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The indications for the Corin Metafix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hemi-arthroplasty femoral heads, as a 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) and congenital dysplasia of the hip (CDH)
  The Corin Metafix Hip Stem is indicated for cementless use only.

The Corin Metafix Hip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from Titanium (TiAL6V4) alloy for surgical implant applications, conforming to ASTM F136-11 and is coated with plasma sprayed hydroxyapatic conforming to ASTM F-1185-03(2009). The stem is currently available in nine sizes (2-10), each available in three offsets including Standard (1359), Lateralized 135°, and Standard (125°).
The Corin Metalix Hip Stem was originally cleared in K082525. This submission is for one additional stem size, size 1 in two available offsets, Standard (1359 and Lateralized 135°. Like the originally cleared Metafix Stems, the additional stem size features a low profile lateral shoulder, a tapered metaphyseal flare as well as a vertically and horizontally grooved stem, providing for rotational and axial stability.
The indications and compatible components for use with the Corin Metafix size 1 are identical to that of the predicate devices (K082525 & K120362).

Here's an analysis of the provided text regarding the acceptance criteria and study for the Corin Metafix Hip Stem:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The non-clinical testing section only mentions "mechanical fatigue testing of the neck and stem" without specifying the number of samples or units tested.
• Data Provenance: Not explicitly stated. The nature of the testing (mechanical fatigue) suggests laboratory-based testing rather than patient data.

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

• Not applicable. This study involved non-clinical mechanical testing, not a diagnostic or prediction study requiring expert-established ground truth from images or clinical assessments.

4. Adjudication Method for the Test Set

• Not applicable. This study involved non-clinical mechanical testing, not a diagnostic or prediction study requiring adjudication.

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

• No. This is a submission for a hip stem, a medical device, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant.

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

• No. As mentioned above, this is for a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on mechanical test standards and engineering principles. The device's ability to withstand specified loads and cycles (fatigue testing) according to ASTM standards (F136-11, F-1185-03(2009)) serves as the basis for determining its safety and effectiveness.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

• Not applicable. As there is no training set for a machine learning model, this question is irrelevant.

Summary of the Study:

The study described is a non-clinical engineering evaluation to demonstrate the substantial equivalence of an additional size (size 1) of the Corin Metafix Hip Stem to previously cleared predicate devices. The primary method of proof relies on mechanical fatigue testing of the neck and stem. The results of this testing are expected to show that the new size is safe and effective for its proposed indications and design compared to the predicate devices. No clinical testing, human-reader studies, or AI-related evaluations were deemed necessary for this submission. The "ground truth" for this type of device is adherence to recognized mechanical testing standards and performance comparable to legally marketed predicates.

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