The SCARF Thread-Head Screw is a threaded bone fixation screw that is 3.0mm in diameter and 10 to 34mm in length (in 2mm increments). It is made of titanium alloy and is cannulated with a threaded head.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called the SCARF Thread-Head Screw. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and device performance.

Therefore, the document does not contain the information requested regarding:

Acceptance criteria and reported device performance
Sample sizes for test sets or training sets
Data provenance
Number of experts or their qualifications
Adjudication method
Multi-reader multi-case (MRMC) comparative effectiveness study
Standalone algorithm performance
Type of ground truth used or how it was established

The document primarily focuses on:

Device Description: A threaded bone fixation screw, 3.0mm in diameter, 10-34mm in length, made of titanium alloy, cannulated with a threaded head.
Intended Use/Indications: Fixation of fractures, fusion of a joint, or bone reconstruction of the mid-foot, metatarsals, and phalanges of the foot. (Note: The "Indications for Use" enclosure on Page 3 lists "phalanges, metacarpals and carpals of the hand," which appears to be a discrepancy or an initial proposed indication that was then changed or clarified in the main document. For this response, I'll use the main document's stated indications).
Predicate Devices: Landos SCARF Thread-Head Screw, Zimmer Herbert-Whipple Bone Screw, and Osteomed M3 Screw.
Regulatory Classification: Class II, product code 87HWC.
Substantial Equivalence Determination: The FDA determined the device is substantially equivalent to predicate devices.

Summary of what can be extracted from the document:

The provided text describes a 510(k) submission for a medical device (SCARF Thread-Head Screw). In a 510(k) pathway, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to conduct studies that prove specific performance metrics against pre-defined acceptance criteria as would be typical for a novel high-risk device or an AI/software as a medical device (SaMD) study.

Therefore, the document does not contain a table of acceptance criteria and reported device performance because the submission method relies on demonstrating equivalence to existing devices rather than meeting new, explicit performance thresholds based on a study of the device itself.

The document does not contain the following requested information:

A table of acceptance criteria and the reported device performance: Not relevant for a 510(k) submission focused on substantial equivalence to predicate devices, where performance is implicitly similar to predicates.
Sample sized used for the test set and the data provenance: No test sets or associated data are described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth for a test set is described.
Adjudication method for the test set: Not applicable.
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, as this is a physical implant device, not an AI or software device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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K971070

SUMMARY OF SAFETY AND EFFECTIVENESS

JUL - 9 1997

MANUFACTURER IDENTIFICATION:	Medinov-AMP27 à 31 rue Lucien Langenieux42335 Roanne FRANCE
ESTABLISHMENT REGISTRATIONNUMBER (Manufacturer):	9681744
SPONSOR IDENTIFICATION:	Cheryl HastingsDePuy, Inc.P.O. Box 988700 Orthopaedic DriveWarsaw, IN 46580
ESTABLISHMENT REGISTRATIONNUMBER (Sponsor):	1818910
PROPRIETARY NAME:	SCARF Thread-Head Screw
PRODUCT CLASSIFICATION CODE:	87HWC
PROPOSED REGULATORY CLASS:	Class II

DESCRIPTION:

INDICATIONS AND INTENDED USE:

This screw is to be implanted for the fixation of fractures, fusion of a joint of bone reconstruction of the mid-foot, metatarsals and phalanges of the foot.

PREDICATE DEVICES:

The predicate devices for this screw are the Landos SCARF Thread-Head Screw, the Zimmer Herbert-Whipple Bone Screw and the Osteomed M3 Screw.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a person with outstretched arms, composed of three curved lines.

Food and Drug Administrațion 9200 Corporate Boulevard Rockville MD 20850

Ms. Cheryl Hastings DePuy, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

JUL - 9 1997

Re : K971070 SCARF Thread-Head™ Screw Requlatory Class: II Product Code: HWC Dated: May 30, 1997 Received: June 2, 1997
Dear Ms. Hastings:

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 The general controls provisions of the Act include Act. 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. 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 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

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Paqe 2 - Cheryl Hastings

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. 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Cella 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		eol	1
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510(k) Number (if known): K971070

Thread-Head Screw Device Name: ____________________

Indications for Use:

Fixation of fracture, fusion of a joint or bone reconstruction (osteotomy) of the phalanges, metacarpals and carpals of the hand.

CONFIOENTIAL

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off)
	Division of General Restorative Devices
510(k) Number	K971070

Prescription Use (Per 21 CFR 801.109)	X
---------------------------------------	---

Over-the-Counter Use
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(Optional Format 1-2-96)

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.