(88 days)
The Fixion Unipolar Modular Hemi-Hip System is intended for use as a hemi hip replacement in case of:
- Femoral head/neck fractures or non-unions
- Aseptic necrosis of the femoral head/neck
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip, with minimal acetabular involvement
The Fixion UH is a modular hemi-hip replacement system, which is composed of a metal stem and neck part ("stem") with an expandable femoral head in various dimensions from metal or Alumina ceramic for use during partial hip replacement.
The provided text describes a 510(k) submission for the Fixion™ Unipolar Modular Hemi-Hip System (Fixion UH), focusing on its substantial equivalence to predicate devices and adherence to performance standards. However, it does not contain information about specific acceptance criteria or a study that rigorously proves the device meets those criteria in the context of AI/ML or diagnostic performance. Instead, it details the engineering and manufacturing standards for an orthopedic implant.
Therefore, many of the requested categories for AI/ML device performance cannot be filled based on the provided text. I will address the sections that can be informed by the document.
Summary of Acceptance Criteria and Device Performance (Based on available information):
| Acceptance Criteria Category | Specific Criteria (from document) | Reference Standard | Reported Device Performance (from document) |
|---|---|---|---|
| Intended Use Equivalence | Intended use and indications for use substantially equivalent to predicates | Not explicitly stated as a separate standard, but forms the basis of 510(k) | Intended use and indications for use are "substantially equivalent" to predicate devices (Depuy Elite® Modular Hip System, S-ROM Total Hip System, Link® Reconstruction Hip) |
| Material Equivalence | Materials (e.g., 316LVM Stainless Steel) comparable to predicates | Not explicitly stated as a separate standard | Stem is made of 316LVM Stainless Steel, identical cross-section to cleared Fixion™ PF Intramedullary Nail |
| Performance - Endurance | Endurance performance of stemmed femoral components with application of torsion | ISO 7206-8 (1995) | "The Fixion UH conforms to the requirements of ISO 7206-8 (1995)" |
| Performance - Femoral Stem Prostheses | Requirements for femoral stem prostheses | FDA Draft Guidance Document for Femoral Stem Prostheses (1995) | "The Fixion UH also conforms to FDA Draft Guidance Documents: Guidance Document for Femoral Stem Prostheses (1995)" |
| Performance - Modular Implant Components | Testing non-articulating, "mechanically locked", modular implant components | FDA Draft Guidance Document for Testing Non-Articulating, "Mechanically Locked", Modular Implant Components (1995) | "The Fixion UH also conforms to FDA Draft Guidance Documents...Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant Components (1995)" |
| Performance - Ceramic Ball Hip Systems | Requirements for ceramic ball hip systems | FDA Draft Guidance Document for the Preparation of Premarket Notification for Ceramic Ball Hip Systems (1995) | "In addition, the Fixion UH conforms to FDA Draft Guidance Document for the Preparation of Premarket Notification for Ceramic Ball Hip Systems (1995)" |
| Safety & Efficacy - Fixation Method | Inflation with sterile saline does not raise new safety and efficacy issues | Comparison to cleared Fixion™ PF Nail | "The inflation of the Fixion UH Stem with saline, ... is identical to the cleared Fixion PF Nail and does not raise any new safety and efficacy issues." |
| Overall Performance | Performance characteristics meet specifications | General "bench tests" | "The performance characteristics of the Fixion UH have been tested and found to meet the specifications through a series of bench tests." |
Information Not Available in the Provided Text (Pertaining to AI/ML or Diagnostic Studies):
The provided 510(k) summary is for a physical medical device (a hemi-hip system) and therefore does not contain the following information typically found in submissions for AI/ML or software as a medical device (SaMD):
- Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical bench testing, not a dataset for AI/ML.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML diagnostic algorithm.
- Adjudication method for the test set: Not applicable.
- 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 an implant, not a diagnostic aid.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an orthopedic implant's performance verification in this context. The "ground truth" would be the engineering specifications and ISO standards met by material and mechanical properties.
- The sample size for the training set: Not applicable for an orthopedic implant.
- How the ground truth for the training set was established: Not applicable for an orthopedic implant.
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.