Search Results

The ULTRA Silver Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic).

Device Description

The ULTRA Silver Dressings are sterile, single-use wound care dressings for use in moist wound management. The dressings are comprised of 4 layers, each performing a specific function; an occlusive synthetic top layer, a polyurethane foam layer, a hot-melt adhesive and a layer of a silver-containing knitted composite fabric.

AI/ML Overview

The provided text is a 510(k) premarket notification for the ULTRA Silver Dressing, and it does not describe an AI medical device. Therefore, the requested information regarding acceptance criteria for an AI device, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document.

The document discusses the substantial equivalence of the ULTRA Silver Dressing to a predicate device (AFM Ultra Ag Dressings) based on non-clinical performance testing.

Here's what can be extracted regarding the device performance and supporting studies, though it does not align with the AI device criteria requested:

Device: ULTRA Silver Dressing (Wound Dressing)

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state acceptance criteria in a numerical or statistical sense for wound dressings as one might for an AI device's performance metrics (e.g., sensitivity, specificity). Instead, it relies on demonstrating that the modified device, with changes to non-patient contacting layers, performs equivalently to the predicate device in terms of established performance categories.

Performance Category	Reported Device Performance (ULTRA Silver Dressings)
Biocompatibility	Fulfills prospectively defined performance criteria.
Antimicrobial Effectiveness	Validation conducted; fulfills prospectively defined performance criteria.
Sterility	Validation conducted; fulfills prospectively defined performance criteria.
Fluid Management Performance	Fulfills prospectively defined performance criteria.
Intended Use	Management of Partial- to Full Thickness Acute and Chronic Wounds (Same as predicate)
Fabric Layer	Silver coated polyester/nylon/lycra (Same as predicate)
Indications	Management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (Same as predicate)
Antimicrobial Components	Silver sodium hydrogen zirconium phosphate (Same as predicate)
Moisture Management Properties	Yes (Same as predicate)
Conformable	Yes (Same as predicate)
Multiple Day Use?	Yes (Same as predicate)
Thickness	≥ 4.0 mm (Predicate was ≥ 5.5 mm; this is a change, but no specific acceptance criterion is stated for it, implying the new thickness is acceptable).
Porous Fabric Layer	Yes (Same as predicate)
Contra-Indications	Known allergy to silver (Same as predicate)
Packaging	Tyvek/Film Medical Pouch (Same as predicate)
Sterilization	Gamma Irradiation (25 kGy) (Same as predicate)

Study Description:

The study proving the device meets the "acceptance criteria" (understood as demonstrating substantial equivalence to the predicate device) is a "Summary of Non-Clinical Performance Testing."

Relevant Sections from the document:

Section 7: SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
"Validation activities to support the use of the ULTRA Silver Dressings consisted of four main elements:
- Biocompatibility Testing
- Validation of Antimicrobial Effectiveness
- Sterility Validation
- Fluid Management Performance
  Testing of the ULTRA Silver Dressings has demonstrated that the wound dressing fulfills prospectively defined performance criteria and that the modification system meets user needs."
Section 8: SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
"No clinical testing was conducted to support this submission."
Section 10: CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
"The similarities in intended use, operational characteristics, and functional technological characteristics between the proposed ULTRA Silver Dressings and the predicate AFM Ultra Ag Dressings lead to a conclusion of substantial equivalence between the proposed and predicate device."

Regarding the specific questions tailored for AI devices (which are not applicable here):

Sample sizes used for the test set and the data provenance: Not applicable. This is a non-clinical device test, not an AI model evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth in the AI sense is established.
Adjudication method: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used: Not applicable. The "ground truth" here is the performance of the predicate device and established standards for wound dressing properties.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Ask a Question

Ask a specific question about this device

Page 1 of 1