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K Number
K061660
Device Name
STRYKER RF PARALLEL BIPOLAR ADAPTOR CABLE
Manufacturer
STRYKER INSTRUMENTS
Date Cleared
2006-10-10

(119 days)

Product Code
GEI,GXI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
K043442,K020354,K053082,K031951,K052878
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Stryker RF Parallel Bipolar Adaptor Cable is intended for coagulation of soft tissues in orthopedic, arthroscopic, spinal, and neurosurgical applications in combination with the separately cleared Stryker RF Generator, Electrodes and Cannulae. Examples of procedures include, but are not limited to, Facette Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, Peripheral Neuralgia, and Rhizotomy

Device Description

The Stryker RF Parallel BiPolar Adaptor Cable will be used in conjunction with the Stryker RF Generator, Electrodes and Cannulae to create radiofrequency lesions in nerve tissue. The generator applies temperature-controlled, radiofrequency (RF) energy into targeted nerve tissue via a pair of electrode probes.

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) summary for a "Stryker RF Parallel BiPolar Adaptor Cable," outlining its intended use, device description, and substantial equivalence to predicate devices. It focuses on regulatory approval rather than performance study results.

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

  1. A table of acceptance criteria and the reported device performance
  2. Sample size used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and their qualifications
  4. Adjudication method for the test set
  5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size
  6. If a standalone performance (algorithm only) was done
  7. The type of ground truth used
  8. The sample size for the training set
  9. How the ground truth for the training set was established

§ 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.