The OsteoCentric 2.4mm and 3.0mm Cannulated Screw are 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 3.5mm Cannulated Screws are intended for fixation of small bones and small bone fragments, such as fractures of the metatarsals, arthrodesis of the carpals and phalanges, steochnondritis dissecans, and ligament fixation.

The OsteoCentric 4.5mm Cannulated Screws are intended for fracture fixation of long bones and long bone fragments.

The OsteoCentric 6.5mm to 8.0mm Cannulated Screws are intended for fracture fixation of long bones and long bone fragments, long bone osteotomies, femoral neck fractures, slipped capital femoral epiphyses as an adjunct to treatment with a dynamic hip screw (DHS) in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, pediatric femoral neck fractures, intercondylar femur fractures, SI joint disruptions, fixation of pelvis and iliosacral joints, 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 (e.g. syndesmosis) as long as there is not increased morbidity associated with the insertion of a nutand-bolt system, as discussed above.

Device Description

The OsteoCentric Technologies Cannulated Fasteners and Nuts 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. The purpose of this submission is to modify the indications for use.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

Regarding Acceptance Criteria and Supporting Study:

The document does not contain any explicit acceptance criteria or a study that proves the device meets those criteria.

Instead, the document is a 510(k) Premarket Notification for OsteoCentric Technologies' Cannulated Fasteners and Nuts. The core of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, rather than proving performance against specific acceptance criteria through new testing.

The key statement that clarifies this is:

"No performance testing was required, as no physical changes were made to the devices, the ranges of sizes are comparable to predicate devices with the same indications, and no additional testing is required for the indications modifications proposed."

Therefore, most of the requested information regarding acceptance criteria, performance data, sample sizes, and expert reviews is not applicable or not present in this specific regulatory submission. The substantial equivalence argument relies on the existing clearance of predicate devices and the lack of significant changes to the subject device that would warrant new performance testing.

However, based on the information provided, we can infer some details related to the regulatory pathway and the basis for clearance:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Material Composition:
Stainless Steel per ASTM F138	Device is manufactured from Stainless Steel per ASTM F138
Titanium per ASTM F136 or F1295	Device is manufactured from Titanium per ASTM F136 or F1295
Technological Characteristics:
Indications for Use identical to predicates	Asserted to be identical to predicates with minor modifications not raising new safety/effectiveness issues.
Materials of manufacture identical to predicates	Asserted to be identical to predicates.
Principles of operation identical to predicates	Asserted to be identical to predicates.
Sizes comparable to predicates	Asserted to be comparable to predicate devices with the same indications.
Safety and Effectiveness:
Not raise new issues of safety and effectiveness compared to predicates	Concluded that minor differences do not raise new issues of safety and effectiveness.
No physical changes made to the devices	No physical changes were made to the devices.
No additional testing required for proposed indications modifications	No additional testing was required for the proposed indications modifications.

Important Note: The "acceptance criteria" here are inferred from the substantial equivalence argument. The document explicitly states "No performance testing was required," meaning there are no new, specific quantitative performance metrics or studies reported in this submission to meet new acceptance criteria. The criteria for clearance are met by demonstrating equivalence to devices that already met prior acceptance criteria.

2. Sample size used for the test set and the data provenance

Not Applicable. The document explicitly states: "No performance testing was required." Therefore, there was no 'test set' in the context of new performance data for this submission. The substantial equivalence is based on the characteristics of the device being analogous to already cleared predicate devices.

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

Not Applicable. As no new performance testing was conducted, there was no test set requiring ground truth established by experts within the scope of this submission. The ground truth for the predicate devices' original clearances would have been established, but that information is not part of this document.

4. Adjudication method for the test set

Not Applicable. No new test set or performance study was conducted.

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 medical implant (cannulated fasteners and nuts), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

Not Applicable. This device is a medical implant, not an algorithm or software. Standalone algorithm performance is not relevant.

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

Not Applicable. No new ground truth was established for this submission, as no new performance testing was conducted. The clearance is based on substantial equivalence to predicate devices, which would have had their performance and safety established through various means (including historical usage, engineering principles, and potentially prior testing) during their initial clearance processes.

8. The sample size for the training set

Not Applicable. This device is a physical medical implant, not an AI or machine learning model that requires a "training set."

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

Not Applicable. As explained above, there is no training set for this device.

Summary

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August 3, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.

OsteoCentric Technologies % Meredith May Director of Consulting Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K211290

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: July 1, 2021 Received: July 6, 2021

Dear Meredith May:

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.

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

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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 (OS) 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 mediation-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,

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal 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) K211290

Device Name

Cannulated Fasteners and Nuts

Indications for Use (Describe)

The OsteoCentric 4.5mm Cannulated Screws are intended for fracture fixation of long bones and long bone fragments.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED#### 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)

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5.510(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:	Meredith Lee May MS, RACEmpirical Testing Corp.719.337.7579MMay@EmpiricalTech.comImage: Empirical Testing Corp. logo
Date Summary was Prepared:	June 9, 2021
Trade or Proprietary Name:	Cannulated Fasteners and Nuts
Common or Usual Name:	Screw, Fixation, Bone (primary) and Washer, Bolt Nut
Device Classification Name	Smooth or threaded metallic bone fixation fastener (primary) andSingle/multiple component metallic bone fixation appliances and accessories
Classification:	Class II per 21 CFR §888.3040 (primary) and §888.3030
Product Code:	HWC (primary) and HTN
Classification Panel:	Orthopaedic and Rehabilitation Devices Panel

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

The OsteoCentric 4.5mm Cannulated Screws are intended for fracture fixation of long bones and long bone fragments.

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neck fractures, tibial plateau fractures, ankle arthrodesis, pediatric femoral neck fractures, intercondylar femur fractures, SI joint disruptions, fixation of pelvis and iliosacral joints, and subtalar arthrodesis.

TECHNOLOGICAL CHARACTERISTICS

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

510k Number	Trade or Proprietary or ModelName	Manufacturer	PredicateType
K210754	Cannulated Fasteners and Nuts	OsteoCentric Technologies	Primary
K170021	SMV Scientific Cannulated Screws	SMV Scientific	Additional
K193214	Biomet Cannulated Screw System	Biomet	Additional
K190324	OrthoPediatrics Cannulated ScrewSystem	OrthoPediatrics	Additional

Table 5-1 Predicate Devices

PERFORMANCE DATA

No performance testing was required, as no physical changes were made to the devices, the ranges of sizes are comparable to predicate devices with the same indications, and no additional testing is required for the indications modifications proposed.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Cannulated Fasteners and Nuts 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.