(349 days)
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.
N/A