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K Number
K992596
Device Name
TOF-WATCH S
Manufacturer
ORGANON TEKNIKA CORP.
Date Cleared
1999-08-30

(27 days)

Product Code
KOI
Regulation Number
868.2775
Type
Special
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The TOF-Watch S device can be used as an objective monitor using accelerometry for measuring the muscle contraction following stimulation of the respective motorneuron, as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring or as a nerve location device.

Device Description

The TOF-Watch S device is a neuromuscular transmission monitor capable of estimating the degree of neuromuscular block in anesthetized patients. It can be used as an objective monitor using accelerometry for measuring the muscle contraction following a stimulation of the respective motorneuron, as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring and as a nerve location device utilizing a needle electrode. The TOF - Watch S device is packaged individually in a neutral carton box. The complete package contains a TOF-Watch S, an acceleration transducer, a surface electrode cable and a multilingual manual.

AI/ML Overview

This 510(k) submission for the TOF-Watch S electric nerve stimulator does not contain a detailed study demonstrating its performance against specific acceptance criteria. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical trial data with predefined acceptance criteria.

The document states:
"In summary, the TOF-Watch S described in this submission is substantially equivalent to the predicate device based on the following similarities:

  • Have the same indicated use.
  • Use the same operating principle.
  • Incorporate the same basic design.
  • Incorporate the same materials ●
  • Packaged the same using the same materials and process."

Given this, I cannot provide the requested information. The document focuses on comparing technological characteristics to a predicate device (TOF-Watch) rather than presenting a performance study with acceptance criteria.

Therefore, for the specific questions:

  1. A table of acceptance criteria and the reported device performance: Not provided in the document.
  2. Sample size used for the test set and the data provenance: Not provided in the document.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the document.
  4. Adjudication method: Not provided in the document.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device for direct patient use, not an AI algorithm.
  7. The type of ground truth used: Not applicable, as no dedicated performance study is described.
  8. The sample size for the training set: Not applicable, as this is a medical device, not an AI/machine learning model that requires a training set.
  9. How the ground truth for the training set was established: Not applicable.

§ 868.2775 Electrical peripheral nerve stimulator.

(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).