The Osteo BOS" System components are used for internal fracture fixation of long and small bones. All Osteo BOS" System components are manufactured from Titanium alloy and include the following:

Plate - Wide (06.5mm/04.5mm)
Plate Narrow (06.5mm/04.5mm) .
. T-Plate (06.5mm/04.5mm)
T-Buttress Plate (06.5mm/04.5mm) .
L-Plate (Ø6.5mm/Ø4.5mm) .
Plate Wide (@4.0mm/03.5mm)
Plate Narrow (e4.0mm/03.5mm) & Osteo Plate (04.0mm/03.5mm)
Small T-Plate (04.0mm/03.5mm) ◆
Plate (@2.7mm)
Cortex Screw (02.7mm) .
. Cortex Screw (03.5mm)
t Cortex Screw (03.5mm with shaft)
Cortex Screw (04.5mm) .
Cortex Screw (04.5mm with shaft) .
Nut for @4.5mm cortex screw .
Ø8mm Washer for Ø4.0mm cancellous screws & . @3.5mm cortex screws
06.5mm Washer for 02.7mm cortex screws
Cancellous Screw (ø4.0mm) ↓
Cancellous Screw ($4.0mm with short thread) .
Cancellous Screw (06.5mm) ♥
Cancellous Screw (06.5mm, thread lengths 16mm & 32mm) .
013.0mm Washer for cancellous screws 26.5mm & . cortex screws 04.5mm

AI/ML Overview

This document describes the Osteo BOS™ System, a bone plate and screw system for fracture fixation. However, the provided text is a 510(k) premarket notification summary and an FDA clearance letter from 1997. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data with detailed acceptance criteria and performance metrics typically found in more recent device submissions or clinical trial reports for AI/software as a medical device (SaMD).

Therefore, the information requested about acceptance criteria, detailed study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is largely not present in the provided text. The document primarily confirms the device's substantial equivalence in design and intended use to existing bone plates and screws.

Here's an analysis based on the available information:

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

No explicit acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) are reported in this 510(k) submission summary. The demonstration of "substantial equivalence" is the primary acceptance criterion for a 510(k). Performance is implied to be equivalent to the predicate device.

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device	Confirmed by FDA letter, based on design, materials (Titanium alloy vs. CP Titanium for predicate), and intended use.

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

Not applicable. This 510(k) summary does not describe a test set or clinical study involving patient data with sample sizes. Substantial equivalence was primarily based on comparing the design, materials, and intended use to a predicate device.

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. No ground truth establishment by experts is described for this type of device submission.

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

Not applicable. No test set or human interpretation 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. The Osteo BOS™ System is a physical medical device (bone plates and screws), not an AI/software device. Therefore, no MRMC study or AI assistance evaluation was conducted.

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

Not applicable. This is not an algorithm or software device.

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

Not applicable. Ground truth, in the context of device performance, as typically understood for diagnostic or AI devices, is not a concept applied in this 510(k) submission for mechanical equivalence. The "ground truth" for demonstrating substantial equivalence for a bone plate system would be its material properties, mechanical testing (which is not detailed here but would have been part of the full submission), and clinical history of similar predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; hence, no training set is relevant.

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

Not applicable. No training set is relevant.

Summary

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Osteo BQ5" System ____________________________________________________________________________________________________________________________________________________________

K972323

510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS SEP 1 0 1997 OSTEO BOS* SYSTEM

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 3, 1997
Device Identification
Proprietary Name:	Osteo BOS™ System
Common Name:	The Titanium Plating System
Classification Name and Reference:	Plate, Fixation, Bone21 CFR §888.3030Smooth Or Threaded Metallic Bone Fixation Fastener21 CFR §888.3040

Predicate Device Identification

The subject Osteo BOS" System components are substantially equivalent to similar bone plates and bone screws offered by Synthes.

Device Description

The Osteo BOS" System components are used for internal fracture fixation of long and small bones. All Osteo BOS" System components are manufactured from Titanium alloy and include the following:

� Plate - Wide (06.5mm/04.5mm)
Plate Narrow (06.5mm/04.5mm) .
. T-Plate (06.5mm/04.5mm)
T-Buttress Plate (06.5mm/04.5mm) .

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L-Plate (Ø6.5mm/Ø4.5mm) .
Plate Wide (@4.0mm/03.5mm) �
Plate Narrow (e4.0mm/03.5mm) & Osteo Plate (04.0mm/03.5mm) �
Small T-Plate (04.0mm/03.5mm) ◆
Plate (@2.7mm) �
Cortex Screw (02.7mm) .
. Cortex Screw (03.5mm)
t Cortex Screw (03.5mm with shaft)
Cortex Screw (04.5mm) .
Cortex Screw (04.5mm with shaft) .
Nut for @4.5mm cortex screw .
Ø8mm Washer for Ø4.0mm cancellous screws & . @3.5mm cortex screws
06.5mm Washer for 02.7mm cortex screws �
Cancellous Screw (ø4.0mm) ↓
Cancellous Screw ($4.0mm with short thread) .
Cancellous Screw (06.5mm) ♥
Cancellous Screw (06.5mm, thread lengths 16mm & 32mm) .
013.0mm Washer for cancellous screws 26.5mm & . cortex screws 04.5mm

Intended Use

The Osteo BOS" System components are intended for long and small bone fracture fixation.

Statement of Technological Comparison

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

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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 consists of a stylized depiction of an eagle or bird-like figure with three distinct head profiles, suggesting a sense of community or collaboration. The bird is positioned within a circular frame, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 1997

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

Re: K972323 Osteo BOS™ System Regulatory Class: II Product Codes: HWC and HRS Dated: June 19, 1997 Received: June 20, 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. Note that labeling or otherwise promoting a device for pedicular screw fixation/attachment would cause the device to be adulterated under 501(f)(1) of the Act. This device, if intended for use in pedicular screw fixation/attachment, would be found not substantially equivalent and would be a class III device under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:

The package insert must prominently state that the device 1. is intended for the specific use(s) described in the enclosure only; and

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Page 2 - Ms. Kate Sutton

You may not label or in any way promote this device for 2. pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. If this device is a screw with outer diameters of 3 mm - 10 mm and overall lengths of 10 mm - 75 mm inclusively, the package insert must include the following statement, This device is not approved for screw "WARNING: attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine." Any pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conduct of the investigation.
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 In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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

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Page 3 - Ms. Kate Sutton

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,

S. Colum M. Witten, Ph.D., M.D.

a M. Witten, Ph.D., M.D. Celi 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): K972323

Device Name: Osteo BOS" System

Indications For Use:

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

The Osteo BOS™ System 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)

(Division Sig. Off)
Division
510(k) Number	K972323

Prescription Use_X

Over-The-Counter Use

(Per 21 CFR 801.109)

(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.