The BioRC Anchor is a bioabsorbable device used to attach soft tissue to bone in arthroscopic or open procedures for the following indications: Shoulder (Bankart lesion repair, SLAP lesion repairs, Acromio-clavicular separation repairs, Rotator cuff tear repairs, Capsular shift or capsulolabral reconstructions, Biceps tenodesis, Deltoid repairs), Foot and Ankle (Hallux Valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions), Elbow, Wrist and Hand (Scapholunate ligament reconstructions, Ulnar or radial collateral ligament reconstructions, Lateral and Medial Epicondylitis, Biceps tendon reattachment), Knee (Extracapsular repairs and reattachments of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia, joint capsule closure to anterior proximal tibia; Extracapsular reconstruction, iliotibial band tenodesis; Patellar realignment and tendon repairs), Bladder Neck Suspension (Soft tissue fixation of the pubic bone for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility).

Device Description

The BioRC Anchor is a cannulated, threaded, sterile, single-use fixation device made from a bioabsorbable homopolymer, Poly(L-lactide acid), which is used to attach soft tissue to bone. The device is preloaded on a disposable driver used to insert it into the bone.

AI/ML Overview

The provided text describes the BioRC Anchor, a bioabsorbable soft tissue anchor, and its substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and detailed performance metrics. Therefore, it does not contain the information required to populate all the requested fields about acceptance criteria and a study proving those criteria.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Inferred)	Reported Device Performance
Material	Poly(L-lactic acid)
Sterility	Sterile
Usage	Single-use
Sterilization Method	Ethylene Oxide
Design/Dimensions	6mm x 22mm, Threaded, cannulated device with a head to attach soft tissue to bone.
Intended Use	Soft tissue to bone fixation for shoulder, knee, foot, ankle, elbow, wrist, hand, and bladder neck suspension procedures.
Safety and Effectiveness	"Testing has been done to prove safety and effectiveness of the device." (No specific metrics provided in this document).
Substantial Equivalence	Determined to be substantially equivalent to Revo Suture Anchor (Linvatec Corporation) and SureTac (Acufex) in design and intended use, and to Preloaded Bio-Anchor Absorbable Suture Anchor (Linvatec Corporation) in materials.

Missing Information/Not Applicable (N/A) based on the provided text:

Specific quantitative acceptance criteria for performance (e.g., tensile strength, degradation rate, pull-out strength). The document states "Testing has been done to prove safety and effectiveness," but it does not report the specific results of these tests or explicit numerical acceptance criteria.
A "study" in the sense of a clinical trial or a detailed engineering performance study with sample sizes, ground truth, experts, adjudication, or AI components. This document is a 510(k) Summary of Safety and Effectiveness, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed standalone performance study results with the requested metrics.

Given this, the following sections will mostly be marked as N/A or "Not specified."

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 (test set): Not specified.
Data Provenance: Not specified. (The document implies engineering and materials testing, but details are absent).
Retrospective/Prospective: Not specified.

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 as this document does not describe a study involving expert-established ground truth on a test set (e.g., for image analysis or diagnostic accuracy). The "ground truth" for a medical device like this would typically involve engineering specifications, material properties, and potentially animal or cadaveric testing, but details are not provided.

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

Not applicable. This document does not describe a study that would involve an adjudication method for a test set.

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

Not applicable. This is a medical device (surgical anchor), not an AI-assisted diagnostic or interpretive system. Therefore, an MRMC study with human readers and AI assistance is not relevant or described.

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

Not applicable. This is a physical medical device, not an algorithm, so standalone performance in that context is not relevant.

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

The implicit "ground truth" for proving safety and effectiveness of a device like this would involve adherence to material specifications, mechanical performance benchmarks (e.g., pull-out strength, fatigue life), biocompatibility standards, and potentially successful histological outcomes in animal models for bioabsorption. However, the exact types of ground truth and how they were established are not specified in this summary. It states "Testing has been done to prove safety and effectiveness," which generically refers to these types of evaluations.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. As above, this is not an AI model.

Summary

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May 13, 1999

SUMMARY OF SAFETY AND EFFECTIVENESS

、「

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the BioRC Anchor 510(k) Number K990770.

A. Submitter

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

Company Contact B.

Laura Seneff Manager, Regulatory Affairs

C. Device Name

Trade Name:	: BioRC Anchor
Common Name	: BioAbsorbable Soft Tissue Anchor
Classification Names	: None Assigned

Proposed Class/Device : Class II-87 MAI, Fastener Product Code Fixation, Biodegradable, Soft Tissue

D. Predicate/Legally Marketed Devices

Revo Suture Anchor Linvatec Corporation

Suretac Acufex

Pre-loaded Bio-Anchor Linvatec Corporation

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Summary of Safety and Effectiveness BioRC Anchor 510(k) # K990770 May 13, 1999 Page 2 of 4

E. Device Description

F. Intended Use

This device is used to attach soft tissue to bone in arthroscopic or open procedures for the following indications:

Shoulder

1. Bankart lesion repair
1. SLAP lesion repairs
1. Acromio-clavicular 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

Elbow, Wrist and Hand

1. Scapholunate ligament reconstructions
1. Ulnar or radial collateral ligament reconstructions
1. Lateral and Medial Epicondylitis
1. Biceps tendon reattachment

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Summary of Safety and Effectiveness BioRC Anchor 510(k) # K990770 May 13, 1999 - -Page 3 of 4

Knee

1. Extracapsular repairs and reattachments of:
- a. medial collateral ligament
  - b. lateral collateral ligament
- c. posterior oblique ligament or joint capsule to tibia
- d. joint capsule closure to anterior proximal tibia
1. Extracapsular reconstruction, iliotibial band tenodesis
1. Patellar realignment and tendon repairs

Bladder Neck Suspension

Soft tissue fixation of the pubic bone for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility.

G. Substantial Equivalence

The BioRC Anchor is substantially equivalent in design and intended use to the Revo Suture Anchor (Linvatec Corporation) and SureTac (Acufex).

The BioRC Anchor is substantially equivalent in materials to the Preloaded Bio-Anchor Absorbable Suture Anchor (Linvatec Corporation).

Testing has been done to prove safety and effectiveness of the device.

The similarities/dissimilarities to the predicate are shown in the attached table.

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Summary of Safety and Effectiveness BioRC Anchor 510(k) # K990770 May 13, 1999 Page 4 of 4

.. .

CHART OF SIMILARITIES AND DISSIMILARITIES

Company	Device Name	Intended Use	Material	Single-UseReusable	Method ofSterilization	Design
NEWPRODUCTLinvatecCorp.	BioRC Anchor	Soft tissue to bone fixation forshoulder, knee, foot, ankle,elbow, wrist, hand and bladderneck suspension procedures.	Poly(L-lactic acid)	SterileSingle-use	EthyleneOxide	6mm x 22mmThreaded,cannulated devicewith a head toattach soft tissue tobone.
PREDICATELinvatecCorp.510(K)#K963932	Revo SutureAnchor	Soft tissue to bone fixation forshoulder, knee, foot, ankle,elbow, wrist, hand and bladderneck suspension procedures.	Titanium Alloy	SterileSingle-use	Gamma Radiation	2.5mm-5.2mmlengthThreaded devicethat attaches softtissue to bone.
PREDICATEAcufex510(K)#K911837	Suretac	Soft tissue to bone fixation.	Polyglyconate	SterileSingle-use	Ethylene Oxide	8mm x 16mmCannulated tackwith ribs to hold thedevice in the bone.
PREDICATELinvatec Corp510(K)#K983186	Pre-loaded Bio-Anchor	Soft tissue to bone fixation forshoulder, knee, foot, ankle,elbow, wrist, hand and bladderneck suspension procedures.	Poly(L-lactic acid)	SterileSingle-use	Ethylene Oxide	3.5mm x 10.5mmRibbed device witha loop at theproximal end tohold suture whichattaches the softtissue.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 1999

Ms. Laura Seneff Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

K990770 Re: Trade Name: BioRC Anchor Regulatory Class: II Product Code: MAI, HWC Dated: May 13, 1999 Received: May 14, 1999

Dear Ms. Seneff:

We have reviewed your Section 510/k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Laura Seneff

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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May 13, 1999

Page 1 of 2

510(k) Number (if known): K990770

Device Name: BioRC Anchor

Indications for Use:

The BioRC Anchor is a bioabsorbable device used to attach soft tissue to bone in arthroscopic or open procedures for the following indications:

Shoulder

1. Bankart lesion repair
1. SLAP lesion repairs
1. Acromio-clavicular 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

Elbow, Wrist and Hand

1. Scapholunate ligament reconstructions
1. Ulnar or radial collateral ligament reconstructions
1. Lateral and Medial Epicondylitis
1. Biceps tendon reattachment

Knee

1. Extracapsular repairs and reattachments of:
- a. medial collateral ligament
- b. lateral collateral ligament
- c. posterior oblique ligament or joint capsule to tibia
- d. joint capsule closure to anterior proximal tibia
1. Extracapsular reconstruction, iliotibial band tenodeşis
1. Patellar realignment and tendon repairs

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of General Restorative Devices	K9907
510(k) Number

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Indications for Use (con't):

Page 2 of 2

Bladder Neck Suspension

Soft tissue fixation of the pubic bone for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Prescription Use

Over-the-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

A. colles

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.