Search Results

Antibacterial bandages are to be applied to the skin for the management of minor cuts.minor scrapes. This device is only applicable to adults.

The device, Antibacterial bandage, is to be applied topically to the skin for management of minor cuts, minor scrapes. Antibacterial bandage is made of polyethylene tape, absorbent pad and release paper. The absorbent pad contains 95±10 ug/cm2 (0.8% by weight) benzalkonium chloride. Antibacterial bandage is available in different sizes. The antibacterial bandage is EO sterilized and is for single use only.

The provided text describes an antibacterial bandage, not an AI device. Therefore, it does not contain information about acceptance criteria or studies related to AI device performance. The document focuses on regulatory approval (510(k)) for the antibacterial bandage based on substantial equivalence to a predicate device.

The document discusses the following for the Antibacterial bandage:

• Acceptance Criteria (as demonstrated by testing):

  • Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic Toxicity, Material-mediated Pyrogenicity, Endotoxin testing)
  • Sterilization (EO sterilization, complying with ISO 11135:2014)
  • Shelf Life (Accelerated Aging per ASTM F1980-16, Real-time ageing study)
  • Storage and Transport (ASTM 4169-16)
  • Antibacterial Finishes (AATCC 100: 2019)
  • Wound Healing Performance (comparable to predicate device in porcine study)

• Study Proving Acceptance Criteria:

  • Non-clinical tests: Conducted to verify the proposed device met design specifications and was safe and effective.
    • Biocompatibility tests
    • Sterilization testing
    • Shelf life testing (accelerated aging and real-time ageing)
    • Storage and transport testing
    • AATCC 100: 2019 for antibacterial finishes.
  • Animal studies: A porcine wound healing study was carried out to evaluate the cytotoxicity and wound healing performance, demonstrating no significant difference from the predicate device.

The document explicitly states: "No clinical study is included in this submission."

Therefore, I cannot provide the requested information regarding AI device acceptance criteria, performance tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI device, as this information is not present in the provided text.

Ask a specific question about this device

Antibacterial bandage is to be applied topically to the skin for management of minor cuts, minor scrapes and minor burns.

The subject device. Antibacterial bandage, is to be applied topically to the skin for the management of minor cuts, minor scrapes and minor burns. The subject devices are available sterile in three models. All of devices contain three layers: (1) adhesive backing layer (fabric or plastic); (2) exactly same antibacterial non-stick absorbent pad layer (composed of Polyester fiber, viscose fiber, PE mesh, Benzalkonium chloride); (3) release liner. Each model is available in different sizes with identical materials, chemicals and physical properties, therefore, size of the device will not affect the function and performance of products. All models of subject device, Antibacterial bandage, are for single use only and sterilized by Ethylene Oxide using conditions validated following ISO 11135:2014.

The provided text describes a 510(k) premarket notification for an "Antibacterial Bandage" (K221311) and compares it to a predicate device (K113583) and a reference device (K200821). The submission aims to demonstrate substantial equivalence, not to prove that the device meets specific acceptance criteria through a clinical study. Therefore, a direct answer to the request regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of device performance metrics often expected for AI or diagnostic devices (e.g., accuracy, sensitivity, specificity, MRMC studies) cannot be fully provided from the given document.

However, I can extract the non-clinical test conclusions which serve as the basis for demonstrating substantial equivalence based on performance and biocompatibility. These tests implicitly define "acceptance criteria" through their methodologies and the successful comparison to the predicate device.

Here's a breakdown of the information that can be extracted, framed as closely as possible to the request:

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

The document does not explicitly list numerical "acceptance criteria" with corresponding "reported device performance" in a typical clinical study outcome format like sensitivity or specificity. Instead, the "acceptance criteria" are implied by the successful completion of specified performance and biocompatibility tests, demonstrating equivalence to the predicate device or compliance with standards.

For Antibacterial Effectiveness, a specific quantitative measure is mentioned for both the subject and predicate devices:

For other performance tests and biocompatibility, the reported "performance" is that the device "met the requirement" or "complied with the corresponding standards," or "was not different" from the control.

Here's how the other "acceptance criteria" and "reported performance" can be inferred from the non-clinical tests:

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

• Non-Clinical Performance Tests & Biocompatibility Tests: The document does not specify sample sizes (e.g., number of bandages tested for peel strength) or the data provenance for these lab-based tests. These are typically performed in a controlled laboratory setting.
• Animal Study: A "porcine wound healing study" was carried out, indicating an animal model. The sample size for this study is not specified, nor is the country of origin of the animal data. It would be considered prospective for the animal subjects involved.

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)

This question is not applicable to the provided document. The device is an antibacterial bandage, not an AI or diagnostic device that requires expert review for ground truth establishment for a diagnostic test set. The ground truth for the non-clinical and animal studies is based on objective laboratory measurements and biological observations, not expert consensus on interpretations of images or signals.

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

This question is not applicable. Adjudication methods like 2+1 are typically used for establishing ground truth in clinical studies involving human interpretation (e.g., radiologists reviewing images). The studies described here are non-clinical and animal studies.

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

No MRMC study was done. This type of study is relevant for AI-powered diagnostic devices, which is not the case for an antibacterial bandage.

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

This question is not applicable. The device is not an algorithm.

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

• Non-Clinical Performance Tests: Ground truth is established by the specified test methods and standards (e.g., EN 13726-1:2002, ASTM D3330/D3330M). The "truth" is the measured physical or chemical property of the bandage.
• Biocompatibility Tests: Ground truth is defined by the biological response observed according to the specific ISO standards (e.g., presence/absence of cytotoxicity, sensitization).
• Animal Study: Ground truth is based on observed wound healing performance characteristics and local tolerance in the porcine model.

8. The sample size for the training set

This question is not applicable. The device (antibacterial bandage) does not involve machine learning or AI, and therefore does not have a "training set" in that context.

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

This question is not applicable, as there is no training set for this device.

Ask a specific question about this device

Antibacterial bandage is to be applied topically to the skin for management of minor scrapes and minor burns.
Antibacterial bandage is to be applied topically to the skin for management of minor cuts, minor scrapes and minor burns.

The device, Antibacterial bandage, is to be applied topically to the skin for management of minor cuts, minor scrapes and minor burns. The proposed devices are available in fabric backing and plastic backing. All of devices consist of (1) backing (fabric or plastic), (2) absorbent pad (composed of Polyester fiber, viscose fiber, PE mesh, Benzalkonium chloride) and (3) release paper (composed of cellulose pulp, water, kaolin, starch, ethanol and ethylene copolymer). Each device type is available in several models. The difference between each model is the device size. This dressing contains 0.08% benzalkonium chloride which has shown effectiveness against (Staphylococcus Aureus, Pseudomonas Aeruginosa, Escherlchia coli, Enterococcus Faecalis, Klebsiella Pneumoniae, Streptococcus Pyogenes, Candida Albicans and Aspergillus Niger) for up to 24 hours, as demonstrated via in vitro testing.

The provided text describes the 510(k) summary for an "Antibacterial Bandage" (K201324) and compares it to a predicate device (K113583). It outlines non-clinical tests performed to demonstrate substantial equivalence, but it does not include a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or details on ground truth for AI model training/testing, as it is not an AI/ML device.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set for an algorithm.

9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI/ML algorithm.

Ask a specific question about this device

Antibacterial bandages are to be applied topically to the skin to help prevent infection in minor cuts, scrapes and burns.

Not Found

This document is an FDA 510(k) clearance letter for the Curad Antibacterial Bandage. It does not contain information on acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information from this document.

Ask a specific question about this device

SciVolutions Antibacterial Gentle Care Bandages are to be applied to the skin for topical application for minor cuts and scrapes.

The Antibacterial Gentle Care Bandages uses the identical BZC antibacterial pad as on The Antibactional Gentre Garden ander K020318. Only the backing (non-woven) our providually clours providing a higher water vapor permeability and soft feel.

Antibacterial Gentle Care Bandages

Non-woven skin color treated hydrophobic backing (Latex Free)

Central pad: High absorption capacity, covered with an anti adherent polyethylene veil, Ochtral pad. Figh abound, impregnated with 1% benzalkonium chloride solution.

Encased in Latex Free Kraft Paper Cold Sealed to make a envelope wrapper

Sizes: .75" x 3" / 1" x 3"

Uses: Gentle Care 25

This document is a 510(k) summary for a medical device (SciVolutions Antibacterial Gentle Care Bandages) and primarily focuses on establishing substantial equivalence to a predicate device. It does not contain information about the acceptance criteria and the detailed study that proves the device meets those criteria for the following reasons:

• Type of Device: This is a bandage with an antibacterial component. For such a device, the primary "performance" is often related to the antibacterial agent's efficacy and the bandage's physical properties (adhesion, breathability, comfort). However, the document provided is a 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. It typically doesn't include detailed performance studies unless new claims are being made that go beyond those of the predicate device.
• Focus on Substantial Equivalence: The document explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined that this device is substantially equivalent... to legally marketed predicate devices." This means the FDA has deemed it similar enough to an existing approved device that new, extensive clinical trials or performance studies specific to novel acceptance criteria are usually not required for market clearance.
• Lack of Specific Data: The document mentions the antibacterial component (Benzalkonium Chloride) and the physical characteristics of the backing and pad but does not present quantitative acceptance criteria (e.g., "bacterial reduction by X%") or the results of studies designed to meet such criteria. It states that the antibacterial pad is "identical" to the predicate, implying that its performance is already established.

Therefore, for this particular 510(k) summary, I cannot extract the specific information requested in your prompt regarding acceptance criteria and performance studies because it explicitly focuses on substantial equivalence rather than presenting new, detailed performance study outcomes with acceptance criteria.

Ask a specific question about this device

Antibacterial Adhesive Bandages are to be applied to the skin for topical application. The bandages help provide an antibacterial barrier for minor cuts and scrapes.

Antibacterial adhesive bandages are similar to many pre-amendment and already cleared products with benzalkonium chloride. They are provided in various sizes in a box for over the counter purchase. The benzalkonium chloride concentration is 1%.

I am sorry, but the provided text does not contain the information required to answer your request. The documents are FDA 510(k) letters and a 510(k) summary for "SciVolutions Antibacterial Bandages." They primarily discuss regulatory classifications, indications for use, and a comparison to a predicate device.

The documents do not include:

• A table of acceptance criteria or reported device performance metrics.
• Details about a study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance).
• Information about training sets.

Therefore, I cannot fulfill your request based on the provided input.

Ask a specific question about this device

Antibacterial bandages are to be applied topically to the skin to help prevent infoctlon in minor cuts, scrapes, and burns.

Not Found

The provided text is a compilation of an FDA 510(k) clearance letter and an "INDICATIONS PAGE" for a medical device. This documentation announces the clearance of "Care Band Antibacterial Bandages" (and private label equivalents) and specifies their intended use.

Crucially, this document does not include information about acceptance criteria, device performance studies, sample sizes for test or training sets, expert qualifications, or ground truth methods.

The letter from the FDA confirms that the device is "substantially equivalent" to a legally marketed predicate device, meaning it has been determined to be as safe and effective as a similar device already on the market. This substantial equivalence is typically established by comparing the new device's technological characteristics and intended use to the predicate device, not necessarily through de novo performance studies against explicit acceptance criteria in the 510(k) submission itself.

Therefore, for the request, I can only provide the following, with the understanding that most of the requested information is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not provided.
• Data Provenance: Not provided. The document implies a comparison to historically marketed devices for substantial equivalence, but details of any test set or its origin are absent.

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

• Number of Experts: Not provided.
• Qualifications of Experts: Not provided.

4. Adjudication method for the test set

• Not provided.

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/Not provided. This device is not an AI/software-as-a-medical-device that typically undergoes MRMC studies involving human readers.

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

• Not applicable/Not provided. This is a physical antibacterial bandage, not an algorithm.

7. The type of ground truth used

• Not provided. For this type of device, ground truth for performance might involve antimicrobial efficacy testing (in vitro or in vivo) or clinical outcomes, but these details are not in the document.

8. The sample size for the training set

• Not provided.

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

• Not provided.

In summary, the provided FDA 510(k) clearance letter and indications page confirm the 'Care Band Antibacterial Bandages' have received market clearance based on substantial equivalence to existing devices. However, this documentation does not contain the detailed study information often found in more extensive regulatory submissions or clinical trial reports that would specify acceptance criteria, explicit performance metrics, or study methodologies for demonstrating de novo performance.

Ask a specific question about this device