SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS by SYNTHES (USA)

The 1.0/1.2 mm Craniofacial Screws are either self-drilling or self-tapping, have a flat head profile with rounded edges with a cruciform recess, and are available in various lengths.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this is a 510(k) summary for a medical device and not a clinical trial report of an AI algorithm. Therefore, many of the requested fields related to AI performance, ground truth, and expert evaluation will be absent or not directly applicable.

This document describes a 510(k) premarket notification for the Synthes 1.0/1.2 mm Craniofacial Screws, a physical medical device. The information provided heavily focuses on regulatory submission for substantial equivalence rather than performance data from a clinical study on an AI device. As such, many of the requested fields regarding acceptance criteria, AI performance, ground truth, and expert evaluation do not apply in the context of this document.

The primary "acceptance criteria" for a 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device. The study described here is focused on establishing this equivalence, not on measuring specific performance metrics against pre-defined thresholds for a novel AI algorithm.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance / Method of Proof
Regulatory Acceptance (510(k))	Substantial equivalence to legally marketed predicate devices. This means the device is as safe and effective as the predicate device(s) and does not raise new questions of safety or effectiveness. This is the overarching "acceptance criteria" for this type of submission.	Concluded that the Synthes 1.0/1.2mm Craniofacial Screws are substantially equivalent to other legally marketed devices, specifically citing the KLS Martin 1.0mm System Center-Drive Screw System and the Synthes Maxillofacial Titanium Micro Set as predicates. The FDA concurred with this determination.
Material/Design Characteristics	Not explicitly stated as acceptance criteria, but implied conformance to predicate device characteristics.	The device description outlines key characteristics: self-drilling or self-tapping, flat head profile with rounded edges, cruciform recess, and various lengths, which are presumably consistent with or improved upon predicate devices.
Intended Use & Indications for Use	The device's intended use and specific indications must align with established medical practice and be comparable to predicate devices.	The intended uses are specified for nasoethmoidal, infraorbital area, and frontal sinus wall fractures, as well as infant craniofacial and general maxillofacial surgery. These indications were reviewed and accepted by the FDA.
Performance (Biocompatibility, Strength, etc.)	Not explicitly detailed in this summary, but would typically involve mechanical testing (e.g., tensile strength, torsion, fatigue) and biocompatibility testing according to relevant standards (e.g., ISO 10993) to demonstrate equivalence to the predicate device. These tests would have acceptance criteria based on established standards or predicate device performance.	The 510(k) summary states, "Documentation is provided which demonstrates that the Synthes 1.0/1.2mm Craniofacial Screws are substantially equivalent to other legally marketed devices." This documentation, though not detailed here, would implicitly include performance testing results that meet relevant safety and functional standards, comparing them to the predicate devices.

Study Details (Applicable to a 510(k) Submission, Not an AI Study)

Sample size used for the test set and the data provenance:
- N/A: This document does not describe a clinical study with a "test set" in the context of an AI algorithm trying to classify data. Instead, it's a regulatory submission for a physical medical device. The "study" here refers to the process of demonstrating substantial equivalence, which would involve comparing the new device's specifications and performance to predicate devices. This typically involves benchmark testing on physical prototypes or models, rather than data samples.
- Data Provenance: Not applicable in the sense of patient data. The provenance of the evidence would be internal company testing and comparisons to predicate device specifications.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A: Ground truth, as understood in AI/ML, is not established for this type of submission. The "ground truth" for a physical device's safety and efficacy is typically established through adherence to recognized consensus standards (e.g., ISO, ASTM) and comparison to predicate devices, which have a history of safe and effective use. The FDA's review involves their own experts.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A: Not applicable for this type of regulatory submission. Adjudication methods are typically used in clinical studies for diagnostic accuracy, which is not what is being reported here.
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:
- N/A: This document is for a physical medical device (screws), not an AI-assisted diagnostic tool. Therefore, an MRMC study is completely irrelevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A: This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A: As mentioned previously, for a physical device 510(k), "ground truth" relates to compliance with engineering specifications, mechanical performance, biocompatibility, and clinical history of predicate devices. There isn't a "ground truth" in the AI sense.
The sample size for the training set:
- N/A: This document does not pertain to an AI algorithm. There is no concept of a "training set."
How the ground truth for the training set was established:
- N/A: No training set or associated ground truth for an AI algorithm.

Summary

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AUG 1 9 2004

3.0	510(k) Summary	Page 1 of 1
	Sponsor:	SYNTHES (USA)
		1690 Russell RoadPaoli, PA 19301(610) 647-9700
	Device Name:	Synthes 1.0/1.2 mm Craniofacial Screws
	Classification:	21 CFR 872.4880: Screw, Fixation, Intraosseous
	Predicate Device:	KLS Martin 1.0mm System Center-Drive Screw SystemSynthes Maxillofacial Titanium Micro Set
	Device Description:	The 1.0/1.2 mm Craniofacial Screws are either self-drilling or self-tapping, have a flat head profile with rounded edges with acruciform recess, and are available in various lengths.
	Intended Use:	The Synthes 1.0/1.2 mm Craniofacial screws are intended for use as follows:Specific Indications:Nasoethmoidal fracturesInfraorbital area fracturesFrontal sinus wall fracturesInfant craniofacial surgery General Indications:Maxillofacial surgery
	SubstantialEquivalence:	Documentation is provided which demonstrates that the Synthes1.0/1.2mm Craniofacial Screws are substantially equivalent to otherlegally marketed devices.
		The term "substantial equivalence" as used in this 510(k)notification is limited to the definition of substantial equivalencefound in the Federal Food, Drug and Cosmetic Act, as amended andas applied under 21CFR 807, Subpart E under which a device canbe marketed without premarket approval or reclassification. Adetermination of substantial equivalency under this notification isnot intended to have any bearing whatsoever on the resolution ofpatent infringement suits or any other patent matters. Nostatements related to, or in support of substantial equivalence hereinshall be construed as an admission against interest under the USPatent Laws or their application by the courts.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 9 2004

Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301

Re: K041887

Trade/Device Name: Synthes (USA) 1.0/1.2 mm Craniofacial Screws Regulation Number: 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: July 8, 2004 Received: July 13, 2004

Dear Ms. Boyle:

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. Boyle

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 pract.ice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); a nd 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 (301) 594-4613. 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/dsma/dsmamain.html

Sincerely yours.

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

510(k) Number (if known):

Device Name:

Synthes (USA) 1.0/1.2 mm Craniofacial Screws

141887

Indications for Use:

The Synthes 1.0/1.2 mm craniofacial screws are intended for use as follows:

Specific Indications:

Nasoethmoidal fractures .
Infraorbital area fractures .
Frontal sinus wall fractures .
Infant craniofacial surgery .

General Indications:

Maxıllofacial surgery .
X Prescription Use (Per 21 CFR 801.109)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODF) (Division Sign Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number. `tcy/1/ff)

Regulation Number and Section

§ 872.4880 Intraosseous fixation screw or wire.

(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.