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The Corin Unipolar Modular Head is indicated for hemi-arthroplasty in cemented and uncemented primary or revision femoral stem applications whose indications include procedures for patients suffering pain and disability due to osteoarthritis, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture and abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal and acetabular replacement is either undesirable or not required.

The Corin Unipolar Modular Head is a polished, truncated sphere with a high tolerance internal female taper. It is designed to be used with a number of femoral hip stem designs which incorporate a compatible male taper. The Corin Unipolar Modular Head is manufactured from Cobalt-Chrome alloy conforming to ASTM F75 and is available in diameters ranging from 40-56mm and a variety of offsets.

Please find below the requested information regarding the acceptance criteria and study details for the Corin Unipolar Modular Head, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document explicitly states: "Non-Clinical Testing: Non-clinical testing and analysis included Finite Element Analysis, mechanical fatigue testing, mechanical axial pull-off and dimensional comparison." No specific sample size for a "test set" in the context of clinical data is mentioned, as the evaluation was based on non-clinical engineering and material testing. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable to this type of testing.

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

Not applicable. The evaluation relied on engineering and material testing standards, not clinical expert consensus for ground truth.

4. Adjudication method for the test set

Not applicable. There was no clinical test set requiring adjudication.

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 mechanical implant, not an AI-assisted diagnostic or therapeutic tool. No MRMC study was performed.

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

Not applicable. This device is a mechanical implant, not an algorithm.

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

For the non-clinical testing, the "ground truth" was based on established engineering principles, material standards (e.g., ASTM F75), and the performance characteristics of legally marketed predicate devices. The objective was to demonstrate substantial equivalence, meaning the new device performs similarly to or better than existing, cleared devices.

8. The sample size for the training set

Not applicable. This device's evaluation did not involve a "training set" in the context of machine learning or AI.

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

Not applicable. No training set was used.

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The ULTIMA* Unipolar Head is indicated for use in conjunction with a modular femoral stem in partial hip replacement procedures for patients suffering severe pain and disability due to:

1. femoral neck fracture,
2. avascular necrosis of the femoral head,
3. osteoarthritis,
4. abnormalities where:

• the major pathology affects the femoral head,
• the acetabular cavity is normal and not deformed or weakened,
• acetabular replacement is not required or desirable.

The ULTIMA* Unipolar Head is provided in a size range of 38mm to 63mm (outer diameter), in 1mm increments. Sizes from 44mm through 63mm are manufactured as a twopiece assembly. The two pieces are made of cast cobalt-chromium-molybdenum alloy conforming to ASTM F75. Both pieces are treated with hot isostatic pressing and solution annealing. The two cast pieces are machined and then joined permanently by electron beam welding to form a hollow unipolar head. Sizes from 38mm through 43mm are cast from cobalt-chromium-molybdenum alloy as a solid head, and are isostatic pressed and solution annealed before machining. Both of these size ranges are finish machined to the outer diameter size. The outer diameter is highly polished for articulation with the implant recipient's natural acetabulum.

The ULTIMA* Unipolar Head has a tapered bore which can receive a variety of Adapter Sleeves. The adapter sleeves can be tapered on the outside to the mate with the unipolar head, and tapered on the inside to mate with the appropriate femoral stem trunnion. The adapter sleeves are available in a 10/12 taper, in size increments for -3mm, +0mm, +5mm. and +10mm neck lengths; in a 11/13 taper, in size increments for +0mm, +6mm, and +12mm neck lengths: and in a 12/14 taper, in size increments for +0mm, +3.5mm, and +7mm neck lengths. The adapter sleeves are machined from cobalt-chromium-molybdenum alloy in wrought bar form conforming ASTM F799.

The provided text describes the ULTIMA* Unipolar Head and Adapter Sleeves, a medical device for hip replacement procedures. The document focuses on establishing substantial equivalence to previously approved devices rather than presenting a study with specific acceptance criteria and performance metrics in the way one would for a diagnostic AI device.

Therefore, an analysis cannot be provided based on the requested format as it is not applicable to the given text.

Here's why and what information can be extracted:

• No Acceptance Criteria and Reported Device Performance Table: The document does not define specific performance metrics (e.g., accuracy, sensitivity, specificity) or acceptance thresholds for these metrics. Its purpose is to demonstrate substantial equivalence, not to prove standalone performance against defined criteria.
• No Sample Size for Test Set or Data Provenance: This is not a study involving patient data for performance evaluation. It's a regulatory submission for a medical device's physical and functional equivalence to existing devices.
• No Experts Used for Ground Truth: The concept of "ground truth" as it applies to diagnostic or AI performance evaluation is not relevant here. The ground truth for this device would be its mechanical and material properties, which are evaluated through engineering tests and adherence to standards, not expert consensus on patient data.
• No Adjudication Method: Not applicable for a device equivalence submission.
• No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study is for evaluating observer performance (e.g., radiologists) with and without AI assistance. The ULTIMA* Unipolar Head is a physical implant, not a diagnostic tool or AI algorithm.
• No Standalone Performance Study: The document focuses on equivalence to existing devices, not a standalone performance evaluation against clinical outcomes or diagnostic accuracy.
• No Type of Ground Truth (Expert Consensus, Pathology, Outcomes Data): As stated, the "ground truth" for this device relates to its engineering specifications and material properties, not typical clinical or AI ground truth.
• No Sample Size for Training Set: There is no "training set" in the context of this device. This is a manufactured product, not a machine learning model.
• No Ground Truth Establishment for Training Set: Again, not applicable.

Information that can be extracted from the document related to "acceptance" (in the sense of regulatory approval) and "study" (in the sense of engineering analysis):

1. Acceptance Criteria and Reported Device Performance (as inferred from "substantial equivalence"):

The document states: "Furthermore, analysis results demonstrate that the ULTIMA* Unipolar Head and Adapter Sleeves meets the set criteria for the establishment of 'substantial equivalence'."

While not explicitly tabular acceptance criteria like for an AI device, the document implies that the device "meets the set criteria" by demonstrating similarity and comparable intended use, design, and materials to predicate devices. The "performance" is implicitly its ability to meet the same functional requirements as the predicate devices.

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

• Test Set: Not applicable. This document refers to the physical and material properties of the device, not a test set of patient data.
• Data Provenance: The "data" pertains to engineering specifications, material standards (ASTM), and comparative analysis with previously approved devices (K940190 and K902365).

The document is a regulatory submission for a physical medical device, not a clinical study or an AI performance evaluation. The "study" referenced is the analysis performed to demonstrate substantial equivalence based on engineering, material, and design comparisons.

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