Search Results

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

The Endoform™ Dermal Template is a wound care device comprised of one or two layers of ovine extracellular matrix and is supplied as a sterile perforated or non perforated sheet ranging in size up to 400 cm2.

The provided 510(k) summary for the Endoform™ Dermal Template (K101546) does not contain the detailed information necessary to complete the requested table and answer all questions.

This 510(k) document establishes substantial equivalence to a predicate device (Endoform™ Dermal Template, K092096) based on material composition, device characteristics, and intended use, and a declaration of conformity to design control requirements and a risk assessment. It explicitly states that the predicate device (K092096) "was shown to be safe and effective as a wound care product" after "extensive non-clinical testing to assess the biocompatibility and the performance of the device." However, the current submission (K101546) does not present new clinical or performance data for the device itself.

Therefore, many of the requested details, such as specific acceptance criteria, reported performance values, sample sizes for test and training sets, expert qualifications, and adjudication methods, are not available within this document.

Here's what can be answered based on the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not available in this document. The submission references non-clinical testing for the predicate device, but no details of a clinical test set for K101546 or its provenance are provided.
• Data Provenance: Not available in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not available in this document.
• Qualifications of Experts: Not available in this document.

4. Adjudication method for the test set

• Adjudication Method: Not available in this 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

• MRMC Study Done?: No. This device is a Dermal Template, not an AI-assisted diagnostic tool. An MRMC study is not applicable.
• Effect Size of Human Reader Improvement: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance Study Done?: Not applicable. This device is a wound care product, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: Not available in this document. The document refers to non-clinical testing for the predicate device (K092096) to establish safety and effectiveness, but details of how "ground truth" was established for such testing are not provided.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a medical device for wound care, not a machine learning algorithm.

9. How the ground truth for the training set was established

• How Ground Truth for Training Set was Established: Not applicable. This device is a medical device for wound care, not a machine learning algorithm.

Ask a specific question about this device