FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Under the supervision of a healthcare professional Silverlon® Island Wound Dressings are intended for up to 7 day use for wounds such as vascular access or peripheral IV sites, orthopedic external pin sites, surgical wounds (donor and graft sites, incisions), and partial to fill thickness dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers).

Silverlon® Island Wound Dressing is indicated for the management of infected wounds, as the silver in the dressing provides an antimicrobial barrier that may be helpful in managing these wounds. In addition, the moist wound healing environment and control of wound bacteria within the Silverlon® Island Wound Dressing may help reduce the risk of wound infection and support the body's healing process.

Silverlon® Island Wound Dressing may be used for the management of painful wounds, Silverlor® Island Wound Dressing's non-adherent wound contact layer reduces pain during dressing changes and evaporation of moisture in the dressing may soothe the wound.

Device Description

Silverlon® Island Wound Dressing is a self-adhesive, elastomeric wound dressing composed of 5 distinct layers (in innermost to outermost order):

• Layer 1 is a non-adherent wound contact layer that consists of a single layer of knitted continuous nylon fiber coated with metallic silver at the rate of 5.05 mg/cm (50.5 g/m²); the silver surface coating is approximately 0.8 – 1.0 µm thick and contains approximately 1% silver oxide.

· Layer 2 is a polyethylene film used to bond the nylon substrate to the pad layer (Layer 3);
Layer 3 is a laminate pad with an absorptive capacity of 65 oz/yd² to absorb wound exudate;

• Layer 4 is an apertured high density polyethylene film that bonds the pad to (Layer 5) described below; and,

· Laver 5 is a tape layer comprised of a widely used, commercially available foam tape component with natural color that is coated with a non-latex medical grade acrylic adhesive on the skin-contacting side. The side of the dressing away from the body is covered by a medical grade polyurethane film that is bonded to the foam membrane by an acrylic adhesive.

All materials are biocompatible per irritation, sensitization and cytotoxicity testing results.

Layer 1 delivers antimicrobial silver ions in the dressing when activated by moisture. The silver ions in the dressing kill wound bacteria held in the dressing and provides an antimicrobial barrier to protect the wound bed. This dressing absorbs high amounts of wound fluid and the dressing intimately conforms to the wound surface.

AI/ML Overview

The provided text describes a medical device, the Silverlon® Island Wound Dressing, and its regulatory clearance (K141573) based on substantial equivalence to a predicate device (K122817). This document is a 510(k) summary, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing extensive de novo clinical study data for acceptance criteria.

Therefore, the information requested about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for AI/software-based devices is not applicable to this type of regulatory submission and device.

Here's an explanation based on the provided text, addressing why most of the requested information cannot be found:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Applicable. The 510(k) summary does not set specific numerical acceptance criteria for performance metrics in the way one would for a diagnostic or AI device. Instead, it asserts that the device is "substantially equivalent" to a predicate device. The performance is assessed by confirming that its changed design (a new tape layer) maintains the same technological characteristics and does not raise new questions of safety or effectiveness compared to the predicate.
The document states: "The technological characteristics have not changed from the previously cleared Silverlon® Island Wound Dressing (K122817)... The minor changes in design do not influence the technological differences, so there are no new questions of safety and effectiveness."
It also lists "In vitro accelerated stability testing for antimicrobial effectiveness, equivalent to 5 years," "Kirby-Bauer Standard Antimicrobial Susceptibility Test," and "Microbiological Consultants - ASTM E2315 Time Kill Assay for Antimicrobial Agents Report" as tests performed. These tests confirm properties of the dressing (like antimicrobial efficacy and stability), but specific "acceptance criteria" against which these were measured are not explicitly stated in this summary.

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

Not Applicable. This is a medical dressing, not a diagnostic or AI device that would have a "test set" of data in the sense of patient images or clinical data for performance evaluation.
The tests performed are "in vitro" and "in vivo biocompatibility tests," and "antimicrobial susceptibility tests." The sample sizes for these laboratory tests are not provided in this summary. Data provenance (country of origin, retrospective/prospective) is typically for clinical data, which was not the primary basis of this submission.

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

Not Applicable. Ground truth, in the context of expert consensus, is relevant for diagnostic devices (e.g., radiologists interpreting images). This device is a wound dressing. The "ground truth" for its properties would be established through laboratory methods and chemical/biological assays, not expert interpretation of clinical cases.

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

Not Applicable. Adjudication methods are used to resolve discrepancies among expert readers in clinical studies, primarily for diagnostic devices. This concept does not apply to the evaluation of a wound dressing.

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 and not an AI device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant.

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 or AI.

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

Not Applicable in the typical sense for AI/diagnostic devices. For this wound dressing, the "ground truth" is derived from:
- Biocompatibility testing: Conformance to ISO 10993 standards (cytotoxicity, sensitization, intracutaneous reactivity).
- Antimicrobial effectiveness testing: In vitro accelerated stability, Kirby-Bauer, and ASTM E2315 Time Kill Assay.
- The "truth" is established by these standardized laboratory and material tests, not clinical outcomes data for this specific 510(k) beyond proving substantial equivalence.

8. The sample size for the training set:

Not Applicable. This is a wound dressing, not an AI device that requires a training set.

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

Not Applicable. As related to point 8, there is no training set for this device.

In summary: The provided document is a 510(k) summary for a wound dressing, which focuses on demonstrating "substantial equivalence" to a predicate device, primarily through non-clinical (laboratory and material) testing and a comparison of technological characteristics. The questions posed are largely relevant to the evaluation of AI/diagnostic software devices and are therefore not addressed in this specific regulatory filing for a wound dressing.

Summary

Regulation Number and Section

N/A