The Pre-loaded Bio-Anchor is a bioabsorbable device with attached suture used to attach soft tissue to bone in arthroscopic or open procedures for the following indications: Shoulder (Bankart lesion repairs, SLAP lesion repairs, Acromio-clavicular separation repairs, Rotator cuff tear repairs, Capsular shift or capsulolabral reconstructions, Biceps tenodesis, Altoid 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 (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 Pre-loaded Bio-Anchor is an injection molded Poly (L-lactic) acid suture anchoring device with an attached nonabsorbable braided polyester surure USP size #2. The device is circular in shape with three cylindrical ribs perpendicular to the long axis. The suture is passed through the eyelet of the anchor and attached to a wire by shrink tubing.

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness for a medical device (Pre-loaded Bio-Anchor Absorbable Suture Anchor). This type of document is a premarket notification to the FDA, demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device.

It is crucial to understand that a 510(k) submission primarily focuses on demonstrating substantial equivalence, not necessarily on presenting original clinical studies with acceptance criteria, sample sizes, and ground truth establishment in the way one might find for a novel, high-risk device requiring PMA (Premarket Approval).

Therefore, the information you've requested about specific acceptance criteria, detailed study designs, and performance metrics (like effect size for MRMC studies or standalone algorithm performance) is not typically found in a 510(k) summary like this one.

Instead, 510(k) submissions typically reference:

Performance data from the predicate device: The new device is compared to a previously cleared device.
Bench testing: To demonstrate physical and mechanical properties.
Biocompatibility testing: To ensure safety when in contact with the body.
Sterilization validation: To confirm the device can be consistently sterilized.

Based on the provided text, here's what can be extracted and what cannot:

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

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in the way a clinical study report would. It states: "Testing has been done to prove safety and effectiveness of the devices." The primary "performance" discussed is the demonstration of substantial equivalence to predicate devices in design, function, and intended use.

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

This information is not provided in the summary. Since the submission focuses on substantial equivalence and refers to "testing," it's likely referring to bench-top mechanical testing, biocompatibility testing, and sterilization validation, not large-scale clinical trials that would have clearly defined test sets in terms of patient data.

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)

This information is not applicable/not provided. The assessment for a suture anchor is generally based on mechanical properties and biological interactions, not interpretation of images or patient data that would require "ground truth" established by human experts in this context.

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

This information is not applicable/not provided. As explained above, the "test set" and ground truth establishment do not align with methods requiring adjudication by experts.

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

An MRMC study is not applicable to this type of device. This device is a physical implant (suture anchor), not an AI diagnostic tool or software.

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

This is not applicable as the device is a physical medical implant, not an algorithm or software.

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

The concept of "ground truth" as typically applied in AI/diagnostic studies is not directly applicable here. For a mechanical device like a suture anchor, "ground truth" would be related to material properties meeting specifications, biomechanical performance (e.g., pull-out strength), and biocompatibility, which are verified through engineering and biological testing, not clinical "outcomes data" in the same sense as a drug or complex diagnostic. The basis for safety and effectiveness is largely demonstrated through comparison to predicates and testing of physical properties.

8. The sample size for the training set

This information is not applicable/not provided. Training sets are relevant for AI algorithms, which this device is not.

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

This information is not applicable/not provided. Training sets and ground truth establishment methods are primarily for AI/machine learning models.

Summary

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OCT 21 1998

October 15,1998

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 the 510(k) Summary of Safety and submitting hereby Effectiveness for the Pre-loaded Bio-Anchor Absorbable Suture Anchor, 510(k) Number K983186.

A. Submitter

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

K983186

Company Contact B.

Carol A. Weideman, Ph.D. Director, Compliance and Regulatory Affairs

c. Device Name

Trade Name:

		Bioabsorbable Suture Anchor
Common Name	:	Suture Anchor
Classification Names	:	None Assigned
Proposed Class/Device	:	Class II, 87 MAI, Fastener
Product Code	:	Fixation, Biodegradable,Soft Tissue

Bio-Anchor, Pre-loaded

Predicate/Legally Marketed Devices D.

Bio-Anchor Linvatec Corporation

Pre-loaded Soft Tissue Anchors Revo/Mini Revo Linvatec Corporation

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Summary of Safety and Effectiveness Pre-loaded Bio-Anchor Absorbable Suture Anchor 510 (k) # K983186 October 15, 1998 Page 2 of 4

E. Device Description

The Pre-loaded Bio-Anchor is an injection molded Poly (Llactic) acid suture anchoring device with an attached nonabsorbable braided polyester surure USP size #2. The device circular ribs in shape with three cylindrical i s perpendicular to the long axis. The suture is passed through the eyelet of the anchor and attached to a wire by shrink tubing.

F. Intended Use

The Pre-loaded Bio-Anchor is a bioabsorbable device with attached suture used to attach soft tissue to bone in arthroscopic or open procedures for the following indications :

Shoulder

1. Bankart lesion repairs
1. SLAP lesion repairs
1. Acromio-clavicular separation repairs
1. Rotator cuff tear repairs
1. Capsular shift or capsulolabral reconstructions
1. Biceps tenodesis
1. Altoid 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. Tennis elbow repair
1. Biceps tendon reattachment

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Summary of Safety and Effectiveness Pre-loaded Bio-Anchor Absorbable Suture Anchor 510 (k) # K983186 October 15, 1998 Page 3 of 4

F. Intended Use (con't)

Knee

l. 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

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

Substantial Equivalence ઉં.

The Pre-loaded Bio-Anchor is substantially equivalent in design, function and intended use to the Bio-Anchor (Linvatec Corporation), and the Revo/Mini Revo Preloaded Suture Anchors, (Linvatec Corporation) .

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

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

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Summary of Safety and Effectiveness Pre-loaded Bio-Anchor Absorbable Suture Anchor 510(k) # K983186 October 15, 1998 Page 4of 4

CHART OF SIMILARITIES AND DISSIMILARITIES

CHART OF SIMILARITIES AND DISSIMILARITIES
Company	Device Name	Intended Use	Material	Single-UseReusable	Sizes
NEW PRODUCTLinvatec	Pre-loaded Bio-AnchorAbsorbableSuture Anchor	Soft tissue to bonefixation for shoulder,knee, foot, ankle,elbow, wrist, hand, andbladder neck suspensionprocedures.	Anchor: Poly (L-lactic)acidSuture: Non-absorbablebraided polyesterSuture Sleeve: FEP TeflonShrink Tube, MIL-1023053/11B or PolyesterShrink TubeWire: 316 Stainless Steel	Single-UseETO SterilizationShipped Sterile	Anchor: 3.5mm x 10.5mmSuture: USP Size #2
PREDICATELinvatecBio-Anchor510(k)#K964805#K963369	Bio-Anchor	Soft tissue to bonefixation for shoulder,knee, foot, ankle,elbow, wrist, hand, andbladder neck suspensionprocedures.	Poly (L-lactic)acid	Single-UseETO SterilizationShipped Sterile	3.5mm x 10.5mm
PREDICATELinvatecPre-loaded SoftTissue Anchors510(k)#K953954	Revo/Mini Revo	Soft tissue to bonefixation.	Anchor: Titanium AlloySuture: Non-absorbablebraided polyesterSuture Sleeve: FEP TeflonShrink Tube, MIL-1023053/11B or PolyesterShrink TubeWire: 316 Stainless Steel	Single-UseGamma SterilizationShipped Sterile	Anchors: 2.5mm - 5.2mmSuture: USP Sizes #0to #2

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the top half of the circle. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1998

Carol A. Weideman, Ph.D. Director, Compliance and Regulatory Affairs Linvatec 11311 Concept Boulevard Largo, Florida 33773

K983186 Re: Trade Name: Pre-loaded Bio-Anchor Absorbable Suture Anchor Requlatory Class: II Product Codes: MAI, HWC, and GAT September 10, 1998 Dated: Received: September 11, 1998

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 aqainst 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 Requlations, Title 21, Parts 800 to 895. તે substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.

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Page 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 requlation (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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September 10, 1998

510(k) Number (if known): K983186

Device Name: Pre-loaded Bio-Anchor Absorbable Suture Anchor

Indications for Use:

The Pre-loaded Bio-Anchor is a bioabsorbable device with attached suture used to attach soft tissue to bone in arthroscopic or open procedures for the following indications:

Shoulder

Bankart lesion repairs 1.
1. SLAP lesion repairs
Acromio-clavicular separation repairs 3.
Rotator cuff tear repairs বা বা বা বা বা করে আর করে আর করে আর করে আর করে আর করে আর করে আর করে আমার করে আমার করে আমার করে আমার করে আমার করে আমার করে আমার করে আমার করে আমার করে আমার করে আমার করে আমার
Capsular shift or capsulolabral reconstructions 5.
Biceps tenodesis 6.
Altoid repairs 7.

Foot and Ankle

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

Elbow, Wrist and Hand

1. Scapholunate ligament reconstructions
Ulnar or radial collateral ligament reconstructions 2.
ကိုးက Tennis elbow repair
Biceps tendon reattachment 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
Extracapsular reconstruction, Iliotibial band tenodesis 2.
1. Patellar realignment and tendon repairs

Pcodefe

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

Kg983182

Prescription Use
(Per 21 CFR 801.109)

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Indications for Use (con't):

Bladder Neck Suspension

l. 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)
-------------------------------------------------------

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K983186

Prescription Use X OR Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

こ

(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.