(88 days)
The Advantage 3000 system diagnoses disorders of the nervous and muscular systems.
The Advantage 3000 is a Diagnostic Electromyography/Evoked Response Electrical Stimulation (EMG/EP) System designed for the monitoring and analysis of electromyography data. A variety of electrophysiologic tests can be performed to determine whether disease of peripheral nerves or muscles is present in adult and pediatric patients.
Using surface electrodes, signals are recorded from the surface of the skin or directly from the nerves or muscles by means of needle electrodes. It is also possible to provide a timed stimulus to the patient, so that the response to the stimulus can be recorded and analysed. The signals from the subject are taken through the headbox to the control module and the computer for display and analysis. The computer is based on the Intel Pentium architecture. Differences from the predicate device are the inclusion of a constant voltage stimulator, a more efficient operating interface, a reduction in the wattage of the speaker, the availability of a portable system, and the size reduction of the laboratory based system. Beyond these differences both devices have the same technological characteristics.
This document is a 510(k) summary for the Advantage 3000 device. A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission generally does not include detailed studies with acceptance criteria in the way a PMA (Premarket Approval) submission would.
Therefore, the provided text does not contain the kind of detailed information requested in the prompt regarding acceptance criteria and a study proving the device meets them, especially with respect to performance metrics like sensitivity, specificity, or reader improvement with AI.
Here's why the prompt's questions cannot be answered from this document:
- No Acceptance Criteria or Reported Device Performance: This document states the device is "substantially equivalent" to a predicate device (Advantage EMG/EP System K885246). Substantial equivalence means it performs comparably, not that specific performance metrics against pre-defined acceptance criteria were met through a new study.
- No Sample Size, Data Provenance, Expert Ground Truth, Adjudication Method, MRMC Study, or Standalone Study: These elements are typical of clinical performance studies that would be required for a PMA or possibly some De Novo submissions, but not generally for a 510(k) where substantial equivalence to an already cleared device is the primary demonstration.
- No Training Set Information: As no new clinical performance study is detailed, there's no mention of a training set or how its ground truth was established.
Summary of available information:
The document describes the Intended Use of the Advantage 3000 as diagnosing disorders of the nervous and muscular systems using electromyography and evoked potentials. It also highlights Technological Characteristics, noting that signals are recorded from the skin, nerves, or muscles, and a timed stimulus can be provided. Differences from the predicate device are primarily related to hardware components (constant voltage stimulator, operating interface, speaker wattage, portability, and size reduction) rather than fundamental performance.
In conclusion, based solely on the provided 510(k) summary, the requested information about acceptance criteria and a detailed study proving the device meets them is not available. The 510(k) process relies on demonstrating substantial equivalence to a predicate device, rather than new clinical trials with specific performance endpoints and acceptance criteria as outlined in the prompt.
§ 890.1375 Diagnostic electromyograph.
(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).