Fixation of fractures in long bones such as the fibula, tibia, humerus, radius and ulna, as well as fractures in the patella
Fixation of small bones such as those in the foot, ankle, wrist and elbow
Ligament reconstruction
Arthrodesis of the foot, ankle, wrist and elbow
Small bone osteotomies
Osteochondritis dissecans

Device Description

This device is a metal screw shaft with a corresponding resorbable screw head. It also has an optional corresponding metal screw head for back-up purposes should the resorbable screw head become contaminated in the surgical environment.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "Modular Head Bone Screw." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria, performance metrics, and detailed study designs for a new device.

Therefore, many of the requested details about acceptance criteria, clinical study methodology, ground truth establishment, expert involvement, and sample sizes for training/test sets are not applicable to this type of regulatory submission.

Here's an explanation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not Applicable (N/A): For 510(k) submissions, the primary "acceptance criterion" is "substantial equivalence" to a predicate device. This is typically met by demonstrating that the new device has the same intended use and technological characteristics as the predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness.	The device's "Summary of Technologies" states: "The Modular Head Bone Screw's technological characteristics are similar to or identical to the predicate devices."The "Non-Clinical Testing" section states: "Mechanical testing was performed to establish substantial equivalence to the predicate devices." Specific performance metrics from this mechanical testing are not provided in this summary.

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

This information is Not Applicable. The document explicitly states: "Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices." Therefore, there was no test set of patient data, no data provenance information, and no clinical performance evaluated in this submission.

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

This information is Not Applicable as no clinical testing was performed and therefore no ground truth needed to be established for a clinical test set.

4. Adjudication Method for the Test Set

This information is Not Applicable as no clinical testing was performed and therefore no test set data requiring adjudication.

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 information is Not Applicable. This device is a bone screw, not an AI-powered diagnostic or assistive technology. No MRMC study was performed, nor would it be relevant for this type of medical device submission.

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

This information is Not Applicable. This device is a bone screw; it is not an algorithm or AI system.

7. The Type of Ground Truth Used

This information is Not Applicable. Since no clinical testing was performed, no "ground truth" (such as expert consensus, pathology, or outcomes data) was established for clinical performance. The substantial equivalence was based on mechanical testing and comparison of technological characteristics to predicate devices.

8. The Sample Size for the Training Set

This information is Not Applicable. There was no AI algorithm involved, so no training set was used.

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

This information is Not Applicable. There was no AI algorithm involved, so no ground truth for a training set was established.

Summary of the Study (as described in the document):

The study to "prove the device meets the acceptance criteria" (in this context, substantial equivalence to predicate devices) was non-clinical mechanical testing. The document states:

"Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence to the predicate devices."
"Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices."

The specifics of the mechanical testing (e.g., number of samples, specific tests like bending strength, torsional strength, pull-out strength, etc., and the results compared to predicate devices) are not detailed in this summary document but would have been part of the full 510(k) submission. The "acceptance criteria" for this mechanical testing would involve demonstrating that the Modular Head Bone Screw's mechanical properties were comparable to or better than those of the identified predicate devices (Self-Countersinking Bone Screw K013534 and Synthes Sterile 3.0mm cannulated Screw K962823) for its intended uses.

Summary

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DEC 0 2 2002

BIOMET

Ko 295.2 page(4)

Summary of Safety and Effectiveness

Applicant/Sponsor:	Biomet Orthopedics, Inc.P.O. Box 587Warsaw, IN 46581-0587
Contact Person:	Kacy Arnold, RN, MBATelephone: (574) 372-1644Fax: (574) 372-1683
Proprietary Name:	Modular Head Bone Screw
Common Name:	Bone Screw

Classification Name: Screw, fixation, bone (888.3040)

Legally Marketed Devices to Which Substantial Equivalence is Claimed:

Self-Countersinking Bone Screw (K013534) ■
프 Synthes Sterile 3.0mm cannulated Screw (K962823)

Device Description:

Indications for Use: The Modular Head Bone Screw is indicated for the following conditions:

Fixation of fractures in long bones such as the fibula, tibia, humerus, radius u and ulna, as well as fractures in the patella
l Fixation of small bones such as those in the foot, ankle, wrist and elbow
트 Ligament reconstruction
Arthrodesis of the foot, ankle, wrist and elbow ■
Small bone osteotomies 해
Osteochondritis dissecans 트

Summary of Technologies: The Modular Head Bone Screw's technological characteristics are similar to or identical to the predicate devices.

Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence to the predicate devices.

Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 - - - - - - - - -

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

0000000

1 -

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.

Public Health Service

DEC 02 2002

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Biomet Orthopedics, Inc. · Kacy Arnold, RN, MBA Regulatory Affairs Specialist P. O. Box 587 Warsaw, Indiana 46581

Re: K022952

Trade/Device Name: Modular Head Bone Screw Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 4, 2002 Received: September 5, 2002

Dear Ms. Arnold:

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 forth in the

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Page 2 - Ms. Kacy Arnold

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. 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. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Miriam C. Provost

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

Enclosure

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510 (k) Number (if known) :

Device Name: Modular Head Bone Screw

Indications for Use:

The indications for the use of the Modular Head Bone Screw include:

Fixation of fractures in long bones such as the fibula, tibia, humerus, radius and 비 ulna, as well as fractures in the patella
Fixation of small bones such as those in the foot, ankle, wrist and elbow 해
Ligament reconstruction 피
Arthrodesis of the foot, ankle, wrist and elbow 트
Small bone osteotomies 비
트 Osteochondritis dissecans

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 112 (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

Muriam C. Provost
Division Sign Off

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

060003

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.