(84 days)
Durasis® Dural Substitute is intended for use as a dura substitute for repairing dura mater. The device is provided sterile and intended for one-time use.
Durasis® Dural Substitute is manufactured from porcine small intestinal submucosa and is supplied in various sizes ranging up to 140 cm². The device is packaged in sterile, sealed double pouches.
The provided text is a 510(k) summary for the Durasis® Dural Substitute, a medical device intended for use as a dura substitute. It describes the device, its intended use, predicate devices, and conclusions drawn from tests. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a specific study proving it.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document states: "The material met the criteria, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence." However, the specific acceptance criteria (e.g., tensile strength thresholds, biocompatibility limits, burst pressure) and the numerical or detailed qualitative performance results are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. It only generally states that the material was subjected to "in vitro, in vivo, and clinical evaluation."
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)
This information is not provided in the 510(k) summary. The document does not describe a study involving "experts" establishing a "ground truth" in the context of diagnostic or interpretive performance, which is typically where such details are relevant. This device is a surgical implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
Given that this device is a dural substitute (a surgical implant) and not an AI-powered diagnostic tool, an MRMC comparative effectiveness study involving "human readers" and "AI assistance" would not be relevant or performed for this type of product. Therefore, this information is not applicable and not provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Again, this is not a diagnostic device with an algorithm. A "standalone" performance evaluation for a physical implant would refer to its direct physical and biological performance characteristics, which are generally summarized as "in vitro, in vivo, and clinical evaluation." The document confirms these evaluations were done but does not detail them.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a dural substitute, "ground truth" would typically refer to established biomechanical standards, biocompatibility requirements (e.g., lack of toxicity, immunogenicity), and successful integration/repair in animal or human subjects. The document states "The material met the criteria, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence." This implies that the 'ground truth' was based on established scientific and medical standards for dural repair materials, likely validated through histological findings (for biocompatibility and tissue integration), mechanical testing, and clinical observations of successful repair (outcomes data). However, the specific types of ground truth for each test are not explicitly detailed. For example, pathology would be used for in vivo biocompatibility, and biomechanical standards for in vitro testing.
8. The sample size for the training set
This information is not provided. The concept of a "training set" is typically associated with machine learning or AI models, which is not applicable to this primarily biological and mechanical medical device.
9. How the ground truth for the training set was established
As above, the concept of a "training set" and its "ground truth" is not applicable here.
Summary Table of Available Information:
| Information Requested | Available in Document (K031850 510(k) Summary) |
|---|---|
| Acceptance Criteria & Reported Performance | Acceptance Criteria: Not explicitly detailed (e.g., no specific tensile strength values). Reported Performance: "The material met the criteria, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence." (General statement) |
| Sample Size (Test Set) & Data Provenance | Sample Size: Not specified. Data Provenance: Not specified (e.g., country, retrospective/prospective). |
| Number of Experts & Qualifications (Ground Truth - Test Set) | Not applicable for this type of device/study. |
| Adjudication Method (Test Set) | Not applicable. |
| MRMC Comparative Effectiveness Study & Effect Size (Human Readers w/wo AI) | Not applicable (device is a surgical implant, not an AI diagnostic tool). |
| Standalone Performance (Algorithm-only) | "In vitro, in vivo, and clinical evaluation" were done, but specific details of "standalone" performance metrics (e.g., a specific algorithm's output without human intervention) are not relevant here. |
| Type of Ground Truth Used | Implied to be based on established biomechanical, biocompatibility, and clinical standards for dural repair materials, likely including histological and outcome data. Specifics are not detailed. |
| Sample Size (Training Set) | Not applicable (not an AI/ML device). |
| How Ground Truth for Training Set was Established | Not applicable. |
In essence, this 510(k) summary provides a high-level overview of the tests performed and the conclusion of substantial equivalence. It lacks the granular detail of specific acceptance criteria, test methodologies, sample sizes, and expert qualifications that would be present in a comprehensive study report or a more detailed submission. This is typical for a 510(k) summary, which is a brief outline rather than a full scientific paper.
§ 882.5910 Dura substitute.
(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).