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Catasyn OTC is indicated for the dressing and management of minor burns, minor cuts, minor lacerations, minor abrasions, and minor irritations of the skin.

Catasyn RX may be used under the direction of a health care professional for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-operative incisions and donor sites) and superficial and partial thickness (second degree) burns.

Catasyn is a clear, colorless hydrogel that is composed of hypromellose, arginine derivatized chitosan, betaine, and methylparaben to form a hydrogel dressing. The device is a non-sterile, preserved hydrogel. The gel is supplied in 0.07oz. (2mL), 0.85oz (25mL), or 3oz (88.7mL) tubes.

Catasyn is a wound hydrogel that provides a moist wound environment. A moist wound environment is supportive to wound healing.

This document is a 510(k) Premarket Notification for a medical device called "Catasyn Advanced Technology Wound Hydrogel." The purpose of a 510(k) submission is to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness.

The document does not describe a study that proves the device meets specific acceptance criteria in the context of an Artificial Intelligence/Machine Learning (AI/ML) powered medical device. Instead, it presents performance data related to the physical and biological properties of the wound hydrogel itself, to show its safety and function compared to a predicate device.

Therefore, I cannot fulfill your request for information related to "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device, as this document is for a non-AI/ML medical device.

To directly answer your prompt, based only on the provided document, the following points are relevant, but not in the context of an AI/ML device:

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

   While not "acceptance criteria" in the sense of an AI/ML model's performance metrics (like sensitivity, specificity, AUC), the document presents a table of Biocompatibility Testing with descriptions of the tests (the "criteria" for safety) and their results (the "performance"):

   Test	Description	Result
   Cytotoxicity Direct Contact	Cytotoxicity was evaluated using ISO-10993-5, Biological evaluation of Medical Devices-Part 5: Tests for In Vitro Cytotoxicity.	Non-toxic
   Maximization Test For Delayed Type Hypersensitivity	Delayed-type hypersensitivity was evaluated according to ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for Irritation and skin sensitization.	No Sensitization reaction was observed in any of the test animals
   Dermal Irritation	Dermal irritation was evaluated according to ISO 10993-10:2010, Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.	No erythema or edema was observed. The Primary Irritation Index for the test article was 0.
   Acute Systemic Toxicity	Acute systemic toxicity was tested according to ISO 10993-11, Biological Evaluation of Medical Devices – Tests for Systemic Toxicity.	No Biological reactivity was observed at any time point
   Hemolysis extraction method and direct contact	Hemolysis was tested according to ASTM 756-13 for both extraction and direct contact methods.	The corrected hemolytic index was 0% for extraction and direct contact. The test article is considered non-hemolytic.

   Additionally, preservation effectiveness and shelf-life data are presented:

   • Preservation: Meets USP 51 Category 2 challenge (immediately following production and at 6-month shelf life).
   • Shelf Life: Meets specifications after 9 months of real-time aging (on a 36-month study).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   For the biocompatibility tests (e.g., Cytotoxicity, Maximization Test, Dermal Irritation, Acute Systemic Toxicity, Hemolysis), the document does not specify the sample sizes of cells, animals, or human subjects used. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective. These are standard in vitro or in vivo (animal) lab tests, not clinical studies on human patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable, as this is not an AI/ML device requiring expert adjudication for ground truth.

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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   Not applicable.

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 (expert concensus, pathology, outcomes data, etc):
   The "ground truth" here refers to established biological and chemical safety standards (e.g., ISO 10993 series, ASTM 756-13, USP 51) and laboratory test results demonstrating the absence of toxicity, irritation, sensitization, or hemolytic reactions.

8. The sample size for the training set:
   Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established:
   Not applicable.

In summary, the provided document is a 510(k) submission for a traditional wound care product (hydrogel) and thus does not contain the information typically required for evaluating an AI/ML medical device.

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Indicated for the management of various types of dermatoses, including atopic dermatitis and allergic contact dermatitis

NEOCERA Advanced Cream is a fragrance-free, water-soluble dressing formulated for the management of various types of dermatoses, including atopic dermatitis and allergic contact dermatitis. NEOCERA Cream is intended for topical application. This product is to be sold by prescription only.

The provided text describes a 510(k) premarket notification for a medical device called NEOCERA Advanced Barrier Cream. It focuses on establishing substantial equivalence to a predicate device, Neosalus cream. Therefore, the "acceptance criteria" and "device performance" are primarily demonstrated through comparison to the predicate device and specific non-clinical and clinical tests. It is essential to note that this document does not describe a study comparing the device against specific, quantitative performance acceptance criteria in the way one might expect for a diagnostic or therapeutic device with measurable outcomes. Instead, it demonstrates safety and biocompatibility to support substantial equivalence.

Here's an analysis of the provided information:

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

Since this is a substantial equivalence submission for a topical cream, the "acceptance criteria" are implied by the performance of the predicate device and the regulatory requirements for similar products, particularly for safety and biocompatibility. The "reported device performance" refers to how NEOCERA cream met these implied criteria through specific tests.

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

• Cytotoxicity Agar Diffusion: Not specified, but generally involves a standard number of cell cultures.
• Primary Dermal Irritation in Rabbits: Not specified, but rabbit irritation tests typically involve 3-6 rabbits.
• Guinea Pig Closed Patch Sensitization Test: Not specified, but standard guinea pig sensitization studies typically use 10-20 animals per group.
• Repeated Insult Patch Test in Humans: Not specified. These studies can range from 50 to over 200 subjects.

The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective, though biocompatibility and human patch tests are typically prospective.

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 section is not applicable as the document describes biocompatibility and safety testing for a topical cream, not a diagnostic device requiring expert interpretation of images or clinical findings to establish a "ground truth." The results of the tests (e.g., cytotoxicity, irritation index) are objective measurements.

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

This is not applicable for the reported non-clinical and clinical (safety) tests. Adjudication methods like "2+1" or "3+1" are typically used in studies where multiple human readers interpret data (e.g., medical images) and a consensus or tie-breaking mechanism is needed to establish ground truth. The tests performed are objective, laboratory-based, or involve direct observation (like irritation scores) by trained personnel according to standardized protocols.

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. An MRMC study is designed for evaluating diagnostic devices, particularly those involving human interpretation, and comparing performance with and without AI assistance. This document pertains to a topical cream, not an AI-enabled diagnostic device.

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

This is not applicable as the device is a topical cream, not an algorithm or AI system.

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

Given the nature of the device and tests, the "ground truth" is defined by:

• For Biocompatibility (cytotoxicity, irritation, sensitization): Standardized ISO (International Organization for Standardization) protocols and GLP (Good Laboratory Practice) standards are used to generate objective quantitative and qualitative results (e.g., cytotoxicity score, irritation index, presence/absence of sensitization).
• For Human Repeated Insult Patch Test: Direct observation and scoring of skin reactions by trained clinicians or dermatologists against a predefined scale, following Good Clinical Practice (GCP) principles as indicated by adherence to the Declaration of Helsinki, ICH E6, and 21 CFR Parts 50 and 56.

8. The sample size for the training set

This is not applicable. This document describes the testing of a cream, not an algorithm that requires a training set. The term "training set" is relevant for machine learning models.

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

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

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Prescription Use: As a prescription topical skin care emulsion to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allerge contact dermatitis. SPB helps maintain a moist wound & skin environment, which is be healing process.

Over-The-Counter Use: An OTC topical skin care emulsion to relieve the burning associated with many common types of skin irritation. SP helps maintain a moist wound & skin environment, which is beneficial to the healing process.

SPB Skin Emulsion is a topical skin care emulsion that is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allergic contact dermatitis. SPB Skin Emulsion contains natural extracts to moisturize the skin.

The provided text describes the regulatory clearance for "SPB Skin Emulsion" and outlines the studies conducted to demonstrate its substantial equivalence to a predicate device, MimyX™ Cream. However, it does not contain acceptance criteria for specific performance metrics (like sensitivity, specificity, accuracy, etc.) nor does it report detailed performance values in a table. It also does not involve an AI device.

Therefore, many of the requested fields cannot be extracted or are not applicable.

Here's a breakdown of what can be inferred or explicitly stated based on the provided document:

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

The document does not provide a table with quantitative acceptance criteria (e.g., specific thresholds for reduction in redness or itching) or numerical performance metrics for the device. The "performance" assessment is qualitative, stating that the device "performed similarly to the predicate with no observable events of either redness or itching."

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

• Sample Size (Test Set): "a limited number of volunteers"
• Data Provenance: Not explicitly stated, but likely prospective as it involved a "double-blind study" with "daily observations." Country of origin is not specified.

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)

The document mentions "daily observations of redness and itching were recorded by trained personnel." It does not specify the number of personnel or their qualifications (e.g., doctors, dermatologists, nurses).

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

Not explicitly stated. It's likely that the "trained personnel" made direct observations, but no formal adjudication process is 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

• MRMC study: Not applicable. This is not an AI device or a diagnostic device involving human readers interpreting results. The study was a "double-blind study" comparing a topical emulsion to a predicate.
• Effect size of human readers with/without AI: Not applicable, as no AI is involved.

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

Not applicable, as this is a topical emulsion, not an algorithm or AI device.

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

The "ground truth" was based on clinical observation of "redness and itching" by "trained personnel" after exposure to a known allergen. This falls under outcomes data or clinical endpoints based on expert observation.

8. The sample size for the training set

Not applicable. This is a medical device (topical emulsion) and the studies described are clinical performance and biocompatibility studies, not machine learning model training.

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

Not applicable, as there is no training set for a machine learning model.

Summary of what is available:

• Device Name: SPB Skin Emulsion
• Predicate Device: MimyX™ Cream (K041342)
• Type of Study: Double-blind study with a limited number of volunteers with acute contact dermatitis.
• Performance Claim: "SPB Skin Emulsion performed similarly to the predicate with no observable events of either redness or itching, and the placebo showing no positive effects."
• Ground Truth: Daily observations of redness and itching recorded by trained personnel.
• Non-Clinical Testing:
  • Cytotoxicity Assay (ISO 10993-5:2010): "no cytotoxic potential."
  • Sensitization Test (ISO 10993-10:2012): "non-sensitizing."
  • Irritation Test (ISO 10993-10:2012): "non-irritating."

The document focuses on demonstrating that the device is "substantially equivalent" to an existing predicate device based on intended use, technological characteristics, and safety/effectiveness data primarily derived from non-clinical biocompatibility testing and a small clinical comparison study. It does not provide the kind of detailed quantitative performance metrics typically associated with AI/diagnostic device approvals.

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Under the supervision of a healthcare professional, for the management and relief of burning, itching and redness associated with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis (post-radiation treatment).

Eletone® Cream is a semi-viscous emulsion/cream formulation intended for topical application supplied non-sterile in 100g plastic tubes.

The provided text is for a 510(k) premarket notification for Eletone® Cream, a wound dressing. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with specific performance criteria against predefined acceptance criteria for a novel device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details is not available in this document.

The conclusion of the 510(k) summary (Section VII) explicitly states: "Functional and performance testing has been conducted to assess the safety and efficacy of Eletone® Cream. Based on the information provided herein, we conclude that the device is substantially equivalent to the above-mentioned predicate devices."

This indicates that the "study" conducted was a comparison to predicate devices to establish substantial equivalence, not a performance trial against specific numerical targets.

However, based on the provided document, here's what can be inferred or stated:

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

• Acceptance Criteria: Not explicitly stated in terms of numerical performance targets. The acceptance criterion for the 510(k) submission is "substantial equivalence" to the predicate devices. This means that the device must be as safe and effective as the predicate.
• Reported Device Performance: The document states that Eletone® Cream is "identical in composition and function to Locobase® Wound and Skin Emulsion (K060272)" and that its "intended use is identical to other legally marketed wound dressing products." This "identity" and "identical use" constitute the primary "performance" reported to meet the substantial equivalence criteria. Functional and performance testing was conducted but the specific results or metrics are not detailed in this summary.

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

• Not applicable/Not provided. Clinical trial data with specified sample sizes for a "test set" are not presented in this 510(k) summary. The comparison is primarily based on the composition and intended use relative to predicate devices.

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):

• Not applicable/Not provided. This type of information is relevant for studies involving diagnostic or AI-driven devices requiring expert-adjudicated ground truth, which is not the case for this wound dressing submission.

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

• Not applicable/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 is a medical device (topical cream) and not a diagnostic imaging or AI-assisted interpretation device.

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

• Not applicable/Not provided. This is a topical cream, not an algorithm.

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

• Not applicable/Not provided in the context of a "test set" for performance evaluation against ground truth. The "truth" for this submission is that the device's composition and intended use are substantially equivalent to already approved devices.

8. The sample size for the training set:

• Not applicable/Not provided. This is relevant for machine learning models, not for a topical cream.

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

• Not applicable/Not provided. Relevant for machine learning models, not for a topical cream.

In summary, the provided 510(k) notification for Eletone® Cream demonstrates substantial equivalence to predicate devices based on similarities in composition and intended use. It does not contain information about clinical trials, specific performance metrics, or "acceptance criteria" in the way a novel device or AI-driven system would. The "study" mentioned ("Functional and performance testing has been conducted") is not detailed in this summary, but its outcome was to support the claim of substantial equivalence to the listed predicate devices.

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