The ICOS® SCREW is indicated for fixing the elective osteotomies of the forefoot and/or mid foot bones and for fractures fixation in the forefoot and/or mid foot and /or hindfoot, including:

*naviculo-cunéiform arthrodesis

*lapidus arthrodesis

*talus osteochondritis

*ankle arthrodesis

*arthrodesis, osteotomies or fractures fixation in the forefoot and/or midfoot and/or the hindfoot.

Device Description

The I.CO.S Screw is a cannulated compression screw with non-threaded shaft, allowing optimal compression. The head of this screw can be screwed and translated along the body in order to increase the compression controlled by the surgeon. It also has a self-tapping screw tip. It comes in diameters from 4.0 mm to 6.5 mm and in length from 26 to 90. The I.CO.S® Screw is a cannulated compression screw made of titanium alloy. Its design includes a non-theaded shaft, allowing optimal compression. The head of this screw can be screwed and translated along the body in order to increase the compression controlled by the surgeon. It also has a self-tapping screw tip.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the I.CO.S® Screw, a cannulated compression screw. It details the device's characteristics, indications for use, and a summary of studies performed. However, the document does NOT contain information regarding:

Specific acceptance criteria in a quantitative table.
A comparative study with a "reported device performance" against acceptance criteria.
Sample sizes for a test set (as no such study is described).
Data provenance for a test set.
Number of experts or their qualifications for establishing ground truth.
Adjudication method for a test set.
A multi-reader multi-case (MRMC) comparative effectiveness study, including human reader improvement with AI.
A standalone (algorithm only without human-in-the-loop) performance study.
The type of ground truth used (expert consensus, pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on design, composition, function, and mechanical testing against recognized standards.

Here's a breakdown of what is available in relation to your request, and where information is missing:

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

Acceptance Criteria Mentioned: The document states, "The I.CO.S® Screw meet the ASTM standards (ASTM F136) for the material and design for medical application." It also mentions "Rupture torque of the I.CO.S.S. Screw was compared with requirements of the French Standard N° NF-S -90414."
Reported Device Performance: "and found to have a resistance torsion in compliance with the selected standard" for the French Standard. For ASTM F136, it only states the device "meet" them.
Missing Information: No specific quantitative table directly comparing acceptance thresholds with measured device performance values is provided. The document implies compliance rather than detailing specific numerical results.

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

Missing Information: The document does not describe a "test set" in the context of clinical or algorithmic performance evaluation. The studies mentioned are material and mechanical tests, not clinical performance studies involving patient data or a "test set" of results.

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)

Missing Information: Not applicable, as no clinical "test set" requiring expert ground truth is described.

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

Missing Information: 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

Missing Information: No MRMC study is mentioned. This device is a bone fixation screw, not an AI-assisted diagnostic or treatment planning tool.

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

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

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

Ground Truth (for mechanical testing): The "ground truth" or reference for the mechanical testing was the specified requirements of the ASTM F136 standard and the French Standard N° NF-S -90414.
Missing Information: No clinical "ground truth" is described as no clinical studies are presented in this summary.

8. The sample size for the training set

Missing Information: Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.

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

Missing Information: Not applicable.

In summary, the provided document is a 510(k) premarket notification for a traditional medical device (a bone screw). The "studies" mentioned relate to material and mechanical properties, demonstrating compliance with existing standards (ASTM F136 and French Standard NF-S-90414) and substantial equivalence to legally marketed predicate devices. It does not include the type of performance data typically associated with AI/software medical devices or comprehensive clinical trials requiring the detailed information you've requested about test sets, experts, or ground truth for such studies.

Summary

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993762 1 af ﻢ

000009

4 2000 FEB

Image /page/0/Picture/2 description: The image shows the contact information for NEWDEAL SA, located at 31 RUE DE LA CONVENTION, PARC 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. The internet email address is NEWDEALFR@AOL.COM.

SUMMARY OF SAFETY AND EFFECTIVENESS 3.

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

ESTABLISHMENT REGISTRATION NUMBER: 9615741 B.

OFFICIAL CONTACT PERSON C.

Norman F. Estrin, Ph. D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac . MD 20854 Tel. : (301) 519-1098 Fax : (301) 519-1389

DATE OF PREPARATION OF THIS SUMMARY: D. October 18, 1999

I.CO.S® Screw PROPRIETARY (TRADE) NAME: E.
F. COMMON NAME: Bone fixation screw, Cannulated compression screw
G. CLASSIFICATION NAME AND REFERENCE Smooth or threaded metallic bone fixation fastener (21 CFR, Section 888.3040)
H. PROPOSED REGULATORY CLASS: Class II
I. DEVICE PRODUCT CODE: 87HWC
J. PANEL CODE: 87 OR Orthopedic

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760 2 993 p 2 of 2

K. DESCRIPTION OF DEVICE:

L. INDICATIONS FOR USE:

The L.CO.Se Screw is indicated for fixing the elective osteotomies of the forefoot and/or mid foot bones and for fractures fixation in the forefoot and/or mid foot and /or hindfoot, including:

*naviculo-cunéiform arthrodesis * lapidus arthrodesis *talus osteochondritis *ankle arthrodesis *arthrodesis, osteotomies or fractures fixation in the forefoot and/or midfoot and/or the hindfoot.

M. PREDICATE DEVICE:

The LCO.Se Screw is substantially equivalent in design, composition and function to other orthopedics screws manufactured and approved for market:

Orthopeadic Biosystem Ltd.:	K963420
AAP Implants Inc.:	K990776
Synthes:	K962823

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: N.

Both the LCO.S® Screw . the Self-drilling Facet Screw from Orthopaedic Biosystems Ltd, Synthes sterile 3.0mm Cannulated screw and threaded washer, and the cannulated screw from Aap implants Inc have the same intended use and all are indicated for fixing fractures or osteotomies.

SUMMARY OF STUDIES: 0.

The I.CO.S® Screw meet the ASTM standards (ASTM F136) for the material and design for medical application. The bone screws are of the same thread configuration and length as offered by Orthopeadic Biosystem Ltd, Aap Implants Inc, Synthes and many other orthopaedic companies. The minor and major lice, Syntacs and many other vize are comparable. Rupture torque of the I.CO.S.S. Screw was compared with requirements of the French Standard N* NF-S -90414 and found to have a resistance torsion in compliance with the selected standard.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB | 4 2000

Mr. Eric Fourcault President NewDeal SA c/o Estrin Consulting Group, Incorporated 9109 Copenhaver Drive Potomac, Maryland 20854

K993762 Re: Trade Name: I.CO.S. Screw Regulatory Class: II Product Code: HWC Dated: November 7, 1999 Received: November 8, 1999

Dear Mr. Fourcault:

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 - Mr. Eric Fourcault

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

Sincerely yours,

Neil R.P. Ogden
James E. Dillard III for

James E. Dillard Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): ﺳﮯ 93 P

I.CO.S. ® Device Name: SCREW

Indications for Use:

The ICOS® SCREW is indicated for fixing the elective osteotomies of the forefoot and/or mid foot bones and for fractures fixation in the forefoot and/or mid foot and /or hindfoot, including:

*naviculo-cunéiform arthrodesis

*lapidus arthrodesis

*talus osteochondritis

*ankle arthrodesis

*arthrodesis, osteotomies or fractures fixation in the forefoot and/or midfoot and/or the hindfoot.

NRO for JZD

(Division Sign-Off) Division of General Restorative Devices K993762 510(k) Number _

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use

(Optional Format 1-2-96)

000008

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.