The device is a nut with a 10mm hex. This nut is made from a composite of a UHMW Polyethylene nut with a built-in Titanium washer. The washer will aid in fixation in osteoporotic bone by helping to distribute the load against the bone.

AI/ML Overview

Here's an analysis of the provided text regarding the DePuy ACE Composite Locking Nut, focusing on acceptance criteria and supporting studies:

It appears the provided document is a 510(k) summary for a medical device (DePuy ACE Composite Locking Nut). This type of document is for demonstrating substantial equivalence to a previously cleared device, not typically for reporting detailed performance against acceptance criteria from a comprehensive clinical trial with human subjects. Therefore, much of the requested information (like MRMC studies, multi-reader performance, expert ground truth for imaging, and large training sets) is not applicable to this type of submission.

The "study" referenced is a mechanical performance test to demonstrate a specific physical characteristic of the new device compared to its predicate devices, rather than a clinical study of diagnostic accuracy or comparative effectiveness in humans.

Here's the breakdown of what can be extracted from the provided text according to your request categories:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
The nut can be applied without rounding the nut due to the ultimate torque being significantly higher than the insertion torque, allowing surgeons to clearly identify seating against the bone prior to accidental over-torque.	Testing has shown that the ultimate torque is approximately 10 times that of the insertion torque. (This ratio "10 times" implies sufficient margin to prevent over-torque and rounding during normal surgical use and is the performance criterion).

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: Not explicitly stated. The text refers to "Testing," suggesting a certain number of units were tested to determine the ultimate and insertion torque values.
Data Provenance: The study was conducted by DePuy ACE Medical Company. No specific country of origin for the data is mentioned beyond the company's location in El Segundo, CA, USA. This was a retrospective engineering test on manufactured devices, not derived from patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. The ground truth for this engineering test was the direct measurement of torque values. It did not involve expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. The "test set" here refers to the physical devices undergoing torque testing. There was no human interpretation or adjudication process involved in measuring a physical property.

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

No, an MRMC comparative effectiveness study was not done. This is a 510(k) for a mechanical device component, not an AI-powered diagnostic tool. The document does not mention any AI component or human reader studies.

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

No. This is a mechanical device. There is no algorithm or standalone performance being evaluated.

7. The Type of Ground Truth Used

The ground truth was direct objective measurement of physical properties: ultimate torque and insertion torque.

8. The Sample Size for the Training Set

Not applicable. There was no "training set" as this is not a machine learning or AI-driven device.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there was no training set (see #8), no ground truth for a training set was established.

Summary of the "Study" (Test Report ET 63-001):

The only "study" mentioned in this 510(k) summary is "Test Report ET 63-001". This appears to be an internal engineering test conducted by DePuy ACE Medical Company.

Purpose: To demonstrate that the DePuy ACE Composite Locking Nut allows for adequate fixation without accidental over-torque during application.
Methodology: Measuring the ultimate torque (the torque at which the nut mechanically fails or rounds) and the insertion torque (the torque typically applied during surgical seating).
Finding: The ultimate torque was found to be approximately 10 times that of the insertion torque.
Conclusion: This 10x ratio is considered sufficient to allow surgeons to clearly identify when the nut is seated against the bone before accidental over-torque or rounding occurs. This finding directly supports the device's substantial equivalence and safe use.

Summary

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OCT 2 6 1998

K983265

510(k) SUMMARY

NAME OF FIRM:

510(k) CONTACT PERSON:

TRADE NAME:

COMMON NAME:

CLASSIFICATION:

DePuy ACE Medical Company 2260 East El Segundo Boulevard El Segundo, CA 90245

Kathleen Dragovich Regulatory Affairs Specialist DePuy ACE Medical Company

DePuy ACE Composite Locking Nut

Nut, Orthopedic

87HTN

888.3030 Single/multiple component metallic Bone fixation appliances and accessories. Class II

DEVICE CODE:

SUBSTANTIALLY EQUIVALENT DEVICES:

DePuy ACE Nut for Cortical Bone Screw DePuy ACE Washer

INTENDED USE:

The DePuy ACE Composite Locking Nut is used as follows:

Cortical bone screws (alone) Intramedullary nails as locking bolts Screws with plates Where extra purchase in far cortex is required

DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:

The DePuy ACE Composite Locking Nut is a combination of the DePuy ACE Nut for Cortical Bone Screws which received clearance under 510(k) K874669 and the DePuy ACE Washer which received clearance under 510(k) K895107. The function of the DePuy ACE Composite Locking Nut is a combination of both the nut and the washer: to act as the mating part to a screw for better fixation and to increase the surface under the nut to help distribute the load against the surface of the bone.

Testing has shown that the ultimate torque is approximately 10 times that of the insertion torque; therefore, the nut can be applied without rounding the nut. This distinct difference indicates that upon insertion and advancement of the surgeon will be able to clearly identify that the nut is seated against the bone prior to accidental over-torque of the nut. (See Test Report ET 63-001 in Exhibit IV.)

Based on the above information, DePuy ACE believes that the DePuy ACE Composite Locking Nut is substantially equivalent to the DePuy ACE Nut for Cortical Bone Screw and the DePuy ACE Washer.

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 6 1998

Mr. Paul Doner Director, Regulatory and Clinical Affairs DePuy ACE Medical Company 2260 East El Segundo Boulevard El Segundo, California 90245

Re: K983265 Trade Name: DePuy ACE Composite Locking Nut Requlatory Class: II Product Code: HTN September 15, 1998 Dated: September 17, 1998 Received:

Dear Mr. Doner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Paul Doner

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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Image /page/3/Picture/0 description: The image shows the logo for DePuy ACE. The logo consists of a black circle followed by the text "DePuy ACE" in a bold, sans-serif font. The letters are all capitalized, and the "TM" symbol is present in the bottom right corner of the "E". The logo is simple and modern, and the black color gives it a sense of authority.

510(k) Number (if known)

Device Name: DePuy ACE Composite Locking Nut

Indication for Use:

The DePuy ACE Composite Locking Nut is used as follows:

Cortical bone screws (alone) Intramedullary nails as locking bolts Screws with plates Where extra purchase in far cortex is required

Concurrence of CDRH, Office of Device Evaluation

Prescription Use
(Per 21 CFR 801.109)

510(k) Number

Over-The-Counter

(Division Sign-Off)
Division of General Restorative Devices

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.