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abrasions
lacerations
minor cuts
minor scalds
minor burns
Under the supervision of a physician, IALUSET HYDROCOLLOID may also be applied to:
leg ulcers (venous stasis ulcers, arterial ulcers)
diabetic ulcers
pressure ulcers (stage I IV)
surgical wounds (postoperative, dermatological excisions, donor sites)
burns (first and second degree only)
traumatic wounds

Device Description

IALUSET HYDROCOLLOID is a 10 cm x 10 cm wound dressing comprised of an inner layer of hydrocolloids (containing sodium hyaluronate and sodium chondroitin sulfate) which are incorporated into an adhesive matrix and spread between a polyurethane film and a silicone release liner. The dressing absorbs wound exudate, thereby allowing for a moist environment that is conducive to normal wound healing. It does not adhere to the wound, which minimizes both pain and damage to the underlying tissue when the dressing is removed.

AI/ML Overview

The provided text is a 510(k) summary for a wound dressing (IALUSET® HYDROCOLLOID). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new device's efficacy through extensive clinical studies with acceptance criteria in the same way a novel AI algorithm would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, effect size, standalone performance, training set size, ground truth for training set) are not applicable to this type of device and submission.

The "acceptance criteria" for this device are essentially demonstrating substantial equivalence to existing legally marketed predicate devices in terms of composition, intended use, and technological characteristics, along with biocompatibility.

Here's an attempt to extract relevant information given the limitations of the provided document:

Acceptance Criteria and Device Performance (IALUSET® HYDROCOLLOID)

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this 510(k) submission are primarily based on demonstrating substantial equivalence to predicate devices, supported by non-clinical biocompatibility data. The performance is compared feature-by-feature to predicate devices rather than against numerical thresholds for efficacy.

Characteristic	Acceptance Criterion (Substantial Equivalence to Predicate)	Reported Device Performance (IALUSET® HYDROCOLLOID)
Composition	Similar hydrocolloid and polyurethane film structure as predicate devices.	Hydrocolloid plus Polyurethane Film (same as predicates)
Surface	Similar extruded & laminated surface as predicate devices.	Extruded & Laminated (same as predicates)
Indication for Use	Similar range of wound types as predicate devices (Superficial Wounds, Dermal Ulcers, Burns (1st & 2nd Degree), Donor Sites, Postoperative Wounds, Protective Dressings).	Superficial Wounds, Dermal Ulcers, Burns (1st & 2nd Degree), Donor Sites, Postoperative Wounds, Protective Dressings (same as predicates). Expanded list in official indications for use includes abrasions, lacerations, minor cuts, minor scalds, leg ulcers, diabetic ulcers, pressure ulcers, surgical wounds, traumatic wounds.
Transparency	Transparent like predicate devices.	Yes (same as predicates)
Self-Adhesive	Self-adhesive like predicate devices.	Yes (same as predicates)
Sterilization Method	Gamma Irradiation like predicate devices.	Gamma Irradiation (same as predicates)
Biocompatibility	No untoward responses in standard biocompatibility tests (Cytotoxicity, Primary Skin Irritation, Skin Sensitization, Subchronic Toxicity, Genotoxicity) compared to vehicle control.	No untoward responses, except for evidence of cytotoxicity in the L929 murine fibroblast assay at the two highest concentrations tested (attributed to osmotic effect). The overall conclusion was that extracts were not found to elicit untoward responses.

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

Not applicable. This is a 510(k) submission for a wound dressing, which relies on demonstrating substantial equivalence to existing devices and non-clinical biocompatibility testing, not a test set of patient data to evaluate an algorithm's performance. The biocompatibility tests would have their own sample sizes for in vitro or in vivo models, but these are not specified in the summary.

Data Provenance (Biocompatibility): The document does not specify the country of origin for the biocompatibility test data. The tests are standard biological evaluation tests (Cytotoxicity, Primary Skin Irritation, Skin Sensitization, Subchronic Toxicity, and Genotoxicity (Ames)), typically performed in a laboratory setting. The study appears to be non-clinical.

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

Not applicable. This device is not an AI algorithm requiring expert ground truth for a test set.

4. Adjudication method for the test set

Not applicable.

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 document is for a wound dressing, not an AI-assisted diagnostic or therapeutic device.

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

Not applicable.

7. The type of ground truth used

For the biocompatibility testing, the "ground truth" would be the established biological responses (e.g., absence of irritation, non-mutagenicity) as determined by validated laboratory assays and compared against control samples. For substantial equivalence, the "ground truth" is the established characteristics and performance of the legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI algorithm.

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

Not applicable.

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