The Bio-Anchor is a bioabsorbable device used for soft tissue to bone fixation in orthopedic applications except for anterior or posterior cruciate ligament repair or reconstruction.

Shoulder:

Bankart lesion repairs
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
Tennis elbow repair
Biceps tendon reattachment

Knee:

Extra-capsular 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
Extracapsular reconstruction, iliotibial band tenodesis
Patellar realignment and tendon repairs

Device Description

The Bio-Anchor is a PLLA suture anchoring device. The device is cylindrical in shape with three circular ribs perpendicular to the long axis. The first and second ribs are the same size, with the proximal, third rib wider to allow for a centrally located eyelet running perpendicular to the long axis of the device. Freely passing suture is then threaded onto the Bio-Anchor by the surgeon. The lack of permanent attachment of the suture to the Bio-Anchor allows the use of sliding knots. Once the Bio-Anchor is implanted, the ends of the suture are passed through the soft tissue and tied for reattachment. Synthetic non-absorbable, polyester USP #0, #1, or #2 suture is recommended for use with this device.

The material used for this device is:

Anchor - Poly (L-lactic) acid (PLLA)

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness for the Linvatec Bio-Anchor™ Absorbable Suture Anchor. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a performance study with quantitative results.

Therefore, many of the requested categories regarding acceptance criteria, study design, sample sizes, ground truth establishment, and MRMC studies cannot be answered directly from the provided document. The document describes the device, its intended use, and its similarities and dissimilarities to predicate devices. It refers to a "chart of similarities and dissimilarities" to demonstrate substantial equivalence, which is a qualitative comparison rather than a formal performance study with acceptance criteria.

Below is an attempt to address your request based only on the information provided in the input, with many fields explicitly marked as "Not provided in the document."

Acceptance Criteria and Device Performance

Since this is a 510(k) submission primarily focused on substantial equivalence, specific numeric acceptance criteria for performance are not explicitly stated in the provided text. The "performance" demonstrated is typically compliance with mechanical and material properties similar to the predicate device. The table below represents a qualitative comparison used for substantial equivalence rather than quantitative acceptance criteria.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (as described in the document)
Intended Use Equivalence: Device's purpose should be similar to predicate.	New Product (Bio-Anchor): Soft tissue to bone fixation in orthopedic applications except for anterior or posterior cruciate ligament repair or reconstruction.Predicate (Preloaded Soft Tissue Anchor): Soft tissue to bone fixation.Predicate (Bio-Anchor Absorbable Suture Anchor - K955486): Soft tissue to bone fixation.
Material Equivalence: Device material should be similar to or already established predicate.	New Product (Bio-Anchor): Poly (L-lactic) acid.Predicate (Preloaded Soft Tissue Anchor): Titanium Alloy.Predicate (Bio-Anchor Absorbable Suture Anchor - K955486): Poly (L-lactic) acid.Note: The new Bio-Anchor's material is identical to the original Linvatec Bio-Anchor (K955486).
Sterilization Method Equivalence: Sterilization method should be standard and similar to predicate or well-established.	New Product (Bio-Anchor): ETO Sterilization.Predicate (Preloaded Soft Tissue Anchor): Gamma Sterilization.Predicate (Bio-Anchor Absorbable Suture Anchor - K955486): ETO Sterilization.
Size Equivalence (where applicable): Device sizes should be comparable or within a reasonable range.	New Product (Bio-Anchor): 3.5mm diameter, Suture: USP Sizes #0 to #2.Predicate (Preloaded Soft Tissue Anchor): 2.5mm - 5.2mm diameter, Suture: USP sizes #0 to #2.Predicate (Bio-Anchor Absorbable Suture Anchor - K955486): 3.5mm diameter, Suture: USP Sizes #0 to #2.
Mechanism of Action/Design Equivalence: Device design and how it achieves its function should be similar.	New Product (Bio-Anchor): Cylindrical shape with three circular ribs, central eyelet for freely passing suture. Lack of permanent suture attachment allows sliding knots.Predicate (Preloaded Soft Tissue Anchor): Not explicitly detailed, but implied to achieve soft tissue to bone fixation. The Preloaded predicate would imply a pre-attached suture, a dissimilarity noted. The Bio-Anchor predicate (K955486) would be very similar in design as it shares the same name and material.

Study Details

Sample size used for the test set and the data provenance: Not provided in the document. The document describes a comparison to predicate devices for substantial equivalence, not a performance study with a defined test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth establishment for a clinical test set is not described as part of this 510(k) submission.
Adjudication method for the test set: Not applicable/Not provided.
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 document is for a medical device (suture anchor), not an AI-assisted diagnostic or therapeutic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used: Not applicable/Not provided. The basis for approval is substantial equivalence to a legally marketed predicate device, primarily based on design, materials, and intended use, rather than a clinical performance study with "ground truth" as typically understood in diagnostic device evaluation.
The sample size for the training set: Not applicable/Not provided. This is a medical device, not an AI model requiring a training set.
How the ground truth for the training set was established: Not applicable/Not provided.

Summary

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K964805

11311 Concept Boulevard Largo, Florida 33773 813 399-5334 Fax 813 399-5264

Carol A. Weideman, Ph.D.

Manager, Regulatory and Clinical Allairs

JUN - 9 1997

510(k) 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 Bio-Anchor™ Absorbable Suture Anchor, 510(k) Number K964805.

A. Submitter

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773

B. Company Contact

Carol A. Weideman, Ph.D. Manager, Regulatory and Clinical Affairs

C. Device Name

Trade Name: Bio-Anchor Common Name: Suture Anchor Classification Name: Soft tissue to bone fixation device

D. Predicate/Legally Marketed Devices

Linvatec Preloaded Soft Tissue Anchor Linvatec Bio-Anchor

Image /page/0/Picture/16 description: The image shows the logo for A Bristol-Myers Squibb Company. The logo consists of a geometric design on the left and the company name on the right. The geometric design is a hexagon made up of smaller triangles. The company name is written in a serif font.

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Summary of Safety and Effectiveness Bio-Anchor Absorbable Suture Anchor 510(k) # K964806 Page 2

E. Device Description

The material used for this device is:

Anchor - Poly (L-lactic) acid (PLLA)

. Intended Use

The Bio-Anchor is a bioabsorbable device used for soft tissue to bone fixation in orthopedic applications except for anterior or posterior cruciate ligament repair or reconstruction.

The Bio-Anchor Absorbable Suture Anchor is available in a 3.5mm size.

G. Substantial Equivalence

The Bio-Anchor Absorbable Suture Anchor is substantially equivalent in function and intended use to Linvatec's Preloaded Soft Tissue Anchor and Linvatec's Bio-Anchor. The material is identical to the original Linvatec Bio-Anchor.

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

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Summary of Safety and Effectiveness Bio-Anchor Absorbable Suture Anchor 510(k) # K964805 Page 3

SUBSTANTIAL EQUIVALENCE INFORMATION:

CHART OF SIMILARITIES AND DISSIMILARITIES

Company Name	Device Name	Intended Use	Material	Single-Use/Reusable	Sizes
New Product:Linvatec	Bio-Anchor	Soft tissue tobone fixation inorthopedicapplicationsexcept foranterior orposterior cruciateligament repair orreconstruction.	Poly (L-lactic)acid	Single-UseETOSterilization	3.5mm diameterSuture:USP Sizes #0 to #2
Predicate:Linvatec:Preloaded Soft TissueAnchor510(k) # K953954	Preloaded SoftTissue Anchor	Soft tissue tobone fixation	Titanium AlloySuture: Non-absorbableBraided Polyester	Single-UseGammaSterilization	2.5mm - 5.2mmdiameterSuture:USP sizes #0 to #2
Predicate:Linvatec:Bio-Anchor AbsorbableSuture Anchor510(k) #K955486	Bio-Anchor	Soft tissue tobone fixation	Poly (L-lactic)acid#0, #1, or #2Non-AbsorbableSuture	Single-UseETOSterilization	3.5mm diameterSuture:USP Sizes #0 to #2

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 9 1997

Carol A. Weideman, Ph.D. Manager, Requlatory and Clinical Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 34643

K964805 Re : Bio-Anchor® Absorbable Suture Anchor Requlatory Class: II Product Code: MAI Dated: March 20, 1997 March 21, 1997 Received:

Dear Dr. Weideman:

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 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 (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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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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Paqe 2 - Carol A. Weideman, Ph.D.

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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11311 Concept Boulevard Largo, Florida

June 3, 1997

Page 1 of 2

510(k) Number (if known): K964805

Device Name: BIO-ANCHOR™ ABSORBABLE SUTURE ANCHOR

Indications for Use:

The Bio-Anchor is a bioabsorbable device used for soft tissue to bone fixation in THE Blo Anonor is a bloaders anterior or posterior cruciate ligament repair or reconstruction.

Shoulder_

Bankart lesion repairs 1.
SLAP lesion repairs 2.
Acromio-clavicular separation repairs 3.
Rotator cuff tear repairs 4.
Capsular shift or capsulolabral reconstructions 5.
Biceps tenodesis ୍.
Deltoid repairs 7.

Foot and Ankle

Hallux Valgus repairs 1 .
Medial or lateral instability repairs/reconstructions 2.
Achilles tendon repairs/reconstructions 3.
Midfoot reconstructions 4.

Elbow, Wrist and Hand

Scapholunate ligament reconstructions 1.
Ulnar or radial collateral ligament reconstructions 2.
Tennis elbow repair 3.
Biceps tendon reattachment 4.

Use
2.801.109)

Prescription Use . (Per 21 CFR 801.109)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number Y964805

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K964805 Bio-Anchor™ Absorbable Suture Anchor Indications for Use June 3, 1997 Page 2 of 2

Knee

Extra-capsular repairs and reattachments of: 1.
- medial collateral ligament a.
- lateral collateral ligament b.
- posterior oblique ligament or joint capsule to tibia « С.
  - joint capsule closure to anterior proximal tibia d.
Extracapsular reconstruction, iliotibial band tenodesis 2.
Patellar realignment and tendon repairs 3.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K964805

Prescription Use (Per 21 CFR 801.109)	X
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Over-the-Counter Use
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(Optional Format 1-2-96)

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.