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The indications for the Corin TriFit TS Hip as a total hip arthroplasty, and when used in combination with a Corin hemi arthroplasty head, as a hip hemi-arthroplasty, include:

• · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• · Rheumatoid arthritis
• · Correction of functional deformity
• · Treatment of non-union and femoral neck fractures
• · Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)

The TriFit TS Hip is intended for cementless use only.

The Corin TriFit TS Hip is a double tapered-wedge blade stem design manufactured from Ti6Al4V Titanium alloy (ASTM F-136-08) with a layer of commercially pure titanium (BS ISO 5832-2: 1999) and calcium phosphate (BONIT®) coating (ASTM F1609-08) applied. The TriFit TS Hip is available in 11 sizes in standard and lateralized offsets with a 127° CCD angle. The device is intended to be used with Corin 12/14 modular taper heads.

The TriFit TS Hip is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

The Corin TriFit TS Hip Stem was originally cleared in K121563. The purpose of this submission is to modify the labeling to remove an indications for use for the TriFit TS Hip Stem, for clarity to ensure safe or effective use. The design and compatible components for use with the Corin TriFit TS Hip stem subject of this submission are identical to that of the predicate device K121563.

This document is a 510(k) premarket notification for a medical device called the Corin TriFit TS Hip. It is a submission to the FDA seeking approval to market the device based on its substantial equivalence to a legally marketed predicate device.

The provided document does not contain information about acceptance criteria and a study proving the device meets those criteria, as it is related to an AI/ML device. The Corin TriFit TS Hip is a physical medical device (hip prosthesis), and the submission focuses on its design, materials, intended use, and equivalence to a predicate device, rather than a performance study with acceptance criteria in the context of AI/ML.

Therefore, the requested information elements related to AI/ML device performance, such as sample sizes for test/training sets, expert consensus, MRMC studies, or standalone algorithm performance, are not applicable and not present in this document.

The document states:

• "Clinical testing was not necessary in this Traditional 510(k)." (Page 5, Section 13)

This indicates that clinical studies, which would typically contain acceptance criteria and performance data, were explicitly not required for this particular submission. The substantial equivalence was established based on non-clinical aspects like design, materials, coatings, and indications for use, as well as comparison to a previously cleared predicate device (Corin TriFit TS Hip Stem, K121563).

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The indications for the Corin TriFit TS Hip as a total hip arthroplasty, and when used in combination with a Corin hemi arthroplasty head, as a hip hemi-arthroplasty, include:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
• Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
  The TriFit TS Hip is intended for cementless use only.

The Corin TriFit TS Hip is a double tapered-wedge blade stem design manufactured from Ti6Al4V Titanium alloy (ASTM F-136-08) with a layer of commercially pure titanium (BS ISO 5832-2: 1999) and calcium phosphate(BONIT®)coating(ASTM F1609-08) applied. The TriFit TS Hip is available in a range of sizes in standard and lateralized offsets with a 127° CCD angle. The device isintended to be used with Corin 12/14 modular taper heads.
The TriFit TS Hip is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients wherethere is evidence of sufficient sound bone to seat and support the components.

Here's a breakdown of the acceptance criteria and study information for the Corin TriFit TS Hip, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Physical Testing: For both femoral hip stem fatigue and femoral stem neck fatigue, 6 stems were tested. The text does not specify the sample size for the range of motion analysis or the various coating tests, but it indicates these tests were performed on the device or its components.
• Data Provenance: The text does not explicitly state the country of origin for the non-clinical testing. It is implied these tests were conducted as part of the device development and regulatory submission process, likely under controlled laboratory conditions, making them prospective in nature for the purpose of demonstrating device performance against established standards.

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

• This device approval is based on non-clinical testing (mechanical, material, and performance evaluations), not clinical data or expert interpretation of medical images. Therefore, the concept of "experts establishing ground truth for a test set" in the context of clinical or diagnostic performance is not directly applicable here. The "ground truth" is defined by the established industry standards and test methods (e.g., ISO, ASTM).

4. Adjudication Method for the Test Set

• Not applicable as this is non-clinical performance testing against pre-defined engineering standards, not a diagnostic or clinical efficacy study requiring expert adjudication of results. The results are quantitative measurements against pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• Not applicable. This document describes the substantial equivalence of a hip prosthesis (a physical medical device), not an AI-assisted diagnostic or triaging tool.

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

• Not applicable. This is not a software or AI-based device.

7. The Type of Ground Truth Used

• The "ground truth" for the non-clinical tests was established by international and national engineering standards and specifications (e.g., ISO 7206-4:2010, ISO 7206-6:1992, ASTM F2068-03, ISO 21535:2009, ASTM F1854) and FDA guidance documents for orthopedic implants and coatings. These standards define the physical properties, mechanical endurance, and other performance characteristics that a hip prosthesis must meet.

8. The Sample Size for the Training Set

• Not applicable. The concept of a "training set" refers to data used to train machine learning models. This device is a physical hip prosthesis, and its evaluation is based on non-clinical engineering tests.

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

• Not applicable, as there is no "training set" in the context of this device's evaluation.

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