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K Number
K040358
Device Name
XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248
Manufacturer
EXCEL TECH. LTD.
Date Cleared
2004-08-06

(175 days)

Product Code
GWF
Regulation Number
882.1870
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Protektor Stimulator is intended to be used for the intraoperative diagnosis of active dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the XLTEK Protektor Stimulator. It does not contain the acceptance criteria, reported device performance, or details of a study proving the device meets those criteria.

The letter explicitly states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means the device meets the safety and effectiveness profile of an existing device, rather than providing new performance data against specific acceptance criteria in this document.

Therefore, I cannot fulfill your request for the following information based on the provided text:

  1. A table of acceptance criteria and the reported device performance: This information is not present.
  2. Sample sized used for the test set and the data provenance: This information is not present.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
  4. Adjudication method for the test set: This information is not present.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This information is not present. The device is an electrical stimulator, not an AI algorithm for image reading.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present.
  7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): This information is not present.
  8. The sample size for the training set: This information is not present.
  9. How the ground truth for the training set was established: This information is not present.

The document primarily covers the administrative details of the 510(k) clearance, including:

  • The device name: XLTEK Protektor Stimulator
  • The 510(k) number: K040358
  • The date of clearance: August 6, 2004
  • The product code: GWF (Evoked response electrical stimulator)
  • The regulatory class: Class II
  • Indications for Use: "The Protektor Stimulator is intended to be used for the intraoperative diagnosis of active dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency."

To obtain the information you requested (acceptance criteria, study details, etc.), one would typically need to review the full 510(k) submission document or related clinical study reports, which are not included here. This letter is the final decision from the FDA, not the detailed submission itself.

§ 882.1870 Evoked response electrical stimulator.

(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).