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Rx Indication: Under the supervision of a health care professional, LOYON is indicated to manage and relieve the burning, itching, erythema, and scaling experienced with various types of dermatoses, including atopic dermatitis, radiation dermatitis, and seborrhea and seborrheic dermatitis.

LOYON® is a non-sterile, oily solution, exclusively indicated for topical application. LOYON® is used to manage and relieve burning and itching and scaling experienced with various types of dermatoses. It will be supplied in 15mL or 50mL amber glass bottles with a pump sprayer.

This document is a 510(k) summary for the device LOYON®, a non-sterile, oily solution intended for topical application to manage and relieve symptoms of various dermatoses. It asserts that LOYON® is substantially equivalent to two predicate devices: Alevicyn SG Antipruritic Gel (K152945) and Tropazone (K090337).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

The provided document does not specify sample sizes for any of the tests (biocompatibility or bench testing).
The data provenance is also not explicitly stated. These tests are typically performed in a laboratory setting by the manufacturer or a contract research organization. There is no mention of patient data (retrospective or prospective) for clinical efficacy, as the submission focuses on substantial equivalence based on technological characteristics and safety (biocompatibility).

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 and not provided in the document. For the types of tests described (biocompatibility and bench testing), "ground truth" is established through standardized laboratory procedures and measurements, not by expert consensus on clinical findings.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document, as no clinical endpoints requiring expert adjudication are described for this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or mentioned. This type of study is typically used for diagnostic devices involving human interpretation of images or data, which is not the case for this topical dermatological product.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to the device (LOYON®) described. This is a medical device (a topical solution), not an algorithm or AI system.

7. The Type of Ground Truth Used

For biocompatibility and bench testing, the "ground truth" is based on:

• Standardized Test Methods and Specifications: For example, compliance with ISO 10993-1 for biocompatibility, and USP , , , for sterility/microbial control.
• Engineering and Production Specifications: For visual inspection, odor, viscosity, functional checks, leakage, and volume, "ground truth" is defined by the product's established specifications derived from design and manufacturing requirements.

There is no mention of expert consensus, pathology, or outcomes data in the context of establishing ground truth for the non-clinical performance data presented.

8. The Sample Size for the Training Set

This question is not applicable as LOYON® is a physical medical device (topical solution), not a machine learning algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as point 8.

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Rx Indications: Under the supervision of a healthcare professional, Microcyn Plus is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material including microorganisms and debris from exudating wounds, acute and chronic dermal lesions including stage I-IV pressure ulcers, diabetic ulcers, post-surgical wounds, first- and second-degree bums, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.

OTC Indications: Microcyn Plus is intended for use in the management of skin abrasions, minor irritations, cuts, and intact skin.

The Oculus Microcyn Plus Wound Care Solution is a colorless, slightly chlorinated odor, clear aqueous solution for moistening of wound dressings, wound debridement, and use with devices intended for wound irrigation with a pH range of 3.5 - 6.0. The solution will be supplied in 40mL glass vials with Teflon lined closures.

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets these criteria in the format requested.

The document is a 510(k) summary for a medical device (Microcyn Plus Wound Care Solution) and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing new performance criteria through a detailed clinical or comparative effectiveness study.

Here's what can be extracted from the text related to performance, but it does not fulfill all the requested points:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information for this Section: The document does not specify quantitative acceptance criteria (e.g., "pH must be between X and Y") for most tests, only that the device "meets specification and performance characteristics."

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

• Test Set Sample Size: Not specified for any of the performance tests (biocompatibility, bench testing).
• Data Provenance: Not specified. These appear to be laboratory tests conducted on the device itself, rather than human or animal studies with specific geographical or temporal provenance.

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

• Not applicable. The tests performed are laboratory-based and do not involve expert interpretation for ground truth establishment.

4. Adjudication method for the test set:

• Not applicable. The tests are laboratory measurements, not subjective evaluations requiring adjudication.

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 or comparative effectiveness study involving human readers or AI assistance was performed or reported. This device is a wound care solution, not an AI diagnostic tool.

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:

• For biocompatibility: Adherence to recognized international standards and FDA guidance for biological evaluation.
• For bench testing (physical/chemical/microbiological): Adherence to predefined specifications and USP standards.

8. The sample size for the training set:

• Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

• Not applicable. There is no training set.

Summary of what the document confirms regarding device performance:

The document primarily states that the Microcyn Plus Wound Care Solution underwent various laboratory tests to establish its safety and performance characteristics, specifically:

• Biocompatibility Testing: Conducted according to FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Tests included Cytotoxicity, Irritation, Sensitization, and Systemic Toxicity. The device is considered a "breached/compromised surface device with limited contact."
• Bench Testing: Performed to assess package integrity, visual inspection, pH, Free Available Chlorine (FAC), fill volume, USP (Antimicrobial Effectiveness Testing), and USP (Microbial Enumeration Tests).

The conclusion is that the Microcyn Plus Wound Care Solution "meets specification and performance characteristics and is substantially equivalent to the predicate device." However, concrete numerical acceptance criteria and the detailed methodology for proving those criteria for each test are not explicitly provided in this 510(k) summary.

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Rx Indications for Use:
Under the supervision of a health care professional Microcyn Plus Skin and Wound Gel is intended for the management of post non ablative laser therapy procedures, post microdermabrasion therapy and following superficial chemical peels. Microcyn Plus Wound Gel may also be used to relieve itch and pain from minor skin irritations, abrasions and minor burns.

OTC Indications for Use:
Microcyn Plus Skin and Wound Gel is intended for the management of minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. Microcyn Plus Skin and Wound Gel may also be used to relieve itch and pain from minor skin irritations, abrasions and minor burns.

The Microcyn Plus Skin and Wound Hydrogel is a clear gel, slightly chlorinated odor, viscous gel. The product has a pH range of 6.2-7.8 and a viscosity target of 12,000-20,000 cP and will be supplied in polyethylene terephthalate (PET) tube-bottles with polypropylene (PP) screw-top closure.

I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance for most of the requested parameters. The document is a 510(k) summary for a medical device (Microcyn Plus Skin and Wound Hydrogel), which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results with acceptance criteria.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative sense for clinical performance. Instead, it reports biocompatibility and bench testing results. The acceptance is implicitly that the device performs safely and effectively, and is substantially equivalent to predicates.

Missing Information:

• 2. Sample sized used for the test set and the data provenance: Not mentioned. These are biocompatibility and bench tests, not clinical trials with human subjects as "test sets" in the typical sense for AI.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Biocompatibility and bench tests are laboratory-based, not expert-adjudicated clinical data.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a hydrogel, not an AI diagnostic 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 biocompatibility, the "ground truth" is defined by standardized test methods and their established biological endpoints (e.g., cell viability, toxicological response). For bench testing, it's defined by product specifications and analytical methods.
• 8. The sample size for the training set: Not applicable. The device is a wound hydrogel, not an AI model.
• 9. How the ground truth for the training set was established: Not applicable.

This document describes a medical device seeking 510(k) clearance, which means it relies heavily on demonstrating substantial equivalence to legally marketed predicate devices, primarily through technological characteristics and non-clinical performance data (like biocompatibility and bench testing) rather than extensive new clinical studies. The questions you've asked are more typically relevant for AI/ML-enabled diagnostic devices or devices that require new clinical efficacy data for approval or clearance.

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Rx Indication: Under the supervision of a health care professional, Alevicyn SG Gel is indicated to manage and relieve the burning, itching, erythema, scaling, and pain experienced with various types of dermatoses, including atopic dermatitis, radiation dermatitis, and sebortheic dermatitis. Alevicyn SG Gel may be also used to relieve the pain of first and second degree burns. Alevicyn SG Gel helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

The Alevicyn SG Gel is an opaque gel, slightly chlorinated odor, low viscosity spray gel. The product has a pH range of 5.5-7.0 and a viscosity target of 500-5000 cP and will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure and a finger pump sprayer.

This document describes a 510(k) premarket notification for the Alevicyn SG Antipruritic Gel. The device is a topical gel indicated for managing and relieving various dermatoses symptoms and pain from burns. The approval is based on substantial equivalence to predicate devices, and the provided text does not include a study demonstrating how the device meets specific acceptance criteria for performance metrics via a clinical trial measuring efficacy outcomes.

Instead, the provided information focuses on biocompatibility testing and bench testing to support the substantial equivalence claim. Since no clinical study on performance outcomes (e.g., reduction in itching, pain, erythema) is presented, I cannot provide details on acceptance criteria and a study that proves the device meets them in the way typically associated with human-in-the-loop or standalone AI performance studies.

Here's an assessment based on the available text:

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

The document does not specify quantitative acceptance criteria for clinical performance (e.g., a specific percentage reduction in itching or pain). The acceptance criteria mentioned are related to manufacturing specifications and safety/biocompatibility.

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

This information is not provided in the document. The document refers to "Biocompatibility Testing" and "Bench Testing" but does not specify the sample sizes (e.g., number of test subjects or samples of the gel) or the provenance of any data used for these tests. There is no mention of a human clinical test set for performance.

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 information is not applicable/provided. The ground truth for biocompatibility and bench testing would be established by laboratory standards and measurements, not by expert consensus in a clinical context.

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

This information is not applicable/provided. Adjudication methods are typically relevant for clinical studies where subjective assessments might be made (e.g., by multiple readers). The tests described (biocompatibility, bench testing) are objective laboratory 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

This information is not applicable/provided. This device is a topical gel, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related effectiveness is not relevant.

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

This information is not applicable/provided. This device is a topical gel, not an algorithm.

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

For Biocompatibility Testing, the "ground truth" is defined by the International Standard ISO 10993-1 and FDA Blue Book Memorandum #G95-1. These are standardized methodologies and criteria for evaluating biological responses to medical devices.

For Bench Testing (package integrity, visual inspection, pH, Free Available Chlorine), the "ground truth" is established by predefined product specifications and validated analytical methods in a laboratory setting.

8. The sample size for the training set

This information is not applicable/provided. The device is a gel, not a machine learning model, so there is no "training set."

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

This information is not applicable/provided. As above, there is no training set for this type of device.

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Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning, and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis and other dry skin conditions, by maintaining a moist wound and skin environment. Ceramax may be used to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Ceramax emollient formulation is a non-sterile, off-white, low odor, fragrance free, topical formulation delivers as a cream or a foam. The cream is dispensed via a tube and rubbed into the skin. When the Ceramax formulation is applied to diseased skin protective barrier that helps to maintain a moist wound and skin environment is formed. 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) Pre-market Notification for the Ceramax Skin Barrier Cream. It establishes substantial equivalence to legally marketed predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, many of the requested details about acceptance criteria, performance studies, expert involvement, and ground truth establishment are not present in this type of regulatory submission. The document focuses on demonstrating that the new device is as safe and effective as existing ones.

Here's a breakdown of the information that can be extracted or deduced from the provided text, and where gaps exist:

1. Table of Acceptance Criteria and Reported Device Performance

This section generally applies to studies demonstrating specific performance targets. For a 510(k) submission not involving new analytical or clinical performance claims, the "acceptance criteria" are primarily met through demonstrating equivalence to predicates in terms of intended use, technological characteristics, and safety/effectiveness.

Note: The document does not provide numerical or quantitative performance metrics against specific "acceptance criteria" for clinical efficacy beyond the statement of "substantially equivalent" intended use. The performance testing mentioned (visual inspection, pH, etc.) are quality control tests for the product's physical and chemical properties, not clinical efficacy.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in this context. The submission is not based on a new clinical study comparing Ceramax to a control or evaluating its performance on a test set of patient data for a diagnostic algorithm. It's a regulatory filing based on demonstrating equivalence to an existing product.
• Data Provenance: Not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is not an AI or diagnostic device requiring expert interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not mentioned or implied, as this is a topical skin barrier cream, not an imaging or diagnostic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this is a medical device (topical cream), not an algorithm or AI system.

7. The Type of Ground Truth Used

Not applicable in the conventional sense. The "ground truth" for this 510(k) submission is the regulatory status and established safety and effectiveness of the predicate devices (Epiceram K052643 and TL-Cermide K110757), to which Ceramax is demonstrating substantial equivalence. The claim is that Ceramax has the same intended use and similar technological characteristics, and therefore similar safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is not an AI or machine learning device requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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Rx Indication: Alevicyn SG Antipruritic Gel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis. Alevicyn SG Antipruritic Gel may be also used to relieve the pain of first and second degree burns. Alevicyn SG Antipruritic Gel helps to relieve dry waxy skin by maintaining a moist wound & skin environment. which is beneficial to the healing process.

OTC Indication: Alevicyn SG Antipruritic Gel is intended to relieve the burning and itching associated with many common types of skin irritation, lacerations, and minor burns. Alevicyn SG Antipuritic Gel is also indicated for the management of irritation and pain from minor burns, including sunburn.

The Alevicyn SG Gel is an opaque gel, slightly chlorinated odor, low viscosity spray gel. The product has a pH range of 5.5-7.0 and a viscosity target of 500-5000 cP and will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screwtop closure and a finger pump sprayer.

The provided 510(k) summary for the Alevicyn SG Antipruritic Gel primarily focuses on establishing substantial equivalence to a predicate device (Epicyn Hydrogel) rather than presenting a standalone study with specific acceptance criteria and performance metrics for the Alevicyn SG. The performance data section describes Biocompatibility Testing and Bench Testing performed.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., specific pain reduction percentages, itching reduction scores) in the way one might expect for a clinical trial. Instead, it relies on demonstrating that the device meets manufacturing specifications and biological safety standards, and that its characteristics are "substantially equivalent" to the predicate.

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

• Test Set Sample Size: Not explicitly stated for specific efficacy studies. The biocompatibility and bench testing would have their own sample sizes based on the respective test protocols.
• Data Provenance: Not specified in terms of country of origin. The studies appear to be laboratory-based (biocompatibility, bench testing) and likely conducted by or for Oculus Innovative Sciences. The nature of these tests suggests they are prospective for the Alevicyn SG device.

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

This information is not provided in the document. The tests described (biocompatibility, bench testing) rely on standardized laboratory protocols rather than expert consensus on clinical outcomes.

4. Adjudication method for the test set

This information is not applicable and not provided. The testing described does not involve expert adjudication of clinical outcomes.

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, a multi-reader multi-case comparative effectiveness study was not performed. This device is a topical gel, not an AI-powered diagnostic tool, so such a study would not be relevant.

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

This question is not applicable as the device is a medical gel, not an algorithm or AI system.

7. The type of ground truth used

For biocompatibility and bench testing, the "ground truth" would be established by the compliance with defined industry standards (ISO 10993) and internal product specifications. For the claim of substantial equivalence, the "ground truth" is based on the characteristics and performance of the legally marketed predicate device (Epicyn Hydrogel K102945) as evaluated by the FDA.

8. The sample size for the training set

This information is not applicable as the device is not an AI/ML algorithm that requires a training set. The term "training set" is not relevant to the type of device and testing described.

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

This information is not applicable for the same reason as in point 8.

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Endocyn Root Canal Irrigation Solution is intended to irrigate, cleanse, and debride root canal systems including the removal of foreign material and debris during root canal therapy. It is also intended to provide for lubrication and irrigation during root canal instrumentation.

The Endocyn Root Canal Irrigation Solution is a colorless, slightly chlorinated odor, clear aqueous solution intended to irrigate, cleanse, and debride root canal systems. The solution will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure.

The provided document is a 510(k) premarket notification for the "Endocyn Root Canal Irrigation Solution." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies against predefined acceptance criteria. Therefore, the information typically found in such a study (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not presented in this document.

Here's an analysis of the available information:

1. Acceptance Criteria and Reported Device Performance

The document does not define explicit "acceptance criteria" in the sense of performance thresholds for efficacy in a clinical study. Instead, the device's performance is demonstrated through a series of tests to show it meets specifications and is comparable to predicate devices.

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

This document describes a 510(k) submission, which relies on performance testing and comparison to predicate devices, not a clinical study involving a test set of patient data. Therefore, there is no "sample size used for the test set" or "data provenance" (country of origin, retrospective/prospective) in the context of a clinical performance study. The tests would have been performed on batches of the Endocyn Root Canal Irrigation Solution itself.

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 as the submission is not a clinical study involving human interpretation of data for ground truth establishment.

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

This information is not applicable for the same reason as point 3.

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:

This is not applicable. The device is an irrigation solution, not an AI-powered diagnostic tool, and therefore no MRMC study would be performed for this product.

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

This is not applicable as the device is not an algorithm or AI system.

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

The "ground truth" for the performance tests (pH, osmolality, etc.) would be established by analytical chemistry and microbiology standards and laboratory testing protocols, not expert consensus or pathology in a clinical sense. For biocompatibility, it relied on established ISO standards (ISO-10993).

8. The sample size for the training set:

This is not applicable as the device is not an AI/machine learning model that requires a training set. The "training" for this device would refer to the development and manufacturing processes to ensure it consistently meets specifications.

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

This is not applicable for the same reason as point 8.

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Rx Indications: Under the supervision of a healthcare professional, Hydrocleanse™ Solution is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material including microorganisms and debris from exudating wounds, acute and chronic dermal lesions including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first- and second- degree bums, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites. It is als intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.

OTC Indications: OTC Hydrocleanse™ Solution is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.

The Oculus Hydrocleanse Wound Care Solution is a colorless, slightly chlorinated odor, clear aqueous solution for moistening of wound dressings, wound debridement, and use with devices intended for wound irrigation with a pH range of 4.0 - 5.8. The solution will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure and sprayer.

The provided text describes the submission of a 510(k) premarket notification for the "Hydrocleanse Wound Care Solution." This document is a regulatory filing with the FDA and primarily focuses on establishing substantial equivalence to previously approved devices. It does not contain information about a specific study designed to prove the device meets acceptance criteria in the way a diagnostic or AI-powered device would.

The "Performance Testing" section states: "The Oculus Hydrocleanse Wound Care Solution meets specification and performance characteristics and is substantially equivalent to the predicate devices."

The "Biocompatibility Testing" section states: "Biocompatibility Testing of the Oculus Hydrocleanse Wound Care Solution confirmed that the device meets the applicable requirements of the Blue Book Memorandum G95-1 entitled Use of International Standards ISO-10993 Biological Evaluation of Medical Devices and is biocompatible."

Based on the provided text, I cannot describe acceptance criteria and a study proving the device meets those criteria in the context of a diagnostic or AI device (e.g., sensitivity, specificity, accuracy, etc.) because this is a wound care solution, and the document is a regulatory submission for premarket notification, not a clinical trial report.

Here's an analysis based on what is available, along with explanations for missing information:

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

The document does not specify quantitative acceptance criteria or detailed performance metrics like sensitivity, specificity, or accuracy, which are typical for diagnostic devices. Instead, the "performance" is described qualitatively as meeting specifications and being substantially equivalent to predicate devices.

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

This information is not provided. The document doesn't describe a "test set" in the context of evaluating a diagnostic algorithm. The "testing" referred to (Performance and Biocompatibility) would have involved laboratory studies on the solution itself, rather than clinical data from human subjects in the sense of a test set for a diagnostic or AI device.

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 information is not provided. Ground truth establishment for a test set is not applicable to this type of device and regulatory submission.

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

This information is not provided. Adjudication methods are relevant for studies involving human interpretation or challenging cases, not for the type of testing described for a wound care solution.

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 such study was mentioned or implied. This type of study is specific to medical imaging or diagnostic AI, not to a wound care solution.

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

No such standalone performance evaluation was mentioned or implied. This is a characteristic of AI or diagnostic algorithms.

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

The concept of "ground truth" as typically applied to diagnostic or AI devices (e.g., confirmed pathology) is not explicitly detailed. For biocompatibility, the "ground truth" would be compliance with ISO standards. For "performance characteristics," it would refer to the physical, chemical, and biological properties of the solution meeting pre-defined specifications.

8. The sample size for the training set

This information is not provided. A "training set" is relevant for machine learning algorithms, which is not applicable to this wound care solution.

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

This information is not provided as there is no training set mentioned.

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Rx INDICATIONS: Under the supervision of a health care professional, Microcyn® Scar Management HydroGel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.

OTC INDICATIONS: Microcyn® Scar Management HydroGel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.

Microcyn® Scar Management HydroGel is a translucent, silicone oil containing hydrogel which is intended for the management of old and new scars including hypertrophic and keloid scarring, on scars resulting from general surgical procedures, as well as trauma wounds, and burns. The product is intended to be applied to intact skin. The product is preserved with a unique mixture of hypochlorous acid and sodium hypochlorite generated through a proprietary process. The mixture of hypochlorous acid and sodium hypochlorite act as a preservative in the non-sterile product to inhibit microbial growth during storage and repeat use. The preservative is identified by the Center for Drug Evaluation and Research (CDER) as an inactive ingredient based on the

The provided text describes a 510(k) summary for a medical device called Microcyn® Scar Management HydroGel. This is a Class I device and the submission seeks to demonstrate substantial equivalence to legally marketed predicate devices, not to prove that the device meets specific acceptance criteria through a study with performance metrics in the way an AI/ML device would.

Therefore, many of the requested categories (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission for this device.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide specific numerical acceptance criteria or performance metrics in terms of sensitivity, specificity, F1-score, etc., as would be common for AI/ML devices. Instead, the "acceptance criteria" for this submission are fundamentally about demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, safety, and effectiveness.

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

• Sample Size: Not specified for any "test set" in the context of an AI/ML device evaluation. The document mentions a "study population" for clinical testing, but the specific number of participants is not provided.
• Data Provenance: Not specified. It's a clinical study, likely prospective, but no details on country of origin are given.

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

• Number of Experts: Not applicable. This type of submission does not involve "ground truth" derived by experts for diagnostic or AI/ML performance evaluation. The clinical study would have assessed outcomes based on standard clinical evaluations.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Not applicable. There's no "test set" or adjudication process described for establishing ground truth as understood in AI/ML validation 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:

• Not applicable. This device is a topical hydrogel, not an AI/ML diagnostic or assistive tool for human readers.

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

• Not applicable. This is not an algorithm.

7. The type of ground truth used:

• Not applicable in the context of AI/ML validation. For the clinical study, efficacy would likely be based on clinical assessments of scar appearance, symptoms, and physician/patient satisfaction, typically compared to the predicate device.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no training set.

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

• Not applicable.

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Under the supervision of a health care professional, Epicyn HydroGel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis and atopic dermatitis. Epicyn HydroGel may be also used to relieve the pain of first and second degree burns. Epicyn HydroGel helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Epicyn™ HydroGel is an emollient containing, non oily pH neutral hydrogel. The product is preserved with a unique mixture of hypochlorous acid and sodium hypochlorite generated through a proprietary process. The gel forms a protective barrier which retains moisture and provides relief of the burning and itching associated with various types of dermatoses including atopic dermatitis. The gel will be supplied in polyethylene terephthalate (PET) tube-bottles with polypropylene (PP) tamper resistant snap-top closure as described in Section 11.3.

The provided text is a 510(k) Premarket Notification for Epicyn™ HydroGel, a wound and burn hydrogel dressing. It focuses on demonstrating substantial equivalence to a predicate device and outlines safety testing. It does not present acceptance criteria for device performance, nor does it describe a study proving the device meets performance-based acceptance criteria.

Therefore, I cannot provide the requested information in the format specified because the document does not contain details about:

• Acceptance criteria for device performance: The document discusses "safety and effectiveness" and "functions as intended" but does not quantify performance metrics or acceptance thresholds.
• A study proving device meets acceptance criteria: The document refers to "in-vitro and in-vivo biocompatibility testing," "bench testing including bioburden, biocompatibility and animal testing," and "USP Antimicrobial Effectiveness Testing and Microbial Enumeration testing characterization studies." These are safety and characterization tests, not performance studies against specific acceptance criteria for the intended use (managing burning, itching, pain, and maintaining a moist wound environment).
• Sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set size, or ground truth for training set.

The document's primary argument for substantial equivalence is based on:

1. Same intended use as the predicate device (Sinclair Wound and Skin Emulsion, Atopiclair®).
2. Similar basic function and technological characteristics (clear, aqueous, emollient-containing, non-oily, pH neutral hydrogel for moisture control, wound exudate management, and barrier protection).
3. Safety established through biocompatibility, in-vitro cytotoxicity, and sensitization testing in animal species (ISO 10993-1 compliance).

The document states: "Performance Testing: Epicyn™ HydroGel has been subjected to in-vitro and in-vivo biocompatibility studies to demonstrate that the device is safe for the indications for use. Extensive bench testing including bioburden, biocompatibility and animal testing have been performed to support the safety and efficacy of the Epicyn™ HydroGel. Test results demonstrate that the gel functions as intended and without adverse effects." However, it does not elaborate on what "functions as intended" means in terms of specific performance metrics or how it was quantitatively measured.

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