To provide interference fixation of soft tissue graft and bone-tendonbone patellar graft during the Anterior Cruciate Ligament repair through arthroscopy or arthrotomy.

Device Description

The PLLA cannulated interference screw is bio-absorbable sterile single use tapered and has a smooth threaded bone screw, which provides interference fixation of soft tissue grafts and bone-tendonbone patellar grafts during Anterior Cruciate Ligament repair through arthroscopy or arthrotomy. The device is cannulated, tapered with a smooth threaded design, which provides interference fixation of soft-tissue grafts and bonetendon-bone patellar grafts during anterior cruciate ligament repair and reconstruction through arthroscopy or arthrotomy procedures. The screw comes in multiple lengths (20mm to 45mm), multiple diameters (6mm to 12mm) in each length and left and right thread design, resulting in a set of screws adapted to the morphology of the graft and the patient.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (PLLA cannulated interference screw). It describes the device, its intended use, and argues for substantial equivalence to predicate devices. However, it does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would.

The substantial equivalence determination is based on similarities in:

Material: Both the PLLA screw and the predicate device use similar biopolymer (polylactic acid).
Design: Overall similar design, with minor modifications not affecting reconstruction.
Intended Use: Overall same intended use.

Therefore, most of the requested information regarding acceptance criteria and a study to prove they are met cannot be extracted from this document, as such a study is not presented.

Here's a breakdown of what can be answered based on the provided text:

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

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself (e.g., specific pull-out strength, degradation rate targets in a clinical context). The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to a legally marketed predicate device.
Reported Device Performance: The document states that the polymer has undergone "many in vitro and in vivo testing," but no specific results or performance values are reported for the PLLA cannulated interference screw itself in human subjects or in a comparative study against specific criteria. The performance is inferred to be similar to the predicate device due to material and design similarities.

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

Not applicable. No performance study with a distinct test set is detailed in this 510(k) summary. The submission relies on demonstrating equivalence rather than presenting new performance data from a specific test set.

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. No performance study with a ground truth established by experts is detailed.

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

Not applicable. No performance study requiring adjudication is detailed.

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 device is a bioabsorbable interference screw, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance metrics are irrelevant to this submission.

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 or software.

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

Not applicable. No specific ground truth for a novel performance study is used or described. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an algorithm or machine learning model for this physical device.

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

Not applicable. See point 8.

Summary

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510(k) SUMMARY FOR THE PLLA CANNULATED INTERFERENCE SCREW

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510k #: K032438

DEC 1 4 2004

ADVANCED BIOMATERIALS Company: 265 Route de La Baronne, St. Jeannet 06640 France Adresse: Phone: +33-4-92-12-04-74 +33-4-92-12-48-70 Fax:

Mr Patrick Janin Contact:

September 10th 2003 Date of submission:

Name of device:

PLLA cannulated interference screw

Common or usual name:

Bioabsorbable interference screw

Classification:

Smooth or threaded bone fixation fastener: 888.3040

Predicate device:

FMS Cannulated bioabsorbable interference screw (K013685) Arthrex Bio-interference screw (K971358)

Device description:

Intended use:

The device is cannulated, tapered with a smooth threaded design, which provides interference fixation of soft-tissue grafts and bonetendon-bone patellar grafts during anterior cruciate ligament repair and reconstruction through arthroscopy or arthrotomy procedures.

The ABS interference screw and predicate device have overall same intended use and design despite some minor modifications which does not affect the reconstruction process.

Both implants are made of similar biopolymer (polylactic acid)

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510(k) SUMMARY FOR THE PLLA CANNULATED INTERFERENCE SCREW

The screw comes in multiple lengths (20mm to 45mm), multiple diameters (6mm to 12mm) in each length and left and right thread design, resulting in a set of screws adapted to the morphology of the graft and the patient.

Substantial equivalence:

The polymer for the ABS interference screw has similar characteristics than the polymer use for the predicate device (both are poly L.D lactic acid) and is currently use in many devices which have received FDA marketing clearance, and has undergone many in vitro and in vivo testing.

The PLLA cannulated interference screw and the predicate device have the same overall design. In addition, the small differences in design do not affect the use, safety and effectiveness, between the device and the predicate device.

The principal difference in the insertion technique between the ABS PLLA screw and the Arthrex bio-interference screw is the method of attaching the screwdriver to the screw during insertion.

The ABS interference screw is equivalent in material, design and intended use as the predicate device.

Based on these similarities and equivalences we believe our PLLA cannulated interference screw and the Arthrex bio-interference screw K971538 are substantially equivalent for the interference fixation of soft tissue and Bone Tendon Bone graft in the ACL reconstruction through arthroscopy or arthrotomy.

Indications for use:

To provide interference fixation of soft tissue graft and bone-tendonbone patellar graft during the Anterior Cruciate Ligament repair through arthroscopy or arthrotomy.

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2004

Mr. Patrick Janin President Advanced Biomaterials 265 Route de la Baronne F-06640 St. Jeannet France

Re: K032830

Trade/Device Name: PLLA cannulated interference screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: October 19, 2004 Received: October 21, 2004

Dear Mr. Janin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your se determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreativent of the enactment date of the Medical Device Amendments, or to connered prof to they 2011-12-12 accordance with the provisions of the Federal Food, Drug, de nees that have been 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 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 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Patrick Janin

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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark Walker

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

Enclosure

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Indications for Use

510(k) Number (if known): Ko Z > { } &

Device name: PLLA cannulated interference screw

Indications For Use:

To provide interference fixation of soft tissue graft and bone-tendonbone patellar graft during the Anterior Cruciate Ligament repair through arthroscopy or arthrotomy.

Prescription Use y 22 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

e-Counter Use
(21 CFR 807 Subpart C) No

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark H. Milliken
Division Sign-Off

Division of General, Restorative, and Neurological Devices

Page 1 of

510(k) Number K032850

Regulation Number and Section

N/A