The OsteoCentric Integrated Hip Fastener System is intended to treat stable and unstable intertrochanteric, subtrochanteric, and basilar neck fractures in which a stable medial buttress can be reconstructed.

Device Description

The OsteoCentric Integrated Hip Fastener System is intended for use in internal fixation of femoral neck fractures. The OsteoCentric Integrated Hip Fastem consist of plates and screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The devices are provided non-sterile. All implantable devices are manufactured from Stainless Steel per ASTM F138.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "OsteoCentric Integrated Hip Fastener System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with strict acceptance criteria and performance metrics.

Therefore, the document does not contain the kind of information typically requested for AI/ML device studies, such as:

A table of acceptance criteria and reported device performance (in terms of sensitivity, specificity, AUC, etc.)
Sample size used for the test set and data provenance (e.g., country of origin, retrospective/prospective)
Number of experts and their qualifications used to establish ground truth
Adjudication method
Multi-reader multi-case (MRMC) comparative effectiveness study
Standalone (algorithm-only) performance
Type of ground truth used (pathology, outcomes data, etc.)
Sample size for the training set
How ground truth for the training set was established

Instead, this document describes an engineering analysis for a mechanical device.

Here's what the document does provide regarding the "study" that proves the device meets the "acceptance criteria" (using these terms loosely in the context of a mechanical device submission):

1. Acceptance Criteria and Reported Device Performance (Mechanical Context):

The acceptance criteria here are implicitly demonstrating substantial equivalence to predicate devices in terms of mechanical properties for the intended use.

Acceptance Criteria (Implicit)	Reported Device Performance (Engineering Analysis Conclusion)
Plate strength and stiffness sufficient for intended use and comparable to predicates.	Plate strength and stiffness was compared by evaluating the material properties and moment of inertia at worst-case locations. The results of the engineering analysis confirmed that the strength, stiffness... of the OsteoCentric Integrated Hip Fastener System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Screw strength sufficient for intended use and comparable to predicates.	Screw strength was evaluated and compared to the predicates using the material properties, screw types and sizes. The results of the engineering analysis confirmed that the... strength... of the OsteoCentric Integrated Hip Fastener System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Screw fixation sufficient for intended use and comparable to predicates (e.g., thread profile provides adequate fixation).	Screw fixation was evaluated and compared to predicates using information about the thread profile. The results of the engineering analysis confirmed that the... fixation of the OsteoCentric Integrated Hip Fastener System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Overall mechanical performance equivalent to legally marketed predicate devices.	"The overall technology characteristics and mechanical performance data lead to the conclusion that the OsteoCentric Integrated Hip Fastener System is substantially equivalent to the predicate device." "The results of the engineering analysis confirmed that the strength, stiffness and fixation of the OsteoCentric Integrated Hip Fastener System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
Materials of manufacture (Stainless Steel per ASTM F138) are appropriate and similar to predicates.	Implied by "All implantable devices are manufactured from Stainless Steel per ASTM F138" and "Materials of Manufacture" being identical between subject and predicates.
Similar technological characteristics to predicates (e.g., modular stainless steel bone fixation system with similar interlocking features, plate angulation, lengths, widths, thicknesses, screw sizes, screw lengths).	"The subject and predicate devices have similar 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." Also, "the subject plating/screw construct is also a modular stainless steel bone fixation system with similar interlocking features, plate angulation, plate lengths, plate widths, plate thicknesses, screw sizes and screw lengths."

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

Test Set: No discrete "test set" in the context of an AI/ML algorithm is mentioned. The assessment was based on an "engineering analysis" comparing physical properties and design features of the subject device to predicate devices. This involves material properties, moment of inertia, screw types/sizes, and thread profiles.
Data Provenance: Not applicable in the context of an engineering analysis of mechanical components. The data would come from specifications, material testing standards (e.g., ASTM F138), and design comparisons.

3. 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 properties is established through engineering principles, material science, and testing standards, not expert consensus in the medical imaging sense. The submission was prepared by Nathan Wright MS, an Engineer & Regulatory Specialist at Empirical Testing Corp.

4. Adjudication method for the test set:

Not applicable. There was no clinical or interpretative "test set" requiring adjudication.

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 is a mechanical bone fixation device, not an AI/ML diagnostic or assistive tool.

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

Not applicable. This is a mechanical device.

7. The type of ground truth used:

Engineering specifications and standards: The "ground truth" for this device's performance relies on established engineering principles, material science (e.g., Stainless Steel per ASTM F138 specifications), and comparative analysis against the known mechanical properties of legally marketed predicate devices. The aim is to show that the new device's mechanical integrity is equivalent or superior to existing devices for the same indications.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of this type of mechanical device submission.

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

Not applicable.

Summary

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April 30, 2021

OsteoCentric Technologies d.b.a. OsteoCentric Trauma % Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K210247

Trade/Device Name: OsteoCentric Integrated Hip Fastener System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDO, KTT Dated: January 28, 2021 Received: January 29, 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.

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

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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.

Christopher Ferreira -S

for

Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty 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: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K210247

Device Name

0steoCentric Integrated Hip Fastener System

Indications for Use (Describe)

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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510(K) SUMMARY

Submitter's Name:	OsteoCentric Trauma
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:	January 28, 2021
Trade or Proprietary Name:	OsteoCentric Integrated Hip Fastener System
Common or Usual Name:	Device, Fixation, Proximal Femoral, Implant
Classification:	Class II per 21 CFR §888.3030
Regulation Name:	Single/Multiple Component Metallic Bone Fixation AppliancesAnd Accessories
Product Code:	JDO, KTT
Classification Panel:	Orthopedic

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

The OsteoCentric Integrated Hip Fastemer System is intended to treat stable and unstable intertrochanteric, subtrochanteric, and basilar neck fractures in which a stable medial buttress can be reconstructed.

TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have similar 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

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510k Number	Trade or Proprietaryor Model Name	Manufacturer	Device Category
K953607	Dynamic Hip Screw	Synthes (USA)	Primary
K923613, K791619	Dynamic Hip Screw	Synthes (USA)	Additional
K914546	Angled Blade Plate	Synthes (USA)	Additional
K193029	Conquest FN	Smith & Nephew, Inc.	Additional
K150818	Versa-Fx FemoralFixation System, Versa-Fx II Femoral FixationSystem, Free-LockFemoral Fixation System	Zimmer, Inc.	Additional
K000972	Trochanter StabilizationPlate for DHS®	Synthes (USA)	Additional
K120772	NCB Periprosthetictrochanter Plates andScrews	Zimmer GMBH	Additional
K170021	SMV ScientificCannulated Screws	SMV Scientific	Reference

PERFORMANCE DATA

An engineering analysis was performed to compare the subject plating construct to the predicates. Similar to the predicates, the subject plating/screw construct is also a modular stainless steel bone fixation system with similar interlocking features, plate angulation, plate lengths, plate widths, plate thicknesses, screw sizes and screw lengths. Plate strength and stiffness was compared by evaluating the material properties and moment of inertia at worst-case locations. Screw strength was evaluated and compared to the predicates using the material properties, screw types and sizes. Screw fixation was evaluated and compared to predicates using information about the thread profile. The results of the engineering analysis confirmed that the strength, stiffness and fixation of the OsteoCentric Integrated Hip Fastemer System 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 OsteoCentric Integrated Hip Fastener System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.