(266 days)
- When used as a hemi-hip replacement system, it is intended for osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal involvement of the corresponding acetabulum, femoral head or neck fractures, aseptic necrosis of the femoral head, previous failed hip arthroplasty where there is evidence of sufficient bone quality to adequately set the implant.
- When used as a total hip replacement system, it is intended for osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal involvement of the corresponding acetabulum, femoral head or neck fractures, aseptic necrosis of the femoral head, previous failed hip arthroplasty where there is evidence of sufficient bone quality to adequately set the implant.
- In addition, the NexFlex Total Hip System is intended for cases where alternative modes of treatment appear less preferable and the associated risks of a total hip replacement are thought to be acceptable. It is intended for severely disabled joints, which could result from arthritis or late stages of avascular necrosis and revisions of unsuccessful acetabular cup arthroplasty and/or femoral procedure.
The NexFlex™ Total Hip System is a sterile total or hemi-hip replacement system. It consists of a series of femoral and acetabular implants that are used to help restore patient range of motion and aid in the treatment of other deformities as histor in the Indications for Use. The purpose of this 510(k) is to provide for HA coated hip sterns and acetabular cups. This submission also includes additions / modifications to the and accedural under formal change control procedures.
The provided text is a 510(k) summary for the NexFlex™ Total Hip System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing the results of a primary clinical or performance study with defined acceptance criteria and detailed statistical analysis as would be expected for a novel AI/software medical device.
Therefore, many of the requested elements for an AI/software device cannot be extracted directly from this document. However, I can provide the information that is present and explain why other sections are not applicable.
Here's the breakdown based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Internal/Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: Performance comparable to or better than predicate devices during fatigue testing. | Demonstrated that the mechanical performance is at least comparable to, if not better than, those of the predicate device. |
| Biocompatibility: Characteristics comparable to or better than predicate devices. | Demonstrated that the biocompatibility characteristics are at least comparable to, if not better than, those of the predicate device. |
| Substantial Equivalence: Device (including HA coated components) is substantially equivalent to legally marketed predicate devices. | FDA determined the device is substantially equivalent to legally marketed predicate devices. |
Explanation: In a 510(k) submission, the primary "acceptance criterion" is often a demonstration of substantial equivalence to a predicate device. For mechanical components like hip implants, this is typically proven through bench testing (fatigue, wear, etc.) and material characterization (biocompatibility). Explicit numerical acceptance criteria and a detailed statistical comparison with a confidence interval, as common for AI devices, are not typically found in these types of summarized 510(k) documents.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "Fatigue testing and microstructure examination" but does not detail the number of samples or specimens used in these tests.
- Data Provenance: Not specified. These are likely bench test results, not human patient data.
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. This document describes mechanical and biocompatibility testing of a physical medical device (hip implant components), not performance evaluation of an AI-based diagnostic or prognostic tool that would require expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This relates to expert consensus for ground truth establishment, which is not relevant to the type of testing described here.
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 describes the evaluation of an AI/software device, which the NexFlex™ Total Hip System is not.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This describes the evaluation of an AI/software device, which the NexFlex™ Total Hip System is not.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Mechanical and Material Standards: The "ground truth" for the performance claims would be established by recognized engineering and material standards for orthopedic implants (e.g., ISO standards for fatigue testing, material properties, and biocompatibility). The document states that the test results "demonstrated that the mechanical performance and biocompatibility characteristics are at least comparable to, if not better than, those of the predicate device," implying a comparison against established benchmarks or the predicate device's known performance.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.