The SMV Scientific 2.0mm and 2.4mm Bone Screws are intended for use in trauma procedures, reconstructive procedures, and general surgery of the hand, wrist, and other small bones and bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The SMV Scientific 2.7mm Bone Screw is intended for fractures and osteotomies of small bones and bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The SMV Scientific 3.5mm and 4.0mm Bone Screws are intended for fixation of fractures, osteotomies and non-unions of the clavicle. scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The SMV Scientific 4.5mm Bone Screw is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

Device Description

The SMV Scientific Bone Screws consist of cortical screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws are provided both sterile and non-sterile. Screws are manufactured from stainless steel.

AI/ML Overview

The provided document describes the SMV Scientific Bone Screws and their substantial equivalence to a predicate device, focusing on mechanical performance rather than clinical efficacy studies involving human readers or AI. Therefore, most of the requested information regarding acceptance criteria for AI models, human reader performance, expert ground truth, and training/test set details cannot be extracted from this document, as it pertains to a mechanical device and not an AI/software product.

Here's what can be extracted and inferred:

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

Acceptance Criteria (Implied for Bone Screws)	Reported Device Performance
Static Torsion (per ASTM F543)	Sufficient for intended use, substantially equivalent to predicate device.
Driving Torque (per ASTM F543)	Sufficient for intended use, substantially equivalent to predicate device.
Pullout Testing (per ASTM F543)	Sufficient for intended use, substantially equivalent to predicate device.
Removal Torque (per ASTM F543)	Sufficient for intended use, substantially equivalent to predicate device.
Material Conformance	Made from stainless steel that conforms to ASTM F138.

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

Sample size: Not explicitly stated. The document refers to "testing" but does not give specific numbers of screws or test runs.
Data provenance: Not applicable in the context of this device. The testing is described as "non-clinical testing," implying laboratory-based mechanical tests rather than patient data.

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

Not applicable as this is a mechanical device, not an AI/software product requiring expert ground truth in a clinical context.

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

Not applicable for the type of mechanical testing described.

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:

No, a multi-reader multi-case study was not done. This is a medical device (bone screw), not an AI-assisted diagnostic tool.

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):

For mechanical tests, "ground truth" would be established by the physical properties and performance metrics defined by standards like ASTM F543. The document states the device was tested "per ASTM F543," indicating conformance to these standardized testing procedures and corresponding acceptance criteria.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI model requiring 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

June 23, 2015

SMV Scientific Mr. Nephi Zufelt Chief Technology Officer 111 Sandra Muraida Way, Unit 18A Austin, Texas 78703

Re: K150981

Trade/Device Name: SMV Scientific Bone Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: March 30, 2015 Received: May 1, 2015

Dear Mr. Zufelt:

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

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Page 2 - Mr. Nephi Zufelt

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 vours.

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)
K150981
Device Name
SMV Scientific Bone Screws
Indications for Use (Describe)
The SMV Scientific 2.0mm and 2.4mm Bone Screws are intended for use in trauma procedures,reconstructive procedures, and general surgery of the hand, wrist, and other small bones and bonefragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growthplates have fused or in which growth plates will not be crossed by screw fixation.
The SMV Scientific 2.7mm Bone Screw is intended for fractures and osteotomies of small bones andbone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) andadolescents (12-21 years) in which growth plates have fused or in which growth plates will not becrossed by screw fixation.
The SMV Scientific 3.5mm and 4.0mm Bone Screws are intended for fixation of fractures, osteotomiesand non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus,femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in whichgrowth plates have fused or in which growth plates will not be crossed by screw fixation.
The SMV Scientific 4.5mm Bone Screw is intended for fixation of various long bones, such as thehumerus, femur and tibia. It is also for use in fixation of non-unions or malunions in adults and in bothchildren (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in whichgrowth plates will not be crossed by screw fixation.
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)

PSC Publishing Services (301) 443-6740 EF

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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
Date Summary wasPrepared	12 June 2015
Trade or Proprietary Name	SMV Scientific Bone Screw
Common or Usual Name	Screw, Fixation, Bone
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 SMV Scientific 4.5mm Bone Screw is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or malunions in adults

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and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The indications for use for the SMV Scientific Bone Screw is similar to that of the predicate devices.

TECHNOLOGICAL CHARACTERISTICS

SMV Scientific Bone Screws are made from stainless steel that conforms to ASTM F138. The subject and predicate device have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are similar between the subject and predicates:

. Indications for Use
Materials ●
Principles of Operation ●

Table 5-1 Predicate Device

510k Number	Trade or Proprietary or Model Name	Manufacturer	Type
K112583	Cortical Screws	Synthes	Primary

PERFORMANCE DATA

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

Static Torsion per ASTM F543
Driving Torque per ASTM F543 ●
Pullout Testing per ASTM F543
. Removal Torque per ASTM F543

The results of this non-clinical testing show that the strength of the SMV Scientific Bone 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 Bone 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.