The Modified BMP™ Trochanteric Plates consist of crimps and trochanteric plates. The crimps are made of either 316LVM stainless steel or Co-Cr-Mo. The CoCr crimps are to be used in conjunction with CoCr wire and stainless steel crimps are to be used in conjunction with stainless steel wire.
The trochanteric plates are made of CoCrMo and are available in two different lengths. The shorter plate is available in both right and left configurations while the longer plate will be straight and have a different contour in the trochanter region than the shorter plates.

AI/ML Overview

The provided text is a 510(k) summary for the "Modified BMP™ Trochanteric Plates" and concerns the regulatory clearance of a medical device, not a study design or performance evaluation of a device using AI, statistical analysis, or reader studies. Therefore, most of the requested information cannot be extracted from this document, as it describes a clearance process based on substantial equivalence to a predicate device, not performance against acceptance criteria proven by a study.

Here's an analysis based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not contain acceptance criteria or reported device performance in the manner typically seen for clinical studies or AI/software evaluations. It is a regulatory clearance document stating that the device is "substantially equivalent" to legally marketed predicate devices. Substantial equivalence means that the device has the same intended use as a predicate device, and the same technological characteristics as the predicate device; or has different technological characteristics from the predicate device and the information submitted demonstrates that the device is as safe and effective as a legally marketed device, and does not raise different questions of safety and effectiveness than the predicate device.

The "Indications For Use" section could be considered the "intended use" aspect of the device, which must align with the predicate device for substantial equivalence.

Acceptance Criteria	Reported Device Performance
Intended Use: For use in lateral trochanteric osteotomies, trochanteric fractures, trochanteric osteotomies.	Device is "substantially equivalent" to devices marketed prior to May 28, 1976, for the stated indications for use, implying it meets the same safety and effectiveness profile.

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

Not applicable. This document is a 510(k) submission for substantial equivalence. It does not describe a clinical study or test set with specific sample sizes or data provenance for performance evaluation. Substantial equivalence is often demonstrated through comparative testing to a predicate device, material characterization, or non-clinical testing rather than human subject data, unless safety/effectiveness cannot be demonstrated by other means.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The clearance is based on substantial equivalence, not on establishing ground truth for a discrete diagnostic or therapeutic outcome through expert consensus.

4. Adjudication Method:

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This document does not describe an MRMC study or any study comparing human readers with and without AI assistance.

6. Standalone Performance Study:

Not applicable. This document does not describe a standalone algorithm performance study.

7. Type of Ground Truth Used:

Not applicable. In the context of a 510(k) for this type of device (a bone fixation appliance), "ground truth" would relate more to the mechanical properties, biocompatibility, and functional equivalence to predicate devices, rather than a diagnostic or interpretive ground truth established by experts or pathology.

8. Sample Size for the Training Set:

Not applicable. This document does not describe an AI or algorithm that would have a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary

{0}------------------------------------------------

NOV 1 6 1999

SUMMARY OF SAFETY AND EFFECTIVENESS

Sponsor: Biomet, Inc.

Manufacturer: Biomet Manufacturing, Inc. Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581-0587

Proprietary Name: Modified BMP™ Trochanteric Plates

Common or Usual Name: Single/Multiple Component Metallic Bone Fixation Appliances

Classification Name: Bone, Fixation, Plate 888.3030

Device Classification: Class II

Device Description: The Modified BMP™ Trochanteric Plates consist of crimps and trochanteric plates. The crimps are made of either 316LVM stainless steel or Co-Cr-Mo. The CoCr crimps are to be used in conjunction with CoCr wire and stainless steel crimps are to be used in conjunction with stainless steel wire.
The trochanteric plates are made of CoCrMo and are available in two different lengths. The shorter plate is available in both right and left configurations while the longer plate will be straight and have a different contour in the trochanter region than the shorter plates.

Indications For Use:

Lateral Trochanteric Plates: extended trochanteric osteotomies, trochanteric fractures, trochanteric osteotomies.

Potential Risks:

1. Nonunion or delayed union which may lead to breakage of implant.
1. Bending or fracture of the implant.
1. Loosening or migration of the implant.
1. Metal sensitivity, or allergic reaction to a foreign body.
1. Limb shortening due to compression of the fracture or bone resorption.
1. Decrease in bone density due to stress shielding.
1. Pain, discomfort, or abnormal sensation due to the presence of the device.
1. Nerve damage due to surgical trauma.
1. Necrosis of bone.
1. Postoperative bone fracture and pain.
1. Inadequate healing.

{1}------------------------------------------------

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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles in a row, with flowing lines beneath them, resembling waves or fabric.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 1999

Mr. Fred McClure Requlatory Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana

Re: K993510 Modified BMP™ Trochanteric Plates Trade Name: Regulatory Class: II Product Code: HRS Dated: October 15, 1999 Received: October 18, 1999

Dear Mr. McClure:

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, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉੱ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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.

{2}------------------------------------------------

Page 2 - Mr. Fred McClure

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 regulation (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,

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510 (k) Number (if known) : _ k 9935 10

Modified BMP™ Trochanteric Plates Device Name:

Indications For Use:

Lateral Trochanteric Plates: extended trochanteric osteotomies, trochanteric fractures, trochanteric osteotomies.

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

Prescription Use
(Per 21 CFR 801.109)

Dcolleto

(Division Sign-Off) (Division of General Restorative Devices & 993SLO
510(k) Number

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.