The SMV Scientific Schanz Screws are intended for use as external fixation for fracture fixation (open and closed); pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.

Device Description

SMV Scientific Schanz Screws are manufactured from medical grade stainless steel. SMV Scientific Schanz Screws are offered in various diameters and lengths. SMV Scientific Schanz Screws are intended to provide fracture fixation.

AI/ML Overview

This document is a 510(k) premarket notification for the "SMV Scientific Schanz Screws." It primarily focuses on demonstrating substantial equivalence to a predicate device based on mechanical performance rather than AI/algorithm performance. Therefore, many of the requested elements for an AI device study are not applicable or cannot be found in this document.

However, I can extract the information relevant to the device's performance testing and acceptance criteria as presented.

Here's an attempt to answer your request based only on the provided text, acknowledging that much of the information you asked for is not present for this type of device submission:

1. Table of Acceptance Criteria and the Reported Device Performance

For this specific device (Schanz Screws), the "acceptance criteria" and "reported device performance" are based on mechanical testing and comparison to a predicate device rather than diagnostic accuracy or AI model metrics.

Acceptance Criteria (Stated Goal)	Reported Device Performance
Sufficient strength for intended use	"strength of the SMV Scientific Schanz Screw is sufficient for its intended use"
Substantially equivalent to legally marketed predicate devices (K040701) in terms of mechanical performance	"substantially equivalent 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)

This document describes non-clinical mechanical testing of physical devices. It does not involve a "test set" of patient data or clinical samples in the way an AI diagnostic device would. Therefore:

Sample Size: Not specified for testing individual screws, but implied to be sufficient for ASTM F1541-02 standards.
Data Provenance: Not applicable in the context of patient data; the data comes from mechanical testing performed on manufactured Schanz screws.

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, in the AI context, refers to a verified diagnosis or condition. For this mechanical device, "ground truth" relates to physical properties, established through standardized testing (ASTM F1541-02), not by expert human interpretation.

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

Not applicable. This concept pertains to resolving discrepancies in expert interpretations for establishing ground truth in clinical/diagnostic studies, which is not relevant for mechanical device testing.

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 device is a bone fixation fastener, not an AI-assisted diagnostic tool. No human reader studies are mentioned or relevant to its 510(k) submission for mechanical equivalence.

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

Not applicable. There is no algorithm or AI component in the SMV Scientific Schanz Screws as described in this document. The "standalone performance" refers to the mechanical properties of the screws themselves.

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

The "ground truth" for this device's performance is established via standardized mechanical testing results (Static Four-point Bending and Static Torsion per ASTM F1541-02). The "ground truth" for equivalence is a comparison to the mechanical performance characteristics of the predicate device (Synthes Self-Drilling Schanz Screws, K040701).

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, so there is no training set.

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

Not applicable. As there is no training set for an AI model, this question is not relevant.

Summary

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Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

March 28, 2016

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

Re: K160603

Trade/Device Name: SMV Scientific Schanz Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: February 29, 2016 Received: March 2, 2016

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 (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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DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug AdministrationIndications for Use	Expiration Date: January 31, 2017See PRA Statement on last page.

510(k) Number (if known)	K160603
Device Name	SMV Scientific Schanz Screws
Indications for Use (Describe)	The SMV Scientific Schanz Screws are intended for use as external fixation for fracture fixation (open and closed); pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.

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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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 ContactPerson:	Kenneth C. Maxwell IIEmpirical Testing Corp.719.291.6874
Date Summary was Prepared:	29 February 2016
Trade or Proprietary Name:	SMV Scientific Schanz Screws
Common or Usual Name:	Smooth or threaded metallic bone fixation fastener.
Classification:	Class II per 21 CFR §888.3040 Device Classification
Product Code:	HWC
Classification Panel:	Division of Orthopedic Devices

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

Indications for Use

The indications for use for the SMV Scientific Schanz Screw is similar to that of the predicate devices in Table 5-1 below.

Table 5-1 Predicate Devices

510k Number	Trade or Proprietary or ModelName	Manufacturer	PredicateType
K040701	Self-Drilling Schanz Screws	Synthes	Primary

PERFORMANCE DATA

The SMV Scientific Schanz Screw has been tested in the following test modes:

Static Four-point Bending per ASTM F1541-02

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o Static Torsion per ASTM F1541-02
The results of this non-clinical testing show that the strength of the SMV Scientific Schanz Screw 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 SMV Scientific Schanz Screw is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.