2.4MM VA-LCP INTERCARPAL FUSION SYSTEM by SYNTHES (USA)

The 2.4mm VA-LCP Intercarpal Fusion System is indicated for fusion of small bones of the hand including: hamate, capitate, lunate, and triquetrum, for the revision of failed partial wrist fusions, and is indicated for use in patients suffering pain and/or loss of function due to:

-Osteoarthritis
-Rheumatoid arthritis
-Post-traumatic or degenerative wrist arthritis
-Carpal instability

Device Description

The 2.4mm VA-LCP Intercarpal Fusion System features low profile circular plates. The plates are available in two sizes: ø15mm (6 holes) and øl 7mm (7 holes). The plates each feature variable angle locking technology. The plates also feature K-wire holes for positioning and temporary fixation.

AI/ML Overview

This document is a 510(k) summary for a medical device called the "2.4mm VA-LCP Intercarpal Fusion System." It describes a traditional medical device (bone fixation system), not a software or AI-powered device. Therefore, the questions related to AI/software performance, such as acceptance criteria based on AI metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies, are not applicable here.

The "study that proves the device meets the acceptance criteria" in this context refers to the engineering and mechanical testing performed to demonstrate substantial equivalence to predicate devices. The acceptance criteria are implicit in showing that the new device performs comparably to or better than existing, legally marketed devices for its intended use.

Here's the information as it applies to this specific document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from Substantial Equivalence to Predicate Devices)	Reported Device Performance (Summary in Document)
Material Composition: Use of biocompatible and mechanically suitable materials comparable to predicate devices.	"The subject and predicate devices are made from stainless steel and titanium alloy (TAN)."
Mechanical Strength & Functional Properties: Demonstrate comparable or superior mechanical strength and functional performance for its intended orthopedic application (e.g., bone fusion) to predicate devices.	"Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject 2.4mm VA-LCP Intercarpal Fusion System to the predicate devices. In support of this submission 1-point bending was performed."
Intended Use: Device is suitable for the specified indications for use.	"The 2.4mm VA-LCP Intercarpal Fusion System is indicated for fusion of small bones of the hand... for the revision of failed partial wrist fusions, and is indicated for use in patients suffering pain and/or loss of function due to: Osteoarthritis, Rheumatoid arthritis, Post-traumatic or degenerative wrist arthritis, Carpal instability."
Design Characteristics: Features (plate size, hole count, locking technology, K-wire holes) are functionally equivalent to predicate devices.	"The plates are available in two sizes: ø15mm (6 holes) and øl 7mm (7 holes). The plates each feature variable angle locking technology. The plates also feature K-wire holes for positioning and temporary fixation." These features are presented as similar to predicate designs.
Manufacturing, Packaging, Sterilization: Methods are identical or comparable to predicate devices.	"In addition, the intended use, manufacturing methods, packaging, and sterilization of the predicate and subject components are identical."

2. Sample size used for the test set and the data provenance

Not Applicable / Not Specified. This document describes a medical device (surgical implant) cleared based on substantial equivalence through mechanical testing, not a data-driven device evaluated with a test set of patient data. The "test set" would be the physical devices subjected to mechanical testing. The exact number of devices tested for 1-point bending is not specified in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. Ground truth in this context is established by engineering standards and direct physical measurements during mechanical testing, not by human expert interpretation of imaging or clinical data.

4. Adjudication method for the test set

Not Applicable. Mechanical testing results are objective measurements against established engineering principles and predicate device performance, not subjective interpretations requiring adjudication.

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 not an AI/software device.

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

Not Applicable. This is not an AI/software device.

7. The type of ground truth used

Engineering Standards and Physical Measurements: The "ground truth" for this device's performance is derived from established mechanical engineering principles, material science data, and direct physical measurements obtained through tests like 1-point bending. The acceptance criteria are implicitly met by demonstrating "comparable mechanical & functional properties" to legally marketed predicate devices.

8. The sample size for the training set

Not Applicable. This is not a machine learning or AI device that requires a "training set."

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

Not Applicable. This is not a machine learning or AI device.

Summary

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K103243

3.0	510(k) Summary
	Date Prepared: Jan 11, 2011
	Page 1 of 1
	Sponsor:
	Synthes (USA)Christopher Hack, Esq.1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6940
	JAN 21 2011
	Device Name:
	2.4mm VA-LCP Intercarpal Fusion System
	Classification:
	Class II, §888.3030 - Single/multiple component metallic bonefixation appliances and accessories, HRS
	Class II, §888.3040 -- Smooth or threaded metallic bone fixationfastener, HWC
	Predicate Device:
	KMI - Wrist Fusion System (K990094)KMI - Wrist Fusion System (K991873)Acumed - Hub Cap Limited Wrist Fusion Plate (K021321)
	Device Description:
	The 2.4mm VA-LCP Intercarpal Fusion System features lowprofile circular plates. The plates are available in two sizes:ø15mm (6 holes) and øl 7mm (7 holes). The plates each featurevariable angle locking technology. The plates also feature K-wireholes for positioning and temporary fixation.
	Intended Use:
	The 2.4mm VA-LCP Intercarpal Fusion System is indicated forfusion of small bones of the hand including: hamate, capitate,lunate, and triquetrum, for the revision of failed partial wristfusions, and is indicated for use in patients suffering pain and/orloss of function due to:-Osteoarthritis-Rheumatoid arthritis-Post-traumatic or degenerative wrist arthritis-Carpal instability
	SubstantialEquivalence:
	The features of the subject components are substantially equivalentto the predicate devices based on similarities in intended use anddesign. Engineering rationale demonstrates substantial equivalenceof the subject components to the predicate device in regards tomechanical strength. In addition, the intended use, manufacturingmethods, packaging, and sterilization of the predicate and subjectcomponents are identical.
	The subject and predicate devices are made from stainless steel andtitanium alloy (TAN). Functional and mechanical testingdemonstrates the comparable mechanical & functional properties ofthe subject 2.4mm VA-LCP Intercarpal Fusion System to thepredicate devices. In support of this submission 1-point bendingwas performed.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Synthes (USA) % Mr. Christopher Hack, Esq. 1301 Goshen Parkway West Chester, PA 19380

Re: K103243

Trade/Device Name: Synthes (USA) 2.4mm VA-LCP Intercarpal Fusion System Regulation Number: 21 CFR 888.3030

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

JAN 2 1 2011

Regulatory Class: II

Product Code: HRS. HWC Dated: October 29, 2010 Received: November 16, 2010

Dear Mr. Hack:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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Page 2 - Mr. Christopher Hack, Esq.

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

Enclosure

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Image /page/3/Picture/0 description: The image shows the logo for Synthes. The logo consists of a circular symbol on the left, followed by the word "SYNTHES" in bold, sans-serif font. The circular symbol contains a stylized image of a bone or joint, possibly representing the company's focus on medical devices and orthopedic solutions. The registered trademark symbol is located on the upper right of the word "SYNTHES".

2.0 Indications for Use

K103243 510(k) Number (if known):

Synthes (USA) 2.4mm VA-LCP Intercarpal Fusion System Device Name:

Indications for Use:

-Osteoarthritis -Rheumatoid arthritis -Post-traumatic or degenerative wrist arthritis -Carpal instability
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)

tor m helkerson

(Division Sign-Oft) (Division Sign-Off, Orthopedic, Division of Suits and Restorative Devices

51.0(k) Number K10322

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.