(624 days)
FOR TOPICAL DERMATOLOGICAL USE ONLY
Description Rx Product:
Under the supervision of a healthcare professional, Sinclair Skin Emulsion is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. Sinclair Skin Emulsion helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Description OTC Product:
Sinclair Skin Emulsion helps to nourish skin and relieve the burning and itching associated with many common types of skin irritation and wounds.
Sinclair Skin Emulsion is a non sterile viscous emulsion / gel formulation, which is presented for both Prescription (requires physician diagnosis of disease state) and over- the-counter (OTC) use.
The provided text does not contain specific acceptance criteria for a device, nor does it detail a study proving the device meets such criteria. Instead, it is a 510(k) premarket notification document for the "SINCLAIR SKIN EMULSION™."
Here's what can be extracted from the document regarding the device and its regulatory submission:
Device Description and Intended Use:
- Device Name: SINCLAIR SKIN EMULSION™
- Common Name: Dressing, Wound & Burn, Hydrogel w/Drug or Biologic
- Classification: Unclassified, Product Code: FRO, MGQ
- Description: A non-sterile viscous emulsion/gel formulation for topical application.
- Intended Use (Prescription): Under healthcare professional supervision, indicated to manage and relieve signs and symptoms of seborrhea and seborrheic dermatitis (itching, erythema, scaling, pain). Helps relieve dry waxy skin by maintaining a moist wound & skin environment beneficial to healing.
- Intended Use (OTC): Helps nourish skin and relieve burning and itching associated with many common types of skin irritation and wounds.
Predicate Device:
- Sinclair Wound and Skin Emulsion 510(k) K024367
Tests and Conclusions (as stated in the document):
- "Functional and performance testing has been conducted to assess the safety and effectiveness of SINCLAIR SKIN EMULSION™ and all results are satisfactory."
- The FDA determined the device is substantially equivalent to legally marketed predicate devices.
What is NOT Present in the Document (and therefore cannot be provided in the requested table/study details):
- Specific Acceptance Criteria: The document does not define measurable performance thresholds the device needed to meet. It broadly states "satisfactory" results.
- Detailed Study Design: There is no description of a clinical or analytical study, its methodology, endpoints, or results.
- Reported Device Performance: While stated as "satisfactory," no quantitative or qualitative performance metrics are provided.
- Sample Size: No information on sample sizes (test set, training set) is available.
- Data Provenance: No details on country of origin or retrospective/prospective nature of data are given.
- Number/Qualifications of Experts: No mention of experts for ground truth establishment.
- Adjudication Method: Not applicable as no ground truth establishment details are provided.
- MRMC Comparative Effectiveness Study: No such study is mentioned or summarized.
- Standalone Performance: No specific standalone algorithm performance is discussed, as this is a medical device, not an AI algorithm in the typical sense.
- Type of Ground Truth: Not applicable, as no ground truth creation process is described.
- Training Set Sample Size: Not applicable, as no training set for an algorithm is mentioned.
- How Training Set Ground Truth was Established: Not applicable.
Conclusion:
The provided text is a regulatory submission document for a medical device (a topical emulsion) seeking a 510(k) clearance based on substantial equivalence to a predicate device. It confirms that functional and performance testing was conducted, and the results were deemed "satisfactory" by the applicant, leading to FDA clearance. However, it does not include the detailed acceptance criteria and a specific study report that outlines the methodology, results, and proof of meeting those criteria. The information you are requesting about acceptance criteria, detailed study design, sample sizes, expert involvement, and ground truth establishment is typically found in dedicated study reports or test protocols, which are not part of this 510(k) summary.
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