(66 days)
The Howmedica® Asymmetric Stem, Vitalock® Cluster & Spiked Shells, and Mesh Ingrowth Shells with Peri-Apatite™ Coating are intended to be used in the primary ingromented reconstruction of the proximal femur and acetabulum, respectively.
The Howmedica® Asymmetric Stem, Vitalock® Cluster & Spiked Shells, and Acetabular Shells with Mesh Ingrowth Surface with Peri-Apatite™ Coating are intended to be used in the primary uncemented reconstruction of the proximal femur and acetabulum. These devices are identical to the previously cleared Asymmetric Stem, Vitalock® Cluster Shell, Vitalock® Spiked Shell and Mesh Shells, except for the presence of a thin layer of hydroxyapatite coating applied to the porous coated surface.
This 510(k) summary (K982248) is for a medical device regulatory submission, not a study evaluating device performance against acceptance criteria. Therefore, most of the information requested in your prompt regarding acceptance criteria, study details, and performance metrics cannot be directly extracted from this document, as it is not a clinical study report.
The document discusses the regulatory clearance of a hip prosthesis with a coating, asserting substantial equivalence to previously cleared devices. Substantial equivalence is the primary "acceptance criteria" for 510(k) submissions, meaning the new device is as safe and effective as a legally marketed predicate device.
Here's an attempt to answer what can be gleaned from the provided text, and where the information is explicitly not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Same as predicate devices for primary uncemented reconstruction of the proximal femur and acetabulum. | The devices are "identical to the previously cleared Asymmetric Stem, Vitalock® Cluster Shell, Vitalock® Spiked Shell and Mesh Shells, except for the presence of a thin layer of hydroxyapatite coating applied to the porous coated surface." The Peri-Apatite™ coating is "the same coating previously characterized and cleared in 510(k) K971206." |
| Materials Equivalence: Same as predicate devices. | Stated as equivalent. |
| Design Equivalence: Same as predicate devices. | Stated as equivalent. |
| Relative Indications and Contraindications Equivalence: Same as predicate devices. | Stated as equivalent. |
| Safety and Effectiveness Equivalence: To be as safe and effective as the predicate devices. | The FDA determined the devices are "substantially equivalent" for the stated indications, indicating they meet this criterion. However, the FDA explicitly restricts claims for "enhanced clinical or radiographic performance, enhanced biological fixation and/or long-term stable fixation," and states that "The data presented support equivalence with no additional claims over a conventional porous coated hip prosthesis (i.e., biological fixation only)." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This document is a regulatory submission based on substantial equivalence, not a clinical study report requiring a test set of patient data. The "data presented" mentioned by the FDA likely refers to engineering testing, material characterization, and comparisons to predicate devices, rather than a clinical outcomes study with a test set of patient cases.
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. Ground truth establishment by clinical experts for a test set is not part of this 510(k) substantial equivalence submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods are relevant for clinical studies, which is not what this document describes.
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 device is a hip implant, not an AI diagnostic tool. Therefore, an MRMC study and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Not provided. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the context of a "test set" for performance evaluation. The "ground truth" for this 510(k) submission is the regulatory acceptance of the predicate devices as safe and effective. The new device is compared against the predicate's known characteristics and regulatory status. Material characterization and engineering testing would have their own "ground truths" (e.g., measured material properties against specifications).
8. The sample size for the training set
- Not applicable / Not provided. This is not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable / Not provided. This is not a machine learning model.
§ 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.