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Trident Acetabular Component System:
Painful, disabling joint disease of the hip from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Restoration ADM Acetabular Cup and MDM Liner Systems:
The indications for use for total hip arthroplasty include:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and,
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
6. Dislocation risks
   RESTORATION ADM HA Cups and MDM Liners are intended for cementless use only.

Accolade II Hip System:
The indications for use of the total hip replacement prostheses include:

1. noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
2. rheumatoid arthritis;
3. correction of functional deformity;
4. revision procedures where other treatments or devices have failed; and,
5. nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
   Additional indication specific to use of ACCOLADE II Femoral Stems with compatible Howmedica Osteonics Constrained Liners:
6. When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability.
   ACCOLADE II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

The subject X3 UHMWPE Acetabular Inserts for the Trident, Restoration ADM and MDM Liner systems are a modified version of their respective predicate devices. The subject device designs are identical to their respective predicates, but the subject devices will have a different method of terminal sterilization (ethylene oxide) and will be formed by consolidating Type 1 (GUR1020) resin via conventional methods which meet the specifications of ASTM F648.

The subject Accolade II Hip System is identical to the predicate Accolade II Hip System, with the exception that it has additional compatibility with new instrumentation which utilizes an addendum to the current surgical protocol.

The provided text is a 510(k) summary for joint replacement devices (Trident® X3® UHMWPE Acetabular Inserts, Restoration ADM® and MDM® X3® UHMWPE Acetabular Inserts, Accolade® II Hip System). It describes the devices, their intended use, and the non-clinical testing performed to establish substantial equivalence to predicate devices.

Based on the provided text, the following information can be extracted regarding acceptance criteria and the study that proves the device meets the acceptance criteria:

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

The document explicitly states: "The subject device designs are identical to their respective predicates... The subject Accolade II Hip System is identical to the predicate Accolade II Hip System..." and "The subject X3 UHMWPE Acetabular Inserts are identical in intended use, indications, design, and operational principles to the predicate devices."

The performance is implicitly compared to the performance of the legally marketed predicate devices. The acceptance criteria for the new devices are that their performance, after modifications (sterilization method and instrumentation compatibility), remains equivalent to the predicate devices. The non-clinical tests serve to confirm this equivalence.

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

• Sample Size for Test Set: Not explicitly stated in terms of a "test set" for a diagnostic algorithm. The document refers to "non-clinical laboratory testing." For these tests (e.g., material testing, mechanical testing), typical sample sizes would be based on statistical power analyses for the specific test, but these details are not provided.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable in the context of this submission. The tests are laboratory-based and non-clinical.

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

This information is not applicable. The submission is for orthopedic implants and relies on engineering and biological testing, not expert interpretation of diagnostic images or clinical data to establish a ground truth.

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

This information is not applicable, as there is no diagnostic test set or human interpretation involved to warrant an adjudication method.

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:

This is not applicable. The device is a medical implant (hip replacement components), not an AI diagnostic tool or software-as-a-medical device, therefore no MRMC study was performed.

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

This is not applicable as the device is a medical implant, not an algorithm.

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

The "ground truth" for this device's performance is established by engineering standards (e.g., ASTM F648, ISO/DIS 14242-1, ISO 11135:2014) and regulatory guidance (e.g., FDA Guidance for UHMWPE, ISO 10993 for biocompatibility). The performance of the modified device is compared against these established standards and the known performance characteristics of the legally marketed predicate devices to demonstrate substantial equivalence.

8. The sample size for the training set:

This is not applicable as the submission is for a medical implant and not an AI/ML algorithm that requires a training set.

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

This is not applicable.

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