Search Results
Found 1 results
510(k) Data Aggregation
(431 days)
This prosthesis is intended for use as a press-fit femoral hip prosthesis where there is evidence that there is sufficient healthy cortical bone to seat the femoral component. This prosthesis is indicated for use in the following conditions: a severely painful and/or severely disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; or failed previous surgery including joint reconstruction, internal fixation, arthrodeses, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.
The KAR Revision Hip is a non-cemented, long femoral stem made from Ti-6Al-4V, completely coated with hydroxyapatite. It has a straight stem with a quadrangular cross-section and blunt corners. The metaphyseal widening presents a bi-dimensional flare and horizontal and vertical grooves for metaphyseal support. The step-like structure of the grooves in the metaphyseal section provides stability. The distal section has symmetrical slopes. The diaphyseal section provides a distal anchor while the distal cross-slotted tip allows for elasticity in the stem and adaptability to the femoral curve. The stem has a 12/14 Morse-like taper.
Here's an analysis of the provided text regarding the KAR Revision Hip Prosthesis, focusing on acceptance criteria and the supporting study:
The provided documents describe a 510(k) submission for the KAR Revision Hip Prosthesis. A 510(k) submission typically aims to demonstrate substantial equivalence to a legally marketed predicate device rather than proving novel safety and effectiveness through extensive clinical trials with predefined acceptance criteria. Therefore, the information provided is structured around this regulatory pathway.
1. Table of Acceptance Criteria and Reported Device Performance
It's important to clarify that for a 510(k) submission, "acceptance criteria" for performance are usually framed as demonstrating comparable performance to a predicate device, rather than meeting specific numerical thresholds for a novel device. The "study" isn't a prospective pivotal clinical trial with a primary endpoint and corresponding statistical hypothesis and power calculation, but rather a comparison study.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Comparable Success Rate (to predicate Corail femoral stem) | "Clinical studies indicate that the KAR femoral stem, a revision of the Corail femoral stem, has a comparable success rate to the Corail." |
| Fewer Post-operative Complications (compared to Osteonics Restoration Monolithic Hip Stem) | "Compared to the Osteonics Restoration Monolithic Hip Stem, the KAR had fewer post-operative complications..." |
| Better Postel Merle D-Aubigne Scores (compared to Osteonics Restoration Monolithic Hip Stem) | "...and better Postel Merle D-Aubigne scores." |
| Mechanical Interlock Performance (no additional claims beyond conventional press-fit) | "The data presented support equivalence with no additional claims over a conventional press-fit hip prosthesis (i.e., mechanical interlock, only)." (This is a condition for clearance, not a direct performance metric, but implies the mechanical properties must be at least equivalent to predicate press-fit devices.) |
2. Sample Size Used for the Test Set and Data Provenance
The documents do not specify the exact sample size for the clinical studies. They generally refer to "Clinical studies."
The data provenance is not explicitly stated in terms of country of origin. However, given the manufacturer (Landanger-Landos, France) and sponsor (DePuy Orthopaedics, Inc., USA), it's possible the data could be from studies conducted in either or both regions, or other international locations.
The studies appear to be retrospective or a combination of retrospective and prospective observational studies, as there's no mention of a pre-planned, controlled clinical trial. The phrasing "Clinical studies indicate" suggests a review of existing clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The documents do not provide information on the number of experts, their qualifications, or how ground truth was established for the clinical data used in this 510(k) submission. This is not typically required to be detailed in this type of regulatory filing, as the focus is on substantial equivalence based on existing clinical outcomes data rather than de novo validation of a diagnostic algorithm.
4. Adjudication Method for the Test Set
The documents do not provide information on any adjudication method used for the clinical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of images, not for orthopedic implants. The study described compares the performance of the implant itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical orthopedic implant (a hip prosthesis), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" here refers to the actual clinical outcomes of patients who received the hip prosthesis. This includes:
- Success Rate: Implies positive patient outcomes, likely measured through various clinical assessments over time.
- Post-operative Complications: Objective reporting of adverse events.
- Postel Merle D-Aubigne scores: A clinical scoring system used to assess hip function (pain, walking, mobility).
The ground truth is essentially clinical outcomes data from patients.
8. The Sample Size for the Training Set
This question is not applicable. The KAR Revision Hip Prosthesis is a physical device, not an AI or algorithm that requires a "training set." The phrase "training set" refers to data used to train machine learning models.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
Ask a specific question about this device
Page 1 of 1