(78 days)
The PERFECTA® Plasma Spray Hip 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:
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- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
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- inflammatory degenerative joint disease such as rheumatoid arthritis;
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- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and, 4)
- ર) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The PERFECTA® Plasma Spray Hip System is manufactured from titanium alloy (ASTM F-136) with a titanium plasma spray coating. The stem is available in standard and reduced flare configurations, collared and collarless. The stem is designed to be press-fit or can be used with bone cement.
The provided text describes a medical device, the PERFECTA® Plasma Spray Hip System, and summarizes its 510(k) submission. However, it does not contain information about acceptance criteria and a study proving a device's performance in a diagnostic or AI-assisted context, but rather focuses on the mechanical and material performance of a hip implant.
Therefore, for the information requested regarding AI/diagnostic device performance, human expert involvement, ground truth, and training data, the answer is that this information is not available in the provided text.
Here's how the provided information relates to the request:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Mechanical/Material): The text implies acceptance criteria related to material equivalence and fatigue strength:
- Plasma spray porous coating comparable to sintered bead coating.
- Fatigue strength of the worst-case device (PERFECTA® 12mm reduced flare, collarless hip stem) comparable to a predicate device (PERFECTA® 12mm calcar revision hip stem).
- Reported Device Performance (Mechanical/Material):
- "Submitted abrasion testing demonstrates that the plasma spray porous coating is comparable to sintered bead coating."
- "Submitted validated finite element analysis indicates that the fatigue strength of the worst case subject device, the PERFECTA® 12mm reduced flare, collarless hip stem, is comparable to the fatigue strength of the predicate PERFECTA® 12mm calcar revision hip stem."
The following information is NOT available in the provided text, as it pertains to AI/diagnostic device studies, not hip implants:
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
* Not applicable/Not provided. The "test set" here refers to mechanical testing, not a diagnostic data set.
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 provided. Ground truth for mechanical testing is based on engineering standards and measurements, not expert human interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable/Not provided.
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 provided. This is for AI-assisted diagnostic devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable/Not provided. This is for AI/diagnostic devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* For the mechanical testing, the ground truth would be established by physical measurements, material science principles, and engineering simulations validated against known standards, not expert clinical consensus or pathology.
8. The sample size for the training set:
* Not applicable/Not provided. "Training set" refers to machine learning, not mechanical device development.
9. How the ground truth for the training set was established:
* Not applicable/Not provided.
In summary, the provided document details the regulatory submission for a hip implant, focusing on its materials, design, and mechanical testing (abrasion, fatigue). It does not involve any AI algorithms, diagnostic claims, or human reader studies, and therefore cannot address most of the specific points in your request regarding AI/diagnostic device performance.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.