(23 days)
The Taperioc® 12/14 Taper Femoral Components and M²a-38™ Modular Heads are indicated for use in cemented or non-cemented total hip replacement in cases of:
- Non-inflammatory 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 by other techniques.
- Revision of previously failed joint replacement.
The Biomet Freedom® Constrained Modular Head is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intra-operative instability, and for whom all other options to constrained acetabular components have been considered.
The Taperloc® 12/14 Taper Femoral Components are straight, collarless, flat, tapered stems designed to match the geometry of the femur. The stems are proportionally sized and shaped in sizes 5.0mm to 25.0mm diameters. A lateralized version of the device is available. The stems are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F-136 or F-1472 and the proximal third of each femoral stem is covered with Biomet's full plasma spray porous coating.
The provided document K041537 outlines the 510(k) summary for the Taperloc® 12/14 Taper Femoral Components. Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Device overall design, materials, and processing methods are similar to predicate devices. | "The overall design, materials and processing methods are similar to the predicate device." (Page 2) |
| Mechanical/Engineering Safety | Engineering analysis demonstrates equivalence to predicates. | "Engineering analysis has demonstrated equivalence between the Taperloc® 12/14 Taper Femoral Components and the predicates." (Page 2) |
| Intended Use | Intended use aligns with legally marketed predicate devices. | Indications for use are provided and are consistent with predicate devices (e.g., total hip replacement for various conditions). The FDA's substantial equivalence determination implies acceptance of the stated indications. (Pages 1 & 4) |
| Biocompatibility | Materials conform to ASTM standards (implied safety). | "manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F-136 or F-1472" (Page 1) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The submission states "Clinical Testing: None provided" (Page 2). This indicates that no human clinical data (which would involve a "test set" of patients) was used to demonstrate the device's performance for this 510(k) submission. The equivalence was established through non-clinical engineering analysis and comparison to predicate devices.
- Data Provenance: Not applicable. Since no clinical testing was performed, there is no provenance for a clinical test set. The data presented is from internal engineering analyses.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No clinical test set was used, and therefore no ground truth derived from expert review of patient data. The "ground truth" for this submission would be the established safety and effectiveness of the predicate devices, which were deemed safe and effective through prior regulatory processes.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set was used.
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
- No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The device is a physical medical implant (femoral component for hip replacement), not an AI-assisted diagnostic or treatment system.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical implant, not an algorithm, so a standalone algorithm performance study is irrelevant.
7. The Type of Ground Truth Used
- For this 510(k) submission, the "ground truth" is primarily based on the established safety and efficacy of the predicate devices. The new device demonstrates substantial equivalence by showing that its design, materials, and performance are similar to devices already legally marketed and proven (through their own regulatory pathways, which may have included clinical data or extensive non-clinical testing). The engineering analysis supports this claim of equivalence.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML product that requires a "training set" in the conventional sense. The "training data" for the design and engineering principles would be decades of biomechanical research, material science, and performance data from similar hip implant designs, but this is not quantifiable as a "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" in the AI/ML context. The design and manufacturing processes are likely informed by industry standards, engineering best practices, and the performance history of similar devices.
§ 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.