This implant is indicated as a temporary implant to aid in the healing of long diaphysis fractures, osteotomies, malunions and nonunions and to prevent further fractures in femur, tibia and humerus in pediatric patients suffering from Osteogenesis Imperfecta without disrupting the bone growth plate. It can be used in procedures such as bone lengthening concomitantly with external fixators in pediatric or small statured patients with limb length discrepancy.

Device Description

The Fassier-Duval Pediatric IM System is a telescopic rod for use in fixation of long bone fractures. The design of the nail includes a female component (which is attached to the proximal -trochanteric- cortex of the bone) and a male component (which is attached to the distal cortex of the bone). Anchorage of the components is achieved through screw-type fixation. The nail is composed of two sliding components that allow for extension of its length as the bone structures heal and normal patient growth occurs. The Fassier-Duval Pediatric IM System can be attached to bony structures without disrupting the bone growth plates.

AI/ML Overview

This document describes a medical device, the Fassier-Duval Pediatric IM System, and its substantial equivalence to predicate devices, rather than a study evaluating the performance of an AI/ML powered device against specific acceptance criteria. Therefore, most of the requested information regarding AI/ML device performance, ground truth, expert adjudication, and sample sizes for training/test sets cannot be extracted from the provided text.

However, I can provide available information related to the device's performance compared to a predicate device based on the text.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Reduction in re-operation rate compared to predicate device #1 (Dubow-Bailey Intramedullary Nail)	3-fold reduction
Reduction in complication rate compared to predicate device #1 (Dubow-Bailey Intramedullary Nail)	2 to 3-fold reduction

Explanation: The document does not state specific quantitative "acceptance criteria" but rather reports comparative clinical outcomes against a predicate device. The implied acceptance, in this context, is that the Fassier-Duval system performs better than the predicate regarding these specific clinical outcomes.

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

Sample Size: Not specified in the provided text.
Data Provenance: The text states "Clinical data submitted with the current application..." which implies retrospective clinical data. The country of origin is not specified but given the contact person is in Montreal, Quebec, Canada, it's possible some data originated from Canada.

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

Not applicable. This is a medical device approval document, not an AI/ML performance study. Clinical data would typically be assessed by treating physicians and medical staff in an observational or interventional study setting.

4. Adjudication method for the test set

Not applicable. This is a medical device approval document, not an AI/ML performance study. Clinical outcomes would be recorded and analyzed from patient records.

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

Not applicable. This document is for a physical medical device (telescopic nail), not an AI/ML system.

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

Not applicable. This document is for a physical medical device.

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

The performance claims are based on clinical outcomes data (re-operation rate and complication rate) from patients.

8. The sample size for the training set

Not applicable. This is a medical device approval, not an AI/ML study.

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

Not applicable. This is a medical device approval, not an AI/ML study.

Summary

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K020885 P i/2

Image /page/0/Picture/1 description: The image shows the logo for Pega Medical. The logo consists of the words "Pega Medical" in a sans-serif font, with "Pega" in a larger, bolder font than "Medical". Above the text is a stylized graphic of a person with curved lines emanating from their head, resembling motion or energy. The logo is in black and white.

9260 Viau Blvd. Montreal Quebec H1R 2V8

FEB 0 6 2003

phone: (514) 322-8560 ax: (514) 328-9548 il: pegamedical@pegamedical.c website www.pegamedical.com

Montreal, January 23, 2003

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

Contact Person: Ariel R. Dujovne, M.Sc

Pega Medical Inc. 9260 boul Viau, Montreal Ouebec. H1R 2V8 CANADA (514) 322-8560 ext. 241

Proprietary Name: Fassier-Duval Pediatric IM System

Common Name: Telescopic Nail

Device Classification: Class II

Classification Name: Intramedullary fixation rod - 21CFR 888.3020/888.3030/888.3040

Establishment Registration Number: 9048931

Intended Use: This implant is indicated as a temporary implant to aid in the healing of long diaphysis fractures, osteotomies, malunions and nonunions and to prevent further fractures in femur, tibia and humerus in pediatric patients suffering from Osteogenesis Imperfecta without disrupting the bone growth plate. It can be used in procedures such as bone lengthening concomitantly with external fixators in pediatric or small statured patients with limb length discrepancy.

Description: The Fassier-Duval Pediatric IM System is a telescopic rod for use in fixation of long bone fractures. The design of the nail includes a female component (which is attached to the proximal -trochanteric- cortex of the bone) and a male component (which is attached to the distal cortex of the bone). Anchorage of the components is achieved through screw-type fixation. The nail is composed of two sliding components that allow for extension of its length as the bone structures heal and normal patient growth occurs. The Fassier-Duval Pediatric IM System can be attached to bony structures without disrupting the bone growth plates.

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Basis for substantial equivalent:

The Fassier-Duval Pediatric IM System is claimed to be substantially equivalent in design and function to the following predicate devices:

1. Dubow-Bailey Intramedullary Nail, Zimmer, Inc. Warsaw, IN (510(k) number - Not available, pre-amendment device)
1. Retrograde Pediatric Nail, Encore Orthopedics, Inc., Austin, TX (K980854)
1. Intramdedullary Fixation Rod/Pin, Synthes (USA), Paoli, PA (K971783)
1. The Grosse & Kempf Intramedullary Nail, Howmedica, Rutherford, NJ (K813371)

The intended uses of these devices are the same as the Fassier-Duval Pediatric IM System.

The technological characteristics of the Fassier-Duval Pediatric IM System are identical to the ones of the Dubow-Bailey Intramedullary Nail except for the method of fixation. Clinical data submitted with the current application demonstrated that in the operative treatment of OI, the Fassier-Duval Pediatric IM System produces a 3fold reduction in the re-operation rate and a 2 to 3-fold reduction in the complication rate, compared to the predicate device #1.

For predicated devices #2, 3 and 4, substantial equivalence was demonstrated by preclinical data according to ASTM F 1264 (four point bending). Although there are several design differences with the predicate devices, they do not raise new questions of safety and effectiveness.

KO208BS

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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 human figure with three faces in profile, representing health and well-being. The figure is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 6 2003

Mr. Ariel R. Dujovne, Ing., M.Sc. Pega Medical, Inc. 9260 Viau Boulevard St-Leonard, (Montreal) Quebec. Canada H1R 2V8

Re: K020885

Trade/Device Name: Fassier Duval Telescopic IM Nail System Regulation Number: 21 CFR $888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: December 4, 2002 Received: December 6, 2002

Dear Mr. Dujovne:

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

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Page 2 -- Mr. Ariel R. Dujovne, Ing., M.Sc.

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.

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), please contact the Office of Compliance at (301) 594-4659. 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 M Millman

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

Enclosure

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INDICATIONS ENCLOSURE

510(k) Number (if known):

Device Name: Fassier-Duval Pediatric Intramedullary Nail System

INDICATIONS FOR USE

This implant is indicated as a temporary implant to aid in the healing of long diaphysis fractures, osteotomies, malunions and nonunions and to prevent further fractures in femur, tibia and humerus in pediatric patients suffering from Osteogenesis Imperfecta without disrupting the bone growth plate. It can be used in procedures such as bone lengthening/shortening concomitantly with external fixators in pediatric or small stature patients with limb length discrepancy.

for Mark N. Millman

(Division Sign-Off) Division of General, Restorative and Neurological Devices

KO20885 10(k) Number _________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.