Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
Revision procedures where other treatments have failed
The device is intended for insertion without bone cement. It is a single use implant.
To provide fixation of any acetabular cup, with appropriate sized screw holes, to the pelvic bone during total hip replacement procedures.

Device Description

Biomet Titanium Low Profile Screws are available in 5.0mm and 6.5mm diameters in lengths from 15mm to 70mm. The 5.0mm screws are for use in screw holes on the rim of an acetabular shell whereas the 6.5mm screws are designed for use in the dome of an acetabular shell. Each screw has a self-tapping point.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device (Titanium Low Profile Screws) and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel study with acceptance criteria and performance data in the way a clinical trial for a new drug or a completely novel device might.

Therefore, the requested information elements related to specific study designs for "acceptance criteria" and "device performance" (especially relating to AI or software, which this device is not) are not present in this document.

However, I can extract information related to how substantial equivalence was established, which serves a similar purpose in the 510(k) pathway.

Here's a breakdown of the available information:

A table of acceptance criteria and the reported device performance
- Not Applicable (N/A): This document does not present acceptance criteria or reported device performance in the form of a study comparing the new device against specific performance metrics. Instead, the "acceptance criteria" for a 510(k) submission are based on demonstrating "substantial equivalence" to a legally marketed predicate device.
- "Performance" implicitly refers to being equivalent to the predicate. The document states: "Biomet's Low Profile Screws are substantially equivalent to acetabular screws depicted with the following competitive acetabular systems: Trilogy Acetabular System - Zimmer (510(k) K934765) and Arthopor Acetabular System - Joint Medical Products Corp. (510(k) K955511)."
- The "performance" implies that the new device shares the same intended use, indications for use, and technological characteristics (e.g., material, dimensions, self-tapping point) as the predicate devices, and therefore is expected to perform similarly with the same associated risks.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A: There is no "test set" in the context of a clinical performance study described. This 510(k) focuses on demonstrating substantial equivalence primarily through comparison of design, materials, and intended use to predicate devices, without presenting data from a standalone clinical study involving a test set.
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)
- N/A: No experts were used to establish ground truth for a test set, as no such study is presented. The "expertise" involved in the 510(k) process is the regulatory review by the FDA (e.g., Celia M. Witten, Ph.D., M.D., Director, Division of General and Restorative Devices).
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A: No adjudication method is mentioned as there is no test set or expert review process described in a clinical study context.
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
- N/A: This device (Titanium Low Profile Screws) is a physical implant, not an AI or software-based device. Therefore, an MRMC study or AI-related effectiveness is not relevant or included.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A: As above, this is a physical implant, not an algorithm or software.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- N/A: The concept of "ground truth" (as typically used in studies evaluating diagnostic accuracy or AI performance) is not applicable here. The "truth" in a 510(k) submission for substantial equivalence is that the device is comparable in fundamental scientific technology and performance to a legally marketed predicate device.
The sample size for the training set
- N/A: There is no "training set" as this is not a machine learning or data-driven software device.
How the ground truth for the training set was established
- N/A: Not applicable for the reasons stated above.

In summary, this 510(k) submission demonstrates substantial equivalence of a physical medical implant (Titanium Low Profile Screws) to existing predicate devices (Zimmer Trilogy Acetabular System and Joint Medical Products Corp. Arthopor Acetabular System). It does not involve a clinical study with an "acceptance criteria" table or elements related to AI, software performance, or specific sample sizes for test/training sets as might be seen for a novel diagnostic or AI-powered device.

Summary

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K991807

8 1999 JUL -

Summarv of Safety and Effectivness

Proprietary Name: Titanium Low Profile Screws

Classification Name: Prosthesis, hip, semi-constrained, metal/polymer, porous, uncemented (888.3358) Device Product Code: 87LPH

Intended Use: To provide fixation of any acetabular cup, with appropriate sized screw holes, to the pelvic bone during total hip replacement procedures.

Indications for Use: Total hip replacement procedures for:

Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis 1)
Rheumatoid arthritis 2)
Correction of functional deformity 3)
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with 4) head involvement, unmanageable using other techniques
Revision procedures where other treatments have failed 5)

The device is intended for insertion without bone cement. It is a single use implant.

Device Description: Biomet Titanium Low Profile Screws are available in 5.0mm and 6.5mm diameters in lengths from 15mm to 70mm. The 5.0mm screws are for use in screw holes on the rim of an acetabular shell whereas the 6.5mm screws are designed for use in the dome of an acetabular shell. Each screw has a self-tapping point.

Substantial Equivalence: Biomet's Low Profile Screws are substantially equivalent to acetabular screws depicted with the following competitive acetabular systems:

Trilogy Acetabular System - Zimmer Arthopor Acetabular System - Joint Medical Products Corp.

510(k) K934765 510(k) K955511

Potential Risks: The potential risks associated with this device are the same as other metallic implants. These include, but are not limited to:

Blood vessel damage Bone fracture Soft tissue imbalance Infection Delaved wound healing Hematoma Implant loosening Implant fracture Dissassociation of components Excessive wear Deformity of the joint Cardiovascular disorders Metal sensitivity Implant migration Nerve damage

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three human profiles in a row, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 8 1999

Patricia Sandborn Beres Director, Regulatory Affairs Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

K991807 Re:

Trade Name: Titanium Low Profile Acetabular Screws Regulatory Class: II Product Code: LPH Dated: May 24, 1999 Received: May 26, 1999

Dear Ms. Beres:

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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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 - Ms. Patricia Sandborn Beres

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,

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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510(k) Number (if known): K99)807

Device Name: Titanium Low Profile Screws

Indications For Use: Total hip replacement procedures for:

Noninflammatory degenerative joint disease including osteoarthritis 1) and avascular necrosis
1. Rheumatoid arthritis
Correction of functional deformity 3)
Treatment of non-union, femoral neck fracture, and trochanteric 4) fractures of the proximal femur with head involvement, unmanageable using other techniques
Revision procedures where other treatments have failed 5)

The devices are single use implants.

Intended Use: To provide fixation of any acetabular cup, with appropriate sized screw holes, to the pelvic bone during total hip replacement procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Division of General Restorative Devices K991807
510(k) Number

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.