SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM by SYNTHES (USA)

Synthes 3.5mm LCP Clavicle Plate System consists of machined metallic plates and screws that offer screw to plate locking designed for various fracture modes of the clavicle.

Synthes 3.5mm LCP Clavicle Plate System enhances fracture fixation by providing pre-contoured plates designed to fit the clavicle and design features which allow additional contouring. minimization of soft tissue irritation, and minimization of vascular trauma. The Synthes 3.5mm LCP Clavicle System includes plates with a lateral extension feature specifically designed to enhance the stability of the fixation of fractures in the distal clavicle and plates without the lateral extension feature for fixation of fractures in the clavicle shaft.

AI/ML Overview

Here's an analysis of the provided text regarding the Synthes 3.5mm LCP Clavicle Plate System, focusing on acceptance criteria and study details.

Based on the provided 510(k) summary (K073186), this device is a metallic bone fixation appliance and, as such, its acceptance criteria and the study proving it meets those criteria are not detailed in the context of typical AI/ML device evaluations. This document describes a medical device (a physical implant) cleared through the 510(k) pathway, which relies on demonstrating substantial equivalence to a predicate device rather than performance against defined acceptance criteria in a clinical study as would be detailed for a diagnostic AI/ML product.

Therefore, many of the requested points, particularly those related to AI/ML performance metrics, retrospective/prospective studies, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment (as applied to AI/ML models), are not applicable to this type of device and submission.

However, I can extract information relevant to the substantial equivalence claim:

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

The concept of "acceptance criteria" and "reported device performance" as typically applied to AI/ML models (e.g., sensitivity, specificity, AUC) does not directly apply here. For a metallic bone fixation appliance cleared via 510(k), "acceptance criteria" are implied by the demonstration of substantial equivalence to a legally marketed predicate device. This typically involves demonstrating that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Acceptance Criteria (Implied by Substantial Equivalence):

Criterion	Description	Device Performance (How the device is shown to meet the criterion)
Intended Use Equivalence	The device's intended use must be the same as the predicate device.	"Synthes 3.5mm LCP Clavicle Plate System is intended for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle." - This is compared to the predicate's indications. The predicate device (Synthes 3.5mm Dynamic Compression Locking (DCL) Plates) is for similar fracture fixation.
Technological Characteristics Equivalence	The material composition, design features, and other technological attributes must be similar to the predicate device, or any differences must be shown not to raise new safety/effectiveness concerns.	"Synthes 3.5mm LCP Clavicle Plate System consists of machined metallic plates and screws that offer screw to plate locking designed for various fracture modes of the clavicle." This is similar to the metallic plates and screws of the predicate. Differences in LCP vs. DCL mechanisms and pre-contoured plates are discussed in terms of enhancement and minimization of irritation/trauma, suggesting they do not raise new safety concerns.
Performance Data (e.g., Biocompatibility, Mechanical Testing)	The device must meet recognized standards for safety and effectiveness for bone fixation appliances. While not explicitly detailed in this summary, such submissions typically include non-clinical testing data to support mechanical strength, fatigue life, and biocompatibility.	The summarized document states "Information presented supports substantial equivalence." This implies that comprehensive data (e.g., mechanical tests comparing the device to the predicate, or to relevant ASTM/ISO standards, and biocompatibility testing) was submitted to FDA and found acceptable. Specific numerical performance values are not in this summary.

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 in the context of typical clinical test sets for AI/ML. This is a physical implant. The "test set" would refer to non-clinical mechanical testing, biocompatibility studies, or potentially limited clinical data (if required for differences from the predicate, though often not for 510k). The document does not specify these details.

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. "Ground truth" in the AI/ML sense (e.g., expert-derived medical diagnoses) is not relevant for this physical implant.

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

Not Applicable.

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 is a physical implant, not an AI-assisted diagnostic tool.

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

Not Applicable.

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

Not Applicable in the AI/ML sense. For a physical implant, "ground truth" for demonstrating safety and effectiveness would come from:
- Mechanical Testing: Based on engineering principles and established ASTM/ISO standards for strength, fatigue, and stiffness.
- Biocompatibility Testing: According to ISO 10993 series for medical devices.
- Clinical Data (if submitted): Patient outcomes (e.g., fusion rates, complication rates) from comparative studies, if such studies were deemed necessary (which is rare for a device cleared via substantial equivalence for minor modifications like this one). The summary does not indicate clinical data was specifically reviewed for equivalence assertion beyond possibly general clinical use of the predicate.

8. The sample size for the training set

Not Applicable. There is no "training set" in the AI/ML sense for this device. If physical testing was done, the "sample size" would refer to the number of devices tested mechanically or biologically, but this is not provided in the summary.

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

Not Applicable. As no training set in the AI/ML context exists, this question is not relevant.

In summary, this 510(k) submission for the Synthes 3.5mm LCP Clavicle Plate System focuses on demonstrating substantial equivalence to a predicate device based on its intended use, technological characteristics, and performance data (not specifically detailed in the summary but typically including non-clinical mechanical and biocompatibility testing). The framework of AI/ML model evaluation (acceptance criteria, test/training sets, ground truth, expert adjudication, MRMC studies) does not apply to this type of medical device submission.

Summary

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K073186

3.0	510(k) Summary	Page 1 of 1
Sponsor:	Synthes (USA)Karl J. Nittinger1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6941DEC 17 2007
Device Name:	Synthes 3.5mm LCP Clavicle Plate System
Classification:	Class II. §888.3030 - Single/multiple component metallic bone fixation appliances and accessories
Predicate Device:	Synthes 3.5mm Dynamic Compression Locking (DCL) Plates as cleared in Synthes Small Fragment DCL System
Device Description:	Synthes 3.5mm LCP Clavicle Plate System consists of machined metallic plates and screws that offer screw to plate locking designed for various fracture modes of the clavicle.Synthes 3.5mm LCP Clavicle Plate System enhances fracture fixation by providing pre-contoured plates designed to fit the clavicle and design features which allow additional contouring. minimization of soft tissue irritation, and minimization of vascular trauma. The Synthes 3.5mm LCP Clavicle System includes plates with a lateral extension feature specifically designed to enhance the stability of the fixation of fractures in the distal clavicle and plates without the lateral extension feature for fixation of fractures in the clavicle shaft.
Intended Use:	Synthes 3.5mm LCP Clavicle Plate System is intended for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle.
Substantial Equivalence:	Information presented supports substantial equivalence.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 2007 % Mr. Karl J. Nittinger Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, PA 19380 Re: K073186 Trade/Device Name: SYNTHES 3.5mm LCP Clavicle Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: Nov 12, 2007 Received: Nov 13, 2007

Dear Mr. Nittinger:

SYNTHES (USA)

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.

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. Karl J. Nittinger

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mulkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2.0

510(k) Number (if known): Device Name: Synthes 3.5mm LCP Clavicle Plate System Indications for Use: Synthes 3.5mm LCP Clavicle Plate System is intended for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle.

Indications for Use

Prescription Use _ X (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 (ODE)

Barbara Bucher

Division of General, Restorative, and Neurological Devices

510(k) Number K073186

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.