The SMV Bone Plate and Screw System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, periarticular and intraarticular fractures.

Device Description

The SMV Bone Plate and Screw System consists of implants and instruments designed for fixation to treat fractures, deformations, revisions and replantations of bones and bone fragments. The system features nineteen (19) types of plates, bone screws for fixation, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel (ASTM F138), and offered in various widths and lengths. Plates and screws are provided non-sterile. The implants in this submission can be used with the screws cleared in K150981 and K150188.

AI/ML Overview

This is a premarket notification (510(k)) for a medical device, the SMV Bone Plate and Screw System. It does not describe a clinical study or acceptance criteria for an AI/CADe device. Instead, it demonstrates substantial equivalence to predicate devices through technological characteristics and non-clinical performance testing. Therefore, most of the requested information regarding acceptance criteria and study details for AI performance cannot be extracted from this document.

Here's what can be extracted based on the provided text, and where gaps exist:

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

The document does not specify "acceptance criteria" in the sense of a numerical threshold for clinical performance (e.g., sensitivity, specificity) that an AI device would need to meet. Instead, it describes a non-clinical testing approach to demonstrate substantial equivalence.

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported Device Performance
Mechanical strength sufficient for intended use	Results of Static and Dynamic Four-point Bending per ASTM F382 demonstrate sufficient strength and substantial equivalence to legally marketed predicate devices.

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. This document refers to mechanical/non-clinical testing, not a clinical test set with patient data.

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 for clinical data is not relevant for this type of non-clinical device testing.

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 not an AI/CADe device.

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

Not applicable. This is not an AI/CADe device.

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

For the mechanical testing, the "ground truth" is implied by the ASTM F382 standards and the performance of the predicate devices. The study aims to show that the new device's mechanical properties are comparable.

8. The sample size for the training set

Not applicable. This is not an AI/CADe device.

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

Not applicable. This is not an AI/CADe device.

Summary of the study:

The study described is a non-clinical performance testing to demonstrate the mechanical strength and substantial equivalence of the SMV Bone Plate and Screw System to legally marketed predicate devices.

Test Methods:
- Static Four-point Bending per ASTM F382
- Dynamic Four-point Bending per ASTM F382
Outcome: The results showed that "the strength of the Bone Plate and Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
Purpose: To support the 510(k) premarket notification for the SMV Bone Plate and Screw System by showing its mechanical characteristics are comparable to existing, legally marketed devices.

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, stacked on top of each other.

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

November 25, 2015

SMV Scientific % Mr. Kenneth Maxwell II Regulatory and Quality Specialist Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K152000

Trade/Device Name: SMV Bone Plate and Screw System 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 28, 2015 Received: October 30, 2015

Dear Mr. Maxwell:

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 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/ResourcesforYou/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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DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: January 31, 2017See PRA Statement on last page.
Indications for Use
510(k) Number (if known)	K152000
Device Name	SMV Bone Plate and Screw System
Indications for Use (Describe)	The SMV Bone Plate and Screw System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, periarticular and intraarticular fractures.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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

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5.510(K) SUMMARY

Submitter's Name:	SMV Scientific
Submitter's Address:	111 Sandra Muraida WayUnit 18AAustin, TX 78703
Submitter Contact Person:	Nephi ZufeltChief Technology Officer512.750.8622
Empirical Consulting Contact Person:	Kenneth C. Maxwell IIEmpirical Testing Corp.719.291.6874
Date Summary was Prepared:	12 November 2015
Trade or Proprietary Name:	SMV Bone Plate and Screw System
Common or Usual Name:	Plate, Fixation, BoneScrew, Fixation, Bone
Classification:	Class II per 21 CFR §888.3030 & §888.3040
Product Code:	HRS, HWC
Classification Panel:	Division of Orthopedic Devices

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

The indications for use for the Bone Plate and Screw System is similar to that of the predicate devices listed in Table 5-1: Predicate Devices.

TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

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. Indications for use
Materials of manufacture ●
Principles of operation ●

Table 5-1: Predicate Devices

510k Number	Trade or Proprietary or Model Name	Manufacturer	Predicate Type
K092609	3.5mm and 4.5mm Curved Narrow and Broad Locking Compression Plates (LCP), Straight Compression, Straight Reconstruction Bone Plates	Synthes	Primary
K001945	Medial Distal Tibia Plates	Synthes	Reference
K011335	One-Third Tubular DCL Plate, One-Third Tubular	Synthes	Reference
K020872	3.5 mm Broad LC-DCP Plates	Synthes	Reference
K082807	3.5mm and 4.5mm Locking Compression Plate (LCP) System	Synthes	Reference

Performance Data

The SMV Scientific Bone Plate and Screw System has been tested in the following test modes:

Static Four-point Bending per ASTM F382 ●
. Dynamic Four-point Bending ASTM F382

The results of this non-clinical testing show that the strength of the Bone Plate and Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Bone Plate and Screw System is substantially equivalent to the predicate device.

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.