Search Results

HPRTM Plus Emollient Foam is indicated to manage and relieve the burning, itching and pain associated with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis. HPRTM Plus Emollient Foam also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

HPR 114 Plus Emollient Foam is a non-sterile, off-white, low odor, fragrance free, topical aerosol foam. When HPRTM 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 HPR " 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 of the disease state and prescribes the product.

This document describes a 510(k) submission for a medical device called HPR™ Plus Emollient Foam. However, the provided text does not contain the kind of detailed information about acceptance criteria and a study design that would apply to an AI/ML-powered diagnostic device, or a device requiring a performance study with specific metrics, sample sizes, and ground truth establishment.

Instead, this submission is for a topical emollient foam. The "study" mentioned is a general statement about "functional and performance testing."

Therefore, I cannot extract the requested information such as:

• A table of acceptance criteria and reported device performance (no specific performance metrics like sensitivity, specificity are mentioned)
• Sample size for the test set and data provenance
• Number of experts and their qualifications
• Adjudication method
• MRMC comparative effectiveness study
• Standalone performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

The only relevant information that can be extracted from the provided text regarding "testing and conclusions" is:

1. Acceptance Criteria and Reported Device Performance:

2. Details of the Study:

The provided text only states:
"Functional and performance testing has been conducted to assess the safety and effectiveness of HPR™ Emollient Foam and all results are satisfactory."

This statement is too general to extract any of the other requested specific details. This type of submission for an emollient foam would likely involve chemistry, manufacturing, and controls testing, biocompatibility, and potentially some clinical safety data (e.g., irritation studies), but not the kind of "study" to prove meeting acceptance criteria in the context of an AI/ML or diagnostic device that the request implies.

Ask a specific question about this device

HPR™ Emollient Foam is indicated to manage and relieve the burning, itching and pain associated with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis. HPRTM Emollient Foam also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

HPR 114 Emollient Foam is a non-sterile, off-white, low odor, fragrance free, topical aerosol foam. When HPR™ 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 HPR™ 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.

The provided document is a 510(k) summary for a medical device called "HPR™ Emollient Foam". It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and a study proving those criteria are met.

Specifically, the document states: "Functional and performance testing has been conducted to assess the safety and effectiveness of HPR™ Emollient Foam and all results are satisfactory." This indicates that testing was performed, but it does not provide any specific acceptance criteria or the results or details of the study itself.

Therefore, I cannot provide most of the requested information.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance

• Cannot provide. The document states that testing was conducted and results were satisfactory but does not specify the acceptance criteria or report any performance metrics.

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

• Cannot provide. The document mentions functional and performance testing but provides no details about sample size, study design, or data provenance.

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)

• Cannot provide. This information is typically relevant for studies evaluating human interpretation aided by or compared to AI. This device is an emollient foam, not an AI or diagnostic imaging device, so "ground truth" in this context would likely refer to clinical outcomes, not expert interpretation of data. Even so, no details of such a study are provided.

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

• Cannot provide. As above, this is not relevant or provided for this type of device.

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

• Cannot provide. This type of study is for diagnostic or AI-assisted devices involving human readers. HPR™ Emollient Foam is a topical product, not an AI or diagnostic tool.

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

• Cannot provide. This refers to AI algorithm performance. HPR™ Emollient Foam is not an algorithm.

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

• Cannot provide. While a clinical trial for an emollient foam would typically use patient-reported outcomes or clinical assessments as "ground truth" (e.g., reduction in itching, pain, skin condition improvement), the document does not mention the specifics of the study, nor how "ground truth" was established.

8. The sample size for the training set

• Cannot provide. This is relevant for AI models, not for a topical emollient foam.

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

• Cannot provide. This is relevant for AI models, not for a topical emollient foam.

In summary, the provided 510(k) document only states that "Functional and performance testing has been conducted... and all results are satisfactory" for the HPR™ Emollient Foam. It does not offer any specifics on the acceptance criteria, study design, sample sizes, expert involvement, or adjudication methods that would be necessary to answer your detailed questions.

Ask a specific question about this device

Emulsion SBTM is intended to be used as a topical skin care preparation applied at least twice daily to affected areas of the skin to improve dry skin conditions and 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.

Emulsion SB 100 is a non-sterile, viscous, lipid rich emulsion intended for topical application. It is presented for prescription (requiring a physician diagnosis disease state) use in a 90 gm tube.

Here's an analysis of the provided text regarding the Emulsion SB™ device, focusing on acceptance criteria and study details:

Analysis of Acceptance Criteria and Device Performance for Emulsion SB™

Based on the provided 510(k) summary (K110732), it is crucial to note that this submission does not contain the detailed study information typically found for devices that rely on clinical performance data for substantial equivalence. This is a topical emulsion, primarily compared to a predicate device (Epiceram®) based on its characteristics and intended use. The 510(k) summary states:

"Functional and performance testing has been conducted to assess the safety and efficacy of Emulsion SB™ and the results are satisfactory."

This statement is very general and does not provide specific acceptance criteria or detailed performance metrics. For devices like topical emulsions, the "acceptance criteria" are often related to:

• Formulation equivalence: Similarity in ingredients and their concentrations compared to the predicate device.
• Biocompatibility: Absence of irritation or sensitization.
• Stability: Shelf-life and physical stability of the emulsion.
• Functionality: Ability to spread, absorb, and maintain a moist environment.
• Clinical Efficacy (if a clinical study was performed): Often assessed through subjective symptom reduction (burning, itching, dryness) and objective measures like skin hydration or barrier function. However, the provided document does not detail any clinical study for Emulsion SB™ beyond the general statement of "satisfactory" results.

Given the lack of specific data in the provided document, the table below will reflect that information is Not Provided (NP) where applicable.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not Provided (NP). The document does not describe a specific clinical test set or its sample size.
• Data Provenance: Not Provided (NP). No information on country of origin or whether data was retrospective or prospective.

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

• Not Applicable (NA). The document does not describe a clinical study involving expert assessment or ground truth establishment in this manner for a test set. This type of detail is more common for diagnostic devices or those requiring subjective clinical endpoints.

4. Adjudication method for the test set

• Not Applicable (NA). No information on a test set or adjudication method.

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 (NA). This device is a topical emulsion, not an AI-assisted diagnostic tool.

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

• Not Applicable (NA). This device is a topical emulsion, not an algorithm.

7. The type of ground truth used

• Not Applicable (NA). For this type of device, "ground truth" (in the sense of a diagnostic standard or confirmed pathology) isn't typically established for a 510(k) submission unless specific clinical endpoints require it. The determination of "satisfactory" safety and efficacy likely relied on standard pre-clinical tests and, if conducted, small-scale clinical observations or patient-reported outcomes, as opposed to a formal diagnostic ground truth. The primary "ground truth" for substantial equivalence is the predicate device's established safety and efficacy profile.

8. The sample size for the training set

• Not Applicable (NA). This device is a topical emulsion; there is no "training set" in the context of machine learning or complex diagnostic algorithms.

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

• Not Applicable (NA). As above, no training set.

Summary of Study Information:

The 510(k) summary for K110732 indicates that "Functional and performance testing has been conducted to assess the safety and efficacy of Emulsion SB™ and the results are satisfactory." However, it does not provide any specific details about these tests, such as study design, sample sizes, endpoints, statistical analyses, or the methodology for establishing safety and efficacy beyond this general statement. The basis of substantial equivalence relies heavily on the comparison of the device's technical characteristics and intended use to the predicate device, Epiceram® (K052643). For topical products like this, the "study" often involves biocompatibility testing, stability testing, and potentially small-scale clinical evaluations that demonstrate equivalence in function and patient tolerance to the predicate. The provided document does not elaborate on these beyond the general affirmation.

Ask a specific question about this device

PR™ cream is indicated to manage various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and irritant contact dermatitis. PR™ cream helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

PR™ cream is a non-sterile cream formulation intended for topical use only. It is presented for Prescription (requiring a physician diagnosis disease state) use. PRTM cream is or topical dermatologic use only. PR™ cream is applied in a thin layer to affected areas 2-3 times per day or as directed by a physician. PRTM cream is a nonsteroidal cream comprised of aluminum magnesium hydroxide stearate, cetyl dimethicone copolyol, cyclomethicone, hexyl laurate, polyglyceryl-4-isostearate, prified water, and sodium chloride. Contains phenoxyethanol and propylparaben as preservatives.

The provided text is a 510(k) summary for PR™ Cream, a topical dermatological cream. It is a marketing authorization document focusing on substantial equivalence to a predicate device, rather than detailed clinical study results demonstrating performance against specific acceptance criteria.

Therefore, the document does not contain the information requested to comprehensively describe acceptance criteria and the study proving the device meets them. Specifically, the following information is missing or not applicable:

• A table of acceptance criteria and the reported device performance: The document states that "Functional and performance testing has been conducted to assess the safety and efficacy of PR Cream™ Cream and results are satisfactory," but it does not provide specific acceptance criteria or quantitative performance measures.
• Sample size used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This device is a topical cream, not an AI-assisted diagnostic tool, so an MRMC study is not relevant.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not relevant as it is not an algorithm-based device.
• The type of ground truth used: Not mentioned.
• The sample size for the training set: Not relevant for a drug/cream.
• How the ground truth for the training set was established: Not relevant for a drug/cream.

Summary of what is present:

The document describes PR™ Cream as a non-sterile cream formulation for topical use, intended for prescription use, and indicated to manage various types of dermatoses (atopic dermatitis, allergic contact dermatitis, and irritant contact dermatitis). It aims to relieve dry, waxy skin by maintaining a moist wound and skin environment beneficial to healing. The submission asserts substantial equivalence to Tetrix® Cream (cleared under K07143). The conclusion states that "Functional and performance testing has been conducted to assess the safety and efficacy of PR Cream™ Cream and results are satisfactory." However, no specific details about this testing (methodology, results, or acceptance criteria) are provided in this summary.

Ask a specific question about this device

Under the supervision of a healthcare professional, PruClair™ non-steroidal cream is indicated to manage various types of dermatoses.
PruClair™ non-steroidal cream is indicated for minor burns, minor lacerations, and minor irritations.

PruClair™ non-steroidal cream is a non-sterile, viscous emulsion/formulation, which is presented for both Prescription (requiring a physician diagnosis disease state) and over-the-counter (OTC) use.

The provided K093156 510(k) summary for "PruClair™ non-steroidal cream" does not contain any information regarding acceptance criteria, device performance metrics, or study details (like sample size, ground truth, expert qualifications, or MRMC studies) typically associated with an AI/ML device.

This document describes a drug/biologic product (a cream), not an AI/ML powered medical device. The "functional testing" mentioned is likely related to the chemical and physical properties of the cream, its stability, safety (e.g., irritation studies), and possibly its efficacy in a clinical setting as a topical treatment for dermatoses, minor burns, cuts, lacerations, and irritations.

Therefore, I cannot fulfill your request for the specific details of acceptance criteria and a study proving device performance as they would apply to an AI/ML device. The information you are asking for is not present in this type of submission for a non-AI/ML product.

Ask a specific question about this device

PruTect™ is a water-based emulated for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, Ist and 2nd degree burns, including sunburns, and radiation dermatis. When applied properly to a wound, PruTect™ provides an optimum moist environment for the healing process and isolates the wound from harmful germs and other external contamination.

PruTectTM is indicated for use in:

• · Full Thickness Wounds, Pressure Sores, Dermal Ulcers including Lower Leg Ulcers
• · Superficial Wounds
• · 1st and 2nd Degree Burns, including Sunburns
• · Dermal Donor and Graft Site Management
• · Radiation Dermatitis
• · Minor Abrasio»

PruTect™ Topical Emulsion is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for prescription (requiring a physician diagnosis disease state) use in both 45 gm and 90 gm tube formats.

The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for PruTect™ Topical Emulsion, which describes its intended use and states that it is substantially equivalent to a predicate device (Biafine® Topical Emulsion).

The document mentions that "Functional and performance testing has been conducted to assess the safety and efficacy of PruTect™ Topical Emulsion and the results are satisfactory." However, it does not provide details about:

• Specific acceptance criteria (e.g., performance metrics, thresholds for success).
• The design, methodology, or results of any study that would demonstrate the device meets such criteria.
• Sample sizes, data provenance, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study proving the device meets them based on the provided text.

Ask a specific question about this device