The Schuhli Implant System is intended for use with Synthes long bone and small bone plates and screws. The Schuhli Assembly locks the screw to the plate (independent of bone contact) and has the potential to decrease the possibility of the screw loosening and backing out of the bone. The devices are designed for, but are not limited to, use in osteoporotic bone for unicortical (of the far cortex) or bicortical fixation in cases of trauma, tumor, or infection, and as fixed angle devices (where the angle between two supporting members is fixed).

Synthes Schuhli Implant System is intended for use with Synthes long home and small bone plates and screws, to lock the screw to the plate in order to prevent the screw from loosening and backing out of the bone. Specifically, they are used in osteuporulic bonc for unicortical (of the near cortex) or bicortical fixation in cases of trauma, tumor, or infection, and as fixed angle devices (where the angle between two supporting members is lixed).

Device Description

The Schuhli Implant System consists of a nut, a washer, and a temporary holding screw. The nut fits into the underside of the plate and has spikes which secure the nut to bone. The temporary holding screw is used to hold the Schuhli to the plate (before the screws are placed) while the surgeon obtains the correct placement of the plate. The washer fits into the plate's screw hole, accepting the head of a screw. The Schuhli Implant System is available in two sizes (4.5 mm and 3.5 mm); each size is available in either titanium or stainless steel, and is used with either titanium or stainless steel compression plates and screws, respectively. Synthes Schuhli Implant System will be provided to the user sterile. Gamma radiation will be used to sterilize the device.

AI/ML Overview

The provided text is a 510(k) summary for the Synthes (USA) Schuhli Implant System, which describes a medical device intended to lock screws to bone plates. It details the device's intended use, classification, and substantial equivalence to existing devices based on mechanical test results. However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found for AI/ML-based medical devices.

Instead, the document focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device through mechanical testing, which is a common pathway for traditional medical devices. The questions posed in the prompt (e.g., sample sizes for test and training sets, ground truth establishment, MRMC studies, expert qualifications) are typically relevant for the validation of AI/ML-driven diagnostics or decision support systems.

Therefore, I cannot extract the requested information from this document. The document primarily describes a mechanical implant's regulatory submission, not the performance evaluation of a device using AI/ML.

Here's a breakdown of why I can't answer your questions based on the provided text:

No Acceptance Criteria/Performance Data: The document states, "Based on mechanical test results, the Schuhli Implant System is substantially equivalent to Synthes Dynamic Compression Plates and screws." It doesn't provide specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or detailed performance metrics against those criteria.
No "Study" in the AI/ML Sense: The "study" mentioned is "mechanical test results" for demonstrating substantial equivalence, not a clinical or AI performance study with test sets, ground truth, or human readers.
No AI/ML Component: The device described (a nut, washer, and temporary holding screw) is a purely mechanical implant. There is no indication of any AI or machine learning component that would require the validation methods outlined in your questions.
No Data Provenance, Experts, Adjudication, etc.: Because there's no AI/ML component or a performance study of that nature, there's no mention of sample sizes for test/training sets, data provenance, expert panels, ground truth methods, or MRMC studies.

Summary

{0}------------------------------------------------

APR 27 1998

Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '980944'. The numbers are written in a simple, slightly irregular style, with varying stroke thicknesses.

ss Information [510(k) Summary Summary of Safety and

SPONSOR NAME AND ADDRESS 1.

Synthes (USA) P.O. Box 1766 1690 Russell Road Paoli, PA 19301 TEL: (610) 647-9700

Contact Person: Angela Silvestri, Regulatory Affairs Manager

DEVICE NAME 2.

Synthes (USA) Schuhli Implant System

3. CLASSIFICATION

Synthes Schuhli Implant System has been classified as Class II devices, under 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories.

INTENDED USE 4.

WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

DEVICE DESCRIPTION ડ.

SUBSTANTIAL EQUIVALENCE 6.

Based on mechanical test results, the Schuhli Implant System is substantially equivalent to Synthes Dynamic Compression Plates and screws.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines representing its body and wings. 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

APR 27 1998

Ms. Angela J. Silvestri ·Manager, Requlatory Affairs Synthes® 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301

K980944 Re : Schuhli Implant System Trade Name: Requlatory Class: II Product Code: HTN Dated: March 10, 1998 Received: March 12, 1998

Dear Ms. Silvestri: ·

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 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 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. 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.

{2}------------------------------------------------

Page 2 - Ms. Angela J. Silvestri

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,

G. Colin M. Witton, Ph.D., M.D.

Celi M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Page __ 1 ____________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Synthes (USA) Schuhli Implant System Device Name. _________________________________________________________________________________________________________________________________________________________________

Indications for use:

. .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Prescription Use(Per 21 CFR 801.109)	X	OR	Over-The-Counter Use
------------------------------------------	---	----	----------------------

Schuhli Implant System Modifications 5110(k) Synthes (USA)

ﺎ ﻳﺒﻠﻎ

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.