The SPIN® SNAP-OFF Screw is intended to be implanted for fixation of bone fractures or for bone reconstructions. The SPIN® SNAP-OFF Screw is indicated for fixing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only. Examples include: -Weil osteotomy - Unicortical small bone fixation. The SPIN® SNAP-OFF SCREW® is indicated for fixing the elective osteotomies in the metatarsal and phalanges of the foot only. Examples include: Weil osteotomy Lesser metatarsal osteotomies

Device Description

The SPIN® SNAP-OFF Screw is a self drilling and self tapping snap-off screw. One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, its head is blocked and the breaking torque is enough important to cause dissociation between the screw and the snap-off. It comes in lengths from 11 to 14 mm.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called the "SPIN® SNAP-OFF SCREW®". It describes the device, its intended use, and a comparison to predicate devices, along with some information about a summary study. However, the document does not contain detailed information about acceptance criteria, comprehensive device performance data, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or how ground truth was established, as typically required for AI/ML device descriptions.

The study described is a basic assessment of the screw's physical properties against a standard, not a clinical performance study using patient data. Therefore, many of the requested points cannot be answered from the provided text.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance (Summary of Studies)
Resistance to torsion "in compliance with the selected standard" (French Standard NF-F 90414)	Rupture torque of the SPIN® SNAP-OFF SCREW was found to have a resistance to torsion in compliance with the French Standard NF-F 90414.

Note: This is an engineering/mechanical acceptance criterion for the device's physical properties, not a clinical performance metric and corresponding acceptance criteria as would be expected for an AI/ML device.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The document only mentions "Rupture torque of the. SPIN® SNAP-OFF SCREW was compared with requirement of the French Standard NF-F 90414". It doesn't detail how many screws were tested.
Data Provenance: Not applicable in the context of patient data. The study relates to the physical characteristics of the screw itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This was a mechanical test against a standard, not a clinical evaluation requiring expert ground truth on patient data.

4. Adjudication method for the test set:

Not applicable. No adjudication process for clinical ground truth 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:

No. This is a medical device, not an AI/ML imaging or diagnostic product. No MRMC study or AI assistance is mentioned.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

For the "Summary of Studies": The "ground truth" was the French Standard NF-F 90414 for resistance to torsion. This is a regulatory/engineering standard, not clinical ground truth like pathology or outcomes data.

8. The sample size for the training set:

Not applicable. This is a physical medical device. The concept of a "training set" for an algorithm does not apply.

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

Not applicable.

In summary: The provided document is a 510(k) submission for a bone fixation screw, focusing on its substantial equivalence to predicate devices and adherence to an engineering standard. It does not provide the type of performance and study details commonly associated with the evaluation of AI/ML-driven medical devices, which the questions in the prompt are tailored for.

Summary

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14 1999 JUII -

Image /page/0/Picture/1 description: The image shows the logo and contact information for NEWDEAL SA. The logo "newdeal" is displayed in a stylized font. Below the logo is the company's address: 31 RUE DE LA CONVENTION, 'ARC D'ACTIVITÉS GARIGLIANO, 38200 VIENNE, FRANCE. The telephone number is (33) 04 74 78 15 15, and the fax number is (33) 04 74 78 15 16.

INTERNET EMAIL : NEWDEALFR@AOL.C

K991477

1999 - 1999

3. SUMMARY OF SAFETY AND EFFECTIVENESS

SPONSOR IDENTIFICATION: A. NewDeal SA
Parc d'Activitiés Garigliano Rue de la Convention 38 200 VIENNE FRANCE

Tél. : (33) 4 74 78 15 15 Fax : (33) 4 74 78 15 16

B. ESTABLISHMENT REGISTRATION NUMBER: Pending

OFFICIAL CONTACT PERSON C.

Norman F. Estrin, Ph. D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac , MD 20854

Tel. : (301) 279 -2899 Fax : (301) 294-0126

DATE OF PREPARATION OF THIS SUMMARY: D. April 15, 1999

E. PROPRIETARY (TRADE) NAME: SPIN® SNAP-OFF SCREW

F. COMMON NAME:

Bone fixation screw, Self drilling and self tapping snap-off screw

Image /page/0/Picture/15 description: The image shows a collection of chromosomes. There are 10 chromosomes in total, arranged in a row. There are also a few smaller, darker spots above the chromosomes, which may be additional genetic material or artifacts in the image.

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CLASSIFICATION NAME AND REFERENCE G. Smooth or threaded metallic bone fixation fastener (21 CFR, Section 888.3040)
Class II H. PROPOSED REGULATORY CLASS:
I. DEVICE PRODUCT CODE: 87HWC
J. PANEL CODE: 21 CFR par. 888.3040

K. DESCRIPTIONOF DEVICE:

INTENDED USE: L.

The SPIN® SNAP-OFF Screw is intended to be implanted for fixation of bone fractures or for bone reconstructions.

M. INDICATIONS FOR USE:

The SPIN® SNAP-OFF Screw is indicated for fixing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only. Examples include:

-Weil osteotomy

Unicortical small bone fixation

PREDICATE DEVICE: N.

The SPIN® SNAP-OFF Screw is substantially equivalent to the Depuy Twist-off Screw, the Howmedica Luhr Screw system, the Synthes Cortex Screw and the Osteomed M3 Screw.

0. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

Both the SPIN® SNAP-OFF Screw and the predicate devices have the same intended use and all are indicated for fixing small fractures or osteotomies. All are made from titanium alloys. The Twist-off Screw, the Luhr Screw system, and the off Screw have a cleavable part. Both supply instrumentation sets.

P. SUMMARY OF STUDIES:

Rupture torque of the. SPIN® SNAP-OFF SCREW was compared with requirement of the French Standard NF-F 90414 and found to have a resistance to torsion in compliance with the selected standard.

000001

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 14 1999

Norman F. Estrin, Ph.D., RAC President Representing NewDeal SA Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, Maryland 20854

Re: K991477

Trade Name: Spin® Snap-Off Screw Regulatory Class: II Product Code: HWC Dated: April 26, 1999 Received: April 28, 1999

Dear Dr. Estrin:

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 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 Radiation Control provisions, or other Federal laws or regulations.

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Page 2 – Dr. Norman F. Estrin

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,

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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510(k) Number (if known): 长9914 77

SPIN® SNAP-OFF SCREW® Device Name:

Indications for Use:

The SPIN® SNAP-OFF SCREW® is indicated for fixing the elective osteotomies in the metatarsal and phalanges of the foot only. Examples include:

Weil osteotomy Lesser metatarsal osteotomies

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use × OR

Over-the-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

to cellefio

al Restorative Device

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.