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The indications for use of the Trident® Porous Titanium Acetabular Component with Peri-Apatite™ Coating, in keeping with those of other legally marketed Howmedica Osteonics acetabular component systems, are as follows:

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

The Trident® Porous Titanium Acetabular Component with Peri-Apatite™ Coating, when used with the commercially available Trident® UHMWPE Acetabular Insert, is an artificial total hip replacement device which consists of an acetabular shell and a mating insert. Each insert/shell assembly is intended to resurface the acetabulum thereby providing a suitable articulating surface for a mating artificial stem/head combination.

The Trident® Porous Titanium Acetabular Component with Peri-Apatite™ Coating is manufactured from ASTM F-136 Ti6Al-4V ELI alloy, and employs a porous coating fabricated from ASTM F-67 Commercially Pure (CP) Titanium. Overlaying the porous coating is a 20 micron thick layer of Peri-Apatite™ coating.

The Trident® Porous Titanium Acetabular Shells with Peri-Apatite™ Coating are characterized by the following features:

• The outer shell has a single radius (hemispherical) geometry
• A shell substrate composed of titanium alloy (Ti6Al-4V ELI) comparable to that used in other Howmedica Osteonics acetabular components
• A titanium porous coating (CP Titanium) which meets the definition of porous coating outlined in 21 CFR 888.3358, and is comparable to that used in other Howmedica Osteonics hip and knee components
• Peri-Apatite™ coating that is used on the Vitalock® Solid Back Shell with Peri-Apatite™ coating.
• An interior geometry which allows a mating with the Trident® UHMWPE inserts through maximum conformity and a wireless locking mechanism.
• Availability with screw hole options and cluster screw holes which accept Osteonics® 5.5mm and 6.5mm Cancellous bone Screws (K873251, K894124). A dome hole which is compatible with the optional, currently marketed Osteonics® Acetabular Dome Hole Plugs (K942809). The Osteonics® 5.0mm Cancellous Screws are available for use with peripheral screw holes.
• A range of outer diameters from 40 through 82mm in 2mm increments.
• The following shell configurations will be available:
  • dome hole only, no screw holes
  • 2-3 cluster screw holes, and dome hole
  • 3-5 cluster screw holes and dome hole
  • 5 cluster screw holes with 4 inferior screw holes, and dome hole
  • 8-12 multiple dome screw holes and dome hole
  • 5-7 peripheral screw holes and dome hole

Here's an analysis of the provided text regarding the Trident® Porous Titanium Acetabular Component with Peri-Apatite™ Coating, focusing on the acceptance criteria and the study that proves the device meets them.

Disclaimer: This 510(k) summary is for a medical device submitted in 2001. The criteria, methodologies, and regulatory landscape for medical device approval have significantly evolved since then. The information presented here reflects the document's content and not necessarily current best practices or regulatory requirements.

The provided document is a 510(k) Summary for the Trident® Porous Titanium Acetabular Component with Peri-Apatite™ Coating. A 510(k) submission is a premarket notification demonstrating that the device is substantially equivalent to a legally marketed predicate device. This process primarily relies on comparing the new device's technological characteristics and proposed indications for use to those of existing predicate devices, rather than comprehensive clinical studies to establish independent acceptance criteria and direct performance metrics in the way a PMA (Premarket Approval) would.

Therefore, the concept of "acceptance criteria" in this context refers to demonstrating that the new device is as safe and effective as the predicate device(s) through comparison of materials, design, indications, contraindications, and performance testing where relevant (e.g., sterilization, biocompatibility, mechanical testing – though specific details of these tests are often summarized rather than fully detailed in the 510(k) summary).

There is no explicit table of discrete acceptance criteria with numerical targets and reported device performance presented in this 510(k) summary. The "study" that proves the device meets the acceptance criteria is primarily the comparative analysis to the predicate devices, supported by characterization of the unique features (like the Peri-Apatite™ coating).

Analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, a formal table is not present in the 510(k) summary. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate devices. The document implies performance through:

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

The document does not specify a "test set" in the context of clinical data or human subject testing for this 510(k) submission. The "test set" here would refer to the technical data and comparisons made to demonstrate substantial equivalence.

• Sample Size: Not applicable in the context of clinical test sets. The "sample" is material and design specifications, and the comparison against predicate devices.
• Data Provenance: Not applicable in the context of patient data. The provenance is internal company data for material characterization and engineering specifications, compared against regulatory standards and predicate device information.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the 510(k) summary. For a 510(k) submission based on substantial equivalence, the "ground truth" is largely established by existing regulatory standards, predicate device performance, and the expertise of the manufacturing team in design controls and testing protocols. No external expert panel for ground truth establishment for a test set is mentioned.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a human 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 hip implant, not an imaging or AI diagnostic tool. MRMC studies are irrelevant to this product's approval pathway as described here.

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

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

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is based on:

• Predicate Device Equivalence: The primary ground truth is the safety and effectiveness of the legally marketed predicate devices (Trident® Porous Titanium Acetabular Component K010170 and Vitalock® Solid Back Shell with Peri-Apatite™ Coating K971206).
• Regulatory Standards: Compliance with relevant ASTM material standards (F-136, F-67) and FDA regulations (21 CFR 888.3358 for porous coating, "Calcium Phosphate [Ca-P] Coating Draft Guidance").
• Engineering and Material Characterization: Internal testing and analysis demonstrating the device's material properties, geometric conformity, and coating characteristics meet established specifications and are comparable to predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model. There is no concept of a "training set" in the context of this submission.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

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