The Osteo Compression Hip Screw System is a proximal fracture fixation system, comprised of compression hip screw plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo Cortical Bone Screws may be utilized with this system for additional compression and fixation. This system is utilized as an aid to healing, not as a substitute for normal intact tissues. The design and materials for the Osteo Compression Hip Screw System are determined to be substantially equivalent via 510(k)s #K971654, #K971321 and #K920037, and remain unchanged from these previous submissions.

AI/ML Overview

The provided 510(k) Premarket Notification for the Osteo Compression Hip Screw System - Expanded Indication does not contain the typical information required to describe acceptance criteria and a study proving device performance as it relates to software or AI/ML-based medical devices.

This submission is for a mechanical medical device (an implantable hip screw system) and therefore the evaluation for its expanded indication focuses on demonstrating substantial equivalence to a predicate device, rather than performance metrics of a diagnostic or predictive algorithm.

Therefore, most of the requested information (items 1-9) about acceptance criteria, study sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training sets is not applicable to this type of device submission.

Here's an explanation based on the content provided:

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

Not Applicable. Mechanical devices like the Osteo Compression Hip Screw System are not typically evaluated using performance metrics like sensitivity, specificity, or accuracy in the same way software devices are. The "acceptance criteria" for such a device largely revolve around demonstrating substantial equivalence in design, materials, and intended use to a legally marketed predicate device, and ensuring it meets relevant safety and performance standards (e.g., mechanical tests, biocompatibility). The document does not report performance data in the context of clinical outcomes or diagnostic accuracy.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. There is no "test set" of patient data in the context of evaluating a diagnostic or predictive algorithm. The device is a physical implant. The evaluation is based on engineering principles, materials science, and comparison to a predicate device, not clinical data demonstrating diagnostic performance on a test set.

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)

Not Applicable. Ground truth, in the context of diagnostic performance, is not established for this type of mechanical device. The "truth" in this context is the safety and effectiveness of the device as an implant, which is assessed through a regulatory pathway of substantial equivalence and adherence to engineering standards.

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

Not Applicable. As there is no test set for diagnostic performance, there is no adjudication method.

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. An MRMC study is relevant for evaluating the impact of AI/software on human diagnostic performance. This device is a surgical implant and does not involve human "readers" or AI assistance in diagnosis.

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

Not Applicable. This is a mechanical surgical implant, not an algorithm.

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

Not Applicable. Ground truth in the diagnostic sense is not used here. Device safety and effectiveness are established through demonstrating substantial equivalence, mechanical testing, and biocompatibility, not by comparing its "readings" to a ground truth.

8. The sample size for the training set

Not Applicable. This is a mechanical device, not an AI/ML algorithm that requires a training set.

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

Not Applicable. No training set exists for this type of device.

Summary of the Provided Information for this Mechanical Device:

The document describes the Osteo Compression Hip Screw System as a proximal fracture fixation system for hip fractures.

Intended Use: To provide strong and stable internal fixation with minimal soft tissue irritation for various femoral fractures.
Expanded Indications: The current submission seeks to expand the indications to include extracapsular fractures of the proximal femur (basal neck, trochanteric, and subtrochanteric fractures).
Predicate Device: Synthes DHS® Dynamic Hip Screw System.
Basis for Acceptance: The submission relies on demonstrating substantial equivalence in intended use, design, and materials to previously cleared Osteo Compression Hip Screw System components (K971654, K971321, K920037) and to the predicate Synthes DHS® Dynamic Hip Screw System for the expanded indications. The FDA's letter (K982553) confirms this finding of substantial equivalence.
Safety and Performance: While not explicitly detailed in the provided snippets, for mechanical devices, "acceptance criteria" would typically involve:
- Material compatibility: Biocompatibility testing to ensure the materials are safe for implantation.
- Mechanical strength and fatigue testing: To ensure the device can withstand the physiological loads it will be subjected to without failure.
- Design similarities: Comparison of design features (e.g., screw threads, plate geometry, dimensions) to predicate devices to argue for similar performance and safety profiles.
- Manufacturing quality: Adherence to Good Manufacturing Practices (GMP) and Quality System Regulation (QS) indicated by the FDA's notice.

The study proving the device meets its "acceptance criteria" in this context is the substantive comparison to predicate devices and established standards, not a clinical study yielding performance metrics against a ground truth as would be done for an AI/ML device.

Summary

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SEP 2 2 1998

982553

Osteo Compression Hip Screw System - Expanded Indication

510(k) Premarket Notification

510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEO COMPRESSION HIP SCREW SYSTEM - EXPANDED INDICATION

Submission Information

Name and Address of the Sponsor of the 510(k) Submission:	Osteonics Corporation59 Route 17Allendale, NJ 07401-1677201-825-4900
Contact Person:	Marybeth NaughtonRegulatory Affairs Team Member
Date Summary Prepared:	July 17, 1998

Device Identification

Proprietary Name:	Osteo Compression Hip Screw System
Common Name:	Compression Hip Screw Plate and Screw
Classification Name and Reference:	Single/Multiple Component Metallic BoneFixation Appliances and Accessories21 CFR §888.3030

Predicate Device Identification

The expanded indication of the subject components of the Osteo Compression Hip Screw System, which is the subject of this premarket notification, are substantially equivalent to the indications of the components of the Synthes DHS® Dynamic Hip Screw System.

Device Description

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Intended Use

The Osteo Compression Hip Screw System is cleared for use via 510(k)s #K971654, #K971321 and #K920037 for the following indications: Intertrochanteric femoral fractures and intracapsular femoral neck fractures. The expanded indications for the Osteo Compression Hip Screw System include: extracapsular fractures of the proximal femur (basal neck fractures, trochanteric fractures, and subtrochanteric fractures).

Statement of Technological Comparison

The subject Osteo Compression Hip Screw System components are substantially equivalent in intended use to the predicate devices offered by Synthes in their DHS® Dynamic Hip Screw System.

(Divir ' Div ... . . . . 510(k) Number_

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Image /page/2/Picture/2 description: The image shows a logo for the Department of Health. The logo features a stylized human head in profile, with three wavy lines representing the hair and face. The words "DEPARTMENT OF HEALTH" are written vertically along the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 1998

Ms. Marybeth Naughton Regulatory Affairs Team Member Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re : K982553 Trade Name: Osteo Compression Hip Screw System Regulatory Class: II Product Code: HRS, HWC Dated: July 21, 1998 Received: July 22, 1998

Dear Ms. Naughton:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). F 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note:

this response to your premarket notification submission does ... not affect any obligation you might have under sections 531 - ----through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Marybeth Naughton

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address

"http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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510(k) Number (if Known): K971654, K971321, K920037

Device Name: Osteo Compression Hip Screw - Expanded Indication

Indications For Use:

Indications:

Cleared via 510(k)s #K971654, #K971321, #K920037

Intracapsular fractures of the femoral neck
♪ Intertrochanteric fractures

Expanded Indication (the subject of this premarket notification)

Extracapsular fractures of the proximal femur:
- ♪ basal neck fractures
- ♪ trochanteric fractures
- subtrochanteric fractures

(PLEASE DO NOT WRITE BFLOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(per 21 CFR 801.109(	X
OR
Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)

Division of General Restorative Devices

510(k) Number	K982553
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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.