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K Number
K041953
Device Name
VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART
Manufacturer
CONMED CORP.
Date Cleared
2004-08-09

(20 days)

Product Code
GXY
Regulation Number
882.1320
Type
Special
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For TENS and Neuromuscular Stimulation

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA letter and attachment does not contain information regarding the acceptance criteria for a medical device and the study that proves the device meets those criteria. The documents are a formal FDA communication about a 510(k) clearance for the ConMed™ VersaStim Neuromuscular Stimulator/TENS and its electrodes.

Specifically, the documents include:

  • A letter granting 510(k) clearance, indicating the device is substantially equivalent to legally marketed devices.
  • Information about regulatory requirements and general controls.
  • An "Indications for Use" statement for the device.

There is no mention of:

  • Specific acceptance criteria (e.g., performance metrics, thresholds).
  • A study design or methodology.
  • Sample sizes for test or training sets.
  • Data provenance.
  • Details about expert ground truth establishment or adjudication.
  • Multi-Reader Multi-Case (MRMC) studies or their outcomes.
  • Standalone algorithm performance.
  • Type of ground truth used (pathology, expert consensus, etc.).

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, or details about a study, as this information is not present in the provided text.

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).