The OsteoCentric 2.4mm Cannulated Screw is intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.

The OsteoCentric Trauma 7.0mm and 8.0mm Cannulated Screws are intended for fracture fixation of large bones and large bone fragments, femoral neck fractures, slipped capital femoral epiphyses, as an adjunct to DHS in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, pediatric femoral neck fractures, intercondylar femur fractures, and subtalar arthrodesis.

The OsteoCentric 7.0mm and 8.0mm Cannulated Nut is indicated for fracture fixation where fracture compression is desired, and where insertion of the nut-and-bolt system does not increase the risk of morbidity due to the need for surgical access to both sides of the compressed area. The device may also be used when compression between separate bones is desired (i.e.- the syndesmosis) as long as there is not increased morbidity associated with the insertion of a nut-and-bolt system, as discussed above.

Device Description

The OsteoCentric Technologies Cannulated Fasteners and Nuts within the product line of the SMV Scientific Cannulated Screws consists of cannulated screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws and nuts are provided non-sterile. The screws and nuts are manufactured from Stainless Steel per ASTM F138 or from Titanium per ASTM F136 or F1295.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Cannulated Fasteners and Nuts" and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria for a novel AI/ML-based medical device. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not present in this document.

However, I can extract the information related to the performance testing that was conducted to support the substantial equivalence claim.

Here's a summary based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format with corresponding reported device performance values. Instead, it states that "OsteoCentric Technologies has conducted mechanical testing with engineering analyses and geometric comparisons to demonstrate that the modifications to the SMV Scientific Cannulated Screws provide adequate and substantially equivalent mechanical performance (torsional strength, driving torque, and pullout strength) for their intended use." This implies the acceptance criteria were based on demonstrating mechanical performance comparable to the predicate devices.

The reported performance is qualitative, stating that the device provides "adequate and substantially equivalent mechanical performance" for the tested parameters.

Performance Testing Summary

Test Category	Acceptance Criteria (Implicit)	Reported Device Performance (Qualitative)
Mechanical Strength	Performance comparable to legally marketed predicate devices for their intended use, demonstrating substantial equivalence. (Specific thresholds are not provided in the document).	"adequate and substantially equivalent mechanical performance (torsional strength, driving torque, and pullout strength) for their intended use."
Torsional Strength	(Implied: Engineering analysis supports substantial equivalence to predicates.)	Engineering analysis conducted. (Specific values or comparison results are not provided).
Pullout Resistance	(Implied: Engineering analysis supports substantial equivalence to predicates.)	Engineering analysis conducted. (Specific values or comparison results are not provided).
Driving Torque	Per ASTM F543 (Implied: Results meet or are comparable to predicate performance and standard requirements).	Testing completed per ASTM F543. (Specific values or comparison results are not provided).
Cleaning Validation	Per AAMI TIR12:2010 and ANSI/AAMI TIR30:2011 (Implied: Validation demonstrates effective cleaning).	Validation completed. (Specific results or acceptance criteria for cleaning are not detailed).
Sterilization Validation	Per AAMI TIR12:2010 (Implied: Validation demonstrates effective sterilization).	Validation completed. (Specific results or acceptance criteria for sterilization are not detailed).
Geometric Comparison	Device characteristics (e.g., sizes) are nearly identical to predicates.	"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: - Indications for Use - Materials of manufacture - Principles of operation - Sizes"

Other Requested Information (Not Applicable or Not Provided in this Document)

The document is a 510(k) summary for a standard orthopedic implant (cannulated fasteners and nuts), not an AI/ML-based device. Therefore, the following information is not present or not relevant in this context:

Sample size used for the test set and the data provenance: Not applicable. The testing described is mechanical, not based on a "test set" of patient data in the AI/ML sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not expert radiologists assessing images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical testing, the "ground truth" would be the results obtained from standardized mechanical tests (e.g., peak torque, ultimate tensile strength) and comparison to established engineering specifications or predicate device performance.
The sample size for the training set: Not applicable (no AI/ML training set).
How the ground truth for the training set was established: Not applicable.

Summary

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April 14, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two main elements: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health and Human Services logo is a stylized representation of an eagle. The FDA acronym is in a blue square, and the full name of the agency is written in blue letters.

OsteoCentric Technologies % Nathan Wright Engineer & Regulatory Special Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K210754

Trade/Device Name: Cannulated Fasteners and Nuts Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: March 12, 2021 Received: March 15, 2021

Dear Nathan Wright:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali -S

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.

510(k) Number (if known) K210754 Device Name

Cannulated Fasteners and Nuts

Indications for Use (Describe)

Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) CONTINUE ON A SEPARATE PAGE IF NEEDED. 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 Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. "

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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510(K) SUMMARY

Submitter's Name:	OsteoCentric Technologies
Submitter's Address:	75 West 300 North, Suite #150Logan, UT 84321
Submitter's Telephone:	1-800-969-0639
Contact Person:	Nathan Wright, MSEmpirical Testing Corp.719-351-0248nwright@empiricaltech.com
Date Summary was Prepared:	April 12, 2021
Trade or Proprietary Name:	Cannulated Fasteners and Nuts
Common or Usual Name:	Screw, Fixation, Bone (primary) andWasher, Bolt Nut
Device Classification Name:	Smooth or Threaded Metallic Bone Fixation Fastener(primary) andSingle/multiple component metallic bone fixationappliances and accessories
Classification:	Class II per 21 CFR §888.3040 (primary) and§888.3030
Product Code:	HWC (primary), HTN
Classification Panel:	Orthopedic

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

The OsteoCentric 7.0mm and 8.0mm Cannulated Nut is indicated for fracture fixation where fracture compression is desired, and where insertion of the nut-and-bolt system does not increase

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the risk of morbidity due to the need for surgical access to both sides of the compressed area. The device may also be used when compression between separate bones is desired (i.e. - the syndesmosis) as long as there is not increased morbidity associated with the insertion of a nutand-bolt system, as discussed above.

TECHNICAL CHARACTERISTICS

The indications for use for the OsteoCentric Cannulated Fasteners and Nuts are same as that of the SMV Scientific Cannulated Bone Screws. The OsteoCentric Cannulated Fasteners and Nuts are made from stainless steel per ASTM F138 and from titanium per ASTM F136 or F1295. 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:

. Indications for Use
Materials of manufacture .
Principles of operation
Sizes

Table 5-1 Predicate Devices

510k Number	Trade or Proprietary or Model Name	Manufacturer	Predicate Type
K170021	SMV Scientific Cannulated Bone Screws	SMV Scientific	Primary
K202680	ExtremiFix Mini & SmallCannulated Screw System	OsteoMed LLC	Additional
K191344	Arthrex Mini ComprehensiveFixation System – 2.0mm & 2.4mmModule	Arthrex Inc.	Additional
K000080	Asnis III Cannulated Screw System	HowmedicaOsteonics Corp.	Additional
K081813	CompresSURE Fracture RepairSystem	U.S. ImplantSolutions, LLC	Additional
K150981	SMV Scientific Bone Screws	SMV Scientific	Additional

PERFORMANCE TESTING SUMMARY

In support of this Special 510(k) Device Modification Premarket Notification, OsteoCentric Technologies has conducted mechanical testing with engineering analyses and geometric comparisons to demonstrate that the modifications to the SMV Scientific Cannulated Screws provide adequate and substantially equivalent mechanical performance (torsional strength, driving torque, and pullout strength) for their intended use. Non-clinical analysis and testing included:

Engineering analysis of torsional strength .
Engineering analysis of pullout resistance .

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Driving torque testing per ASTM F543 .
Instrument Cleaning Validation per AAMI TIR12:2010 and ANSI/AAMI TIR30:2011 .
Sterilization Validation per AAMI TIR12:2010 .

CONCLUSION

The subject OsteoCentric Cannulated Fasteners and Nuts are very similar to previously cleared Cannulated Screws (K170021). The indications for use for the subject are the same to that of the previously cleared predicates. The subject screws have similar intended uses, indications, technological characteristics, and principles of operation as the predicate devices. The modifications of additional sizes and inclusion of nuts raise no new types of safety or effectiveness questions. The overall technology characteristics and mechanical performance evaluation lead to the conclusion that the OsteoCentric Cannulated Fasteners and Nuts are substantially equivalent to the predicate devices.

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.