Search Results

The CODMAN DURAFORM Dural Graft Implant is intended for use in procedures where the repair or substitution of the patient's dura mater is needed.

The CODMAN DURAFORM Dural Graft Implant is a collagen sponge manufactured from processed bovine tendons. It is a sterile, absorbable implant intended for the repair of the patient's dura matter. The CODMAN Dural Graft Implant is designed to be a sutureless, onlay graft, but tensionless sutures can be used if preferred by the surgeon.

The provided document K041518 is a 510(k) summary for the CODMAN DURAFORM Dural Graft Implant. It is a "Special 510(k) submission" and the key information regarding acceptance criteria and device performance is specifically described as follows:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document states: "No additional testing required for this special 510(k) submission. All testing submitted in original 510(k), K033395." Due to this, the provided document K041518 does not contain specific acceptance criteria or reported device performance for new tests. Instead, it relies on the predicate device (K033395) for its substantial equivalence claim regarding performance.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. As noted above, no new testing was performed for this special 510(k) submission (K041518). Information regarding sample size and data provenance for the original 510(k) (K033395) is not available in the provided document.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. Since no new testing was conducted, there was no expert review process described for establishing ground truth within this document. This kind of information would typically be found in the original 510(k) submission (K033395) if clinical or performance data was gathered requiring expert evaluation.

4. Adjudication Method for the Test Set

Not applicable. No new testing requiring adjudication was performed for this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not performed as part of this 510(k) submission, as it is a special 510(k) relying on equivalence to a predicate device without new performance testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a dural graft implant, not an AI algorithm. Therefore, no standalone algorithm performance study was done.

7. The Type of Ground Truth Used

Not applicable. As this is a medical implant and no new performance testing was conducted, there is no discussion of ground truth in the context of an AI algorithm or diagnostic device. The substantial equivalence is based on the physical properties, intended use, and materials of the implant compared to its predicate.

8. The Sample Size for the Training Set

Not applicable. This device is a medical implant, not an AI algorithm. Therefore, there is no training set mentioned.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this type of medical device.

Ask a specific question about this device