ACRYDERM GEL WOUND DRESSING

• K Number: K970693
• Device Name: ACRYDERM GEL WOUND DRESSING
• Manufacturer: ACRYMED, INC.
• Date Cleared: 1997-03-21 ( 24 days)
• Product Code: MGQ
• Regulation Number: N/A
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

AcryDerm Gel is an external wound dressing that is designed as a moisture donating substrate for use in promoting natural autolytic debridement by rehydrating necrotic tissues. AcryDerm Gel is indicated for use as an external wound dressing in the management of chronic wounds such as pressure sores, diabetic ulcers, radiation dermatitis, peristomal skin irritations, and stasis ulcers, and acute wounds such as surgical wounds, lacerations, donor site, first and second degree burns, and abrasions. AcryDerm Gel may be used on infected wounds under medical supervision. AcryDerm Gel is not intended as a long duration dressing for the treatment of third degree burns.

Device Description

AcryDerm Gel Wound Dressing is a clear amorphous hydrogel moist wound dressing for external use. AcryDerm Gel will be supplied in the following sizes: 1/2-oz squeeze tube: 1-oz squeeze tube; and 3-oz squeeze tube. AcryDerm Gel will be supplied sterile (gamma radiation), in individual primary squeeze tubes packaged with Instructions for Use into an intermediate labeled box and distributed in various case sizes.

AI/ML Overview

This document, K970693, is a 510(k) premarket notification for the "AcryDerm Gel Wound Dressing." It is a submission to the FDA to demonstrate substantial equivalence to a legally marketed device, not a study designed to establish new performance criteria or clinical efficacy with detailed acceptance criteria and a comprehensive study report as one would find for a novel AI/ML device.

Therefore, most of the requested information regarding acceptance criteria, study design (sample sizes, ground truth, experts, MRMC studies, standalone performance), and training data is not applicable to this 510(k) submission.

Here's a breakdown of what can be extracted and why other sections are not applicable:

1. A table of acceptance criteria and the reported device performance

   • Not Applicable in the traditional sense for a new AI/ML device. This 510(k) focuses on demonstrating "substantial equivalence" based on technological characteristics and intended use, rather than meeting specific performance metrics against pre-defined acceptance criteria from a clinical trial.
   • Reported "Performance Characteristics" (as stated in the document):
     • "AcryDerm Gel is an amorphous gel that is designed to provide intimate contact with the wound or irritated tissues and to donate moisture to tissues surrounding the application site."
     • "Laboratory tests have shown that AcryDerm Gel releases moisture to absorbent substrates."
   • Implicit Acceptance Criteria (for 510(k) purposes): The device must exhibit characteristics (composition, intended use, manufacturing, performance) that are "substantially equivalent" to predicate devices (AcryDerm Advanced Wound Dressing, IntraSite Gel, Carrasyn Hydrogel Wound Dressing). The document states: "The classification, intended uses, composition, and methods of manufacturing of AcryDerm Gel wound Dressing are substantially equivalent to the predicate devices."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not Applicable. No clinical test set data is provided or referenced in the summary. The "laboratory tests" mentioned are likely in-vitro, not clinical.

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)

   • Not Applicable. No clinical ground truth or expert review process is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not Applicable. No clinical adjudication process 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 is a physical wound dressing, not an AI/ML device that assists human readers.

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

   • Not Applicable. This is a physical wound dressing, not an AI/ML algorithm.

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

   • Not Applicable for clinical efficacy. For demonstrating substantial equivalence, the "ground truth" implicitly relies on the established safety and effectiveness of the predicate devices and the direct comparison of technological characteristics. The document mentions "Biocompatibility has been established according to Part-1 of the ISO standard (Biological Evaluation of Medical Devices)," which would involve its own set of tests and acceptance criteria for biocompatibility, but these are not for clinical efficacy as requested.

8. The sample size for the training set

   • Not Applicable. This is not an AI/ML device requiring a training set.

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

   • Not Applicable. This is not an AI/ML device requiring a training set.

In summary: K970693 is a 510(k) submission for a traditional medical device (wound dressing) aiming for substantial equivalence. It does not provide the type of detailed performance criteria, study design, and ground truth information typically associated with the evaluation of novel AI/ML devices outlined in your request. The "study" here is primarily a presentation of the device's characteristics and a comparison to predicate devices, along with some basic laboratory testing for moisture release and biocompatibility.

Regulation Number and Section

N/A