This submission pertains to a medical device, the Acumed Clavicle Screw System, rather than an AI/ML powered device. As such, the information typically requested for AI/ML device studies (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not applicable or available in the provided text.

However, I can extract information regarding the device's performance data and how substantial equivalence was demonstrated.

Here's the relevant information based on the provided text:

Acceptance Criteria and Device Performance (for a non-AI/ML device):

Acceptance Criteria	Reported Device Performance
Mechanical Performance and Equivalence (implied from the submission, focusing on material and dimensional characteristics, and function for clavicle repair)	The Acumed Clavicle Screw System is made of titanium alloy per ASTM F136 and is supplied in multiple diameters and lengths. These characteristics are shared with predicate devices. A cadaver study was performed to demonstrate substantial equivalence.
Safety and Effectiveness (demonstrated through substantial equivalence to legally marketed devices)	Based on similarities in technological characteristics and performance to predicate devices (DePuy Rockwood Clavicle Pin - K991649, True/Flex Clavicle Rod System - K934148, Hagie Pin - K903258, Steinmann, Knowles, and Hagie Pins - K863734, Herbert Bone Screw - K792022), the device is deemed substantially equivalent in safety and effectiveness.
Intended Use (to repair an acute fracture, mal-union or non-union of the clavicle)	The cadaver study supports the intended use, aiding in demonstrating substantial equivalence.

Study Information (Non-AI/ML Device):

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a numerical sample size in the context of individual cases. The study mentioned is a "cadaver study."
- Data Provenance: A cadaver study. The country of origin is not specified but implicitly within the context of the manufacturer (Acumed, LLC) being in the USA. This is a prospective study design for demonstrating performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a cadaver study of a bone fixation device, "ground truth" would relate to mechanical stability, anatomical fit, and repair efficacy, typically assessed by orthopedic specialists or biomechanical engineers, but no specific number or qualifications are provided in this regulatory submission.
Adjudication method for the test set: Not applicable. This type of study would involve direct observation and measurement, not typically an adjudication process in the sense of expert review for diagnostic accuracy.
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 not an AI/ML powered device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML powered device.
The type of ground truth used: In the context of a cadaver study for a bone fixation device, the "ground truth" would be objective biomechanical data, observable anatomical fit and stability, and the ability of the device to facilitate the repair as intended.
The sample size for the training set: Not applicable. This is not an AI/ML powered device, so there is no "training set."
How the ground truth for the training set was established: Not applicable. There is no training set for this device.

Summary

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K083144 pg 1 of 2

510(k) Summary	JUN 1 6 2009
Contact:	Alyssa ThomasAcumed, LLC5885 NW Cornelius Pass Rd.Hillsboro, OR 97124-9432(503) 627-9957 x1294FAX: (503) 686-7102
Device Trade Name:	Acumed Clavicle Screw System
Manufacturer:	Acumed, LLC5885 NW Cornelius Pass Rd.Hillsboro, OR 97124-9432
Common Name:	Pin, Fixation, Threaded
Classification:	21 CFR 888.3040
Class:	II
Product Code:	JDW

Indications for Use:

The Acumed Clavicle Screw System is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.

Device Description:

The Acumed Clavicle Screw System includes screws with associated instruments to repair acute fractures, mal-unions or non-unions of the clavicle.

Technological Characteristics:

The screws are made of titanium alloy per ASTM F136. The screw is supplied in multiple diameters and multiple lengths. The predicate devices share these dimensional and material characteristics.

Performance Data:

A cadaver study using the Acumed Clavicle Screw was performed to help demonstrate substantial equivalence. .

A discussion of clinical and non-clinical tests is not applicable.

Acumed LLC Page 5.2a

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K083144 pg 2 of 2

AGUMED® LLC

5885 NW Cornelius Pass Road, Hillsboro, OR 97124 Phone: (503) 627-9957 Fax: (503) 686-7102

Predicate Device(s):

DePuy Rockwood Clavicle Pin - K991649 True/Flex Clavicle Rod System - K934148 Hagie Pin - K903258 Steinmann, Knowles, and Hagie Pins - K863734 Herbert Bone Screw - K792022

Based upon the similarities of the Acumed Clavicle Screw System and the predicated devices studied, the safety and effectiveness of the Acumed Clavicle Screw System is substantially equivalent to the predicate devices referenced.

Acumed LLC Page 5.3a

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three overlapping wing segments, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Public Health Service

od and Drug Administratio 200 Corporate Boulevard Rockville MD 20850

JUN 1 6 2009

Acumed, LLC % Ms. Alyssa Thomas 5885 NW Cornelius Pass Road Hillsboro, OR 97124

Re: K083144

Trade/Device Name: Acumed Clavicle Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener accessories Regulatory Class: II Product Code: JDW Dated: May 14, 2009 Received: May 18, 2009

Dear Ms. Thomas:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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Page 2 - Ms. Alyssa Thomas

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Barbara Buchner

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

Enclosure

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Indications for Use

510(k) Number (if known): KOK 3 | 4 9

Device Name: Acumed Clavicle Screw System

Indications for Use:

The Acumed Clavicle Screw System is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.

Prescription Use _ × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sonitu
Jen (Division Sign-Off) Sign Ofn
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number .

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.