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K Number
K131338
Device Name
DERMA HOOD
Manufacturer
GLOBALMEDIA GROUP, LLC
Date Cleared
2013-07-10

(62 days)

Product Code
PEQ
Regulation Number
880.6320
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Derma Hood is an accessory for the TotalExam HD Examination Light. The Derma Hood utilizes standard off-the-shelf light filters and lenses. The Derma Hood accessory is designed for use within healthcare facilities (Doctor's offices, clinics, hospitals, etc.).

Device Description

The Derma Hood is an accessory for the TotalExam HD Examination Light. The Derma Hood utilizes standard off-the-shelf light filters and lenses.

AI/ML Overview

I am sorry, but based on the provided document, there is no information about the acceptance criteria, study details, or performance of the "Derma Hood" device. The document is an FDA 510(k) clearance letter, which primarily focuses on classifying the device and confirming its substantial equivalence to a predicate device. It does not include the detailed technical performance data or specific study results you've requested.

The document mentions:

  • Trade/Device Name: Derma Hood
  • Regulation Number: 21 CFR 880.6320 (AC-Powered Medical Examination Light)
  • Regulatory Class: I
  • Product Code: PEQ
  • Indications for Use: "The Derma Hood is an accessory for the TotalExam HD Examination Light. The Derma Hood utilizes standard off-the-shelf light filters and lenses. The Derma Hood accessory is designed for use within healthcare facilities (Doctor's offices, clinics, hospitals, etc.)."

However, it does not provide any of the following information requested in your prompt:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size for the test set or data provenance.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method for the test set.
  5. MRMC comparative effectiveness study results or effect size.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 880.6320 AC-powered medical examination light.

(a)
Identification. An AC-powered medical examination light is an AC-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.(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 § 880.9.