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The PROCOTYL-E Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. inflammatory degenerative joint disease such as 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.

The PROCOTYL-E Acetabular System consists of single use components that are intended to accommodate for bone loss. This system is to be used in conjunction with associated WMT polyethylene and metal Acetabular liners articulating with associated WMT metal and ceramic femoral heads as part of an uncemented total hip arthroplasty.

The PROCOTYL-E Acetabular System consists of metal acetabular shells, plates and hooks.

The added design features of the PROCOTYL-E Acetabular Shell are summarized below:

• The PROCOTYL-E Acetabular shell feature an oblong dual hemispherical outer geometry with a hemispherical offset to accommodate for bone loss.
• Eccentricity and offset are increased to accommodate for bone loss and screw fixation.
• The PROCOTYL-E shell allows use of a wide range of plates, hooks, all of which are manufactured from titanium alloy, available in various types and sizes, thus guaranteeing a stable and secure anchorage of the shell to enhanced fixation and stability.

This K043073 submission is a 510(k) for the PROCOTYL-E Acetabular System, which is a Class II/III medical device (Hip joint metal/polymer/metal semi-constrained porous - coated uncemented prosthesis, Prosthesis, Hip, Semi-Constrained, metal/ ceramic/ polymer, cemented or non-porous uncemented, Hip joint metal/ metal semiconstrained, with uncemented acetabular component prosthesis).

Based on the provided document, there is no information about acceptance criteria or specific studies proving the device meets acceptance criteria in the context of device performance as typically described for a new or modified medical device requiring detailed efficacy or safety studies with quantitative performance metrics.

The document is a Summary of Safety and Effectiveness for a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device.

Here's an breakdown of the requested information based on the provided text, highlighting what is not available:

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

   • Not available. The document does not provide a table with quantitative acceptance criteria (e.g., specific thresholds for wear, fatigue life, or clinical outcomes) or reported performance metrics against such criteria. The "performance" mentioned is in the context of substantial equivalence to existing devices.

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

   • Not available. The document states that the "safety and effectiveness of the PROCOTYL-E Acetabular Shell are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification." However, it does not specify the sample sizes or provenance of any test data. The testing mentioned refers to "materials data, and testing results," which typically implies mechanical or bench testing for orthopedic implants, not clinical trials with human subjects that would have a "test set" in the context of AI/software performance.

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)

   • Not applicable/Not available. This type of information is relevant for AI/software devices where human expert annotation establishes a "ground truth" for evaluating algorithm performance. For an orthopedic implant like the PROCOTYL-E Acetabular System, the "ground truth" for its safety and effectiveness is established through different means, primarily bench testing, substantial equivalence to predicates, and potentially clinical follow-up data (though not detailed here). There's no mention of experts establishing a ground truth for a test set in the context of the device's functional integrity.

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

   • Not applicable/Not available. Similar to point 3, this type of adjudication is typically used in clinical studies or for evaluating diagnostic AI algorithms where expert consensus is needed to resolve discrepancies. It is not relevant for the type of device and submission described.

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/Not available. An MRMC study is specific to diagnostic imaging devices where human readers interpret medical images. This device is an orthopedic implant, not an imaging or diagnostic AI device.

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

   • Not applicable/Not available. This question pertains to the performance of an algorithm or AI independently. The PROCOTYL-E Acetabular System is a physical implant, not an algorithm.

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

   • Implied ground truth: For an orthopedic implant seeking 510(k) clearance, the "ground truth" for safety and effectiveness is generally established through:
     • Mechanical and material testing: Demonstrating compliance with industry standards (e.g., ISO for implants) for strength, fatigue, wear, biocompatibility.
     • Substantial equivalence: Comparison to a legally marketed predicate device that has established safety and effectiveness.
     • Clinical outcomes (potentially): While not explicitly detailed as a primary study in this summary, long-term clinical performance data on the predicate device or similar designs would implicitly contribute to the "ground truth" of what constitutes a safe and effective hip replacement component.
   • The document mentions "materials data, and testing results," which points to mechanical/material testing as a key basis for safety and effectiveness.

8. The sample size for the training set

   • Not applicable/Not available. "Training set" is a term used in machine learning for AI algorithms. This device is an orthopedic implant.

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

   • Not applicable/Not available. As above, this terminology does not apply to the PROCOTYL-E Acetabular System.

Summary of what is known from the document regarding acceptance:

• The 510(k) summary states that the PROCOTYL-E Acetabular Shell is "substantially equivalent" to competitive devices previously cleared for market. This is the primary "acceptance criterion" for a 510(k) submission.
• The basis for this substantial equivalence includes the intended use, material, type of interface, and design features.
• The document broadly mentions "materials data, and testing results" as supporting the safety and effectiveness. This implies that the device underwent mechanical and material characterization to ensure it functions as intended and is safe for implantation, likely conforming to recognized standards for orthopedic implants. However, specific test results or quantitative acceptance criteria for those tests are not provided in this summary.
• The FDA's clearance letter on May 4, 2005, signifies that the agency has accepted the manufacturer's claim of substantial equivalence, thereby allowing the device to be marketed.

In essence, this 510(k) summary focuses on demonstrating that the PROCOTYL-E Acetabular System is "just as safe and effective" as legally marketed predicate devices, rather than presenting detailed studies with specific numeric acceptance criteria and performance data for a novel device.

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