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The Tritanium® Peri-Apatite™ Acetabular Shell is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function.

The indications for use of the total hip replacement prostheses include:

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

Additional indications for use when using constrained liners: The device is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

Additional indications for use when using modular dual mobility (MDM) liners: The device is indicated for use as a component of a total hip prosthesis and 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;
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; and
6. Dislocation risks

The MDM liners are intended for cementless use only. The acetabular shell is intended for cementless use only.

The Tritanium® Peri-Apatite ™ acetabular shells are available in both solid backed and cluster screw-hole designs for cementless, biologic fixation. The Howmedica Osteonics Tritanium® Peri-Apatite™ Acetabular Shell consists of a hemispherical, metallic acetabular shell with a Tritanium® (CPTi) coating referred to as a Particle Sintered Foam (PSF) coating with an overlying Peri-Apatite coating (precipitated calcium phosphate coating). The Peri-Apating process is identical to that cleared in K971206 but to a greater thickness range of 35-75 microns. The Tritanium® CPTi PSF coating originally manufactured from material conforming to ASTM F67 was modified to conform to ASTM F1580. The dual coating (Peri-Apatite™ overlying the PSF coating) at the thickest specification met the definition of a porous coating per 21 CFR 888.3358 with no additional claims over biologic fixation. The dome hole plugs are optional devices which are available to seal the Howmedica Osteonics Tritanium® Acetabular Shells. The plugs are to be threaded into the dome holes of the shell.

The shells will be available in sizes 44-72 mm outside diameter (OD) in 2 mm increments. The acetabular shells are forged from Ti-6Al-4V alloy per ASTM F136; the Tritanium® coating is fabricated from Commercially Pure Titanium per ASTM F1580; and the Peri-Apatite™ coating is a precipitated calcium phosphate coating per ASTM F-1609.

The Tritanium® Peri-Apatite™ Acetabular Shells are compatible with polyethylene Trident® inserts, constrained liners and modular dual mobility liners. The subject shells have an identical insert locking mechanism to that employed with compatible Tritanium acetabular shell system predicates. All shells are single use devices. The outer surface of the acetabular shell has the identical geometry as the predicate Tritanium® Acetabular Shell System determined substantially equivalent via 510(k) K081171.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Tritanium® Peri-Apatite™ Acetabular Shell System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a medical device submission (510(k)) for substantial equivalence, not a detailed performance study with explicit numerical acceptance criteria and reported device performance values in the typical sense of a diagnostic or predictive algorithm.

However, we can infer the "acceptance criteria" as meeting the requirements of the referenced guidance documents and demonstrating substantial equivalence to predicate devices. The "reported device performance" is that it met these criteria.

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

This document describes a submission for a physical medical device (an acetabular shell system), not a software algorithm or AI device that would typically use "test sets" or "training sets" of patient data.

• Sample Size for Test Set: Not applicable. The "test set" here refers to physical samples of the device and its materials, subjected to various mechanical and material property tests. The exact number of samples for each test (e.g., how many shells were fatigue tested) is not specified, but it would be sufficient to meet the requirements of the referenced ASTM standards and FDA guidance documents for device materials and mechanical performance.
• Data Provenance: Not applicable in the context of patient data. The provenance for the testing is "non-clinical laboratory testing" performed by the manufacturer, Howmedica Osteonics Corp., in the USA (implied as they are a US company submitting to the FDA). The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission.

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

This is not applicable to this type of device submission. "Ground truth" in this context is established by:

• Engineering measurements (e.g., dimensions, material composition, mechanical properties) where the "truth" is the measured value against a standard specification.
• Expert interpretation of those measurements by qualified engineers, material scientists, and regulatory affairs personnel within the manufacturing company, ensuring compliance with standards and guidance documents.
• The FDA reviewers themselves act as experts evaluating the presented data against regulatory requirements.

There are no "experts" in the sense of clinicians establishing a diagnostic ground truth.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" for a test set of patient data described here. The evaluation involves comparing test results of the physical device and its materials against predefined engineering and regulatory specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI devices where human readers interpret medical images or data. This submission is for an orthopedic implant.

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

• No, a standalone performance study was not done. This concept is only applicable to AI/algorithm-based devices. The device described is a physical orthopedic implant.

7. The Type of Ground Truth Used

The "ground truth" for this device's efficacy and safety claims (leading to substantial equivalence) is based on:

• Material Specifications: Adherence to ASTM standards for various materials (F136, F67/F1580, F1609).
• Mechanical Testing Results: Measurements of static tensile, static shear, shear fatigue bond strength, four-point bend fatiguing, abrasion, and fatigue strength, compared against established performance benchmarks in the relevant FDA guidance documents and presumably internal specifications.
• Biocompatibility/Coating Characterization: X-ray diffraction, dissolution rate, solubility product parameters, and porosity measurements, compared against NIST standards (SRM 2910(a)) and FDA guidance for porous and HA-coated implants.
• Substantial Equivalence to Predicate Devices: The ultimate "ground truth" for regulatory clearance is that the device is shown to be as safe and effective as legally marketed predicate devices, meaning that the differences do not raise new questions of safety or effectiveness.

8. The Sample Size for the Training Set

• Not applicable. As stated earlier, this is not an AI/algorithm-based device, so there is no "training set" of data in the AI sense.
  • One could loosely interpret "training" as the iterative design and testing process of the device leading up to the submission, where materials and designs may have been refined based on prior test results. However, this is not a formal "training set" as understood in machine learning.

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

• Not applicable. Since there is no "training set" in the AI sense, there's no ground truth to establish for it.

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