Shoulder - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair, and anterior shoulder instability repair

Wrist - Scapholunate ligament reconstruction

Elbow - Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction, and lateral epicondylitis repair

Knee - Extracapsular Repair (Medial collateral ligament repair, lateral ligament repair, and posterior oblique ligament repair), joint capsule closure, iliotibial band tenodesis reconstruction, patellar realignment and tendon repair, and vastus medialis obliquus (VMO) muscle advancement

Foot and Ankle - Hallux valgus repairs, medial or lateral instability repair/reconstruction, Achilles tendon repair/reconstruction, midfoot reconstruction, and metatarsal ligament/tendon repair/reconstruction

Hip - Capsular Repair (acetabular labral repair)

Device Description

The Harpoon® Suture Anchor is comprised of either stainless steel or titanium material designed with a collar that provides resistance to pullout of the device. It is preloaded with a polyethylene suture and available in two sizes.

AI/ML Overview

The provided text is a 510(k) Summary for the Harpoon® Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the way typically seen for diagnostic or AI-driven medical devices.

Therefore, most of the requested information cannot be extracted from this document.

Here's an assessment based on the available text:

Acceptance Criteria and Device Performance

The document does not specify quantitative acceptance criteria or a reported device performance table as would be expected for a diagnostic or AI device. Instead, it states:

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

Acceptance Criteria	Reported Device Performance
Not specified	Not specified
General statement of functionality. No specific metrics or thresholds provided.	"The results indicated that the device was functional within its intended use."

2. Sample size used for the test set and the data provenance

A test set was not used in the context of performance evaluation against acceptance criteria, as no clinical testing or specific non-clinical performance evaluation against predefined criteria is detailed.

Sample Size (Test Set): Not applicable, as no dedicated "test set" for performance evaluation is described.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no ground truth was established from expert review for a test set in this 510(k) submission.

4. Adjudication method for the test set

Not applicable, as no test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."

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

This concept is not relevant to the Harpoon® Suture Anchor, which is a physical medical device (suture anchor), not an algorithm or a software device.

7. The type of ground truth used

Not applicable. The "ground truth" concept (e.g., pathology, expert consensus) is typically associated with the evaluation of diagnostic or prognostic devices/algorithms. For a physical device like a suture anchor, "ground truth" would refer to its physical properties and mechanical performance, which were assessed via non-clinical testing. However, the details of how this was established are not provided other than: "Non-clinical laboratory testing was performed to determine substantial equivalence."

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm that requires a training set.

Summary of what the document does provide regarding "proof" of meeting criteria:

The document leverages the concept of substantial equivalence to predicate devices. The "study" that proves the device meets (implicitly, rather than explicitly stated) acceptance criteria is the non-clinical laboratory testing that compared the Harpoon® Suture Anchor to its predicates.

"Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."

This implies that the non-clinical tests (e.g., mechanical strength, pull-out force, material biocompatibility, etc. – although not detailed in this summary) demonstrated performance comparable to the predicate devices, thereby supporting the claim that it is "functional within its intended use" and "substantially equivalent." No specific quantitative acceptance criteria or detailed results from these non-clinical tests are included in this 510(k) Summary.

Summary

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

Ko71816

page of

510(k) Summary

SEP 2 0 2007

Preparation Date: June 29, 2007

Applicant/Sponsor: Biomet Sports Medicine (Formerly known as Arthrotek, Inc.)

Contact Person: Elizabeth Wray

Proprietary Name: Harpoon® Suture Anchor

Common Name: Suture Anchor

Classification Name:

� MBI (888.3040): Fastener, fixation, nondegradable, soft tissue
HWC (888.3040): Screw, fixation bone ♥

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Device	Harpoon® Suture Anchor	BioRaptor™	Metal Screw Anchor(Currently Ti Screw)
Manufacturer	Biomet Sports Medicine	Smith & Nephew	Biomet Sports Medicine
510(k) Number	K973775	K053344	K012503

Device Description: The Harpoon® Suture Anchor is comprised of either stainless steel or titanium material designed with a collar that provides resistance to pullout of the device. It is preloaded with a polyethylene suture and available in two sizes.

Indications for Use/Intended Use:

Harpoon® and Mini-Harpoon® Suture Anchors are indicated for use in soft tissue reattachment procedures. Specific Indications are:

Wrist - Scapholunate ligament reconstruction

Elbow - Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction, and lateral epicondylitis repair

SSL, 1939 - Commen

Knee - Extracapsular Repair (Medial collateral ligament repair, lateral ligament repair, and posterior oblique ligament repair), joint capsule closure, iiiotibial band tenodesis reconstruction, patellar realignment and tendon repair, and vastus medialis obliquus (VMO) muscle advancement

२-१

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

page 2 of 2

Hip - Capsular Repair (acetabular labral repair)

Summary of Technologies: The technological characteristics (materials, design, sizing, and indications) of the Harpoon® Suture Anchor are similar or identical to the predicate device or other previously cleared devices.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc. except BioRaptor™ of Smith & Nephew.

{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 depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 0 2007

Biomet Sports Medicine, Inc. % Ms. Elizabeth Wray Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K071816

Trade/Device Name: Harpoon® Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, JDR, MBI Dated: June 29, 2007 Received: July 2, 2007

Dear Ms. Wray:

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 devive can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, TDA more 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the sectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 - Ms. Elizabeth Wray

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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or 240-276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Harbque Buehng

M. J. N. M.

Mark N. Me 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):

Device Name:

Indications For Use:

Harpoon® and Mini-Harpoon® Suture Anchors are indicated for use in soft tissue reattachment procedures. Specific Indications are:

Wrist - Scapholunate ligament reconstruction

Elbow - Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction, and lateral epicondylitis repair

Hip - Capsular Repair (acetabular labral repair)

Prescription Use _ YES AND/OR AND/OR CON Over-The-Counter Use NO (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Muchin
(Division Sign Off)

Division of General, Restorative, and Neurological Devices

510(k) Number: K071876

Page 1 of 1

4 - 1

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.