a.) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
b.) Rheumatoid arthritis.
c.) Correction of functional deformity.
d.) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
e.) Revision of previously failed total hip arthroplasty due to recurrent dislocations.

The Tri-Polar System is intended for cemented or press-fit application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.

Device Description

The Tri-Polar prosthesis consists of a Bi-Polar femoral head, which articulates with a mating acetabular liner that fits into any standard line acetabular component. Once the Bi-Polar femoral head is used with an acetabular component the device becomes the Tri-Polar.

The Tri-Polar System consists of an all polyethylene or metal backed acetabular cup with a polyethylene liner designed to fit on a Bi-Polar head. The Bi-Polar femoral head component contains a modular head, which is attached to the femoral stem component. In other words, the Tri-Polar system adds an acetabular bearing component to a Bi-Polar hip replacement.

The Tri-Polar liners fit into any currently approved Biomet RingLoc® acetabular shells. The liner is retained in the shell by means of Biomet's standard RingLoc® mechanism. (A current listing of shells is found in Exhibit I). The liner and shell are properly aligned with one another and then locked into position with a metal ring (RingLoc®). The metallic shell has six to eight scalloped semi-circles, which mate with analogous semi-circular cutouts on the liner for prevention of rotation.

Biomet's all polyethylene acetabular cup has two outer concentric rings to facilitate cement interdigitation and an embedded wire for x-ray visualization. The all polyethylene has two outer concentric rings to facilitate cement interdigitation and an embedded wire for x-ray visualization. The all polyethylene acetabular component is intended to be cemented in the aceatabulum or used with a Biomet recovery cage.

The Bi-Polar femoral head consists of a larger outer shell with a polyethylene insert, which contains within it a modular head. The modular head is captured by the polyethylene insert, which is captured by means of a RingLoc® mechanism similar to that previously described above. The 22mm Bi-Polar component c. 1 be used with either size 24 or 25 Tri-Polar liners or the 54, or 57 all polyethylene cup. While the 28mm Bi-Polar component can be used with either size 26, 27, or 28 Tri-Polar liners or the 63, 66, or 69 all polyethylene cup. A polyethylene thickness of 4.0mm is the general standard for a hip prosthesis. The Tri-Polar system utilizes a minimum thickness of 4.8mm, which is greater than the general standard.

The Tri-Polar System does not incorporate any new technology that has not previously been available. The device simply combines this technology.

AI/ML Overview

This document is a 510(k) summary for a medical device called the "Tri-Polar System," which is a hip replacement prosthesis. It primarily focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting the results of a study to prove acceptance criteria with specific performance metrics.

Therefore, many of the requested sections about acceptance criteria, study details, and performance metrics cannot be filled from the provided text because these elements are typically found in clinical trial reports or detailed performance studies, which are not part of a standard 510(k) summary. A 510(k) submission generally asserts that a new device is as safe and effective as a legally marketed predicate device, often relying on design comparisons and, in some cases, limited performance testing that may not involve human subjects or complex statistical analysis as described in the prompt.

Based on the provided text, here's what can be extracted and what cannot:

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

The document does not provide a table of acceptance criteria or specific reported device performance metrics in the way one would see for, say, an AI diagnostic device. The "performance" described here is primarily about the physical design and components of the Tri-Polar System and its similarity to predicate devices. The claim of "substantial equivalence" implies that its performance is equivalent to established devices.

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

Not applicable. This document does not describe a clinical study with a test set of data. It is a submission for regulatory clearance based on substantial equivalence.

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)

Not applicable. No test set or ground truth establishment by experts is described.

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

Not applicable. No test set or adjudication process is described.

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

Not applicable. This device is a hip prosthesis, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. No ground truth is mentioned in the context of a study. The information provided is about the device's design and intended use, comparing it to existing, legally marketed predicate devices to establish substantial equivalence.

8. The sample size for the training set

Not applicable. There is no mention of a training set for an algorithm.

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

Not applicable. There is no mention of a training set or ground truth.

Summary of what is available in the document:

Intended Use: The Tri-Polar System is indicated for total reconstruction of the hip joint for conditions such as non-inflammatory degenerative joint disease (including osteoarthritis and avascular necrosis), rheumatoid arthritis, correction of functional deformity, treatment of specific femoral fractures, and revision of previously failed total hip arthroplasty due to recurrent dislocations. It is for cemented or press-fit application in skeletally mature individuals.
Device Description: The Tri-Polar System consists of a Bi-Polar femoral head articulating with an acetabular liner that fits into a standard acetabular component. It essentially adds an acetabular bearing component to a Bi-Polar hip replacement. Key features include:
- Tri-Polar liners designed to fit into approved Biomet RingLoc® acetabular shells.
- Locking mechanism (RingLoc®) between liner and shell.
- All-polyethylene or metal-backed acetabular cups with specific features for cement interdigitation or X-ray visualization.
- Bi-Polar femoral head with a modular head captured by a polyethylene insert.
- Provides a minimum polyethylene thickness of 4.8mm, which is greater than the general standard of 4.0mm.
- Claims no new technology, but rather combines existing technology.
Potential Risks: The risks are the same as with any joint replacement device, including fracture of components, cardiovascular disorders, implant loosening/migration, soft tissue imbalance, deformity, tissue growth failure, delayed wound healing, metal sensitivity, bone fracture, hematoma, blood vessel damage, nerve damage, excessive wear, infection, dislocation, and breakdown of the porous surface.
Substantial Equivalence: The Tri-Polar Acetabular System is described as similar to previously marketed devices, specifically a traditional hip device with the addition of a Bi-Polar bearing surface. Predicate devices listed are: THARIES Surface Replacement System, Indiana Conservative Hip, and Mallory Head Total Hip. The FDA found the device substantially equivalent for its stated indications for use.

In conclusion, this document is a regulatory submission demonstrating substantial equivalence for a medical device (hip prosthesis) and does not contain the kind of study data or acceptance criteria typically associated with performance evaluations for AI or diagnostic devices as implied by your detailed request.

Summary

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SEP 1 0 1999

SUMMARY OF SAFETY AND EFFECTIVENESS

SPONSOR:	Biomet, Inc.P.O. Box 587Airport Industrial ParkWarsaw, Indiana 46581-0587
CONTACT PERSON:	Michelle L. McKinley
DEVICE NAME:	Tri-Polar System
CLASSIFICATION NAME:	Prosthesis, hip, semi-constrained metal/polymer, cementedProsthesis, hip, semi-constrained metal/polymer, uncemented

INTENDED USE:

The Tri-Polar System is indicated for use in patients requiring total reconstruction of the hip joint due to the following:

a.) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
b.) Rheumatoid arthritis.
c.) Correction of functional deformity.
d.) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
e.) Revision of previously failed total hip arthroplasty due to recurrent dislocations.

The Tri-Polar System is intended for cemented or press-fit application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.

DEVICE DESCRIPTION:

The Tri-Polar System consists of an all polyethylene or metal backed acetabular cup with a polyethylene liner designed to fit on a Bi-Polar head. The Bi-Polar femoral head component

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contains a modular head, which is attached to the femoral stem component. In other words, the Tri-Polar system adds an acetabular bearing component to a Bi-Polar hip replacement.

The Tri-Polar System does not incorporate any new technology that has not previously been available. The device simply combines this technology.

POTENTIAL RISKS:

The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:

Fracture of the component Cardiovascular disorders Implant loosening/migration Soft tissue imbalance Deformity of the joint Tissue growth failure Delayed wound healing Metal sensitivity
Bone fracture Hematoma Blood vessel damage Nerve damage Excessive wear Infection Dislocation Breakdown of the porous surface

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SUBSTANTIAL EQUIVALENCE:

The Tri-Polar Acetabular System is similar to previously marketed devices. The device is similar to a traditional hip device consisting of a femoral stem, modular head, and metal backed polyethylene component, with the addition of a Bi-Polar bearing surface between the modular head and acetabular bearing surface. Direct comparison was made with the following predicates:

THARIES Surface Replacement System Indiana Conservative Hip Mallory Head Total Hip

000137

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

SEP 1 0 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Michelle L. McKinley Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K991990 Trade Name: TriPolar System Regulatory Class: II Product Code: KWY and LPH Dated: June 4, 1999 Received: June 14, 1999

Dear Ms. McKinley:

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. Michelle L. McKinley

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,

to colle

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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Page | of |

510(k) Number if Known:_K991990 Device Name: Tri-Polar System

The indications for use are:

ﻟﻢ ﺍﻟﻤﺴﺎﻫﻤﺔ ﺍﻟﻤﺴﺘﻤﺮ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍ .

a.) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
b.) Rheumatoid arthritis
c.) Correction of functional deformity
d.) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
e.) Revision of previously failed total hip arthroplasty due to recurrent dislocation.

The Tri-Polar System is intended for cemented or ress-fit application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ X (Per CFR 801.109)

or Over the Counter Use (Optional Format 1-2-96)

bcoolly
Division Sign-Off

(Division agn-om
Division of General Restorative Devices K991990
510(k) Number.

000004

Regulation Number and Section

§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.