Tri-Fit Total Hip System is indicated for the relief of pain and restoration of hip function following the effects of osteo, rheumatoid and inflammatory arthritis, post-traumatic disease effects, hip fractures, avascular necrosis and total hip revision. Tri-Fit Hip System Components are intended to be used in press-fit applications or with bone cement.

Device Description

The Tri-Fit Femoral Stem is a modular stem that accepts femoral heads onto its 12/14 Eurocone male taper (either cobalt-chrome or ceramic femoral heads). The stem substrate is made from a Ti6Al4V and is proximally coated with commercially pure titanium plasma spray. The stem is available in six (6) sizes ranging from 7.5mm to 20mm distal diameter. Four (4) modifications made to the CTi II femoral stem are comprised in the Tri-Fit femoral stem: Modifications to proximal surface coating, distal surface finish, trunnion dimensions and addition of stem introducer holes. These changes do not effect the fundamental scientific technology or the indications for use.

AI/ML Overview

This document is a 510(k) Summary submission for the Tri-Fit Femoral Hip System. It is a premarket notification for a medical device seeking clearance from the FDA, asserting substantial equivalence to a predicate device. This type of submission DOES NOT include acceptance criteria and a study that proves the device meets the acceptance criteria in the way you've outlined for performance studies.

Here's why and what information is provided:

This 510(k) submission is focused on demonstrating substantial equivalence to an already marketed device (the CTi II femoral stem), not on proving performance against specific acceptance criteria for a new, novel technology. Therefore, many of your requested points, particularly those related to clinical studies, ground truth establishment, expert review, MRMC studies, and detailed performance metrics, are not applicable in this context.

The "study" mentioned is bench testing to validate modifications, not a clinical trial or performance study against specific clinical acceptance criteria.

Here's a breakdown of the available information based on your request:

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

Not applicable in the format requested for clinical performance. This document does not present clinical acceptance criteria or clinical performance data.
What's available: The submission states that "Bench testing was carried out to validate the modifications as determined by the Risk Analysis provided in Section 9. The findings indicate that these design modifications will not change the safety or efficacy of the previous design."
- This implies that the acceptance criteria for the bench testing were that the modifications not adversely affect the safety or efficacy properties of the predicate device.
- The "reported device performance" is that the modifications did not change the safety or efficacy of the previous design. However, specific quantitative results from this bench testing are not provided in this summary. It directs readers to "Section 7, pages 1 and 2" which are not included in the provided text.

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

Not applicable. This pertains to clinical studies, which were not conducted for this 510(k) submission. The "test set" would refer to the samples used in the bench testing. The sample size for this bench testing is not specified in the provided text, nor is the provenance of any data (as it's bench testing, not human subject data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in this context typically refers to clinical diagnosis or outcome, which is not established for bench testing on a device modification. The decision of substantial equivalence is made by the FDA based on the provided documentation, not by external experts establishing ground truth for a test set.

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

Not applicable. This concerns adjudication of expert opinions in clinical studies.

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 is a device modification submission for a physical implant, not an AI or imaging device that would involve human readers or AI assistance.

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

Not applicable. This question is for AI/software devices.

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

Not applicable for clinical ground truth. For the bench testing, the "ground truth" would be the engineering specifications and performance characteristics of the predicate device, against which the modified device's performance (e.g., mechanical properties) would be compared to ensure equivalence. This "ground truth" is inherent to the design and testing standards of the predicate device.

8. The sample size for the training set

Not applicable. This question is for AI/machine learning models.

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

Not applicable. This question is for AI/machine learning models.

Summary of Relevant Information from the Provided Text:

Acceptance Criteria (Implied for Bench Testing): The modifications to the Tri-Fit Femoral Stem (compared to the CTi II femoral stem) must not change the safety or efficacy of the previous design.
Study Proving Acceptance: Bench testing was carried out to validate the four modifications.
- Modifications Tested:
  1. Addition of unalloyed titanium plasma sprayed coating to the proximal portion of the stem.
  2. Change 11/13 trunnion taper dimensions to Eurocone 12/14.
  3. Addition of two holes in the proximal face for stem introducer instrument attachment.
  4. Change polished finish of distal stem to shotblast finish.
Reported Performance: "The findings indicate that these design modifications will not change the safety or efficacy of the previous design." Specific quantitative data or detailed results are referred to as being in "Section 7, pages 1 and 2," which are not provided.
Data Provenance/Study Type: Bench testing. No information on sample size or specific test methodologies is provided in this summary.
Purpose: To demonstrate substantial equivalence to a predicate device (CTi II femoral stem), rather than de novo market clearance based on extensive clinical trial data against specific performance criteria.

Summary

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FEB 1 5 2001

KO10243 510(k) SUMMARY

Device: Tri-Fit Femoral Hip System

Date: 01/23/01

Applicant's name:

Corin USA 10500 University Center Drive, Suite 190 Tampa, FL 33612

Phone: (813) 977-4469 (813) 979-0042 Fax:

Contact person:

Joel Batts, Regulatory Affairs Manager

Classification name: Prosthesis, hip, semi-constrained, metal/polymer, uncemented

Product codes: LWJ

C.F.R. section: not specified

Device class: II

Classification panel: Orthopedic

Indications for use

Tri-Fit Total Hip System is indicated for the relief of pain and restoration of hip function following the effects of osteo, rheumatoid and inflammatory arthritis, post-traumatic disease effects, hip fractures, avascular necrosis and total hip revision. Tri-Fit Hip System components are intended to be used in press-fit applications or with bone cement.

Device description

The Tri-Fit Femoral Stem is a modular stem that accepts femoral heads onto its 12/14 Eurocone male taper (either cobalt-chrome or ceramic femoral heads). The stem

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substrate is made from a Ti6Al4V and is proximally coated with commercially pure titanium plasma spray. The stem is available in six (6) sizes ranging from 7.5mm to 20mm distal diameter. Four (4) modifications made to the CTi II femoral stem are comprised in the Tri-Fit femoral stem: Modifications to proximal surface coating, distal surface finish, trunnion dimensions and addition of stem introducer holes. These changes do not effect the fundamental scientific technology or the indications for use.

Substantial equivalence basis

The sponsor claims substantial equivalence (SE) of the Tri-Fit femoral stem to the CTi II femoral stem on which the Tri-Fit is based. The Tri-Fit contains four (4) modifications of the original CTi II stem which are as follows:

Addition of unalloyed titanium plasma sprayed coating to proximal portion of stem

Change 11/13 trunnion taper dimensions to Eurocone 12/14
Addition of two holes in the proximal face, lateral to the trunnion for stem introducer instrument attachment
Change polished finish of distal stem to shotblast finish

Bench testing was carried out to validate the modifications as determined by the Risk Analysis provided in Section 9. The findings indicate that these design modifications will not change the safety or efficacy of the previous design. Summary results are located in Section 7, pages 1 and 2.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Public Health Service

FEB 1 5 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Joel K. Batts Regulatory Affairs Manager Corin U.S.A. 10500 University Center Drive, Suite 109 Tampa, Florida 33612

Re: K010243 Trade Name: Tri-Fit Femoral Stem Regulatory Class: II Product Codes: LWJ and LZO Dated: January 24, 2001 Received: January 25, 2001

Dear Mr. Batts:

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 control provisions of the Act. The general control 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.

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.

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Page 2 - Mr. Joel K. Batts

If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific acvice for your as ic devices), please contact the Office of Compliance at additionally 607.10 for mire craguestions on the promotion and advertising of your device, (201) 594-4639. Additionally, 101 quest at (301) 594-4639. Also, please note the regulation prease contact the Orice of Comphanse (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionnees and more (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark A Millman

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

Enclosure

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Page _ of _

510(k) NUMBER (IF KNOWN):_____________________________________________________________________________________________________________________________________________________

DEVICE NAME: Tri-Fit Total Hip System

INDICATIONS FOR USE:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark n Mellers

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

510(k) Number. K010243

Regulation Number and Section

§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.