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K Number
K213247
Device Name
JETT PLASMA Medical II
Manufacturer
Compex, Spol. s.r.o
Date Cleared
2023-03-14

(530 days)

Product Code
QVJ
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

JETT PLASMA Medical II is used in the removal and destruction of skin lesions and coagulation of tissue.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.

The document is an FDA 510(k) clearance letter for the "JETT PLASMA Medical II" device. It primarily discusses:

  • The FDA's determination of substantial equivalence to a predicate device.
  • Regulatory requirements the manufacturer must follow.
  • The indications for use of the device: "removal and destruction of skin lesions and coagulation of tissue."

It does not include:

  • A table of acceptance criteria or reported device performance metrics.
  • Details on specific studies, sample sizes, data provenance, or ground truth establishment.
  • Information about expert adjudication, MRMC studies, or standalone algorithm performance.

To provide the information you've requested, I would need a different type of document, such as a clinical study report, a performance validation report, or a summary of safety and effectiveness from the 510(k) submission itself (which often contains more technical details than the clearance letter).

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.