The SMV Scientific 4.5mm Bone Screws are intended to treat fractures of various bones including the clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and small bones (metacarpals, metatarsals, and phalanges).

Device Description

The SMV Scientific 4.5mm Solid Bone Screws consist of cortical screws in a variety of lengths to accommodate different anatomic sizes of patients. The screws are provided non-sterile and are self-tapping. Screws are manufactured from stainless steel.

AI/ML Overview

The SMV Scientific 4.5mm Bone Screws are subject to acceptance criteria derived from mechanical performance tests, as outlined in the 510(k) summary (K150188).

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

Test Mode	Standard Applied	Acceptance Criteria	Reported Device Performance
Static Torsion	ASTM F543	Not explicitly stated in the provided text, but implies performance comparable to the predicate device.	The strength of the SMV Scientific 4.5mm Bone Screw is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Driving Torque	ASTM F543	Not explicitly stated in the provided text, but implies performance comparable to the predicate device.	The strength of the SMV Scientific 4.5mm Bone Screw is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Pullout Testing	ASTM F543	Not explicitly stated in the provided text, but implies performance comparable to the predicate device.	The strength of the SMV Scientific 4.5mm Bone Screw is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Removal Torque	ASTM F543	Not explicitly stated in the provided text, but implies performance comparable to the predicate device.	The strength of the SMV Scientific 4.5mm Bone Screw is sufficient for its intended use and is 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)
The document does not specify the sample size used for the mechanical performance tests, nor does it provide information on data provenance (country of origin or retrospective/prospective nature). The tests are described as "non-clinical testing," suggesting a in vitro laboratory setting.

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)
This information is not applicable. The device is a bone screw, and its performance is evaluated through mechanical testing against engineering standards, not through expert-based assessment of clinical images or patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple experts, which is not the nature of this mechanical 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
This information is not applicable. The device is a bone screw and its evaluation does not involve AI assistance or human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a bone screw and mechanical testing is performed on the physical device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the mechanical performance tests is established by the specifications and requirements of the ASTM F543 standard. The performance of the SMV Scientific 4.5mm Bone Screw is compared directly against the predicate device's performance under these same mechanical tests, aiming for substantial equivalence.

8. The sample size for the training set
This information is not applicable as this is a medical device (bone screw) undergoing mechanical testing, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of device evaluation.

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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image 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

April 29, 2015

Summit MedVentures % Mr. Kenneth C. Maxwell II Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K150188

Trade/Device Name: SMV Scientific 4.5 mm 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: April 3, 2015 Received: April 6, 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Kenneth C. Maxwell II

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, 2017
	See PRA Statement on last page.

Indications for Use

510(k) Number ( if known )	K150188
Device Name	SMV Scientific 4.5mm Bone Screws
Indications for Use ( Describe )	The SMV Scientific 4.5mm Bone Screws are intended to treat fractures of various bones including the clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and small bones (metacarpals, metatarsals, and phalanges).

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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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)

FORM FDA 3881 (9/13) PSC Publishing Services (301) 443-6740 EF

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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 ConsultingContact Person	Kenneth C. Maxwell IIEmpirical Testing Corp.719.291.6874
Date Summary wasPrepared	16 April 2015
Trade or Proprietary Name	SMV Scientific 4.5mm 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

TECHNOLOGICAL CHARACTERISTICS

The SMV Scientific 4.5mm Bone Screw is 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 identical between the subject and predicates:

Indications for Use
Materials
Principles of Operation ●

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Table 5-1 Predicate Device

510k Number	Trade or Proprietary or Model Name	Manufacturer	Type
K092889	Osteo-Plate and Screw Fixation	Syntec	Primary

PERFORMANCE DATA

The SMV Scientific 4.5mm 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 o

The results of this non-clinical testing show that the strength of the SMV Scientific 4.5mm 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 4.5mm 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.