The Osteo Compression Condyle Screw System is a femoral fracture fixation system, comprised of compression condyle plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo cancellous and cortical bone screws (#K913269) 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.

Indications Cleared via 510(k) #K971321 and 510(k) #K920037:

Intercondylar fractures .
Supracondylar fractures .
. Unicondylar fractures

Expanded Indications (the subject of this premarket notification):
Fractures of the proximal femur:

Transverse subtrochanteric fractures .
. Short oblique subtrochanteric fractures
. Long oblique subtrochanteric fractures

The Osteo Compression Condyle Screw System is used in the proximal femur in situations which require a more proximal placement of the lag screw in the femoral head, which the 95 degree plate angle accommodates. This allows for the placement of one or more bone screws in the proximal fragment which is intended to result in greater stability in the proximal femur, transmission of load across the fracture site and control of the rotation of the fracture fragment

Device Description

The Osteo Compression Condyle Screw System is a distal and proximal femoral fracture fixation system, comprised of compression condyle plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo cancellous and 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 #K920037 and remain unchanged from these previous submissions.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Summary for the "Osteo Compression Condyle Screw System - Expanded Indications." This document details the submission of a medical device seeking clearance from the FDA, specifically for expanded indications of use for an existing device.

The fundamental aspect of a 510(k) submission, particularly for devices seeking clearance based on substantial equivalence to predicate devices, is to demonstrate that the new or modified device is as safe and effective as a legally marketed device (the predicate). This demonstration often relies on comparing design, materials, technological characteristics, and intended use, and not typically on extensive clinical trials demonstrating new performance metrics against specific acceptance criteria like those found in studies for novel technologies or drugs.

Therefore, for this specific submission, the traditional "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the sense of a numerical performance metric (e.g., accuracy, sensitivity, specificity) derived from a clinical study with a test set, ground truth established by experts, etc., are not applicable or present in the provided document.

Here's why and what information is available:

Type of Device: The "Osteo Compression Condyle Screw System" is a bone fixation appliance used in orthopedic surgery to fix fractures. These are mechanical devices.
Regulatory Pathway: This is a 510(k) submission for expanded indications. This pathway emphasizes substantial equivalence, not de novo clinical effectiveness.
Focus of the Document: The document focuses on demonstrating that the expanded indications for the device (fractures of the proximal femur) are substantially equivalent to the predicate device (Synthes® Dynamic Condylar Screw System). The previously cleared indications (distal femur fractures) were already deemed substantially equivalent in prior 510(k)s (K971321 and K920037).

What the document does provide in lieu of "acceptance criteria" and performance studies:

The "acceptance criteria" for this type of submission are implicitly related to demonstrating substantial equivalence to the predicate device. This means showing that:

Intended Use is the Same or Similar: The device is intended for similar types of femoral fractures.
Technological Characteristics are the Same or Similar: The design and materials are the same or similar.
Performance is the Same or Similar: While not explicitly detailed with quantitative metrics in this summary, the assumption is that the mechanical performance (stability, fixation strength) for the expanded indications is comparable to existing devices through design comparison.

Based on the provided text, I cannot complete the requested table or sections because the information typically associated with establishing acceptance criteria and performance against a test set (as would be done for AI/diagnostic devices) is not relevant to this 510(k) submission for a mechanical bone fixation device.

Here is a breakdown of why each requested point cannot be answered from the provided text:

A table of acceptance criteria and the reported device performance: Not applicable. The "acceptance criteria" for this submission are a successful demonstration of substantial equivalence to a predicate device, as determined by the FDA. There are no reported numerical performance metrics like sensitivity or accuracy.
Sample size used for the test set and the data provenance: Not applicable. No test set or clinical study demonstrating performance metrics for a test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth established by experts for performance evaluation is described.
Adjudication method 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 a mechanical device, not an AI or diagnostic device that involves human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of available information relevant to the submission's approval:

Predicate Device: Synthes® Dynamic Condylar Screw System
Basis for Substantial Equivalence: Design and materials are substantially equivalent, and the expanded indications regarding proximal femoral fractures are comparable to the intended use of the predicate.
Result: The FDA determined the device to be substantially equivalent for the expanded indications, allowing it to be marketed.

In conclusion, this document describes a 510(k) clearance for a mechanical medical device based on substantial equivalence, not a performance study against specific acceptance criteria for a diagnostic or AI-driven device.

Summary

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

Submission Information

Name and Address of the Sponsor of the 510(k) Submission:	Osteonics Corporation
	59 Route 17
	Allendale, NJ 07401-1677
	201-825-4900
Contact Person:	Marybeth Naughton
	Regulatory Affairs Team Member
Date Summary Prepared:	October 6, 1998
Device Identification
Proprietary Name:	Osteo Compression Condyle Screw System
Common Name:	Compression Condyle Plate and Screw
Classification Name and Reference:	Single/Multiple Component Metallic BoneFixation Appliances and Accessories21 CFR §888.3030

Predicate Device Identification

The Osteo Compression Condyle Screw System has previously been determined substantially equivalent via 510(kOs #K971321 and #K920037. The expanded indications are substantially equivalent to those of the Synthes® Dynamic Condylar Screw System.

Device Description

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Intended Use

....

The Osteo Compression Condyle Screw System is indicated for the following fractures of the distal femur: Intercondylar fractures, Supracondylar fractures, and Unicondylar fractures and for the following fractures of the proximal femur: Transverse subtrochanteric fractures, and long and short subtrochanteric fractures.

Statement of Technological Comparison

The subject Osteo Compression Condyle Screw System components (compression condyle plates and lag screws) have been previously determined substantially equivalent in design and materials, and are substantially equivalent with regard to intended use to the predicate devices offered by Synthes in their Dynamic Condylar Screw System.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble a ribbon or banner. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 1998 DEC

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

K983508 Re: Osteo Compression Condyle Screw System - Expanded Indications Regulatory Class: II Product Code: HWC Dated: November 11, 1998 Received: November 12, 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 Regulations, 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 requlations.

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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 (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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K983508

510(k) Number (if known): K#K920037, #K971321-

Device Name: Osteo Compression Condyle Screw System - Expanded Indications

Indications for Use:

Indications

Cleared via 510(k) #K971321 and 510(k) #K920037

Intercondylar fractures .
Supracondylar fractures .
. Unicondylar fractures

Expanded Indications (the subject of this premarket notification)

Fractures of the proximal femur:

Transverse subtrochanteric fractures .
. Short oblique subtrochanteric fractures
. Long oblique subtrochanteric fractures

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

OR Over-The-Counter Use (Optional Format 1-2-96)

scosella

(Division Sign-Off
Division of General Restorative Devdass K983508
510(k) Number.

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.