Synthes 3.5mm LCP Periarticular Proximal Humerus Plates are indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

Device Description

The Synthes 3.5mm LCP Periarticular Proximal Humerus Plates are low-profile, pre-contoured bone fixation plates intended for the treatment of fractures of the humerus. The plates are offered sterile and non-sterile and are available in stainless steel and titanium.

AI/ML Overview

The provided documents are a 510(k) summary and FDA clearance letter for the Synthes (USA) 3.5mm LCP Periarticular Proximal Humerus Plates. This is a medical device, specifically a bone fixation appliance, and the clearance process for such devices relies on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria and performance studies in the way one might evaluate a new diagnostic or AI-driven system.

Therefore, the requested information elements related to AI/algorithm performance, sample sizes for test/training sets, expert adjudication, and ground truth establishment (as typically applied to diagnostic or AI studies) are not applicable to this type of device submission.

Here's a breakdown of what is available and relevant to the substantial equivalence determination:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices seeking 510(k) clearance, "acceptance criteria" are typically met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is usually achieved through comparing design features, materials, mechanical properties, and intended use. Performance is then "reported" by demonstrating that these aspects are equivalent to or better than the predicate.

Acceptance Criteria (Demonstration of Safe & Effective Equivalence)	Reported Device Performance (Synthes 3.5mm LCP Periarticular Proximal Humerus Plates)
Intended Use Equivalence: Indicated for similar conditions as predicate.	Indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone. (Matches predicate's general use for humerus fixation).
Technological Characteristics Equivalence: Similar design, materials, and operating principles.	Low-profile, pre-contoured bone fixation plates. Offered sterile and non-sterile. Available in stainless steel and titanium. (Implied similar design/materials to predicate LCP Proximal Humerus Plates and Small Fragment Dynamic Compression Locking Plates).
Performance Data (Bench/Mechanical Testing, if applicable): Often involves showing comparable mechanical strength, fatigue life, etc., to the predicate.	The 510(k) summary states "Information presented supports substantial equivalence," which typically includes bench testing and design comparisons to demonstrate comparable mechanical integrity and fit-for-purpose to the predicate devices. Specific quantitative data is not provided in this summary but would have been part of the full 510(k) submission.
Safety and Effectiveness Equivalence: No new safety or effectiveness concerns raised compared to the predicate.	No new safety or effectiveness issues identified by the FDA, as evidenced by the clearance letter. Device is considered "substantially equivalent."

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

Not Applicable. This is a hardware medical device, not a diagnostic or AI algorithm that uses test sets of data. Evaluation is based on design, materials, and mechanical testing, not analysis of patient data in a "test set" in the traditional sense.

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

Not Applicable. As above, there is no "test set" in the context of diagnostic/AI performance. The expertise involved would be engineering and regulatory professionals at Synthes, and FDA reviewers (e.g., engineers, clinicians, toxicologists) who assess the technical documentation against regulatory standards for substantial equivalence.

4. Adjudication Method for the Test Set

Not Applicable. No test set or human adjudication process for diagnostic/AI performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Applicable. This is a bone fixation plate, not a diagnostic imaging device or an AI assistant for human readers.

6. Standalone (Algorithm Only) Performance Study

Not Applicable. No algorithms are involved in the function of this bone plate.

7. Type of Ground Truth Used

For a device like this, "ground truth" relates to the performance specifications (e.g., strength, durability, biocompatibility) of the device and its predicate. The "truth" is established by adherence to recognized standards (e.g., ASTM, ISO for medical implants) and demonstrating that the new device meets or exceeds the critical performance characteristics of its predicate through engineering analyses, material characterization, and mechanical testing (benchtop studies). This demonstrates that it functions as intended for its stated use.

8. Sample Size for the Training Set

Not Applicable. This device does not involve a "training set" in the AI/machine learning sense.

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

Not Applicable. No training set.

In summary: The Synthes 3.5mm LCP Periarticular Proximal Humerus Plates received 510(k) clearance by demonstrating substantial equivalence to existing predicate devices (Synthes LCP Proximal Humerus Plates and Synthes Small Fragment Dynamic Compression Locking Plates). This demonstration relies on comparing the new device's intended use, technological characteristics (design, materials, mechanical properties), and performance (typically through bench testing) to those of the legally marketed predicates, ensuring that no new questions of safety or effectiveness are raised. The concepts of "acceptance criteria," "test sets," "training sets," and "expert ground truth" as applied to AI/diagnostic algorithms are not relevant to this type of device submission.

Summary

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3.0	510(k) Summary	Page 1 of 1
	Sponsor:	Synthes (USA)Karl J. Nittinger1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6941DEC 17 2008
	Device Name:	Synthes (USA) 3.5mm LCP Periarticular Proximal Humerus Plates
	Classification:	Class II, §888.3030 - Single / multiple component metallic bonefixation appliance and accessories.
	Predicate Device:	Synthes LCP Proximal Humerus PlatesSynthes Small Fragment Dynamic Compression Locking Plates
	Device Description:	The Synthes 3.5mm LCP Periarticular Proximal Humerus Plates arelow-profile, pre-contoured bone fixation plates intended for thetreatment of fractures of the humerus. The plates are offered sterileand non-sterile and are available in stainless steel and titanium.
	Intended Use:	Synthes 3.5mm LCP Periarticular Proximal Humerus Plates areindicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
	SubstantialEquivalence:	Information presented supports substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular fashion around the caduceus symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 2008

Synthes (USA) % Mr. Karl J. Nittinger Sr. Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K082625

Trade/Device Name: Synthes (USA) 3.5 mm LCP Periarticular Proximal Humerus Plates Regulation Number: 21 CFR 888.3030

Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

Regulatory Class: II

Product Code: HRS Dated: December 4, 2008 Received: December 5, 2008

Dear Mr. Nittinger:

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 the reporting 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Mulhearn

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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Indications for Use

510(k) Number (if known):

Synthes (USA) 3.5mm LCP Periarticular Proximal Humerus Plates Device Name:

Indications for Use:

Synthes 3.5mm Periarticular Proximal Humerus Plates are indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

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)

Mark H. Milken

(Division Sign-Off) (Division Signeral, Restorative, and Neurological Devices

510(k) Number

2.0

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.