(79 days)
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
| Acceptance Criteria Category | Specific Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Safety | NP (Assumed: Biocompatibility, non-toxicity) | "Satisfactory" |
| Efficacy | NP (Assumed: Reduction of dry skin, burning, itching; maintenance of moist skin environment) | "Satisfactory" for assessing safety and efficacy |
| Material/Formulation | Equivalence to predicate (non-sterile, viscous, lipid-rich emulsion) | "Substantially Equivalent to Epiceram®" |
| Intended Use | To improve dry skin conditions and relieve burning/itching associated with various dermatoses (atopic, irritant contact, radiation dermatitis) | Stated intended use matches description, determined substantially equivalent |
| Functional/Performance | NP | "Satisfactory" |
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.
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