(29 days)
Indications for Use:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Correction of functional deformity.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- Revision of previously failed total hip arthroplasty.
The Altra™ Press-Fit Hip System is intended for uncemented use only.
The Altra™ Press-Fit Hip System consists of a hip stem made from Ti-6AJ-4V titanium alloy conforming to ASTM F-136.
The provided document is a 510(k) summary for the Biomet Altra™ Press-Fit Hip System. It describes the device, its intended use, and claims substantial equivalence to a predicate device.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (Fine Grain Cast Cobalt Chromium Hip Stem - K953925) | Mechanical testing demonstrated that the Altra™ Press-Fit Hip System is substantially equivalent to the predicate device. |
| Similar Design & Technological Features | The Altra™ Press-Fit Hip System incorporates a similar design with similar technological features as the predicate hip stem. |
| Same Intended Use & Indications for Use | It has the same intended use, indications for use. |
| Utilizes Same Biomet Type I Taper | Utilizes the same Biomet Type I Taper as the predicate stems. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Clinical testing was not conducted in support of substantial equivalence." Therefore, there is no test set sample size or data provenance to report for clinical performance. The evaluation was based on non-clinical (mechanical) testing.
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. No clinical testing was performed, so no experts were needed to establish ground truth for a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical testing was performed.
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. This device is a medical implant (hip system), not an AI-powered diagnostic device. Therefore, an MRMC study related to human reader performance with AI assistance is irrelevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical implant (hip system), not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" was established by engineering specifications and established mechanical testing standards to demonstrate substantial equivalence to the predicate device. For example, mechanical properties like fatigue strength, wear resistance, and construct stability would have been compared against the predicate and relevant standards. The document doesn't specify the exact standards but refers to "Mechanical testing".
8. The sample size for the training set
Not applicable. This device is a medical implant, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 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.