(79 days)
The Howmedica® Modular Replacement System - Proximal Femur is presently cleared for use with bone cement in Oncology patients where radical resection and replacement of the proximal femur is required (reference premarket notification K952970). Howmedica seeks clearance to expand this indication to include use with bone cement in limb salvage procedures where radical resection and replacement of the proximal femur is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous hip arthroplasties, and/or Oncology indications. All of these surgical interventions have in common the need for radical resection of the proximal femur, and the need for a prosthetic replacement. This device achieves fixation by the use of bone cement.
The Howmedica® Modular Replacement System - Proximal Femur
This document is a 510(k) summary for a medical device (Howmedica® Modular Replacement System - Proximal Femur), not a study report on the device's performance against acceptance criteria in the way a clinical trial or AI algorithm validation study would be presented.
Therefore, most of the information requested in your prompt (acceptance criteria, device performance, sample sizes for test/training, number of experts, adjudication, MRMC studies, standalone performance, ground truth types, etc.) is not present in the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not available. The document states "testing of the modular tapers and fatigue testing of the proximal femur was presented," but it does not specify the acceptance criteria for these tests or report the numerical performance results against those criteria. It's a summary of the intent to submit, not the detailed test results themselves.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available. This type of information is not relevant for a 510(k) submission focusing on mechanical testing. There's no "test set" in the context of clinical data for an algorithm.
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 available. This is not applicable to a physical medical device's mechanical testing or its indication expansion.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available. Not applicable.
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 available. This is a physical orthopedic implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not available. Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not available. For mechanical testing, the "ground truth" would be the engineering specifications and material properties, but these are not detailed here. For clinical effectiveness, the document describes the use case (limb salvage in radical resection), but it doesn't present outcomes data to establish "ground truth" for success rates.
8. The sample size for the training set
- Not available. Not applicable.
9. How the ground truth for the training set was established
- Not available. Not applicable.
Summary of what the document does provide:
- Device Name: Howmedica® Modular Replacement System - Proximal Femur
- Previous Clearance: K952970, for use with bone cement in Oncology patients requiring radical resection and replacement of the proximal femur.
- Proposed Expanded Indication: Use with bone cement in limb salvage procedures where radical resection and replacement of the proximal femur is required. This explicitly includes:
- Severe trauma
- Failed previous hip arthroplasties
- Oncology indications
- Fixation Method: Bone cement.
- Basis for Clearance: Comparison to other legally marketed products, and "testing of the modular tapers and fatigue testing of the proximal femur was presented." (However, the specific criteria and results are not in this summary).
In essence, this document is a high-level summary of a regulatory submission to expand the indications for a known physical device; it is not a performance study report for an AI or diagnostic tool.
§ 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.