(191 days)
The Endoform™ Dermal Template is supplied sterile and is intended for single use in the treatment of the following wounds:
- partial and full-thickness wounds
- pressure ulcers
- venous ulcers
- diabetic ulcers
- chronic vascular ulcers
- tunneled/undermined wounds
- surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery; podiatric, wound dehiscence)
- trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
- draining wounds
Endoform™ Dermal Template is a wound dressing primarily composed of ovine collagen and is supplied as a sterile intact, perforated or meshed sheet ranging in size from 9cm2 to 400cm2.
The provided text describes a 510(k) summary for the Mesynthes Limited, Endoform™ Dermal Template. It does not include information about specific acceptance criteria or a detailed study proving the device meets particular performance metrics. Instead, it focuses on the device description, intended use, technological characteristics, and a broad statement about performance testing for substantial equivalence.
Therefore, I cannot populate the requested table and sections with specific values as the information is not present in the provided text.
Here's how I would present the absence of that information based on the given text:
Acceptance Criteria and Device Performance Study
The provided 510(k) summary for the Mesynthes Limited, Endoform™ Dermal Template states that the device has undergone "extensive non-clinical testing to assess the biocompatibility and the performance of the device" and that "Endoform™ Dermal Template was shown to be safe and effective as a wound dressing." However, specific acceptance criteria, detailed study designs, and reported performance metrics are not provided in this document. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against pre-defined quantitative criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document | Not specified in the provided document beyond a general statement of "safe and effective" |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as no specific test set or ground truth establishment by experts is detailed in the provided document.
4. Adjudication method for the test set
- Not applicable as no specific test set or adjudication process is detailed in the provided document.
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. This is a wound dressing, not an AI-assisted diagnostic device. The document does not describe an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a wound dressing, not an algorithm. The document does not describe an algorithm-only performance study.
7. The type of ground truth used
- Not applicable, as specific performance metrics and ground truth establishment methods are not detailed. The submission relies on demonstrating substantial equivalence to predicate devices based on material composition, device characteristics, and intended use.
8. The sample size for the training set
- Not applicable. This is a wound dressing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a wound dressing, not a machine learning model.
N/A