(172 days)
The CERSR™ Electromyography System is used to monitor and display the bioelectric signals produced by muscles to aid in the diagnosis and prognosis of muscular disease or dysfunction.
CERSR™ is an electromyography system. CERSR™ is substantially equivalent to legally marketed predicate electromyographic systems. Like most electromyographic systems. CERSR™ allows for the monitoring and displaying of the bioelectrical signals generated by muscles. CERSR™ is specifically designed for a real-time recording of muscle electrophysiology. Most electromyographic systems have at most five channels for monitoring and displaying the activity of several muscle groups simultaneously. The CERSR™ reduces the problems associated with too few channels and allows for a real-time recording from multiple locations by applying an array of surface electrodes over the anatomical region of interest. Each electrode is connected to its own channel with preamplifier, amplifier, buffers and filters. The CERSR™ produces a user display of the myoelectric signals. These recordings may viewed in one of three standard formats, as a typical waveform, RMS display or as a frequency spectral analysis plot.
This document is a 510(k) summary for the CERSR™ Electromyography System from 1999. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study of the device's performance against specific acceptance criteria.
Based on the provided text, there is no information that directly describes acceptance criteria or a study proving the device meets those criteria in a quantitative sense. The document asserts substantial equivalence based on the device's technological characteristics and its ability to perform core functions similar to existing devices.
Therefore, many of the requested details cannot be extracted from this summary.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not define specific acceptance criteria (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio requirements) or report quantitative performance metrics for the CERSR™ system in a study format. The claim is one of "substantial equivalence" in function and technological characteristics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. No test set or related data is discussed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Cannot be provided. No ground truth establishment activity is mentioned for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. No test set or adjudication process is mentioned.
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
- Cannot be provided. This device is an electromyography system, not an AI-assisted diagnostic tool for "human readers" in the context of MRMC studies typical for imaging or AI. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This is an EMG system designed for monitoring and displaying bioelectric signals, inherently used by a human clinician. It does not operate as a standalone algorithm in the sense of AI or automated diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No ground truth for performance evaluation is mentioned. The device's "ground truth" functionally lies in its ability to accurately record muscle bioelectric signals, but no formal validation study is presented here.
8. The sample size for the training set
- Cannot be provided. There's no mention of a "training set" as this predates (or doesn't involve) machine learning/AI development in this context. The device's design is based on established electromyography principles.
9. How the ground truth for the training set was established
- Cannot be provided. As there's no training set, this question is not applicable.
Summary based on the document:
The 510(k) summary for the CERSR™ Electromyography System functions as a regulatory submission arguing for "substantial equivalence" to existing, legally marketed predicate devices. It asserts that the CERSR™ shares the same indications for use and technological characteristics (monitoring and displaying bioelectric signals in standard formats) as these predicates. The approval letter from the FDA (dated August 27, 1999) confirms this determination of substantial equivalence, allowing the device to be marketed.
This type of submission typically relies on comparing the new device's design, materials, and intended use against those of already approved devices, rather than conducting a de novo performance study against pre-defined acceptance criteria for a new clinical claim.
§ 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).