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K Number
K984115
Device Name
SCAREASE & SCAREASE ADHESIVE GEL
Manufacturer
SCAREASE, INC.
Date Cleared
1999-02-12

(87 days)

Product Code
MDA
Regulation Number
878.4025
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • ScarEase is indicated for use in the management of hypertrophic and keloid scars.
  • ScarEase is effective in the management of hypertrophic and keloid scars. .
  • Consistent use of ScarEase can reduce hypertrophic and keloid scarring. .
  • lf used following surgical procedures, ScarEase may prevent hypertrophic . and keloid scarring.
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the ScarEase and ScarEase Adhesive Gel, indicating that the device is substantially equivalent to legally marketed predicate devices.

The letter mentions:

  • Trade Name: ScarEase and ScarEase Adhesive Gel
  • Regulatory Class: Unclassified
  • Product Code: MDA
  • Indications for Use: Management of hypertrophic and keloid scars; reduction of hypertrophic and keloid scarring with consistent use; prevention of hypertrophic and keloid scarring if used following surgical procedures.

However, the document does not include any details about:

  1. A table of acceptance criteria or reported device performance.
  2. Sample sizes for test sets, data provenance, or retrospective/prospective study design.
  3. Number or qualifications of experts for ground truth establishment.
  4. Adjudication methods.
  5. Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
  6. Standalone (algorithm-only) performance studies.
  7. Type of ground truth used (e.g., pathology, outcomes data).
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

Therefore, I cannot fulfill your request based on the provided text.

§ 878.4025 Silicone sheeting.

(a)
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.