SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM by SYNTHES (USA)

Synthes Olecranon Osteotomy Nailing System consists of machined metallic olecranon nails, end caps and screws which are designed for use in fixation of fractures and osteotomies of the olecranon process of the ulna. Synthes Olecranon Osteotomy Nailing System offers a unique alternative to current techniques for olecranon fracture and olecranon osteotomy fixation. The system allows for quick realignment of the olecranon fragment following procedures which

AI/ML Overview

This document is a 510(k) summary for the Synthes Olecranon Osteotomy Nailing System. It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. As such, it does not detail acceptance criteria and a study proving device performance in the way a clinical trial report for an AI/ML device would.

The information provided describes a medical device (intramedullary fixation rod used for olecranon fractures and osteotomies), not an AI/ML device. Therefore, the questions related to AI/ML device performance (like multi-reader multi-case studies, standalone algorithm performance, training/test set data, expert ground truth adjudication) are not applicable to this document.

The document primarily focuses on establishing substantial equivalence to existing predicate devices, which is the regulatory pathway for this type of medical device.

Here's a breakdown of the relevant information from the provided text, addressed for a non-AI/ML medical device submission:

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

Since this is a 510(k) submission for a non-AI/ML device, the concept of "acceptance criteria" and "reported device performance" typically refers to demonstrating substantial equivalence to predicate devices based on design, materials, indications for use, and technological characteristics. There isn't a direct table like you might find for an AI/ML diagnostic's sensitivity/specificity.

The "performance" is implicitly demonstrated through comparison to the predicate devices and the summary states:

Criterion	Description / Performance
Device Name	Synthes Olecranon Osteotomy Nailing System
Intended Use	Synthes Olecranon Osteotomy Nailing (OleON) System is intended to treat olecranon osteotomies as well as simple fractures of the olecranon. This matches the intended use of the predicate devices.
Device Description	Consists of machined metallic olecranon nails, end caps, and screws designed for fixation of fractures and osteotomies of the olecranon process of the ulna. It offers a "unique alternative to current techniques" allowing for "quick realignment of the olecranon fragment."
Predicate Devices	Pioneer Surgical Technology SS Cables with Crimp, Synthes Kirschner Wires, Synthes 6.5mm Cancellous Screws, Acumed Small Bone Locking Rod System II, Biomet S.S.T. Small Bone Locking Forearm Nail. The new device is compared to these on technological characteristics, materials, and intended use to establish equivalence.
Substantial Equivalence	"Information presented supports substantial equivalence." This is the ultimate "acceptance" for a 510(k) pathway. The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...".
Classification	Class II, 21 CFR 888.3020 - Intramedullary fixation rod.

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 in the context of this 510(k) summary. For traditional medical devices like this, "test sets" in the context of clinical trials (with sample sizes, data provenance, etc.) are typically not required for 510(k) submissions unless the device introduces new technology or raises new questions of safety and effectiveness that cannot be addressed by comparison to predicates. The focus here is on engineering, material, and design equivalence to already marketed devices. Pre-clinical bench testing for mechanical properties (e.g., strength, fatigue) would have been performed, but specific "sample sizes" of clinical patient data are not detailed here.

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. See point #2. Ground truth, expert consensus, and reader qualifications are relevant for diagnostic AI systems, not for a bone fixation device's 510(k) submission.

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

Not Applicable. See point #2 and #3.

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 is a hardware implantable device, not an AI diagnostic tool.

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

Not Applicable. This is a hardware implantable device, not an AI algorithm.

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

Not Applicable. For this type of device, the "ground truth" for demonstrating safety and effectiveness for a 510(k) submission largely relies on established clinical practice for the predicate devices, engineering principles, biocompatibility testing, and mechanical testing, rather than patient outcomes or pathology data in a comparative study mentioned within this summary.

8. The sample size for the training set

Not Applicable. There is no "training set" for this non-AI medical device.

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

Not Applicable. There is no "training set" for this non-AI medical device.

In summary: The provided document is a 510(k) summary for a traditional medical device (an intramedullary fixation rod). The "acceptance criteria" and "proof" in this context revolve around demonstrating substantial equivalence to predicate devices already on the market, based on manufacturing, materials, design, and intended use. The questions posed are highly relevant for AI/ML-enabled diagnostic devices, but not for this type of submission.

Summary

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510(k) Summary		Page 1 of 1
Sponsor:	Synthes (USA)Karl J. Nittinger1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6941
Device Name:	Synthes Olecranon Osteotomy Nailing System
Classification:	Class II, 21 CFR 888.3020 - Intramedullary fixation rod.
Predicate Device:	Pioneer Surgical Technology SS Cables with CrimpSynthes Kirschner WiresSynthes 6.5mm Cancellous ScrewsAcumed Small Bone Locking Rod System IIBiomet S.S.T. Small Bone Locking Forearm Nail
Device Description:	Synthes Olecranon Osteotomy Nailing System consists ofmachined metallic olecranon nails, end caps and screws which aredesigned for use in fixation of fractures and osteotomies of theolecranon process of the ulna.
	Synthes Olecranon Osteotomy Nailing System offers a uniquealternative to current techniques for olecranon fracture andolecranon osteotomy fixation. The system allows for quickrealignment of the olecranon fragment following procedures which
Intended Use:	Synthes Olecranon Osteotomy Nailing (OleON) System is intendedto treat olecranon osteotomies as well as simple fractures of theolecranon.
SubstantialEquivalence:		Information presented supports substantial equivalence.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted with a staff entwined by two snakes and topped with wings. The text is in all capital letters and is evenly spaced around the symbol.

FEB 29 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Synthes (USA) % Mr. Karl J. Nittinger Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K073402

Trade/Device Name: Olecranon Osteotomy Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: February 13, 2008 Received: February 15, 2008

Dear Mr. Nittinger:

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. Karl J. Nittinger

forth in the quality systems (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millican

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2.0	Indications for Use
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510(k) Number (if known):	K073402
Device Name:	Synthes Olecranon Osteotomy Nailing System
Indications for Use:

Synthes Olecranon Osteotomy Nailing (OleON) System is intended to treat olecranon osteotomies as well as simple fractures of the olecranon.

Prescription Use (Per 21 CFR 801.109)	X	AND/OR	Over-The-Counter Use (21 CFR 807 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Brown

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

510(k) Number Ko73402

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.