(30 days)
The PROFEMUR® Tapered Hip Stem 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; and,
- revision procedures where other treatments or devices have failed
The design features of the PROFEMUR® Tapered Hip Stem are summarized below:
- Modular neck taper
- Tapered cylindrical distal stem
- Plasma Sprayed proximal body
- Grit blasted distal stem
- Polished bullet tip
- Spines
This document is a 510(k) summary for the PROFEMUR® Tapered Hip Stem. It asserts substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in this type of document.
Here's an analysis based on the provided text, highlighting what is and isn't present:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable. This 510(k) summary does not present specific quantitative acceptance criteria or a study demonstrating direct device performance against those criteria. Instead, it argues for substantial equivalence to existing predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. No new study involving a test set is described. The submission relies on "substantial equivalence information, materials information, and analysis data" (page 1) in comparison to predicate devices. The data provenance and sample sizes for this "analysis data" are not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. There is no described test set requiring ground truth establishment by experts.
4. Adjudication Method for the Test Set:
Not applicable. No test set or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
Not applicable. This device is a hip stem (a medical implant), not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies involving human readers or 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. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
Not applicable. No new ground truth for performance evaluation is established or described explicitly. The basis for safety and effectiveness is "substantial equivalence" to predicate devices, implying that the established safety and effectiveness of the predicates serve as the basis for comparison.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/algorithm-based device requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This is not an AI/algorithm-based device.
Summary of what is available from the document:
The document, a 510(k) Summary of Safety and Effectiveness, focuses on establishing substantial equivalence of the PROFEMUR® Tapered Hip Stem to legally marketed predicate devices.
- Basis for Equivalence: The submission states, "The safety and effectiveness of the PROFEMUR® Tapered Hip Stem are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification" (page 1).
- Predicate Devices: The device is deemed substantially equivalent to the PROFEMUR® Z Hip Stem, the PERFECTA® RS Hip Stem, and the PERFECTA® Plasma Sprayed Hip Stem. The indications for use and materials are stated to be identical to the PROFEMUR® Z Hip Stem.
- Device Information: The document provides a description of the device's design features (e.g., modular neck taper, tapered cylindrical distal stem, plasma sprayed proximal body).
- Intended Use/Indications for Use: These are clearly defined for total hip arthroplasty in skeletally mature patients with conditions such as non-inflammatory degenerative joint disease, inflammatory degenerative joint disease, correction of functional deformity, and revision procedures.
In essence, a 510(k) submission like this does not typically include a direct study proving device performance against acceptance criteria in the way an AI/software device would. Instead, it's a regulatory pathway to demonstrate that a new device is as safe and effective as a legally marketed predicate device.
§ 888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.