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The indications for the Trinity™ EVO Acetabular Shell as a total hip arthroplasty include:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Correction of functional deformity.
• Developmental dysplasia of the hip (DDH)/Congenital dislocation of the hip (CDH)

The Trinity™ EVO acetabular shell is also indicated for use in revisions of a previously failed total hip arthroplasty.

The Trinity™ EVO Acetabular Shell is indicated for cementless use only.

The Trinity™ EVO acetabular shell forms part of a modular acetabular system. The Trinity™ EVO acetabular shell is a hemispherical press fit titanium alloy shell for use with cobalt chrome alloy (Trinity™ Dual Mobility only) or polyethylene liners and a dedicated range of ceramic and cobalt chrome alloy modular 12/14 taper femoral heads providing ceramic on polyethylene and metal on polyethylene articulations for use in total hip arthroplasty (THA) procedures using Corin metal stems with a 12/14 taper connection. The Trinity™ EVO acetabular shell has a porous structure manufactured from titanium alloy powder, produced via additive manufacturing using Laser Powder Bed Fusion (LPBF), and is available with or without an additional layer of electrochemically deposited calcium phosphate. The Trinity™ EVO acetabular shell is provided in sizes permitting the use of titanium bone screws to provide additional fixation, if required. The Trinity™ EVO acetabular shell is also available without screw holes. A titanium occluder is provided to occlude the apical introducer hole.

The Trinity™ EVO acetabular shell is intended for use in primary and revision THA in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged hip joint articulation when there is evidence of sufficient sound bone to seat and support the components.

The provided document is a 510(k) Clearance Letter for the Trinity EVO Acetabular Shell. This type of submission focuses on demonstrating substantial equivalence to a previously cleared device, not necessarily proving clinical efficacy through a direct comparative study like a Multi-Reader Multi-Case (MRMC) study for an AI-powered diagnostic device.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing conducted to show that the new device performs as safely and effectively as its predicate devices, rather than a clinical trial with human readers.

Here's a breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the standards and internal protocols cited for the non-clinical testing. The device is deemed to meet these criteria if the test results demonstrate comparable or acceptable performance to the predicate devices. The document states: "The results of this testing show that the Trinity™ EVO Acetabular Shell is substantially equivalent to the predicate devices."

Table of Acceptance Criteria and Reported Device Performance:

Study Information Specific to the Device Clearance (non-clinical)

The information provided in the 510(k) summary focuses on non-clinical testing. Questions related to "test set," "data provenance," "experts," "adjudication," "MRMC studies," "standalone algorithm performance," and "ground truth" are not applicable in the context of this specific regulatory submission as it's for a physical orthopedic implant, not a diagnostic AI software.

However, based on the general structure, here's what can be inferred or stated as "Not Applicable" for this type of device:

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: For mechanical testing, the "sample size" refers to the number of physical devices or representative specimens tested per condition, as per the respective ASTM/ISO standards. This specific number is not disclosed in the provided summary but would be detailed in the full submission.
   • Data Provenance: The data provenance is from the manufacturing and testing facility of Corin USA Limited, a medical device manufacturer. The tests are "non-clinical" and conducted on physical prototypes/products.

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

   • Not Applicable. This is a physical device, and "ground truth" is established by physical measurements and performance against established engineering standards and specifications, not expert interpretation of medical images or clinical outcomes in a diagnostic context. The "experts" involved would be engineers, materials scientists, and quality assurance personnel.

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

   • Not Applicable. Adjudication relates to resolving discrepancies in expert interpretations, which is relevant for diagnostic studies, not mechanical testing. Test results are objective measurements compared against predefined limits.

4. 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:

   • No. An MRMC study is relevant for evaluating the impact of AI algorithms on human reader performance in diagnostic tasks. This device is a passive, physical implant.

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

   • Not Applicable. This is a physical orthopedic implant, not a software algorithm.

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

   • Engineering Standards and Specifications. The "ground truth" for the device's performance is defined by established international standards (ASTM, ISO) and internal engineering design specifications that ensure the device's mechanical integrity, biocompatibility, and functional characteristics are met.

7. The sample size for the training set:

   • Not Applicable. This is a physical device, not an AI/ML algorithm that requires a "training set." The design and manufacturing processes are refined through engineering development and quality control, not machine learning.

8. How the ground truth for the training set was established:

   • Not Applicable. (See point 7).

In summary, the 510(k) for the Trinity EVO Acetabular Shell demonstrates "substantial equivalence" based on extensive non-clinical (mechanical, materials, and physical) testing to established engineering standards, asserting that it performs as safely and effectively as its predicate devices, rather than through clinical studies involving human readers or AI algorithms.

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