(78 days)
The DePuy Luster Stem is indicated for cemented use as the femoral component in total hip arthroplasty for replacing the hip joint of a patient whose hip joint has been damaged by degenerative joint disease, fracture, or the failure of a previous arthroplasty.
The DePuy Luster Stem is a polished, distally tapered femoral stem with a proximal anterior/posterior flange, a medial 30° collar, and an oval driver hole in the lateral proximal shoulder. The DePuy Luster Stem is available in five sizes (1, 2, 3, 4, and 5) each with two offset options, standard and high, and is manufactured from forged cobalt chrome molybdenum alloy.
This document is a 510(k) summary for the DePuy Luster Stem, a hip prosthesis. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a study with acceptance criteria and performance data in the context of an AI/algorithm-driven medical device.
Therefore, most of the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, ground truth, MRMC study, standalone performance, training set details) is not applicable or not provided in this document.
Here's how to break down the request based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not applicable / Not provided. This document is a 510(k) for a physical medical device (hip prosthesis) demonstrating substantial equivalence, not an AI/algorithm device with performance metrics like sensitivity, specificity, etc. The "acceptance criteria" here implicitly refer to meeting the requirements for substantial equivalence, which is assessed based on design, material, and intended use similarities to predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. There is no "test set" in the context of an AI/algorithm evaluation for this physical device. The review is based on device design specifications, materials, and intended use compared to predicate devices.
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 / Not provided. No "ground truth" establishment by experts is described for a test set in this 510(k) submission. FDA reviewers assess the submission against regulatory guidelines and predicate device information.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. There is no test set or adjudication process described for the performance of an AI/algorithm.
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 / Not provided. This is a physical hip prosthesis, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. There is no algorithm discussed for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. The "ground truth" concept as applied to AI performance metrics is not relevant here. The substantial equivalence is based on established FDA-cleared predicate devices.
8. The sample size for the training set
- Not applicable / Not provided. 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 / Not provided. There is no "training set" or "ground truth" establishment for a training set in this context.
Summary derived from the provided document:
The DePuy Luster Stem is a hip prosthesis submitted for 510(k) clearance by demonstrating substantial equivalence to previously cleared predicate devices. The basis of equivalence is a comparison of design, material, and intended use.
Acceptance Criteria (Implied for 510(k) Substantial Equivalence):
The primary acceptance criterion for this 510(k) submission is that the DePuy Luster Stem is substantially equivalent to legally marketed predicate devices in terms of:
- Indications for Use: The Luster Stem has the same intended use as the predicate devices.
- Technological Characteristics: The Luster Stem shares similar design, materials, and functional principles with predicate devices. Any differences (e.g., surface finish) do not raise new questions of safety or effectiveness.
Study/Evidence that Proves Acceptance Criteria are Met:
The "study" here is a comparison analysis outlined in the 510(k) submission against predicate devices, rather than a clinical trial with end-point statistics.
Table of Comparison for Substantial Equivalence:
| Feature | DePuy Luster Stem | ENURANCE (K942370) | CPT (K960658) | EXETER (K974054, K980843) |
|---|---|---|---|---|
| Material | Cobalt-Chrome | Cobalt-Chrome | Cobalt-Chrome | 316L Stainless Steel |
| Use | Cemented | Cemented | Cemented | Cemented |
| Design | Medial 30° Collar, Proximal Flange, Two Tapers, Polished Finish | Medial 30° Collar, Proximal Flange, Two Tapers, Matte Finish (lateral & distal), grit blasted (proximal flange) | Collarless, Slim Profile, Two Tapers, Polished Finish | Collarless, Slim Profile, Two Tapers, Polished Finish |
| Modular Heads | Yes | Yes | Yes | Yes |
| EndCaps/Centralizers/Cement Restrictors | Yes | Yes | Yes | Yes |
| Intended Use | Femoral component in total hip arthroplasty for degenerative joint disease, fracture, or failed previous arthroplasty. | Femoral component in total hip arthroplasty for degenerative joint disease, fracture, or failed previous arthroplasty. | Femoral component in total hip arthroplasty for degenerative joint disease, fracture, or failed previous arthroplasty. | Femoral component in total hip arthroplasty for degenerative joint disease, fracture, or failed previous arthroplasty. |
Reported Device Performance:
The document asserts that "The Luster Stem is identical in design, material and intended use to the FDA cleared Endurance (K942370) femoral stem." The only difference noted is the surface finish. It also states similarities to the CPT and Exeter systems, particularly regarding material, polished surface, and cemented use. The FDA's clearance letter confirms that the device is "substantially equivalent" for its stated indications for use. This indicates that based on the comparative analysis, the device is expected to perform as safely and effectively as its predicate devices.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.