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For over-the-counter use, Calcium Alginate Dressing with Antimicrobial Silver may be used for:

• abrasions
• minor lacerations
• minor cuts
• minor scalds and burns

Under the supervision of a healthcare professional, Algicelle Ag (Calcium Algiante Dressing with Antimicrobial Silver) dressing is an effective barrier to bacterial penetration in moderate to heavily exuding wound such as:

• diabetic foot ulcer
• leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology
• pressure ulcers/sores (partial and full thickness)
• donor sites, and traumatic and surgical wounds.

Calcium Alginate Dressing with Antimicrobial Silver is a primary wound dressing made of Calcium Alginate containing 1.4% Silver. In the presence of wound exudate, the sodium ions from the exudates take the place of the silver ions, releasing the silver ions. As wound exudate is absorbed, the alginate forms a gel, which assist in maintaining a moist environment for optimal wound healing, and allows intact removal. The silver ions released in the presence of wound fluid protect the dressing from bacterial colonisation, and provides an effective barrier to bacterial penetration. The Sciences Derma Calcium Alginate Dressing with Antimicrobial Silver are sterile, single-use wound care dressings for use in moist wound management. This dressing is offered in several sizes including the following: 2"X2". 4.25"X4.25",4"X5",4"X8",8"X12".

The provided 510(k) summary for the Derma Sciences Calcium Alginate Dressing with Antimicrobial Silver primarily focuses on demonstrating substantial equivalence to a predicate device and includes performance testing related to its antimicrobial properties and biocompatibility.

Here's an analysis based on your requested information:

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

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

The document does not specify sample sizes for the antimicrobial efficacy or biocompatibility tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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

This information is not applicable or provided in the context of these types of performance tests for a wound dressing. Ground truth in this context would be defined by the outcome of the laboratory tests themselves (e.g., bacterial inhibition, cellular viability).

4. Adjudication method for the test set

Not applicable for these types of laboratory performance tests.

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 device is a medical dressing, not an AI-powered diagnostic or assistive technology for human readers.

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

Not applicable. This device is a medical dressing.

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

The ground truth for the performance tests would be established by the results of the standardized laboratory assays:

• Antimicrobial Efficacy: Bacterial, yeast, and mold growth inhibition conforming to the standards of ASTM E2549-01.
• Biocompatibility: Absence of toxic or irritating effects in the specified in vitro and in vivo models according to established biological evaluation standards.

8. The sample size for the training set

Not applicable. This document describes performance testing for a physical medical device (dressing), not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no mention of a training set or machine learning algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The device's performance was validated through a series of laboratory tests:

• Antimicrobial Testing: Antimicrobial testing was performed using ASTM E2549-01 to demonstrate successful inhibition of bacteria, yeast, and mold at the 7th day. The document states this was "performed successfully."
• Biocompatibility Testing: A suite of biocompatibility studies including Cytotoxicity, Sensitization, Skin Irritation Study, Intracutaneous Study, Systemic Toxicity Study, and Muscle Implantation study were performed. These studies were also reported as having been "performed successfully" using the Derma Sciences Calcium Alginate Dressing with Antimicrobial Silver.

The focus of this 510(k) submission is to demonstrate substantial equivalence to a predicate device (Calcium Alginate Dressing with Antimicrobial Silver, K052536). The performance testing was conducted to address modifications to the previously cleared 510(k), specifically the inclusion of an over-the-counter use claim and an increase in the duration of use from 5 days to 7 days, necessitating the demonstration of sustained antimicrobial activity for the extended duration.

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Under the supervision of a healthcare professional, API-MED™ ACTIVE MANUKA HONEY ABSORBENT Dressing provides a moist environment conducive to wound healing and is indicated for moderate to heavily exuding wounds such as:

• diabetic foot ulcers .
• leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed . etiology)
• pressure ulcers / sores (partial and full thickness) .
• 1st and 2nd degree partial thickness burns .
• donor sites, and traumatic and surgical wounds. .

Derma Sciences API-MED™ Active Manuka Honey Absorbent Dressing

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Derma Sciences API-MED™ Active Manuka Honey Absorbent Dressing." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

The letter primarily:

• Confirms the FDA's review of the 510(k) submission (K053095).
• States that the device is substantially equivalent to legally marketed predicate devices.
• Grants permission to market the device, subject to general controls provisions.
• Outlines general regulatory responsibilities.
• Includes an "Indications for Use" statement for the device.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and study details based on the given input. The document is solely a regulatory approval letter, not a technical report or study summary.

Ask a specific question about this device

Under the supervision of a healthcare professional, Algicell® Ag dressing is an effective barner to bacterial penetration in moderate to heavily exuding wounds such as diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology), pressure ulcers/sores (partial and full thickness), donor sites, and traumatic and surgical wounds.

Calcium Alginate Dressing with Antimicrobial Silver

I'm sorry, but this document does not contain the information you requested about acceptance criteria and device performance studies. The document is an FDA 510(k) clearance letter for a medical device (Calcium Alginate Dressing with Antimicrobial Silver) and primarily focuses on the substantial equivalence determination for marketing the device. It outlines regulatory aspects, such as compliance with FDA regulations and an "Indications for Use" statement, but it does not provide details about specific performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert qualifications.

Ask a specific question about this device