SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM by SYNTHES (USA)

The Synthes (USA) Rapid Resorbable Fixation System is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. In addition, resorbable meshes, sheets, screws and tacks may be used in non-load bearing applications for maintaining the relative position of, and /or containing, bony fragments, bone grafts, (autograft or allograft), or bone graft substitutes in reconstruction of the craniofacial or mandibular areas.

Device Description

The Synthes Rapid Resorbable Fixation System consists of Plates, Meshes, Sheets, Screws and Tacks. The system is provided in a variety of shapes and sizes and, when used in conjunction with resorbable screws, the system provides fixation and aids in the alignment and stabilization of craniofacial bones. To facilitate shaping to the contours of the anatomy, the thermoplastic implants may be heated above the glass transition temperature of 55°C or they may be cut to the desired shape.

AI/ML Overview

The provided document describes the Synthes (USA) Rapid Resorbable Fixation System, a medical device used for craniofacial fracture repair and reconstructive procedures. However, the document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed studies on acceptance criteria and device performance.

Therefore, the document does not contain the information requested regarding acceptance criteria, specific device performance metrics, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for either training or test sets.

The information typically found in a 510(k) summary includes:

Device Name: Synthes (USA) Rapid Resorbable Fixation System
Intended Use: Fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. Also for maintaining the relative position of bony fragments, grafts, or substitutes in non-load bearing applications in craniofacial or mandibular areas.
Predicate Device(s): Synthes (USA) Rapid Resorbable Tack System, Synthes (USA) Poly (L-Lactide-co-Glycolide) Resorbable Fixation System, Synthes (USA) Rapid Resorbable Cranial Clamp, Biomet, Inc., Lactosorb Trauma Plating System.
Material: Poly (L-lactide-co-glycolide)
Regulatory Class: Class II
Substantial Equivalence: Claimed and accepted by the FDA.

To directly answer your numbered points based on the provided text:

A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document primarily focuses on demonstrating substantial equivalence to predicate devices, not on setting and meeting specific performance acceptance criteria through studies.
Sample sized used for the test set and the data provenance: This information is not provided. The 510(k) process relies on demonstrating equivalence through comparison to existing devices, often involving material testing and functional comparisons rather than specific clinical outcome studies with defined test sets as might be seen for AI/software devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
Adjudication method for the test set: This information is 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: This is a physical medical device (fixation system), not an AI/software device. Therefore, an MRMC study with human readers and AI assistance is not applicable and not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is a physical medical device, not an algorithm. Therefore, "standalone algorithm performance" is not applicable and not mentioned.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not provided as it pertains to a physical device evaluated for equivalence rather than a diagnostic device requiring ground truth for accuracy.
The sample size for the training set: This information is not provided.
How the ground truth for the training set was established: This information is not provided.

In summary, the provided document is a regulatory approval document for a physical medical device and does not contain the detailed study results, acceptance criteria, or performance metrics typically associated with the evaluation of AI or software-as-a-medical-device (SaMD) products.

Summary

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Kob2789

3.0	Summary of Safety and Effectiveness Information	Page 1 of 1
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SPONSOR:	Synthes (USA)1302 Wrights Lane EastWest Chester, PA 19308(610) 719-5000	FEB 27 2007
DEVICE NAME:	Synthes (USA) Rapid Resorbable Fixation System
CLASSIFICATION:	Class II, §872.4760 - Bone PlateClass II, §888.3030 - Screw Fixation, IntraosseousClass II, §882.5360 - Cranioplasty plate fastener
PREDICATE DEVICE:	Synthes (USA) Rapid Resorbable Tack SystemSynthes (USA) Poly (L-Lactide-co-Glycolide) Resorbable Fixation SystemSynthes (USA) Rapid Resorbable Cranial ClampBiomet, Inc., Lactosorb Trauma Plating System
DEVICE DESCRIPTION:	The Synthes Rapid Resorbable Fixation System consists of Plates, Meshes,Sheets, Screws and Tacks. The system is provided in a variety of shapesand sizes and, when used in conjunction with resorbable screws, the systemprovides fixation and aids in the alignment and stabilization of craniofacialbones. To facilitate shaping to the contours of the anatomy, thethermoplastic implants may be heated above the glass transitiontemperature of 55°C or they may be cut to the desired shape.
INTENDED USE:	The Synthes (USA) Rapid Resorbable Fixation System is intended for usein fracture repair and reconstructive procedures of the craniofacial skeletonin pediatric and adult populations. In addition, resorbable meshes, sheets,screws and tacks may be used in non-load bearing applications formaintaining the relative position of, and /or containing, bony fragments,bone grafts, (autograft or allograft), or bone graft substitutes inreconstruction of the craniofacial or mandibular areas.
CONTRAINDICATIONS:	These devices are not intended for use in load bearing applications, such asthe mandible, unless used in conjunction with traditional rigid fixation. TheSynthes Rapid Resorbable System is not intended for areas with active orlatent infection or for patient conditions including limited blood supply orinsufficient quantity or quality of bone. These devices are not intended foruse in the spine.
SUBSTANTIALEQUIVALENCE	Comparative information presented supports substantial equivalence.
MATERIAL:	Poly (L-lactide-co-glycolide)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jeffrey L. Dow Director, Regulatory Affairs Synthes (USA) 1230 Wilson Drive West Chester, Pennsylvania 19380

FEB 2 7 2007

Re: K062789

Trade/Device Name: Synthes (USA) Rapid Resorbable Fixation System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: February 2, 2007 Received: February 5, 2007

Dear Mr. Dow:

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 - Mr. Dow

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), please contact the Office of Compliance at (240) 276-0115. 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 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/industry/support/index.html.

Sincerely yours,

Susan Rumer

~Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2.0 Indications for Use Statement

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Kob2789 510(k) Number (if known):

Device Name:

Indications:

Contraindications:

These devices are not intended for use in load bearing applications, such as the mandible, unless used in conjunction with traditional rigid fixation. The Synthes Rapid Resorbable System is not intended for areas with active or latent infection or for patient conditions including limited blood supply or insufficient quantity or quality of bone. These devices are not intended for use in the spine.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	X	OR	Over-The-Counter Use __________
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Anesthesiology General Hospital
mi Control, Dansa, Devices
K060789
-5-

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.