The BioSorbFX O/M 2.0/2.4 System is intended for use in trauma and reconstructive procedures in the midface, maxilla and mandible. Specifically, the device is indicated for use in surgical repair procedures in the treatment of trauma to the midface, maxilla and mandible, and in orthognathic and reconstructive procedures of the midface, maxilla or mandible. The BioSorbFX O/M 2.0/2.4 System stabilizes bone during healing, in conjunction with appropriate postoperative immobilization. Especially in mandible BioSorbFX O/M System must be used in conjunction of appropriate maxillomandibular fixation (MMF).

The BioSorbFX O/M 2.0/2.4 System implants are not intended for use in and are contraindicated for:

Mandibular tumor resection.
Situations where internal fixation is otherwise contraindicated e.g., active or potential infection; patient conditions, including blood supply limitations, insufficient quantity or quality of bone; and where patient co-operation cannot be guaranteed (e.g., alcoholism).
Significant comminuted fractures, including significant bone loss; of the mandible.
Intermaxillary fixation without an appropriate external fixation by other means.

Device Description

The BioSorbFX™ O/M 2.0/2.4 Bioabsorbable Fixation Systems consists of various place configurations, which are attached to the bone by 2.0, 2.4 and 2.8mm/threaded fasteners (i.c., screws) of various lengths. The specifications for the BioSprbFXTM O/M 2.0/2.4 System plates and fastencrs will require a self-reinforced copolymer derived from Llactide and D/L-lactide ("PLA copo."), which consists of 70 molar percent poly-L-lactide and 30 molar percent poly-D, L-lactide, with strength retention time 18-36 weeks.

AI/ML Overview

Here's an analysis of the provided text regarding the BioSorbFX™ O/M 2.0/2.4 Bioabsorbable Fixation System, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary for a medical device. 510(k) submissions typically demonstrate substantial equivalence to a predicate device, rather than proving a device meets specific, novel acceptance criteria through extensive clinical trials for efficacy and safety. Therefore, much of the requested information (like detailed acceptance criteria and standalone study results, detailed ground truth establishment for a training set, or MRMC studies) is generally not found in a 510(k) summary for this type of device. The focus is on demonstrating that the new device is as safe and effective as existing legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary for a bone fixation system, the "acceptance criteria" are primarily related to material specifications, mechanical properties, and equivalence in intended use and operating principles to predicate devices. The document does not explicitly state quantitative "acceptance criteria" in the way one might see for an AI algorithm's performance metrics (e.g., sensitivity, specificity thresholds). Instead, the performance is implicitly "accepted" if found substantially equivalent to the predicate devices.

Acceptance Criteria (Implied by 510(k))	Reported Device Performance
Material Composition: Self-reinforced copolymer of L-lactide and D/L-lactide.	Consists of 70 molar percent poly-L-lactide and 30 molar percent poly-D, L-lactide.
Strength Retention Time: Adequate for stabilization during healing.	Strength retention time: 18-36 weeks. Stabilizes bone during healing in conjunction with appropriate postoperative immobilization.
Biodegradation Time: Complete absorption within a reasonable timeframe.	Biodegradation takes place within two to three years.
Intended Use: Similar to predicate devices (midface, maxilla, mandible trauma/reconstruction).	Intended for use in trauma and reconstructive procedures in the midface, maxilla, and mandible. Specifically, for surgical repair in trauma and orthognathic/reconstructive procedures. This is the same intended use as the predicate device BioSorbFX™ 2.0/2.4 System (K982721) and similar to other cited predicates.
Operating Principles: Same as predicate devices.	Uses the same operating principles as BioSorbFX 2.0/2.4 System (K982139) and other specified predicate devices (Biomet LactoSorb, Synthes, Lorenz, Macropore).
Basic Design: Same as predicate devices.	Incorporates the same basic design as BioSorbFX 2.0/2.4 System (K982139) and same design principles as other specified predicate devices. Consists of various plate configurations and 2.0, 2.4, and 2.8mm threaded fasteners.
Manufacturing/Packaging/Sterilization: Same as predicate devices.	Manufactured, packaged, and sterilized using the same machinery and processes as BioSorbFX 2.0/2.4 System (K982139).
Instrument Set: Identical/Substantially equivalent to predicate devices.	Instrument set is identical with previously cleared BioSorbFX™ 2.0/2.4 System (K982721) and substantially equivalent with BioSorbFX™ 1.5/2.0 System (K982139) and BioSorb™ Endobrow Screw™ (K972919).

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a "test set" in the context of an AI/software algorithm evaluation. Instead, the submission relies on:

Engineering/Bench Testing: Implied by the discussion of material properties (strength retention, biodegradation). No specific sample sizes for these tests are provided in this summary.
Comparison to Predicate Devices: The primary "test" is to demonstrate substantial equivalence to previously cleared devices. This involves comparing specifications, intended use, operating principles, and materials. The "sample" in this case is the new device itself, being compared element-by-element to the predicate devices.
Data Provenance: Not applicable in the context of human data. The "data" here refers to the device's design, material properties, and intended function.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is a bioabsorbable fixation system, not a diagnostic AI system requiring expert-established ground truth from medical images or patient data. The "ground truth" for this submission is whether the device's characteristics (material, strength, design, intended use) are substantially equivalent to legally marketed predicate devices, which is assessed by the FDA based on the submission's technical details.

4. Adjudication Method for the Test Set

Not applicable. There's no "adjudication method" in the sense of resolving discrepancies in expert interpretations, as there's no expert labeling task described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is a surgical implant designed to stabilize bone, not a diagnostic tool, and therefore an MRMC study is not relevant or described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense, the evaluation of the device's physical and mechanical properties (material composition, strength retention, biodegradation time) can be considered a "standalone" assessment of the device's intrinsic characteristics. However, this is not an "algorithm-only" standalone performance as typically discussed for AI/software. The device itself (the implant) is the "standalone" subject of the evaluation, separate from its use in a patient (human-in-the-loop). No specific study in this format is detailed beyond the general statements of properties.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices already on the market. The BioSorbFX™ O/M 2.0/2.4 System is deemed safe and effective because it is substantially equivalent to these predicate devices. The factual basis for this substantial equivalence includes:

Material Science/Engineering Data: Data on the polymer composition, strength, and degradation characteristics.
Design Specifications: Detailed blueprints and specifications of the plates, screws, and instrument set.
Previous FDA Clearances: The regulatory history and clearance (510(k) numbers K982139, K982721, K981666, etc.) of the predicate devices serve as the "ground truth" for what is considered safe and effective for this product type.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical implant, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set is involved.

Summary

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K011569

FEB 2 2 2002

510(k) Summary Bionx Implants Inc.'s BioSorbFX™ O/M 2.0/2.4 Bioabsorbable Fixation System

Submitter's Name, Address, Telephone Number, and Contact Person

Bionx Implants, Inc. 1777 Sentry Parkway West Gwynedd Hall, Suite 400 Bluc Bell, PA 19422

Contacts:

Gerard S. Carlozzi President and Chief Executive Officer (215) 643-5000 Phone: Facsimile: (215) 653-0984

Bionx Implants Ltd. Tuija Annala Quality Manager P.O.Box 3 FIN-33721 Tampere Finland Phone: 358-3-316 5679 358-3-316 2629 Facsimile:

February 22, 2002 Date prepared:

Name of the Device: BioSorbFX ()/M 2.0/2.4 Bioabsorbable Fixation System

Common or Usual Name:

Bioabsorbable Craniofacial Bone Plates and Plate Fasteners

Classification Name: Bone Plate and fasteners (Product Code 76 JEY)

Predicate Devices:

1. Bionx Inplants, Inc. BioSorbFX™ 1.5/2.0 Bioabsorbable Fixation! System ("BioSorbFX"M 1.5/2.0 System") (K982139)
1. Bionx Implants, Inc. BioSorbFX™ O/M 2.0/2.4 Bioabsorbable Fixation System ("BioSorbFXTM O/M 2.0/2.4 System") (K982721)
1. Biomet Inc. 2.5mm LactoSorb® Screws (K981666)
1. Biomet Inc. LactoSorb@ Sheets (K992158)
5.1 Synthes SMF Resorbable Meshes and Sheets (K003786)
1. Lorenz Resorbable Distractor System (K002083)
1. Macropore MacroporeMX Mandibular Fixation System (K000696)

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8. Macropore Protective Sheet (K983360)

Intended Use

. .

The BioSorbPX O/M 2.0/2.4 System is intended for use in traum: and reconstructive The Bloodbres in the midface, maxilla and mandible. Specifically, the device is indicated processives in and repair procedures in the treatment of trauma to the midface, maxilla and mandible, and in orthognathic and reconstructive procedures of the]midface, maxilla or mandible. The BioSorbFX O/M 2.0/2.4 System stallizes bone during healing, in conjunction with appropriate postoperative immobilization. Which used in the mandible, the BioSorbFX O/M System must be used in conjunction with appropriale maxillomandibular fixation (MMF).

The BioSorbFX O/M 2.0/2.4 System implants are not intended for use in and are contraindicated for:

1. Mandibular tumor resection.
1. Situations where internal fixation is otherwise contraindicated e.g., active or potential infection; patient conditions, including blood supply limitations, insufficient quantity or quality of bone; and where patient co-operation cannot be guaranteed (e.g., alcoholism).
Significant comminuted fractures, including significant bone loss, of the 3. mandible.
1. Intermaxillary fixation without an appropriate external fixation by other uncans.

Technological Characteristics and Substantial Equivalence

Properly used, in the presence of adcquate immobilization, absortuble BioSprtFX'"> O/M 2.0/2.4 System implants stabilize bone during healing. The BioSorbFX™ O/M 2.0/2.4 System implants gradually lose their strength during 18-36, weeks. Biodegradation takes place within two to three years. The BioSorbFX™ Ont 2.0/2.4 System includes an instrument set containing bone drills, bone taps, screwdrivers, plate benders and cheek retractors. This instrument set is identical with the previously cleared BioSorbFX™ 2.0/2.4 System (K982721) and substantially equivalent with the previously cleared BioSorbFX™ 1.5/2.0 System (K982139) and BioSorb™ Endobrow ScrewTM (K972919).

The BioSorbFX™ O/M 2.0/2.4 System has the same intended use and printiples of operation and is substantially equivalent to the devices previously cleared by FDA operation the Bionx Implants Inc. BioSorbFX™ 2.0/2.4 System (K982721),

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BioSorbFX™ 1.5/2.0 System (K982139), Biomet, Inc. 2.5mm LactoSorb® Screws (K981666) and LactoSorb® Sheets (K992158), Synthes SMF Resorbable Meshes and Sheets (K003786), Lorenz Resorbable Distractor System (K002083), Macropore Sheets (1000-78), Mandibular Fixation System (K000696) and Macropore Protective Sheet (K983360) -

The BioSorbFX O/M 2.0/2.4 System has following similarities with previously cleared BioSorbFX 2.0/2.4 System (K982139):

Uses the same operating principles ー
Incorporates the same basic design ।
Is manufactured, packaged and sterilized using the same machinery and । processes.

The BioSorbFX O/M 2,0/2.4 System has following similarities with previously cleared Biomet Inc. 2.5mm LactoSorb® Screws (K981666) and LactoSorb@ Sheets (K992158), Synthes SMF Resorbable Meshes and Sheets (K003786), Lorenz Resorbable Distractor System (K002083), Macropore MacroporeMX Mandibular Fixation System (K000696) and Macropore Protective Sheet (K98.3360).

Uses the same operating principles -
Incorporates the same design principles -
Is used for similar indications ।

In summary the BioSorbPX O/M 2.0/2.4 System described in this submission is, in our opinion, substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 2002

Bionx Implants, Incorporated Ms. Tuija Annala Director, Quality and Regulatory Affairs Bionx Implants, Limited Hermiankatu 6-8 L Tampere, FINLAND

Re: K011569

Trade/Device Name: BioSorbFX™ O/M 2.0/2/4 System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: November 22, 2001 Received: November 26, 2001

Dear Ms. Annala:

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 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.

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Page 2 - Ms. Annala

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.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). 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,

Swoon Quarr

Image /page/4/Picture/5 description: The image shows a black and white drawing of an abstract symbol. The symbol appears to be composed of curved and straight lines, forming a complex shape. The lines are thick and bold, creating a strong contrast against the white background. The symbol's design is somewhat geometric, with a sense of movement or flow.

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(K) Number (if known):

Device Name:

BioSorbFX™ O/M 2.0/2.4 Bioalisorbable Fixation System

Indications for Use:

Indications for Ose.
The BioSorbFX O/M 2:0/2.4 System is intended for use in trauma and recorpstituctive The Blosotor'A One 2.0/2.4 Bystein a mandible. Specifically, the device is 'ndicated for use in surgical repair procedures in the treatment of trauma to the midface, maxilla and mandible, and in orthognathic and reconstructive procedures of the midface, maxilla or mandible. The BioSorbFX O/M 2.0/2.4 System stabilizes borge duling healing, in conjunction with appropriate postoperative immobilization. Especially in mandible BioSorbFX O/M System must be used in conjunction of appropriate maxillomandibular fixation (MMF).

The BioSorbFX O/M 2.0/2.4 System implants are not intended for use in and are contraindicated for:

1. Mandibular tumor resection.
1. Situations where internal fixation is otherwise contraindicated e.g., active or potential infection; patient conditions, including blood supply limitations, insufficient quantity or quality of bone; and where patient co-operation cannot be guaranteed (e.g., alcoholism).
1. Significant comminuted fractures, including significant bone loss; of the mandible.
Intermax illary fixation without an appropriate external fixation by other means.

. (Please do not write below this line - continue on another page is needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-off Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _

ﺳﺎ Prescription Use_ : (Per 21 CFR 801.109)

Over-The-Counter Use OR

Siven Rung

(Timision Sign-Off) intelan Sign-Um)
Inform of Dental, Infection Control, - oneral Hospital Devices ﺗﻘﺪﻳﻢ ﺍﻟﻤﺘﺎﺑﻌﺔ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.