(132 days)
Signature Orthopaedics' Evolve UniPolar Head is intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head is indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:
- Acute femoral head or neck fracture
- . Fracture dislocation of the hip
- Avascular necrosis of the femoral head ●
- Non-union of femoral neck fractures
- Certain high subcapital and femoral neck fractures in the elderly ●
- . Degenerative arthritis involving only the femoral head
The Evolve™ UniPolar Head is a metallic (per ISO 5832-12) ball with a tapered bore. The head connects to a femoral stem from Signature Orthopaedics' range via taper sleeve. The taper sleeve is manufactured from cobalt-chromium alloy per ISO 5832-12, and includes a 12/14 taper. The head's outer surface is highly polished to articulate against the patient's natural acetabulum as part of a hip hemi-arthroplasty.
This document is a 510(k) premarket notification for the Evolve™ UniPolar Head, a hip prosthesis. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a novel device requiring extensive clinical studies with acceptance criteria and ground truth evaluations typically seen for AI/ML devices or new technologies.
Therefore, many of the requested items related to acceptance criteria, ground truth, expert adjudication, MRMC studies, and standalone performance for AI/ML are not applicable to this type of submission.
Here's a breakdown of the information that can be extracted, and where the requested information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Evaluation | Acceptance Criteria (Not explicitly stated as numerical criteria, but implied by successful completion) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Range of motion analysis | Adequacy for anticipated in-vivo use (implied) | Adequate |
| Component connection strength testing | Adequate for anticipated in-vivo use (implied) | Adequate | |
| Fretting corrosion testing | Adequate for anticipated in-vivo use (implied) | Adequate | |
| Femoral stem fatigue testing | Adequate for anticipated in-vivo use (implied) | Adequate | |
| Material Composition | Metallic material (head) | Conformance to ISO 5832-12 | Conforms to ISO 5832-12 |
| Taper sleeve material | Conformance to ISO 5832-12 | Conforms to ISO 5832-12 | |
| Design Similarity | Articular surface and taper connection geometry | Similar to Signature Orthopaedics CoCr Femoral Head (K121297) | Similar to K121297 |
| Intended Use | Hemi-hip arthroplasty | Similar to Signature Orthopaedics BiPolar Head (K133370) and Smith & Nephew Tandem UniPolar Head (K896580) | Similar to K133370 & K896580 |
Study Proving Acceptance Criteria:
The "study" proving the device meets the acceptance criteria is a series of non-clinical tests and engineering evaluations. These are outlined in the "Performance Testing" section:
- Range of motion analysis
- Component connection strength and fretting corrosion testing
- Femoral stem fatigue testing
The report states that these tests were conducted "to verify that the performance of the Evolve™ UniPolar Head is adequate for anticipated in-vivo use." The conclusion is that "Non-clinical testing results support the substantial equivalence claim. The Evolve UniPolar Head is expected to perform adequately during clinical use."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This document details a 510(k) submission for a traditional medical device (hip prosthesis) based on mechanical and material engineering testing, not a data-driven device like AI/ML. There is no "test set" in the sense of a dataset for an algorithm. The "data" provenance would refer to the origin of the materials and manufacturing, and the engineering tests are conducted in a lab setting.
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, in the context of expert consensus, is not relevant for the mechanical and material testing performed for this device. The "ground truth" for these tests is the physical measurement and observation of the device's behavior under simulated conditions.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods are used to resolve discrepancies in human expert labeling or diagnosis for ground truth establishment, which is not part of this device's testing.
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 is a physical medical device, not an AI/ML diagnostic aid. MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device. There is no algorithm to evaluate in standalone mode.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineering/Physical Ground Truth: The "ground truth" for the performance testing is based on established engineering principles, material science standards (e.g., ISO 5832-12), and physical measurements obtained from laboratory testing (e.g., range of motion, connection strength, fretting corrosion, fatigue). Outcomes data might be considered relevant in post-market surveillance for long-term device performance but is not part of this premarket submission.
8. The sample size for the training set
- Not applicable / Not provided. This device does not involve a "training set" in the context of machine learning. The design and manufacturing processes are refined through engineering development, which could be seen as an iterative "training" process in product design, but not through statistical learning from a data set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no "training set" in the ML sense, there is no ground truth needing establishment for it. The "ground truth" for design decisions and manufacturing quality would be established through engineering specifications, material standards, and quality control processes.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.