Search Results
Found 1 results
510(k) Data Aggregation
(87 days)
DURACON POSTERIOR FEMORAL SPACER
The Duracon® Femoral Posterior Spacer is intended to be used with the femoral components of the Duracon® Total Knee System (reference premarket notifications K910235, K920034, K932070, and K954138) to augment bone loss in the area of the posterior condyle of the femur. Posterior bone loss that requires augmentation by spacers may be noted in primary or revision total knee arthroplasty cases.
The Duracon® Femoral Posterior Spacer is cemented to the femoral component, and then the spacer-femoral component assembly is cemented into place.
The provided 510(k) summary for the Duracon® Femoral Posterior Spacer Device (K963242) is a premarket notification for a medical device. This type of document is filed with the FDA to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device.
It is important to understand that 510(k) summaries, especially from 1996, typically do not contain the type of detailed performance criteria and study results that would be found in a current regulatory submission for an AI/ML-based diagnostic device. The regulatory landscape and expectations for evidence of performance have evolved significantly since 1996, particularly concerning software as a medical device and AI.
Therefore, most of the requested information regarding acceptance criteria and detailed study data (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance of an algorithm) is not present in the provided text. The device described is a physical implant, not an AI diagnostic tool.
Below is an attempt to answer your questions based only on the provided text, acknowledging its limitations for an AI/ML context:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Intended Use: Used with femoral components to augment bone loss in the posterior condyle of the femur. | The device is described as "intended to be used with the femoral components of the Duracon® Total Knee System... to augment bone loss in the area of the posterior condyle of the femur." This suggests it meets its intended function to physically augment bone. |
| Method of Use: Cemented to the femoral component, then the spacer-femoral component assembly is cemented into place. | The method of use is clearly described, implying the device is compatible with standard surgical cementing techniques for knee arthroplasty components. |
| Material/Design Compatibility: Compatible with Duracon® Total Knee System femoral components. | The device is explicitly named "Duracon® Femoral Posterior Spacer" and stated to be used with "Duracon® Total Knee System femoral components." |
| Substantial Equivalence: Similar in principle of operation, technological characteristics, and intended use as other legally marketed predicate devices. | The document explicitly states, "The Duracon® Femoral Posterior Spacer is substantially equivalent to several other legally marketed devices." It then lists 6 predicate devices. This is the primary "performance" criterion for a 510(k) – that it is as safe and effective as a predicate. |
| Safety and Effectiveness: Assumed to be at least as safe and effective as predicate devices. | Not explicitly stated with performance metrics, but inherent in the concept of substantial equivalence to already cleared devices. |
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. The document does not describe a "test set" in the context of an AI/ML study. Clinical data or testing that would typically be described with sample sizes, provenance, or retrospective/prospective nature is not included in this 510(k) summary for a physical implant. The basis for clearance is substantial equivalence to predicates, not specific clinical trial data described here.
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. This information is relevant for validating diagnostic algorithms, not for the clearance of a physical orthopedic implant. No ground truth establishment by experts for a "test set" is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. See response to question 3.
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 physical knee implant component, not an AI system or an aid for human interpretation. Therefore, an MRMC study related to AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. This device is a physical product, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. Given this is a physical implant, "ground truth" for its performance would implicitly relate to its mechanical properties, biocompatibility, and clinical outcomes (e.g., in vivo stability, wear characteristics, patient function). However, these are not quantified or discussed as "ground truth" in this summary. The primary "ground truth" for its regulatory acceptance is its substantial equivalence to predicate devices, which have already demonstrated appropriate safety and effectiveness.
8. The sample size for the training set
- Not Applicable / Not Provided. The concept of a "training set" is for AI/ML models. This document refers to a physical device.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. See response to question 8.
Summary of Limitations:
The provided document (K963242) is a 1996 510(k) summary for an orthopedic implant. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study data or performance metrics using methodologies common for AI/ML devices in today's regulatory environment. Therefore, most of the questions, particularly those pertaining to AI/ML validation (test sets, training sets, expert consensus, adjudication, MRMC studies), cannot be answered from the given text.
Ask a specific question about this device
Page 1 of 1