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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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The modification does not alter the intended use of the predicate systems as cleared in the referenced premarket notifications. The subject ADM and ADM/MDM Acetabular Inserts are sterile, single-use devices intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. These devices are intended to be used only with currently available Howmedica Osteonics 22.2 mm and 28 mm diameter femoral heads.

The indications for use for total hip arthroplasty include:

• Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis: l )
• 2. Rheumatoid arthritis:
• 3. Correction of functional deformity:
• 4. Revision procedures where other treatments or devices have failed:
• 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

The ADM and MDM Systems are intended for cementless use only.

The Restoration® Anatomic Dual Mobility (ADM) and Modular Dual Mobility (MDM) Systems utilize Duration® and X3® Polyethylene Acetabular Inserts that retain a femoral head. The outer diameter of the insert articulates on the inner surface of either the polished ADM Acetabular Cup or, for certain sizes of inserts, the MDM Acetabular Liner. The Duration® and X30 polyethylene inserts therefore function as a dual mobility device as there are two articulating surfaces.

The provided submission is a 510(k) summary for the Restoration® Anatomic Dual Mobility™ and Modular Dual Mobility™ Systems Duration® and X3® Acetabular Inserts. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through clinical trials. Therefore, much of the requested information cannot be extracted from this document as it pertains to clinical study results.

Here's a breakdown of what can be inferred and what cannot:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices through engineering and risk analysis, and laboratory testing.

• Device comparison (intended use, materials, operational principles)
• Engineering and risk analysis
• Laboratory testing (Wear, lever-out and pull out force testing, and range of motion analysis) |

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

The document states: "Clinical Testing: Clinical testing was not required for this submission." This indicates there was no clinical "test set" in the context of a traditional clinical study with human subjects. The "test set" for demonstrating substantial equivalence consisted of laboratory tests on the device itself.

• Sample Size: Not specified as it refers to laboratory testing, not human subjects.
• Data Provenance: Laboratory testing.

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

Not applicable. There was no clinical ground truth established by experts for a patient test set as clinical testing was not performed.

4. Adjudication method for the test set

Not applicable, as 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 an orthopedic implant, not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used

For the laboratory testing, the "ground truth" would be the measured physical and mechanical properties of the device, compared against known industry standards, design specifications, and the performance of predicate devices. This is a technical "ground truth" rather than a clinical one.

8. The sample size for the training set

Not applicable. There was no "training set" in the context of machine learning. The design and validation of the device were based on engineering principles and knowledge, not data-driven training.

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

Not applicable. Without a training set, this question is not relevant.

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