(48 days)
Endoform Topical Matrix is indicated for the management of the following wounds:
- partial and full-thickness wounds
- · pressure ulcers
- · venous ulcers
- · diabetic ulcers
- chronic vascular ulcers
- tunnelled / 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 Topical Matrix is an advanced collagen matrix comprised of natural >70%, non-reconstituted collagen designed to cover, protect, and provide a moist wound environment. The device is supplied in a variety of sizes and thicknesses which can be trimmed by the surgeon to meet the individual patient's needs.
The provided document is a 510(k) summary for the Endoform Topical Matrix. It does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria using performance data. Instead, it argues for substantial equivalence based on similarities to a predicate device and a reference device, along with the device's technological characteristics.
Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth, and expert involvement are not available in this document as it relies on a different pathway for clearance (substantial equivalence to existing devices rather than a de novo performance study against defined acceptance criteria).
However, I can extract the information that is present:
Device: Endoform Topical Matrix
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria nor reported device performance against those criteria. The clearance is based on substantial equivalence.
2. Sample size used for the test set and the data provenance
Not applicable. Substantial equivalence was not based on a new clinical performance study. The document mentions "literature review" for in vivo use, but does not provide details on specific sample sizes or data provenance for that review.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment activity for a test set is described.
4. Adjudication method for the test set
Not applicable. No test set requiring adjudication is described.
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 device is a medical matrix, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
Not applicable. No specific ground truth methodology for a performance study is described. The basis for clearance is substantial equivalence to a predicate device already on the market.
8. The sample size for the training set
Not applicable. No training set is described as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. No training set is described.
Summary of Information Available in the Document:
Basis for Clearance: Substantial Equivalence to Predicate Device (Endoform Dermal Template, K092096) and Reference Device (Endoform Plastics and Reconstructive Matrix, K162461).
Argument for Equivalence:
- Raw Material: Identical (ovine forestomach tissue).
- Tissue Processing: Identical.
- Intended Use: Identical.
- Indications for Use: Identical.
- Technological Characteristics: The only difference is the Endoform Topical Matrix is a multi-layer device with a proprietary 'lug lamination' process, which was previously cleared via the reference device (K162461).
Non-Clinical Performance Data:
- Warranted Testing: "no additional bench performance testing was warranted" because the subject and predicate devices are made of identical material and the multi-layer design was cleared via the reference device.
- Existing Evidence: Mentions that the use of collagen wound dressings is well-established in clinical use and studies, and the collagen matrix used in all Aroa Biosurgery Endoform devices has been previously studied in in vivo models and is in wide-spread clinical use.
- In vivo evaluation: "evaluated via a literature review to demonstrate that the subject device is appropriate for the proposed indications based on equivalence to commercially available devices with equivalent composition and indications." (No specific details of the literature review are provided, such as sample size or data provenance).
Clinical Performance Data:
- "Substantial equivalence was not based on an assessment of clinical performance data."
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