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Dryodine™ Antibacterial Gel is indicated for use in the management/cleaning of wet ulcers and wounds such as venous stasis ulcers, pressure sores, diabetic foot ulcers, and traumatic and surgical wounds. Dryodine™ Antibacterial Gel assists to keep lesions soft and pliable.

Dryodine™ Antibacterial Gel consists of 0.1mm diameter biodegradable hydrophilic beads of cadexomer dispersed in a hydrophilic gel comprised of polyethylene glycol and poloxamer and contains 0.9% by weight iodine. The device is presented as a prescription product that requiring a physician to diagnosis the disease state and prescribe the product.

The provided text describes a 510(k) premarket notification for a medical device called Dryodine™ Antibacterial Gel. This type of submission is focused on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies with acceptance criteria as one might see for novel devices or drugs.

Therefore, the response will reflect the information available in the provided document, which primarily focuses on demonstrating substantial equivalence rather than detailed performance study with acceptance criteria.

Acceptance Criteria and Device Performance Study for Dryodine™ Antibacterial Gel

The provided 510(k) Premarket Notification for Dryodine™ Antibacterial Gel focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and conducting a primary performance study against those criteria in the typical sense of a novel device. The "performance testing" referenced is in vitro, and its specific acceptance criteria and results are not detailed in the provided summary.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set:
The provided document does not describe a clinical "test set" in the context of a prospective human study for Dryodine™ Antibacterial Gel. The evaluation is based on a comparison to predicate devices already on the market.

• Sample Size: Not applicable in the context of a traditional performance study.
• Data Provenance: Not applicable, as the equivalence is based on the characteristics of the device and its predicate, rather than human data.

3. Number of Experts and Qualifications for Ground Truth:
Not applicable. The ground truth for this submission is established through comparison to legally marketed predicate devices and relevant regulations, not through expert consensus on a test set of cases.

4. Adjudication Method for the Test Set:
Not applicable. There was no test set requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not performed. The submission is for a gel wound dressing, not an imaging or diagnostic device where such a study would be relevant.

6. Standalone (Algorithm Only) Performance Study:
Not applicable. This is a physical medical device (antibacterial gel), not an algorithm or AI system.

7. Type of Ground Truth Used:
The "ground truth" for the substantial equivalence determination is the regulatory acceptance and established safety and effectiveness of the identified predicate devices (Iodosorb Gel and Triosyn T40 Antimicrobial Dressing). The ground for this submission is substantial equivalence to legally marketed predicate devices.

8. Sample Size for the Training Set:
Not applicable. The device is a physical product, not an algorithm or AI system that requires a "training set."

9. How Ground Truth for the Training Set Was Established:
Not applicable. There was no training set for this device.

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Under the supervision of a healthcare professional, Hylatopic™ Plus Emollient Foam, an aerosol-based emollient foam, is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Hylatopic™ Plus Emollient Foam also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Hylatopic™ Plus Emollient Foam is indicated for use in:

• Atopic Dermatitis
• Allergic Contact Dermatitis
• Radiation Dermatitis

Hylatopic™ Plus Emollient Foam is a non-steroidal, non-sterile, off-white, low odor, fragrance free, topical aerosol foam. When Hylatopic™ Plus Emollient Foam is dispensed, foam is formed. The propellant in the foam dissipates very quickly and the foam is then rubbed on the affected skin. The Hylatopic™ Plus Emollient Foam when applied to diseased skin forms a protective barrier that helps to maintain a moist wound and skin environment. This device is presented as a prescription product that requires the physician to diagnosis the disease state and prescribe the product.

The provided text describes a medical device called Hylatopic™ Plus Emollient Foam and its 510(k) submission for premarket notification. However, the text does not include the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The document states:

• "Functional and performance testing has been conducted to assess the safety and effectiveness of Hylatopic™ Plus Emollient Foam and all results are satisfactory." (Section 2.9, page 2)
• "To the best of our knowledge there are no performance standards applicable to these devices that have been adopted under section 514 of the Act." (Section 2.10, page 2)

This indicates that internal testing was performed and deemed satisfactory, but the report does not detail the methodology, acceptance criteria, or results of these tests, nor does it refer to a specific clinical study with statistical endpoints. It is a submission for a topical emollient foam, which typically undergoes different kinds of equivalence testing than, for example, an AI-powered diagnostic device.

Therefore, I cannot provide the requested information from the given text. The prompt's questions are tailored for a different type of medical device submission (e.g., an AI/ML device with performance metrics like sensitivity/specificity, reader studies, etc.) than what is presented in this 510(k) summary for a topical emollient foam.

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Under the supervision of a healthcare professional, Hylatopic™ Emollient Foam, an aerosolbased emollient foam. is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Hylatopic™ Emollient Foam also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Hylatopic TM Emollient Foam is indicated for use in:

• · Atopic Dermatitis
• Allergic Contact Dermatitis
• Radiation Dermatitis .

Hylatopic™ Emollient Foam is a non-steroidal, non-sterile, off-white, low odor, fragrance free, topical aerosol foam. When Hylatopic™ Emollient Foam is dispensed, foam is formed. The propellant in the foam dissipates very quickly and the foam is then rubbed on the affected skin. The Hylatopic™ Emollient Foam when applied to diseased skin forms a protective barrier that helps to maintain a moist wound and skin environment. This device is presented as a prescription product that requires the physician to diagnosis of the disease state and prescribes the product.

This document is a 510(k) Premarket Notification for a medical device called Hylatopic™ Emollient Foam. It focuses on demonstrating substantial equivalence to previously cleared devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the requested information elements cannot be fully extracted as they are typical for a study demonstrating analytical or clinical performance of a diagnostic or therapeutic device through specified metrics.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The document does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy, or quantitative measures of clinical effectiveness) and therefore no reported performance against such criteria. The submission is for substantial equivalence to predicates, implying similar intended use and safety profiles.

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

Not applicable. The document does not describe a clinical study with a "test set" in the context of device performance evaluation. The submission is based on comparison to predicate devices and functional/performance testing of the product itself.

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

Not applicable. There is no mention of a "test set" requiring expert-established ground truth for device performance evaluation.

4. Adjudication method for the test set:

Not applicable. No "test set" and corresponding adjudication method are described.

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 topical Emollient Foam, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

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

Not applicable. This is not an algorithm-based device.

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

Not applicable. There is no mention of a "ground truth" as typically defined for performance studies of diagnostic or AI devices. The basis for the 510(k) is substantial equivalence, functional testing, and intended use as an emollient foam.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning model that requires a training set.

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

Not applicable. As above, this is not an AI/machine learning model.

Summary of what the document does state regarding "Tests and Conclusions":

"Functional and performance testing has been conducted to assess the safety and effectiveness of Hylatopic™ Emollient Foam and all results are satisfactory."

This statement indicates that internal testing was performed to ensure the device met its functional specifications and was safe for its intended use. However, it does not provide details on:

• Specific acceptance criteria for this testing (e.g., pH limits, viscosity, stability, microbiological purity, etc.).
• The actual results of these tests.
• Whether these tests involved human subjects or were solely bench/lab tests.

The 510(k) process for this type of device (a topical emollient foam) primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices with the same intended use and similar technological characteristics, rather than extensive clinical efficacy trials against strict performance metrics. The stated "Tests and Conclusions" are sufficient for a 510(k) submission where substantial equivalence is the primary pathway to market.

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