SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM by SYNTHES (USA)

Synthes Retrograde/Antegrade Femoral Nail System is composed of femoral nails, spiral blades and end caps. Depending on the length of the nail, the nail may be inserted from a retrograde approach or from either a retrograde or antegrade approach. Spiral blades, end caps and Synthes commercially available locking bolts and screws are used to secure the nail in the bone, preventing rotation and axial compression.

AI/ML Overview

This document, a 510(k) summary for the Synthes (USA) Retrograde/Antegrade Femoral Nail System, is a premarket notification for a medical device seeking clearance based on substantial equivalence to previously marketed devices. It does not describe the acceptance criteria or a study that proves the device meets specific performance criteria in the way you've outlined for AI/software-based devices.

Instead, this document focuses on demonstrating that the new device is "substantially equivalent" to existing predicate devices already cleared by the FDA. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.

Therefore, I cannot populate the table or answer most of your detailed questions regarding acceptance criteria, device performance metrics (like accuracy, sensitivity, specificity), sample sizes for test/training sets, expert qualifications, or adjudication methods, as these are not relevant to a 510(k) submission for a physical orthopedic implant like a femoral nail.

Here's an explanation based on the provided text:

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

Cannot be provided. This document does not present acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity) for a software or AI device. The "acceptance criteria" for a 510(k) submission for a physical device like a femoral nail are around demonstrating substantial equivalence to a predicate device in terms of design, materials, indications for use, and mechanical properties.
Reported device performance: The document states "Documentation is provided which demonstrates that the Synthes Retrograde/Antegrade Femoral Nail System is substantially equivalent* to other legally marketed devices." This "performance" is about meeting the FDA's criteria for substantial equivalence, not clinical or algorithmic performance metrics.

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

Not applicable. This pertains to studies for software or AI performance. For a physical device like a femoral nail, typical testing might involve mechanical bench testing, but the document does not provide details of such tests, their sample sizes, or data provenance. The assessment here is primarily regulatory based on equivalence.

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)

Not applicable. Ground truth establishment for a diagnostic or AI algorithm is not part of this type of 510(k) submission for a physical orthopedic implant.

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

Not applicable. This relates to expert review for AI/software performance, not a physical device submission.

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 applies to AI-assisted diagnostic or decision support systems.

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

Not applicable. This applies to AI/software performance.

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

Not applicable. This relates to AI/software performance evaluation. The "ground truth" for a physical device is generally its conformity to design specifications and mechanical properties, demonstrated through engineering tests and material analyses, which are not detailed here beyond the claim of substantial equivalence.

8. The sample size for the training set

Not applicable. This applies to AI/software development.

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

Not applicable. This applies to AI/software development.

In summary, the provided document is a 510(k) summary for a physical medical device (a femoral nail system), seeking market clearance based on substantial equivalence to existing devices. It does not contain the type of performance evaluation data (acceptance criteria, study details, expert review, AI performance metrics) that would be found in a submission for a software or AI-driven diagnostic device.

Summary

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FEB - 5 2004

ATTACHMENT III: REVISED 510(k) SUMMARY

Revised 510(k) Summary:

Sponsor:	Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700
Contact:	Bonnie Smith
Device Name:	Synthes (USA) Retrograde/Antegrade Femoral Nail System
Device Classification:	21 CFR 888.3020 - "Intramedullary fixation rod"21 CFR 888.3040 - "Smooth or threaded metallic bonefixation fastener"
Predicate Device:	Synthes Distal Femoral Nail, Synthes Cannulated Femoral Nail, andDePuy ACE ART Femoral Nail.
Description of Device:	Synthes Retrograde/Antegrade Femoral Nail System is composed offemoral nails, spiral blades and end caps. Depending on the length ofthe nail, the nail may be inserted from a retrograde approach or fromeither a retrograde or antegrade approach. Spiral blades, end capsand Synthes commercially available locking bolts and screws areused to secure the nail in the bone, preventing rotation and axialcompression.
Indications:	Synthes Retrograde/Antegrade Femoral Nail System is intended tostabilize fractures of the distal femur and the femoral shaft, includingsupracondylar fractures, including those with intra-articular extension;ipsilateral hip/shaft fractures; ipsilateral femur/tibia fractures; femoralfractures in multiple trauma patients; fractures proximal to total kneearthroplasty; fractures distal to a hip implant; fractures in the morbidlyobese; fractures in osteoporotic bone, impending pathologic fractures;and malunions and nonunions.
Material:	Titanium alloy
Substantial Equivalence:	Documentation is provided which demonstrates that the SynthesRetrograde/Antegrade Femoral Nail System is substantiallyequivalent* to other legally marketed devices.
	* The term "substantially equivalent" as used in this 510(k) notification islimited to the definition of substantial equivalence found in the Food, Drug,and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E,under which a device can be marketed without pre-market approval orreclassification. A determination of substantial equivalency under thisnotification is not intended to have any bearing whatsoever on the resolutionof patent infringement suits or any other patent matter. No statements relatedto, or in support of substantial equivalence herein shall be construed as anadmission against interest under the US Patent Laws or their application by thecourts.

Ko3618

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Image /page/1/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized symbol that resembles three wavy lines or stripes, possibly representing a flag or a symbol of movement and progress.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 5 2004

Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli. Pennsylvania 19301

Re: K033618

Trade/Device Name: Synthes (USA) Retrograde/Antegrade Femoral Nail System Regulation Numbers: 21 CFR 888.3020 and 888.3040 Regulation Names: Intramedullary fixation rod and Smooth or threadcd metallic bone fixation fastener Regulatory Class: II Product Codes: IISB, HWC Dated: November 17, 2003 Received: November 18, 2003

Dear Ms. Smith:

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 he 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 sct 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 - Ms. Bonnie J. Smith

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). You may obtain other general information on your responsibilities under the Act 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 A. Melleuson

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

Enclosure

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Indications for Use

510(k) Number (if known): K033618

Device Name:

Indications for Use:

Synthes (USA) Retrograde/Antegrade Femoral Nail System

Synthes Retrograde/Antegrade Femoral Nail System is intended to stabilize fractures of the distal femur and the femoral shaft, including:

· supracondylar fractures, including those with intraarticular extension
· ipsilateral hip/shaft fractures
ipsilateral femur/tibia fractures .
femoral fractures in multiple trauma patients .
fractures proximal to total knee arthroplasty .
fractures distal to a hip implant .
fractures in the morbidly obese �
fractures in osteoporotic bone .
impending pathologic fractures .
· malunions and nonunions

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✗
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
fo Mal A Millers

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.