The VLP MINI-MOD Small Bone Plating System and VLP MINI-MOD Talus Plates are indicated for adolescent (12–18 years) and transitional adolescent (18–21 years) subpopulations and adults, as well as patients with osteopenic bone.

The VLP MINI-MOD Small Bone Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.

Device Description

The subject VLP MINI-MOD 2.0mm Column Plates are line addition plates to the VLP MINI-MOD Small Bone Plating System. The VLP MINI-MOD Small Bone Plating System was initially cleared for market via K132886 as the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System. The proposed plates are intended to be used with the 2.0mm Locking and Cortex screws previously cleared via K132886.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (VLP MINI-MOD 2.0mm Column Plates), not an AI/ML medical device. Therefore, much of the requested information regarding AI/ML device studies, such as sample sizes for test and training sets, expert consensus, MRMC studies, and ground truth establishment, is not applicable.

However, I can extract the acceptance criteria and the study type for this specific medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Performance (Fatigue): Non-inferiority to previously cleared predicate	Achieved the acceptance criteria by being found non-inferior to the fatigue log cycles to failure of a previously cleared predicate when tested at the same bending moment. (Leveraged existing four-point bend fatigue testing on the worst-case plate of the VLP MINI-MOD product family (K132886) because the subject plate did not represent a new worst case).
Bacterial Endotoxin Limits: Met acceptable endotoxin limits	Met the acceptable endotoxin limits as stated in the FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile", "Pyrogen and Endotoxins Testing: Questions and Answers", and ANSI/AAMI ST72. (Performed bacterial endotoxin testing).
Worst-Case Design Assessment (FEA): Did not represent a new worst case	The subject plate did not represent a new worst case compared against existing MINI-MOD plates cleared via K132886. (Based on Finite Element Analysis (FEA)).
Substantial Equivalence: Similar intended use, indications for use, and performance characteristics to predicates	Device comparisons demonstrated that the proposed VLP MINI-MOD 2.0mm Column Plate is substantially equivalent to the legally marketed predicate devices (K132886, K993106) with regard to intended use, indications for use, and performance characteristics. (Based on device comparisons, engineering rationale, and mechanical testing).

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

Mechanical Testing (Four-point bend fatigue): The document refers to "the worst-case plate of the VLP MINI-MOD product family cleared via K132886". It does not specify the exact number of samples used in that previous testing, but it was sufficient to establish non-inferiority.
Bacterial Endotoxin Testing: The number of samples tested is not specified, but it was conducted to meet regulatory standards.
FEA: This is a computational analysis; it doesn't involve a "test set" in the traditional sense of physical samples, but rather a model of the device.

Data provenance is not explicitly stated in terms of country of origin or retrospective/prospective, but these are pre-clinical (in vitro/computational) tests conducted by the manufacturer.

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. This is a submission for a metallic bone fixation device, not an AI/ML imaging device that requires expert interpretation for ground truth. The "ground truth" here is based on engineering principles, material science, and established regulatory standards for mechanical and biological performance.

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

Not applicable. This is not an AI/ML diagnostic or prognostic device involving human adjudication of results.

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 medical device and does not involve human readers or AI assistance in diagnostic interpretation.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device is based on:

Engineering Standards: Meeting established mechanical performance requirements (e.g., fatigue resistance).
Regulatory Standards: Compliance with bacterial endotoxin limits as specified in FDA guidance and ANSI/AAMI ST72.
Comparability: Demonstrating substantial equivalence to predicate devices based on intended use, indications for use, and performance characteristics.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary

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

December 21, 2016

Smith & Nephew, Inc. Samantha Staubach Regulatory Affairs Specialist 1450 Brooks Rd Memphis. Tennessee 38116

Re: K163086

Trade/Device Name: VLP MINI-MOD 2.0 mm Column 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 Dated: November 2, 2016 Received: November 3, 2016

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 Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Vincent J. Devlin -S

for

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

Enclosure

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Indications for Use

510(k) Number (if known) K163086

Device Name VLP MINI-MOD 2.0mm Column Plates

Indications for Use (Describe)

The VLP MINI-MOD Small Bone Plating System and VLP MINI-MOD Talus Plates are indicated for adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone.

The VLP MINI-MOD Small Bone Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.

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)

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Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	December 21, 2016
Contact Person and Address:	Samantha StaubachRegulatory Affairs SpecialistT 901-399-6132F 901-566-7596
Name of Device:	VLP MINI-MOD 2.0mm Column Plates
Common Name:	Bone plates
Device Classification Name andReference:	21CFR 888.3030 Single/multiple component metallic bonefixation appliances and accessories
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	HRS

Predicates

Table 5-1: Substantially equivalent predicates

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew, Inc.	Smith & Nephew Variable-AngleLocking Mini-Fragment PlatingSystem (Primary Predicate)	K132886	2/4/2014
Smith & Nephew, Inc.	Smith & Nephew Bone PlateSystem	K993106	12/9/1999

Device Description

Indications for Use

The VLP MINI-MOD Small Bone Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments. This

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system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.

Technological Characteristics

Device comparisons described in this premarket notification demonstrated that the proposed VLP MINI-MOD 2.0mm Column Plate is substantially equivalent to the legally marketed predicate devices described in Table 5-1 with regard to intended use, indications for use, and performance characteristics.

Summary of Pre-Clinical Testing

Finite element analysis (FEA) was conducted on the proposed VLP MINI-MOD 2.0mm . Column Plate to determine if it represented a new worst case compared against the existing MINI-MOD plates cleared via K132886. The subject plate did not represent a new worst case plate design.
An engineering rationale was used to leverage the four-point bend fatigue testing that was previously conducted on the worst-case plate of the VLP MINI-MOD product family cleared via K132886. 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 when tested at the same bending moment. Due to the fact that the subject plate did not represent a new worst case, the testing was also applicable to the subject line addition plate.
. Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance , "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.

Conclusion

This Traditional 510(k) premarket notification is being submitted to required clearance for the line addition VLP MINI-MOD 2.0mm Column Plate. Based on similarities to the predicate component and a review of the engineering rationale/mechanical testing previously conducted, the devices are substantially equivalent to the predicates described in Table 5-1.

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.