The Osteo Anatomical Bone Plates are used for fracture fixation on various long bones. All Osteo Anatomical Bone Plates are manufactured from stainless steel and include the following: Form Plates, Humeral Plates, Plates for Multi-Condylar Fragments ACP, Plates for Distal Femur ACP, Trochanter Hip Plates ACP, Narrow and Wide Elongation Plates.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Osteo Anatomical Bone Plates." However, this submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria, human reader studies, or training set information.

Therefore, most of the requested information cannot be extracted from this document, as it is generally not part of a 510(k) submission for this type of device (bone plates). 510(k) submissions for mechanical devices like bone plates typically rely on mechanical testing, material characterization, and comparison to predicate devices, rather than clinical performance studies with acceptance criteria as one might see for AI/ML-driven diagnostic devices.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Cannot be provided. The document does not specify performance acceptance criteria in terms of clinical outcomes or metrics like sensitivity/specificity. It focuses on substantial equivalence in design and materials.

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

Cannot be provided. This type of information is not relevant to a 510(k) submission for bone plates, which typically involves mechanical testing and material characterization, not patient data sets.

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)

Cannot be provided. "Ground truth" in the context of expert review is not applicable to this device submission.

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

Cannot be provided. Not applicable.

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

Cannot be provided. This is not an AI/ML device, so MRMC studies are not relevant.

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

Cannot be provided. This is not an AI/ML device.

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

Cannot be provided. "Ground truth" in this context is not applicable. For bone plates, performance is typically assessed through mechanical testing against standards and comparison to predicate devices.

8. The sample size for the training set

Cannot be provided. Not applicable.

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

Cannot be provided. Not applicable.

Summary based on the provided document:

The Osteo Anatomical Bone Plates submission (K972196) is a 510(k) Premarket Notification based on substantial equivalence to predicate devices. The "study" proving the device meets criteria is primarily a comparison to legally marketed predicate devices (Waldemar Link GmbH & Co. and Synthes).

Acceptance Criteria (Implied by Substantial Equivalence): The implicit acceptance criterion for a 510(k) is that the device is substantially equivalent in terms of intended use, design, material, and performance (e.g., mechanical properties) to a legally marketed predicate device, and that it does not raise new questions of safety and effectiveness.
Reported Device Performance: The document states that the Osteo Anatomical Bone Plates are substantially equivalent in design and intended use to the predicate bone plates offered by Waldemar Link GmbH & Co., Synthes, and Osteo AG. All subject and predicate plates are manufactured from stainless steel, and they are intended for internal fracture fixation of various long bones. While specific mechanical performance data is not included in this summary, it would have been part of the full 510(k) submission to support the claim of substantial equivalence.

In essence, this document is a regulatory filing for a conventional medical device, not a performance study for an AI/ML-driven diagnostic device, thus many of the questions are not applicable.

Summary

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K972196

Osteo Anatomical Bone Plates

510(k) Premarket Notification | of 2

510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEO ANATOMICAL BONE PLATES

AUG 25 1997

Submission Information

Name and Address of the Sponsor of the 510(k) Submission:	Osteonics Corporation59 Route 17Allendale, NJ 07401-1677201-825-4900
Contact Person:	Kate SuttonRegulatory Affairs Specialist
Date Summary Prepared:	June 6, 1997

Device Identification

Proprietary Name:	Osteo Anatomical Bone Plates
Common Name:	Bone Plates
Classification Name and Reference:	Plate, Fixation, Bone21 CFR §888.3030

Predicate Device Identification

The subject Osteo Anatomical Bone Plates are substantially equivalent to similar bone plates offered by Waldemar Link GmbH & Co. and Synthes.

Device Description

The Osteo Anatomical Bone Plates are used for fracture fixation on various long bones. All Osteo Anatomical Bone Plates are manufactured from stainless steel and include the following:

Form Plates
Humeral Plates ●
Plates for Multi-Condylar Fragments ACP
Plates for Distal Femur ACP ●
Trochanter Hip Plates ACP
Narrow and Wide Elongation Plates ●

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Intended Use

The plates that comprise the Osteo Anatomical Bone Plates are intended for the following uses:

Internal fracture fixation of various long bones. .

Statement of Technological Comparison

The subject Osteo Anatomical Bone Plates are substantially equivalent in design and intended use to the predicate bone plates offered by Waldemar Link GmbH & Co., Synthes, and Osteo AG. All subject and predicate plates are manufactured from stainless steel.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three human profiles forming its body. The profiles are stacked on top of each other, creating a sense of unity and collaboration. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

AUG 25 1997

K972196 Re: Osteo Anatomical Bone Plates Requlatory Class: II Product Code: HRS Dated: June 6, 1997 Received: June 10, 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 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 Regulations, Title 21, Parts 800 to 895. ਸ 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. 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 requlation (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.

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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510(k) Number (if known): K972196

Device Name: Osteo Anatomical Bone Plates

Indications For Use:

The indications for the use of these bone plates, in keeping with those of other legally marketed bone plates, are as follows.

The Osteo Anatomical Bone Plates are intended for internal fracture fixation of various long . bones.

(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) -

Acotes

Divisi Sign-Off) Division of General Restorative Devices Kg 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.