The HALLU® -PLATES are intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint. Examples include:
-Hallux rigidus
-Severe hallux valgus (IM angle > 20° and HV angle > 40°)
-Deformity from rheumatoid arthritis
-Failed previous surgical procedure
-Traumatic arthritis
-Neuromuscular instability.

Device Description

The HALLU® -PLATES are available in two different designs :

the HALLU®-C PLATE -
the HALLU®-S PLATE -
The HALLU®-C PLATE and the HALLU® -S PLATE are low profile Titanium plates dedicated to first metatarso-phalangeal arthrodesis. Those implants are pre-bent for optimal anatomical adaptation (10° valgus and 10°dorsiflexion). Their fixation is provided by Titanium SNAP-OFF® screws available in a two diameters: 3.0 and 2.7 mm. They exist in different colors for size identification. The bone contact surface is sand blasted in order to maximize plate stability. The range of HALLU -C PLATE and HALLUS S PLATE include 6 sizes ( 31eft/3right) for optimal anatomic fit. Moreover, the HALLU®-S PLATE has an anatomical design providing optimal bone coverage.

AI/ML Overview

The provided text describes a medical device, the HALLU®-PLATES, and its regulatory clearance based on substantial equivalence to predicate devices, rather than a study proving performance against specific acceptance criteria for a new AI/software device. Therefore, much of the requested information regarding AI/software device studies (e.g., sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, ground truth for training) is not applicable.

However, I can extract the information related to the device's testing and the standards it met.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Bending Strength	French Standard ISO 9585	In compliance
	ASTM Standard F-382-99	In compliance
Bending Stiffness	French Standard ISO 9585	In compliance
	ASTM Standard F-382-99	In compliance
Fatigue Strength	Not explicitly stated	Risk of rupture is minimal

Detailed Breakdown of Applicable Information:

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

Sample Size: Not explicitly stated as this was a physical device test, not a data-driven software evaluation. The document mentions "Test 1" and "Test 2," implying multiple samples of the plate were tested for bending and fatigue.
Data Provenance: The tests were conducted to comply with French Standard ISO 9585 and ASTM Standard F-382-99. This implies the tests were performed in a controlled laboratory setting, likely in the country of origin of the sponsor (France) or a qualified testing facility. The study type is experimental/bench testing, not retrospective or prospective human data.

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

This question is not applicable as the "ground truth" for a physical device test like this is defined by established engineering standards (ISO 9585 and ASTM F-382-99) and the physical properties of the materials and design, not by expert human interpretation.

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

This question is not applicable for a physical device test. The compliance is determined by measurements against predefined standard thresholds.

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, a MRMC comparative effectiveness study was not done. This is a physical bone plate, not an AI or imaging device that would involve human readers.

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

Yes, a standalone test was done. The device's performance (bending strength, stiffness, fatigue strength) was evaluated independently against established physical standards. This is analogous to a "standalone" test for a physical product.

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

The ground truth was based on established engineering standards for bone plates: French Standard ISO 9585 and ASTM Standard F-382-99.

8. The sample size for the training set:

Not applicable. This device underwent physical bench testing, not a machine learning training process.

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

Not applicable. As above, there was no training set for a machine learning model.

Summary

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AUG 1 2 2002

K021626 p113

SUMMARY OF SAFETY AND EFFECTIVENESS 3.

SPONSOR IDENTIFICATION: A. NewDeal SA Parc d'Activitiés Garigliano Rue de la Convention 38 200 VIENNE FRANCE
Telephone: (33) 4 74 78 15 15
Fax: (33) 4 74 78 15 16

B. ESTABLISHMENT REGISTRATION NUMBER: 9615741

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: April 11th, 2002 D.

HALLU®PLATES PROPRIETARY (TRADE) NAME: E.

Metatarsal-phalangeal arthrodesis plate F. COMMON NAME:

CLASSIFICATION NAME AND REFERENCE G.

Plate, Fixation, Bone (21 CFR, Section 888. 3030)

H. PROPOSED REGULATORY CLASS: Class II
DEVICE PRODUCT CODE: I. 87 HRS
87 OR Orthopedic J. PANEL CODE:
K. DESCRIPTION OF DEVICE:

The HALLU® -PLATES are available in two different designs :

the HALLU®-C PLATE -
the HALLU®-S PLATE -

The HALLU®-C PLATE and the HALLU® -S PLATE are low profile Titanium plates dedicated to first metatarso-phalangeal arthrodesis. Those implants are pre-bent for optimal anatomical adaptation (10° valgus and 10°dorsiflexion). Their fixation is provided by Titanium SNAP-OFF® screws available in a two diameters: 3.0 and 2.7 mm. They exist in different colors for size identification. The bone contact surface is sand blasted in order to maximize plate stability. The range of HALLU -C PLATE and

01 2005

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K021624 p²/3

HALLUS S PLATE include 6 sizes ( 31eft/3right) for optimal anatomic fit. Moreover, the HALLU®-S PLATE has an anatomical design providing optimal bone coverage.

The HALLU® -PLATES are intended to be implanted for L. INTENDED USE: fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint.

INDICATIONS M. The HALLU®-PLATES are intended to be implanted for FOR USE: fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint. Examples include:

-Hallux rigidus

-Severe hallux valgus (IM angle > 20° and HV angle > 40°)

-Deformity from rheumatoid arthritis

-Failed previous surgical procedure

-Traumatic arthritis

-Neuromuscular instability.

N. PREDICATE

DEVICE:

The HALLU - PLATES are substantially equivalent to the Howmedica Luhr plate (K935448) and Howmedica Profyle® Hand and Small Fragment System (K961497) , the Acumed Congruent bone plate system (K012655) and the Synthes modular foot system (K001941).

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: 0.

The HALLU® - PLATES, the Howmedica Luhr and

Howmedica Profyle plates, the Acumed plate and Synthes

modular foot system are intended for internal bone fixation for bone fractures or reconstruction.

Luhr® HALLU®- PLATES, the Howmedica The and Howmedica Profyle® plates, the Acumed plate and Synthes modular foot system are all indicated for bone fractures or reconstruction in the foot.

The HALLU® - PLATES, the Howmedica Profyle " plates and the Acumed plate are in Titanium alloy TIAI6V4 whereas the Synthes modular foot system is manufactured in Stainless steel 316 L and the Howmedica Luhr in Vitallium alloy .

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All those systems are fixed with screws except for the Synthes modular foot system attached to bone via buttress pins.

KOZIG 26

Test 1 : Determination of bending strength and stiffness of SUMMARY OF STUDIES: bone plates was compared with requirement of the French Standard ISO 9585 and ASTM standard F-382-99 and found to have a bending stiffness and strength in compliance with the selected standards.

Test 2 : Determination of fatigue strength of bones plates were conducted and have shown the risk of rupture of the plate is minimal.

() . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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" around the perimeter. Inside the circle is an abstract symbol resembling three stylized human profiles or birds in flight, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NewDeal SA c/o Norman F. Estrin, PhD, RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, Maryland 20854

AUG 1 2 2002

Re: K021626

Trade/Device Name: HALLU®-Plates System Regulation Number: 21 CFR §888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: May 14, 2002 Received: May 17, 2002

Dear Dr. Estrin;

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Norman F. Estrin, PhD, RAC

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark H-Milliman

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

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Page 1 of 1

510(k) Number (if known): 《ՀՀՀՆՆՀՀՀ

HALLU®-PLATES SYSTEM Device Name: Indications for Use:

The HALLU® -PLATES are intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint. Examples include:

-Hallux rigidus

-Severe hallux valgus (IM angle > 20° and HV angle > 40°)

-Deformity from rheumatoid arthritis

-Failed previous surgical procedure

-Traumatic arthritis

-Neuromuscular instability.

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

for

(Division Sign-Off)

Division of General, Restorative
and Neurological Devices

510(k) Number	K021626
---------------	---------

004E

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.