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K Number
K981534
Device Name
VIPERCAM
Manufacturer
INTEGRA MEDICAL
Date Cleared
1998-07-23

(85 days)

Product Code
EIA
Regulation Number
872.6640
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The intraoral camera system, Vipercam, of Integra Medical Corporation is used to provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his mouth showing the patient results of the dental procedures which the dentist has performed on him.

Device Description

Vipercam, intraoral camera system, and accessories

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA for a device called "Vipercam." This document grants market clearance based on substantial equivalence to a predicate device. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request for:

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

The document is primarily a regulatory approval letter based on "substantial equivalence" to a predicate device, meaning it's similar enough to an already approved device that a full new trial is not required. It focuses on the legal and regulatory framework for marketing the device, not the detailed technical and clinical performance data that would typically be found in a study report.

§ 872.6640 Dental operative unit and accessories.

(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.