The Osteo BOS" System in Stainless Steel components are used for fracture fixation of long and small bones. All Osteo BOS" System components are manufactured from ASTM F-138-92 Stainless Steel and include the following:

Plate Wide (06.5mm/04.5mm)
Plate - Narrow (06.5mm/04.5mm)
Plate Wide (04.0mm/03.5mm)
One-Third Tubular Plate (e4.0mm/03.5mm)
Plate (@2.7mm)

AI/ML Overview

This document describes a 510(k) Premarket Notification for the Osteo BOS™ System in Stainless Steel, a bone plating system. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically seen for performance evaluation studies of medical devices generating quantitative performance metrics (e.g., diagnostic devices).

Instead, this submission is focused on demonstrating substantial equivalence to a predicate device, which is a different type of regulatory pathway. Substantial equivalence is established by comparing the subject device's technological characteristics and intended use to a legally marketed predicate device. The "proof" is the argument and documentation that the new device is as safe and effective as the predicate.

Here's a breakdown of why many of your requested points cannot be directly answered from the provided text, and what information is available:

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

Not applicable in the provided context for performance metrics. This document is a 510(k) summary, which for this type of device (bone plate), focuses on showing it's "substantially equivalent" to an existing device rather than presenting acceptance criteria for a performance study (like sensitivity/specificity for a diagnostic tool). The "performance" in this context refers to its ability to perform the intended function as a bone fixation device, which is inferred by its similarity to the predicate device and manufacturing materials.

Instead, the "acceptance criteria" here is the FDA's determination of substantial equivalence. The "reported device performance" is implicitly understood to be equivalent to the predicate device.

Acceptance Criteria (for 510(k) pathway)	Reported Device Performance (as demonstrated for 510(k))
Substantial Equivalence to Predicate Device (Synthes bone plates) in terms of:
- Intended Use	- Intended Use: Fracture fixation of long and small bones. (Matches predicate)
- Technological Characteristics	- Material: ASTM F-138-92 Stainless Steel. (Matches predicate type)
	- Design: Various plate sizes/types (Wide, Narrow, One-Third Tubular, etc.). (Comparable to predicate)
- Performance (Safety and Effectiveness)	- Implied safety and effectiveness are equivalent due to similar materials, design, and intended use as the predicate device. No new safety/effectiveness concerns raised.

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

Not applicable. This submission does not describe a clinical performance study with a "test set" of patients or data samples. The "testing" discussed is primarily related to material composition and design comparison against a predicate, not clinical outcomes in a sample population.

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

Not applicable. There is no "ground truth" derived from expert review for a test set in this 510(k) submission. The "ground truth" for regulatory assessment is the established performance and safety of the predicate device.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication is described.

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 passive, implantable bone plate, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant here.

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

Not applicable. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" in the context of this 510(k) is the established safety and effectiveness profile of the legally marketed predicate device (Synthes bone plates). The Osteo BOS™ System in Stainless Steel demonstrates substantial equivalence to this predicate.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI-driven device.

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

Not applicable. As above, no training set or its associated ground truth establishment method is relevant here.

Summary of the Study/Evidence Provided in the Document:

The "study" in this context is a comparison to a predicate device to demonstrate substantial equivalence, required for a 510(k) premarket notification.

Device Name: Osteo BOS™ System in Stainless Steel
Predicate Device: Similar bone plates offered by Synthes.
Basis for Equivalence:
- Intended Use: Both the subject device and the predicate are intended for "fracture fixation of long and small bones."
- Technological Characteristics: Both are manufactured from stainless steel (Osteo BOS™ uses ASTM F-138-92 Stainless Steel). They both comprise various plate designs (wide, narrow, one-third tubular, etc.).
Conclusion: The FDA reviewed the 510(k) submission and determined the device is substantially equivalent to devices marketed prior to May 28, 1976, and therefore may be marketed. This decision essentially "proves" that the device meets the regulatory acceptance criteria for substantial equivalence.

This type of regulatory submission relies on comparison to existing, proven technologies rather than generating new clinical performance data for every single new iteration of a well-understood device type.

Summary

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USTEDNICS-REG AFFAIRS SEP-19-1997 09:55 FRONI

516

SEP 25 1997 K973204

y
oods Revision

Osteo BOS" System in Stainless Steel

510(k) Premarket Notification

510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEO BOS" SYSTEM IN STAINLESS STEEL

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 19, 1997
Device Identification
Proprietary Name:	Osteo BOS ™ System in Stainless Steel
Common Name:	Stainless Steel Plating System
Classification Name and Reference:	Plate, Fixation, Bone21 CFR §888.3030

Predicate Device Identification

The subject Osteo BOS® System in Stainless Steel components are substantially equivalent to similar bone plates offered by Synthes.

Device Description

Plate Wide (06.5mm/04.5mm) �
� Plate - Narrow (06.5mm/04.5mm)
Plate Wide (04.0mm/03.5mm) .
One-Third Tubular Plate (e4.0mm/03.5mm) �
Plate (@2.7mm) �

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Osten BQS " System in Stainless Steel

510(k) Premarket Notification

Intended Use

The Osteo BOS" System in Stainless Steel components are intended for fracture fixation of long and small bones.

Statement of Technological Comparison

The subject Osteo BOS" System in Stainless Steel components are substantially equivalent in design and intended use to the predicate bone plates offered by Synthes. Both the subject and predicate plates are manufactured from stainless steel.

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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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

SEP 2 5 1997

Re: K973204 Osteo BOSTM System in Stainless Steel Regulatory Class: II Product Code: HRS Dated: August 25, 1997 Received: August 26, 1997

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, Drug, and Cosmetic Act (Act). 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 Regulations, Title 21, Parts 800 to 895. ਸੇ 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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. Kate Sutton

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,

Colia M. Witton, Ph. D.

a 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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Page 1 of 1

510(k) Number (if known):	K973204
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Device Name: Osteo BOS" System in Stainless Steel

Indications For Use:

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

The Osteo BOS" System in Stainless Steel components are intended for long and small bone ● fracture fixation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	restorative Devices K973204

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

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.