(67 days)
The PROFEMUR® TL Classic Stems are 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:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed.
The PROFEMUR® TL Classic Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.
The PROFEMUR® TL Classic Stems are monolithic stems manufactured from a forged titanium alloy (ASTM F620) and designed for use in uncemented total hip arthroplasty. The PROFEMUR® TL Classic Stems are available in 12 sizes (1-12) and are coated with titanium plasma spray conforming to ASTM F1580. Each size is available in two neck offset options, Standard (neutral) and Extended (varus). The distal stem geometry, neck length, and neck offset are designed to create options identical to those available with the predicate modular device.
The provided 510(k) summary for the PROFEMUR® TL Classic Stems does not describe a study involving a device that produces output like an algorithm or AI. Instead, it outlines the regulatory submission for a physical medical device (femoral hip stems) and its non-clinical performance testing.
Therefore, many of the requested categories in your prompt related to acceptance criteria for an algorithm, AI, or clinical study involving human readers are not applicable to this document.
However, I can extract the relevant information regarding the physical device's performance and the non-clinical testing performed.
Revised Acceptance Criteria and Study Information (for a physical medical device):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ISO standards) | Reported Device Performance |
|---|---|
| Proximal Fatigue Tests: Satisfy ISO 7206-4 | Satisfied the acceptance criteria of ISO 7206-4 |
| Distal Fatigue Tests: Satisfy ISO 7206-6 | Satisfied the acceptance criteria of ISO 7206-6 |
| Distal Fatigue Tests: Satisfy ISO 7206-8 | Satisfied the acceptance criteria of ISO 7206-8 |
| Range of Motion Evaluation: Satisfy ISO 21535 | Satisfied the acceptance criteria of ISO 21535 |
| Titanium Plasma Spray Coating: Applied according to WMT specification and identical to predicate device (K060358) | Verified by testing present within a vendor Master File and summarized in the premarket notification. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test, but standard test methods for mechanical testing of implants typically involve a small number of samples per test condition (e.g., n=5 or n=10).
- Data Provenance: The tests were non-clinical (laboratory-based) and conducted to international standards (ISO). The titanium plasma spray coating verification was summarized from a vendor Master File.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A: This is a physical device undergoing non-clinical mechanical and material testing. "Ground truth" in this context refers to the measured physical properties meeting predetermined engineering standards, not expert clinical assessment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A: Not applicable to non-clinical mechanical testing. Adherence to standards is typically assessed quantitatively.
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:
- N/A: No clinical study, MRMC study, or AI component was involved.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A: No algorithm or AI component was involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering Standards and Specifications: The "ground truth" for the device's performance is adherence to established international standards (ISO 7206-4, 6, 8; ISO 21535) for mechanical properties and the manufacturer's own material specifications (ASTM F620 for titanium alloy, ASTM F1580 for plasma spray coating).
8. The sample size for the training set:
- N/A: No AI or algorithmic training set for this physical device.
9. How the ground truth for the training set was established:
- N/A: No AI or algorithmic training set for this physical device.
In summary: The PROFEMUR® TL Classic Stems are a physical orthopedic implant. Their acceptance criteria are based on meeting established international engineering standards for fatigue strength and range of motion, and material specifications, demonstrated through non-clinical laboratory testing. There is no mention of clinical studies, AI algorithms, or expert consensus on clinical data in this 510(k) summary.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.