(84 days)
The Revelation™ Porous Hip Stem is intended for treatment of patients who are candidates for total hip arthroplasty because of degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.
The Revelation™ Porous Hip Stem is fabricated from wrought/forged or cast Ti-6A1-4V that conforms to ASTM F136 or F1108, respectively. The outside surface of the stem is porous coated with commercially pure titanium (ASTM F67 grade 2) beads to provide a porous surface for enhanced fixation. The Revelation™ Porous Hip Stem is collarless and has a Morse type taper to receive modular heads.
This document is a 510(k) summary for the K973685 Revelation™ Porous Hip Stem.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fatigue testing on the Morse type taper | "Testing on this device included fatigue testing on the Morse type taper." (No specific quantitative acceptance criteria or results are provided in the summary.) |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary for K973685 does not specify a separate "test set" in the context of clinical data for performance evaluation. The device is a hip stem, and the testing mentioned is mechanical fatigue testing. Therefore, details about data provenance (country of origin, retrospective/prospective) are not applicable as there's no clinical trial data discussed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the summary discusses mechanical testing, not a study involving human experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set
This is not applicable as the summary discusses mechanical testing, not a study involving adjudication of clinical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. The device is a hip stem, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI performance improvement are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not applicable. The device is a hip stem, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the mechanical testing would be the physical properties and failure points observed during the fatigue testing. For a hip stem, this would likely involve reaching a specified number of cycles without failure or exceeding a certain strain/deflection. The summary does not detail the specific ground truth metrics or methodology beyond stating "fatigue testing" was performed.
8. The Sample Size for the Training Set
This is not applicable. The device is a hip stem undergoing mechanical testing, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
§ 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.