and suture slide properties of the BIORAPTOR Curved 2.3 PK anchors are substantially equivalent to the Smith & Nephew BIORAPTOR 2.3 PK anchors.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's services. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

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

Smith & Nephew Endoscopy, Inc. % Ms. Kathleen Solomon 150 Minuteman Road Andover, MA 01810

DEC 1 3 2010

Re: K102660

Trade/Device Name: Bioraptor Curved 2.3 PK Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: September 13, 2010 Received: September 15, 2010

Dear Ms. Solomon:

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.

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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Ms. Kathleen Solomon

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 (21 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/CDRHOffices/ucm115809.htm 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" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (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.

Sincerely yours.

Foll Rihm Din

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):

K102660 (pg. 1/12)

Device Name: BIORAPTOR Curved 2.3 PK Suture Anchors

DEC 1 3 2010

Indications For Use:

The Smith & Nephew BIORAPTOR Curved 2.3 PK Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications;

Hip

Hip capsule repair - Acetabular labrum reattachment

Shoulder

Elbow, Wrist, and Hand Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair

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

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

Prescription Use

AND/OR

Over-The-Counter Use

(Per 21 CFR 801 Subpart D) 7

(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)

Smith & Nephew Endoscopy BIORAPTOR Curved 2.3 PK Suture Anchor

for M. Melkerson
22-01-13

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

510(k) Number K102660

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.