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The Trinity™ Dual Mobility System is intended for use in the following indications:

• 1. Non-inflammatory degenerative joint disease, including osteoarthritis & avascular necrosis
• 2. Rheumatoid Arthritis
• 3. Correction of functional deformity
• 4. Revision of previously failed total hip arthroplasty,
• 5. Patients at increased risk of dislocation
• 6. Developmental dysplasia of the hip (DDH)

The TrinityTM Dual Mobility System is indicated for cementless use only.

The Trinity™ Dual Mobility System is a modular system consisting of two articulating surfaces in the same joint space. The system includes a highly polished Cobalt Chromium Alloy (CoCr) liner that articulates with an ECiMa™ (Vitamin E Ultra-High-Molecular-Weight Polyethylene) mobile insert. A Trinity™ femoral head, 22mm or 28mm CoCr or 28mm BIOLOX® delta heads, articulates within the ECiMa™ mobile insert to allow for a second articulation. The Trinity™ Dual Mobility System is intended to be used only with compatible Trinity™ acetabular Shells. The Trinity™ Dual Mobility System is designed for use with any Corin femoral stem with a 12/14 taper connection. The Trinity™ Dual Mobility System is intended for use in primary and revision total hip arthroplasty (THA) to provide increased stability and reduce pain by replacing the hip joint articulation where there is evidence of sufficient sound bone to seat and support the components.

The Trinity™ Dual Mobility System is intended to be used with the following approved devices:

• Trinity™ Acetabular Shells (Sizes 2- 5) (K093472, K123705, K122305, K130128) .
• 28mm CoCr heads (K110087, K131647) .
• . 28mm BIOLOX® delta Ceramic Heads (K103120)

This document is a 510(k) premarket notification for a medical device called the "Trinity Dual Mobility System," which is a hip prosthesis. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy in a de novo manner. Therefore, the information provided does not detail an acceptance criteria table or a study proving the device meets an algorithm's acceptance criteria in the way one might expect for a digital health or AI-driven device.

Based on the provided text, here's an analysis of the "acceptance criteria" and "study" that relate to this medical device:

1. A table of acceptance criteria and the reported device performance:

The document does not present a formal table of acceptance criteria with specific numerical targets for performance in the context of an algorithm or diagnostic accuracy. Instead, the "acceptance criteria" for this device's FDA clearance revolved around demonstrating substantial equivalence to existing predicate devices through non-clinical testing.

The acceptance criteria are implied by the types of non-clinical tests performed and their successful outcomes, which showed the device is "expected to be safe and effective."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

For this type of device (hip prosthesis), the "test set" refers to the physical prototypes and materials subjected to non-clinical mechanical and biological testing.

• Sample Size: The document does not specify the exact sample size for each non-clinical test (e.g., how many liners were subjected to wear testing or how many components to push-out tests). This level of detail is typically found in the full test reports, not the 510(k) summary.
• Data Provenance: The tests were conducted to evaluate the device itself. There's no "country of origin for data" in the sense of patient data. The tests would have been performed in a laboratory setting, likely in the country of manufacture or a certified testing facility.

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):

This question is not applicable to a physical medical device like a hip prosthesis in the context of its 510(k) submission for substantial equivalence. "Ground truth" and "experts" in this sense typically refer to the validation of diagnostic accuracy for software or imaging devices. For this device, standard engineering and materials science testing methods are used, and the "ground truth" is established by adherence to recognized ASTM or ISO testing standards. The experts involved would be qualified engineers and scientists in fields such as mechanical engineering, materials science, and biocompatibility testing. Their qualifications are not specified in this summary.

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

Not applicable. Adjudication methods like "2+1" are used in studies involving human interpretation (e.g., radiologists reviewing images) to resolve discrepancies. The non-clinical tests for this device involve objective measurements against predetermined acceptance limits based on engineering standards.

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. MRMC studies are associated with the evaluation of diagnostic performance for imaging systems or AI algorithms where human interpretation plays a role. This document concerns a physical implant.

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

Not applicable. This device is not an algorithm.

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

The "ground truth" for the non-clinical testing of this device is established by:

• Engineering Standards: Compliance with industry-recognized ASTM, ISO, or other relevant standards for mechanical strength, wear, corrosion, and material properties.
• Predicate Device Performance: The performance characteristics of the legally marketed predicate devices serve as an established baseline that the new device must meet or exceed to demonstrate substantial equivalence.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of a physical hip prosthesis device or its 510(k) clearance process. This terminology applies to machine learning algorithms.

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

Not applicable. As there is no training set, there is no ground truth for it.

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