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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) or congenital dysplasia of the hip (CDH)
  The Corin Metafix Hip Stem is intended 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 (TiAL,V ) alloy for surgical implant applications, conforming to ASTM F136-11 and is coated with plasma sprayed hydroxyapatite conforming to ASTM F-1185-03(2009). The stem is indicated for use with Corin CoCr modular femoral heads and ceramic modular femoral heads with a 12/14 taper. (NOTE : the ceramic modular heads are not subject of this 510(k) submission.) The stem is available in nine sizes, each available in three offsets including standard (135°), lateralized 135°, and standard (125°).

The Corin Bipolar Head (K925897) is comprised of an outer CoCr shell, an inner liner of ultra high molecular weight polyethylene (UHMWPE), and an inner CoCr head. The Bipolar head is available in a range of outer diameter sizes and a variety of head offsets and is compatible with all Corin 12/14 taper femoral stems. The Corin Optimom Modular Head (K111911) is a polished, truncated CoCr alloy sphere with a high tolerance internal female taper and is available in a range of diameters with a variety of offsets. It is compatible with Corin 12/14 taper titanium and stainless steel femoral stems. The Bipolar and the Optimom Modular Heads are indicated for hip hemi-arthroplasty.

The purpose of this submission is to modify the labeling for the Metafix Femoral Hip Stem to include hip hemi-arthroplasty to the indications for use when the stem is mated with a Corin CoCr hemi-arthroplasty femoral head.

The provided text describes a 510(k) premarket notification for a medical device, the Corin Metafix Femoral Stem for Hemi-arthroplasty. This document is a regulatory submission for pre-market clearance, not a study evaluating device performance against acceptance criteria in the way a clinical trial would.

Here's an analysis based on the information provided, specifically addressing why certain sections of your request cannot be fulfilled:

1. Table of Acceptance Criteria and Reported Device Performance

This information is typically found in a clinical study report or a design verification/validation report, neither of which is present in the provided 510(k) summary. The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against pre-defined acceptance criteria through a specific study.

The document states:

• "A comparison of design, materials, size range, and indications for use demonstrate substantial equivalence with the predicate components."
• "Testing was submitted in the predicate 510(k) submissions and as demonstrated in the substantial equivalence table, the Metafix Femoral Stem, when coupled with the Corin hip hemi-arthroplasty heads is substantially equivalent to the predicate devices and expected to be safe and effective for the proposed indications."

Therefore, there are no specific performance acceptance criteria or reported device performance metrics in this document. The "performance" is implicitly tied to the established performance of the predicate devices.

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. No "test set" in the context of a clinical study or performance evaluation is discussed. The submission relies on equivalence to predicate devices, which would have had their own historical data, but that data is not detailed here.

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 "ground truth" establishment by experts for a test set is described.

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

Not applicable. No adjudication method is described as there is no test set in the context of this submission.

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 physical hip prosthesis, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not applicable. This device is a physical hip prosthesis, not an algorithm.

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

Not applicable. No specific ground truth determination process is described for the device itself. The established safety and effectiveness of the predicate devices serve as the "ground truth" for the equivalence claim.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary of the Study (as described in the document):

The document describes a Substantial Equivalence Study documented in a 510(k) premarket notification (K120362).

• Study Goal: To demonstrate that the Corin Metafix Femoral Stem for Hemi-arthroplasty is substantially equivalent to legally marketed predicate devices, particularly for an expanded indication for hip hemi-arthroplasty.
• Methodology:
  • Comparison to Predicate Devices: The Metafix Femoral Stem (K082525), Corin Optimom Modular Heads (K111911), and Corin Bipolar Heads (K925897) were identified as predicate devices.
  • Basis of Equivalence: The submission argues that the Corin Metafix Hip Stem, when used for hemi-arthroplasty with compatible Corin CoCr hemi-arthroplasty femoral heads, is substantially equivalent based on:
    • Identical Intended Use/Indications for Use (for the heads): The Optimom and Bipolar heads are identical to predicate femoral heads in these aspects.
    • Identical Design, Materials, and Sizes: For the Metafix Femoral Stem, it is identical to the previously cleared Metafix Femoral Stem (K082525) in materials and sizes. The subject of the submission is a modification of Indications for Use.
    • Similar Components: The inner 26mm Eurocone CoCr femoral head of the Corin Bipolar Head is manufactured of the same material, is similar in design, and is within the range of previously indicated compatible components for the Metafix Femoral Stem.
  • Non-Clinical Testing: The document states, "Testing was submitted in the predicate 510(k) submissions." This implies that the current submission relies on the non-clinical testing performed for the predicate devices to support the equivalence claim, rather than presenting new non-clinical tests for the modified indication. This non-clinical data would have included mechanical testing, material characterization, etc.
  • Clinical Testing: The document explicitly states, "Clinical testing was not necessary to determine substantial equivalence between the Metafix Femoral Stem for total hip arthroplasty and the Metafix Femoral Stem for Hemi-arthroplasty." This indicates that no new clinical study was conducted for this specific submission to demonstrate performance.

In essence, the "study" is a regulatory comparison against existing, cleared devices, rather than a de novo performance study against defined acceptance criteria.

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