(87 days)
- Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
- Revision of previously failed hip arthroplasty.
Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.
The Metasul LDH large diameter head system consists of large diameter femoral heads, Durom acetabular components and neck adapters for neck length variation.
The Metasul LDH femoral heads are made of CoCrMo alloy, and are available in diameters ranging from 38 to 60mm. They are modular in design, and are for use with four head/neck length adaptors (-4 to +8mm), also manufactured from CoCrMo alloy. The femoral heads and neck adapters are compatible with 12/14 taper femoral stems.
The Durom Acetabular component is a metal monoblock CoCrMo alloy cup with a coating of titanium plasma spray. It is available is sizes from 44 to 66mm, and is intended for press-fit fixation in the acetabulum.
The provided text is a Summary of Safety and Effectiveness for a medical device called the "Durom Acetabular Component" and "Metasul LDH Large Diameter Heads," which is a total hip prosthesis.
Based on the information provided in the text, here's a breakdown of the acceptance criteria and the study as requested:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Safety | The device must be demonstrated to be safe. | "The results of non-clinical analysis demonstrate that the device is safe..." |
| Effectiveness | The device must be demonstrated to be effective for its intended use. | "...and effective and substantially equivalent to the predicate device(s)." |
| Substantial Equivalence | The device must have the same intended use, similar performance characteristics, similar materials, similar manufacturing processes, and similar design to legally marketed predicate devices. The differences, if any, should not raise new questions of safety or effectiveness. | "The proposed device has the same intended use, has similar performance characteristics, is manufactured from similar materials using similar processes, and is similar in design to the predicate devices." |
Study Information
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document states "The results of non-clinical analysis." This generally refers to bench testing, simulations, and literature reviews rather than patient test sets. Therefore, there is no information provided about a "test set" in the context of patient data, nor its provenance or nature (retrospective/prospective). -
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):
This information is not provided. The study appears to be entirely non-clinical, without a "ground truth" derived from expert interpretation of clinical data in the traditional sense of AI/diagnostic device validation. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set requiring expert adjudication is described. -
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. The device is a physical hip prosthesis, not an AI or diagnostic tool designed to assist human readers. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as the device is a physical prosthesis. The "non-clinical analysis" would be standalone in the sense that it evaluates the device's physical and mechanical properties. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For non-clinical analysis, the "ground truth" would typically be established engineering specifications, material standards, biomechanical testing results (e.g., fatigue strength, wear rates), and historical data/literature on predicate devices. The document explicitly mentions "non-clinical analysis" which implies this type of engineering and material science validation. -
The sample size for the training set:
Not applicable. This is a physical medical device, not an AI algorithm requiring a training set of data. -
How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI algorithm.
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.