The indications for use of the Osteo BOS" System bone plates and Kirschner wire, in keeping with those of other legally marketed bone plates and Kirschner wires, are as follows.

The indications for each of the Osteo BOS" System product line extension bone plates are:

. Internal fracture fixation of long and small bones.
The indications for the Kirschner wires with a trocar point are:
For use as guide wires in hip pinning procedures.
. For use in aligning and reducing long bone fractures.
For use in securing non-long bone fractures such as olecranon fractures, patella fractures, . tibial plateau fractures, small hand and foot bone fractures, humeral, and humeral, radial and ulnar fractures, etc.
. For use with cerclage wire/cable in treating greater trochanter fractures.

Device Description

The Osteo BOS" System product line extension components are used for fracture fixation on various small and long bones. All Osteo BOS" System product line extension components are manufactured from Titanium alloy and include the following:

Oblique T-Plate, ø4.0/03.5
One-Third Tubular Plate, 04.0/03.5
Kirschner wire with trocar point

AI/ML Overview

This document is a 510(k) Premarket Notification for the "Osteo BOS" System Product Line Extension," a set of bone plates and Kirschner wires used for fracture fixation. The submission aims to demonstrate substantial equivalence to predicate devices, primarily those offered by Synthes.

Based on the provided text, the following information can be extracted regarding acceptance criteria and the "study" that proves the device meets them:

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

The document does not outline specific, quantifiable acceptance criteria or report device performance in terms of metrics like accuracy, sensitivity, specificity, or precision. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The "performance" being assessed is primarily technological and intended use equivalence, rather than a clinical outcome or diagnostic accuracy.

Acceptance Criteria (Implied by Substantial Equivalence):

Acceptance Criteria (Implied)	Reported Device Performance
Design Equivalence: The device's design (e.g., shape, size, material) should be similar to legally marketed predicate devices.	The Osteo BOS™ System product line extension components are substantially equivalent in design to the predicate bone plates and Kirschner wires offered by Synthes. Specifically: - Plates: Both subject and predicate plates are for internal fracture fixation. - Kirschner wires: Both subject and predicate are for skeletal traction, guide wires, and fracture fixation.
Intended Use Equivalence: The device's intended use should be the same as legally marketed predicate devices.	The Osteo BOS™ System product line extension bone plates are intended for internal fracture fixation of various long and small bones. The Kirschner wires are intended for use in skeletal traction, as guide wires, and for fracture fixation. These indications are in keeping with those of other legally marketed bone plates and Kirschner wires (including the Synthes predicate).
Technological Characteristics Equivalence: The materials and fundamental technological principles should be similar to legally marketed predicate devices.	Plates: Subject plates are manufactured from Titanium alloy. Predicate plates are manufactured from CP Titanium. The document implies this is equivalent for the intended use. Kirschner wires: Both subject and predicate Kirschner wires are manufactured from Titanium alloy.

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

There is no mention of a "test set" or any experimental data being collected from patients or subjects. This is a premarket notification for a medical device that relies on demonstrating substantial equivalence to existing devices, not on proving clinical efficacy via a clinical trial with a test set. Therefore, there's no information on sample size or data provenance.

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. As no "test set" or clinical study was conducted, there were no experts establishing ground truth in that context. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices.

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

Not applicable. No "test set" or clinical study was conducted, so no adjudication method was used.

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 submission for bone plates and Kirschner wires, which are mechanical fixation devices, not an AI or diagnostic imaging device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

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

Not applicable. This is not an algorithm-based device.

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

The "ground truth" for this 510(k) submission is the established safety and efficacy of the predicate devices (Synthes bone plates and Kirschner wires) that are already legally marketed. The submission's goal is to show the new device is "substantially equivalent" to these known safe and effective products. There is no mention of pathology, outcomes data, or expert consensus relating to a new clinical study.

8. The sample size for the training set

Not applicable. This type of submission does not involve a "training set" in the context of an algorithm or machine learning.

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

Not applicable. No training set was used.

Summary

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Osteo BOS" System - Product Line Extension

510(k) Premarket Notification

ﺮﻡ ﺩ

510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEO BOS" SYSTEM PRODUCT LINE EXTENSION

DEC - 9 1997

Submission Information

Name and Address of the Sponsorof the 510(k) Submission:	Osteonics Corporation59 Route 17Allendale, NJ 07401-1677201-825-4900
Contact Person:	Kate SuttonRegulatory Affairs Specialist
Date Summary Prepared:	September 9, 1997
Device Identification
Proprietary Name:	Osteo BOS™ System Product Line Extension
Common Name:	Plating/Fixation System
Classification Name and Reference:	Plate, Fixation, Bone21 CFR §888.3030Smooth or Threaded Metallic BoneFixation Fasteners21 CFR §888.3040

Predicate Device Identification

The subject Osteo BOS" System product line extension components are substantially equivalent to similar bone plates and Kirschner wires offered by Synthes.

Device Description

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9 4

Oblique T-Plate, ø4.0/03.5
One-Third Tubular Plate, 04.0/03.5
Kirschner wire with trocar point

Intended Use

The Osteo BOS" System product line extension bone plates are intended for internal fracture fixation of various long and small bones. The Kirschner wires are intended for use in skeletal traction for alignment and reduction of long bone fractures, as guide wires in hip pinning, and as fracture fixation devices in certain other small bone fractures.

Statement of Technological Comparison

The subject Osteo BOS" System product line extension components are substantially equivalent in design and intended use to the predicate bone plates and Kirschner wires offered by Synthes. The subject plates are manufactured from Titanium alloy, and the predicate plates are manufactured from CP Titanium. Both subject and predicate Kirschner wires are manufactured from Titanium alloy.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is a stylized caduceus symbol, which is often associated with medicine and healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 1997

Ms. Kate Sutton Requlatory Affairs Specialist Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

K973438 Re : Osteo BOS System Product Line Extension Trade Name: Requlatory Class: II Product Codes: HRS and HTY Dated: September 9, 1997 September 10, 1997 Received:

Dear Ms. Sutton:

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, Druq, 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, 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 Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: 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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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 Other general premarket notification" (21 CFR 807.97). 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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510(k) Number (if known): K 9 - 3 8 8

Device Name: Osteo BOS" System Product Line Extension

Indications For Use:

The indications for use of the Osteo BOS" System bone plates and Kirschner wire, in keeping with those of other legally marketed bone plates and Kirschner wires, are as follows.

The indications for each of the Osteo BOS" System product line extension bone plates are:

. Internal fracture fixation of long and small bones.
The indications for the Kirschner wires with a trocar point are:
For use as guide wires in hip pinning procedures. �
. For use in aligning and reducing long bone fractures.
For use in securing non-long bone fractures such as olecranon fractures, patella fractures, . tibial plateau fractures, small hand and foot bone fractures, humeral, and humeral, radial and ulnar fractures, etc.
. For use with cerclage wire/cable in treating greater trochanter 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

. . .

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

pcate

(Division Sign-Off) (Division Sign-On)
Division of General Restorative Devices rg7348 510(k) Number _

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.