(567 days)
The PERFECTA® Femoral Stem with calcium sulfate coating is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and,
- treatment of fractures that are unmanageable using other techniques.
The PERFECTA® Femoral Stem with calcium sulfate coating is for single use only, and is intended for use in conjunction with existing Wright Medical Technology ceramic or metal femoral heads, acetabular liners and shells, as a part of an uncemented total hip arthroplasty.
The design features and functions of the PERFECTA® Femoral Stem with calcium sulfate coating will be identical to the design features and functions of the currently available PERFECTA® Femoral Stem (510(k): K991123 and K004032), with the exception of the calcium sulfate coating.
The PERFECTA® Femoral Stem will be available in a range of sizes (9-22.5 mm) and will feature the Wright Medical Technology (SLT) 12/14 taper.
This is a 510(k) premarket notification for a medical device, the PERFECTA® Femoral Stem with calcium sulfate coating. As such, the documentation focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study data with specific acceptance criteria and performance metrics typically found in clinical trials for novel devices.
Here's an analysis based on the provided text, addressing the requested points where possible, and noting where information is not available:
1. A table of acceptance criteria and the reported device performance
This document does not contain a table of acceptance criteria and reported device performance in the manner requested for efficacy or safety metrics. The basis for clearance is substantial equivalence to a previously cleared predicate device.
The "device performance" in this context is implicitly considered to be equivalent to the predicate device due to identical design features and functions, with the only specified difference being the calcium sulfate coating.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided. As this is a 510(k) submission based on substantial equivalence, detailed clinical study data with test sets, sample sizes, and provenance are typically not included unless there are significant design or material changes that warrant new clinical testing. The submission states "The safety and effectiveness of the PERFECTA® Femoral Stem with calcium sulfate coating are adequately supported by the information provided in the Premarket Notification". This would refer to non-clinical testing (e.g., mechanical, biocompatibility) and comparison to the predicate.
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)
This information is not applicable/not provided. Ground truth establishment by experts for a test set is relevant for studies evaluating diagnostic or predictive AI devices, or for clinical trials with subjective endpoints. This 510(k) submission is for an orthopedic implant, where "ground truth" and expert consensus for a "test set" in this context would typically relate to clinical outcomes and safety, which are not detailed in this type of submission focused on substantial equivalence.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/not provided for the same reasons as point 3.
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
This information is not applicable/not provided. MRMC studies are used to evaluate the performance of diagnostic imaging devices or AI tools that assist human readers in tasks like detection or diagnosis. The PERFECTA® Femoral Stem is an orthopedic implant, not a diagnostic or AI-assisted imaging device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This refers to AI algorithm performance in isolation. The PERFECTA® Femoral Stem is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable/not provided in detail. For an orthopedic implant, "ground truth" for safety and effectiveness would ultimately involve long-term patient outcomes (e.g., pain reduction, improved function, revision rates, adverse events). However, in a 510(k) based on substantial equivalence, the primary "ground truth" is established by the successful clinical history and regulatory clearance of the predicate device. The submission relies on the predicate's established safety and effectiveness.
8. The sample size for the training set
This information is not applicable/not provided. Training sets are relevant for machine learning algorithms. The PERFECTA® Femoral Stem is a physical implant, not an AI/ML product.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reasons as point 8.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as per 510(k) process):
The "study" that proves the PERFECTA® Femoral Stem with calcium sulfate coating meets acceptance criteria is the demonstration of Substantial Equivalence to legally marketed predicate devices.
- Predicate Devices: PERFECTA® Femoral Stem (510(k) numbers: K991123 and K004032).
- Methodology: The submission asserts substantial equivalence based on:
- Identical Intended Use: The indications for use are the same as the predicate devices.
- Identical Design Features and Functions (with one exception): The design of the subject device is stated to be identical to the predicate, with the exception of the calcium sulfate coating.
- Identical Materials (implicitly, except for the coating): The statement mentions "material" in the context of substantial equivalence, implying that the core materials (e.g., for the stem itself) are the same as the predicate.
- Identical Type of Interface: The interface (e.g., with existing Wright Medical Technology ceramic or metal femoral heads, acetabular liners and shells) is stated to be identical.
- "Proof": The FDA's clearance letter (NOV 22 2004) to Wright Medical Technology, Inc., explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This determination by the FDA serves as the regulatory "proof" that the device meets the acceptance criteria for market clearance under the 510(k) pathway.
- Underlying Data: While not detailed in this summary, the "adequately supported by the information provided in the Premarket Notification" likely refers to non-clinical performance testing (e.g., mechanical strength, fatigue, biocompatibility, coating adhesion, and elution characteristics of the calcium sulfate) for the new coating, demonstrating that the addition of the calcium sulfate coating does not adversely affect the safety or effectiveness profile as established by the predicate 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.