This device is a traditional medical implant, not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sensitivity, specificity, or AUC) does not apply directly. Instead, the device's acceptance is based on demonstrating substantial equivalence to a predicate device through non-clinical performance data.

Here's a breakdown of the requested information based on the provided text, adapted for a non-AI device:

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

Acceptance Criteria (Demonstrated Substantial Equivalence to Predicate Device)	Reported Device Performance
Intended Use: Repair of acute fracture, mal-union, or non-union of the clavicle.	The EnsplintCMx™ is intended to be used to repair an acute fracture, mal-union, or non-union of the clavicle. (Matches predicate's intended use)
Performance Characteristics: Comparable mechanical and functional properties to the predicate.	Non-clinical (bench top and cadaver) laboratory testing demonstrates that the device is substantially equivalent in performance characteristics.
Materials: Use of similar materials as the predicate device.	The EnsplintCMx™ configuration consists of an implant made of 316 stainless steel. (Similar material to predicate, though specific predicate material not explicitly stated, it's implied by "similar materials").

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

Sample Size for Test Set: The document mentions "bench top and cadaver" testing. The specific number of samples (e.g., number of cadavers, number of devices tested in benchtop) is not provided.
Data Provenance: The origin of the data (country) is not specified. The testing described is non-clinical, suggesting a laboratory setting, which aligns with prospective testing for device characterization.

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)

This question is not applicable as the device is a physical medical implant, not an AI diagnostic tool. There is no "ground truth" in the sense of expert annotation of medical images or data. The "ground truth" for this device would be established engineering and biomechanical principles and measurements.

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

This question is not applicable for a non-AI medical device. Adjudication methods are typically used to resolve discrepancies in expert labeling for AI training/testing. Performance was assessed through non-clinical (benchtop and cadaver) laboratory testing.

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

This question is not applicable for a non-AI medical device. MRMC studies are designed for assessing the impact of AI on human reader performance, which doesn't apply here. The device itself is an implant for physical fixation.

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

This question is not applicable as there is no algorithm involved. The performance evaluation was of the physical device's mechanical properties and function.

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

As explained previously, the concept of "ground truth" in the context of expert consensus or pathology is not directly applicable to this type of device. The "truth" in this context is based on:

Biomechanical testing results: Measuring parameters like strength, stiffness, fatigue resistance in laboratory (benchtop) settings.
Anatomical compatibility: Assessing fit and function in cadaveric models.
Material properties: Verifying that the 316 stainless steel meets established standards.

8. The sample size for the training set

This question is not applicable. As a non-AI device, there is no "training set" in the machine learning sense. Device design and validation are based on engineering principles, materials science, and non-clinical testing.

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

This question is not applicable for the same reasons as point 8.

Summary

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OCT 1 0 2008

510(k) Summary

Submitter's name	Sonoma Orthopedic Products, Inc.
Address	650 Larkfield Center, Suite CSanta Rosa, CA 95403
Phone Number	707-526-1335
Fax Number	707-526-2022
Name of contact person	Charles L. Nelson
Date summary was prepared	June 30, 2008
Proprietary name/Trade name	EnsplintCMxTM GWG (gripper-wavy-gripper)EnsplintCMxTM GGW (gripper-gripper-wavy)
Common Name	Clavicle Pin
Classification Name	Intramedullary rod, 21 CFR 888.3020Pin, Fixation, Threaded 21 CFR 888.3040
Predicate Device	DePuy RockwoodTM Clavicle PinK991649, cleared July 14, 1999
Description of device	The EnsplintCMxTM configuration consists ofan implant made of 316 stainless steel.
Intended use of device	The EnsplintCMxTM is intended to be used torepair an acute fracture, mal-union, or non-union of the clavicle
Comparison to Predicate Device	The EnsplintCMxTM has similar intendeduse, performance characteristics, andmaterials to the predicate device.
Performance Data (Non clinical)	The results of the non-clinical (bench topand cadaver) laboratory testing demonstratethat the device is substantially equivalent.Clinical evaluation of the device is notrequired.

Confidential Information

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, positioned to the right. To the left of the caduceus, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the edge of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2008

Sonoma Orthopedic Products, Inc. % Mr. Charles L. Nelson 650 Larkfield Center, Suite C Santa Rosa, CA 95403

Re: K081832

It on 6-2 Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: September 22, 2008 Received: September 22, 2008

Dear Mr. Nelson:

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 Forid, Or ug, 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, l'isting 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 - Mr. Charles L. Nelson

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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Mulhausen

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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Indications for Use

510(k) Number (if known): K081832

Device Name: ENSPLINTCMx™ Clavicle Pin GWG (gripper-wavy-gripper)

Indications for Use:

INDICATIONS

The ENSPLINTCMx™ Clavicle Pin is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milkeison

Page 1 of 1

Sign-Off) Division of General, Restorative, Enti Notrological Devices

Number K081832

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.