SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES by SYNTHES (USA)

Synthes 2.7 mm Reconstruction Plates are used with 2.7 mm Syllules 2.7 min Reconbilable in lengths from 48 mm Cortex Serews: "The places oured with bending irons. The plates to 192 film and can be connects steel and are available as sterile.

AI/ML Overview

The provided text is a 510(k) summary for the Synthes 2.7 mm Reconstruction Plates, submitted in 1998. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a modern clinical trial would for AI/ML devices. Therefore, much of the requested information cannot be found in this type of regulatory submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria or report device performance in the manner of a clinical trial or a study assessing performance metrics for a medical device. The 510(k) process in 1998 for devices like bone plates relied heavily on demonstrating a high degree of similarity to already-marketed devices (predicate devices) concerning materials, design, and intended use. The "acceptance criteria" here implicitly refer to the FDA's regulatory requirements for a 510(k) submission, primarily demonstrating substantial equivalence.

Acceptance Criteria (Implied by 510(k))	Reported Device Performance (from summary)
Substantial Equivalence to Predicate Device (Synthes 2.7 mm Reconstruction Plates) regarding:	"Synthes 2.7 mm Reconstruction Plates are used with 2.7 mm Cortex Screws. The plates are available in lengths from 48 mm to 192 mm and can be contoured with bending irons. The plates are made of stainless steel and are available as sterile." (This describes the device's characteristics and its similarity to predicate devices).
- Intended Use	"Intended for distal humerus fractures." (Matches the general use of predicate bone fixation plates).
- Materials	"made of stainless steel" (Common material for bone plates, expected to be similar to predicate).
- Design/Technology	"used with 2.7 mm Cortex Screws" and "can be contoured with bending irons" (Standard design features for reconstruction plates, expected to be similar to predicate).
- Performance (e.g., mechanical testing, if included)	Not explicitly detailed in this summary. For metallic implants, mechanical testing (fatigue, bending strength) would typically be performed to ensure material and design integrity, and the results would be compared to predicate devices or established standards. However, specific results are not provided here.

Study Proving Device Meets Acceptance Criteria:

The "study" proving the device meets acceptance criteria in this context is the 510(k) submission itself, which argues for substantial equivalence. It is not a clinical study in the sense of comparing outcomes in patients, nor an AI performance study.

2. Sample Size Used for the Test Set and the Data Provenance

Not applicable. This is a submission for a medical device (bone plate), not a data-driven AI/ML device. There is no "test set" of data in the context of an AI algorithm.

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 AI algorithm being evaluated, and thus no "ground truth" establishment for a test set by experts in this context.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" or adjudication method for an AI algorithm.

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 bone plate and does not involve human readers interacting with AI.

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

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

Not applicable in the AI/ML sense. For medical devices like bone plates, "ground truth" would relate to accepted engineering standards for material properties, biomechanical performance, and surgical outcomes (from literature or predicate device history). The 510(k) relies on the established safety and effectiveness of the predicate device as fundamental "ground truth" against which the new device is compared.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, and thus there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for an AI/ML model, there's no ground truth to establish for it in this context.

Summary of what can be gleaned from a 1998 510(k) for a bone plate:

Acceptance Criteria: Implicitly, the device must be "substantially equivalent" to a legally marketed predicate device (Synthes 2.7 mm Reconstruction Plates) in terms of intended use, technological characteristics (materials, design), and principles of operation to ensure similar safety and effectiveness.
Study Proving Acceptance: The 510(k) submission itself serves as the "study." It would typically include:
- Comparison tables detailing similarities and differences between the new device and the predicate.
- Biocompatibility data (if materials are novel or not well-established).
- Mechanical testing results (e.g., fatigue, static strength) to demonstrate equivalent performance to the predicate or established standards, though specifics are not in this summary.
- Manufacturing process controls.
Key Missing Information (from the AI/ML context): All points related to data sets, expert review, AI performance metrics, and clinical outcomes specific to the new device are not typically found in this type of 510(k) summary from this era. The focus is on demonstrating equivalence, not necessarily on a de novo demonstration of safety and effectiveness through a dedicated clinical study for every new iteration.

Summary

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SYNTHES
MAR 18 1998

K974908

Attachment VI: Summary of Safety and Effectiveness Information [510(k) Summary]

Synthes (USA) SUBMITTER: 1690 Russell Road Paoli, PA 19301 (610) 647-9700

Contact: Kevin J. O'Connell

Plate, Fixation, Bone COMMON OR USUAL

21 CFR, Section: 888.3030 CLASSIFICATION CODE:

Synthes 2.7 mm Reconstruction Plates PREDICATE DEVICE:

DESCRIPTION:

NAME:

Intended for distal humerus fractures. INTENDED USE:

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle symbol with three curved lines representing the eagle's head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 8 1998

Mr. Kevin J. O'Connell Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301

K974908 Re: Synthes Sterile 2.7mm Reconstruction Plates Regulatory Class: II Product Code: ਮਝੜ Dated: December 30, 1997 Received: December 31, 1997

Dear Mr. O'Connell:

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. ਜੋ 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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Page 2 - Mr. Kevin J. O'Connell

This letter will allow you to beqin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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,

Kinnell J. Taylor

/ - 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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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A small registered trademark symbol is located to the upper right of the word.

SYNTHES (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301 Telephone 610-647-9700

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Page _________________________________________________________________________________________________________________________________________________________________________

K974908 510(k) Number (if known):

Synthes (USA) Sterile 2.7 mm Reconstruction Plates____________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for use:

The Synthes 2.7 mm Reconstruction Plates are intended for distal humerus fractures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Russell P. Ayon

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

Original Instruments and Implants of the Association for the Study of Internal Fixation-AO/ASIF

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.