The VLP Mini-Mod Talus Plates can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP Mini-Mod Talus Plates are indicated for fracture fixation, reconstruction or arthrodesis of small bones, in the forefoot, midfoot and hindfoot.

Device Description

The subject premarket notification describes talus plate line additions to the VLP Mini-Mod Small Bone Plating System. Subject plates consist of several varieties of medial and lateral talus plates in left and right designs. All described implant devices are manufactured from implant-grade titanium alloy material (Ti-6Al-4V) and designed for single-use. They will be provided in a sterile-packaged option and will be sterilized via Gamma irradiation.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the VLP Mini-Mod Talus Plates. It includes information about the device, its indications for use, and a summary of pre-clinical testing conducted. However, it does not contain a table of acceptance criteria or detailed results of a study designed to directly prove these criteria were met in a comparative performance study with reported device performance against those criteria.

Here's a breakdown of the available information based on your request:

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

The document does not provide a specific table of acceptance criteria with corresponding device performance metrics in the format you requested (e.g., specific quantitative values for strength, durability, etc.). Instead, it summarizes the outcome of the testing:

Acceptance Criteria (Implied): The fatigue log cycles to failure should be non-inferior to a previously cleared predicate.
Reported Device Performance (as stated in the conclusion of the fatigue testing): "Results of the testing concluded that the number of log cycles to failure achieved by the proposed bone plates met the acceptance criteria in that they were found to be non-inferior to the fatigue log cycles to failure of a previously cleared predicate."

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

Sample Size:
- For Finite Element Analysis (FEA), no specific sample size is given, as FEA is a computational method. The document mentions it was conducted on "the proposed talus plate designs."
- For Four-point bend fatigue testing, it was conducted on "worst-case examples of the proposed bone plates, as identified through FEA testing." The exact number (sample size) of these "worst-case examples" is not specified.
- For Packaging testing, no specific sample size (i.e., number of packages tested) is provided.
Data Provenance: The studies were pre-clinical (laboratory testing) conducted by the manufacturer, Smith & Nephew, Incorporated. No information about country of origin of data beyond "Smith & Nephew, Inc." is given, nor is it described as retrospective or prospective (which would typically apply to clinical studies rather than material/mechanical testing).

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

This information is not applicable to the pre-clinical mechanical and packaging testing described. Ground truth and expert consensus are relevant for clinical studies, especially those involving image interpretation or diagnostic accuracy, which are not detailed here. The "ground truth" for mechanical testing is typically defined by engineering standards and predicate device performance.

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

This information is not applicable for the type of pre-clinical testing described. Adjudication methods are typically used in clinical trials to resolve discrepancies among expert readers or reviewers.

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:

This information is not applicable. The document describes a medical device (bone plates), not an Artificial Intelligence (AI) diagnostic or interpretive device. Therefore, no MRMC study or AI assistance evaluation was performed or mentioned.

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

This information is not applicable. As mentioned above, this is not an AI/algorithm-based device. "Standalone" performance would typically refer to the algorithm's performance without human intervention, which is not relevant here.

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

For the Finite Element Analysis (FEA), the "ground truth" for evaluation would be accepted engineering principles, material science properties, and established failure criteria.
For Four-point bend fatigue testing, the "ground truth" for determining acceptance was comparison against a previously cleared predicate device. The performance of the predicate device serves as the benchmark against which the new device is judged for "non-inferiority."
For Packaging testing, the "ground truth" for acceptance would be industry standards for sterility maintenance, package integrity, and product protection during shipping.

8. The sample size for the training set:

This information is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable as there is no training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three stylized profiles facing to the right. The profiles are connected and flow together, creating a sense of unity and collaboration.

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

November 12, 2015

Smith & Nephew, Incorporated Ms. Samantha Staubach Regulatory Affairs Specialist I 1450 East Brooks Road Memphis, Tennessee 38116

Re: K152976 Trade/Device Name: VLP Mini-Mod Talus Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: October 6, 2015 Received: October 8, 2015

Dear Ms. Staubach:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

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

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K152976

Device Name VLP Mini-Mod Talus Plates

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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We are smith&nephew

Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	November 10, 2015
Contact Person and Address:	Samantha StaubachRegulatory Affairs Specialist IT 901-399-6132F 901-566-7596
Name of Device:	VLP Mini-Mod Talus Plates
Common Name:	Bone plates
Device Classification Name andReference:	21 CFR 888.3030 Single/multiple component metallic bonefixation appliances and accessories21 CFR 888.3040 Smooth or threaded metallic bone fixationfastener
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	HRS, HWC

Predicates

Manufacturer	Description	SubmissionNumber	ClearanceDate
Smith & Nephew,Inc.	VLP FOOT Plating System and PERI-LOCAnkle Fusion Plating System - Locking BonePlates and Screws (Primary Predicate)	K110670	7/12/11
Smith & Nephew,Inc.	Smith & Nephew Variable-Angle LockingMini-Fragment Plating System	K132886	2/4/14
Synthes (USA)	Synthes (USA) 2.4/2.7mm Locking FootModule	K071264	7/9/2007
Smith & Nephew,Inc.	Smith & Nephew Bone Plate System (BonePlates, Bone Screws, and Accessories)	K993106	12/9/1999

Device Description

Indications for Use

The VLP Mini-Mod Talus Plates can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic

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bone. The VLP Mini-Mod Talus Plates are indicated for fracture fixation, reconstruction or arthrodesis of small bones, including those in the forefoot, midfoot and hindfoot.

Technological Characteristics

Device comparisons described in this premarket notification demonstrated that the proposed talus plates are substantially equivalent to the legally marketed primary predicate devices cleared in K110670 with regard to intended use, indications for use, and performance characteristics.

The subject VLP Mini-Mod Talus Plates feature characteristics very similar to the VLP FOOT Plating System talus plates cleared via K110670 with the primary differences being the material selection, the addition of device-specific bone template instrumentation and different packaging configuration. The subject plates feature identical indications for use and intended use as the talus plates offered in K110670 and the same plate design options from K110670 will be available with the VLP Mini-Mod system.

Summary of Pre-Clinical Testing

Finite element analysis (FEA) was conducted on the proposed talus plate designs to . evaluate the effect of the material change from Stainless Steel to Ti-6Al-4V. This testing was used to determine the worst case plate as well as the high stress region of the plates.
. Four-point bend fatigue testing was conducted on worst-case examples of the proposed bone plates, as identified through FEA testing. Results of the testing concluded that the number of log cycles to failure achieved by the proposed bone plates met the acceptance criteria in that they were found to be non-inferior to the fatigue log cycles to failure of a previously cleared predicate.
Engineering analysis based on the device geometry and nominal material properties. .
. Packaging testing consisting of post-sterilization visual inspection, a package challenge test, post package challenge test visual inspection, and seal integrity bubble emission testing showed that the product will not be damaged during shipping and will maintain sterility post-shipping.

Conclusion

This Special 510(k) premarket notification is being submitted to request clearance for the VLP Mini-Mod Talus Plates. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to the predicate talus plates.

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.