(27 days)
The CHARTR® EP with ASSR System is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.
The CHARTR® OAE is indicated for the determination of cochlear function in infants, children, and adults which provides information about hearing without subjective response from the individual being tested.
The CHARTR® EP with ASSR CHARTR® OAE Systems Product is substantially equivalent to the CHARTR® EP and CHARTR OAE Systems which has a cleared 510(k): K002985.
The CHARTR® EP with ASSR System is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.
The CHARTR® OAE is indicated for the determination of cochlear function in infants, children, and adults which provides information about hearing without subjective response from the individual being tested.
ASSR (Auditory Steady-State Response) testing is based on the longestablished principle that stimuli presented at fast rates evoke brain responses that overlap (so-called "steady-state" responses). The overlap results in a stable sinusoidal pattern in the patient's electroencephalogram (EEG). The pattern is detectable with computer algorithms, and is stable only in the EEG of patients whose auditory system responds to the stimulus.
With auditory stimuli, amplitude- and/or frequency-modulation of a sine wave (pure tone) results in a stimulus that is both relatively frequencyspecific and capable of evoking a detectable steady-state response. Research studies have demonstrated that when several such stimuli are presented to a patient simultaneously, the response to each stimulus can be extracted from the (composite) EEG, and the results are comparable to those obtained when the stimuli are presented sequentially. This technique enables assessment of hearing at several frequencies at once.
Responses are detected through analysis of digital samples of the patient's EEG. The analysis consists of two stages: estimation and statistical detection. Estimation involves calculations performed on the EEG samples to produce periodic values for amplitude and/or phase of each response sought. Estimates for each response are passed to a statistical algorithm that calculates the confidence, in percent, that the estimates are consistent with a stable response to the corresponding stimulus. The software declares a response to be present when the confidence reaches a predetermined threshold (i.e. 95%). If the confidence does not reach this threshold within a predetermined amount of time (i.e. 5 minutes of testing), the software declares that no response could be found.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ICS Medical CHARTR® EP with ASSR and CHARTR® OAE Systems:
Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results. As such, some of the requested information (e.g., precise sample sizes for test/training, number and qualifications of experts for ground truth, adjudication methods, MRMC study details, specific effect sizes, and detailed ground truth establishment for training) is not explicitly present in this type of document. The responses below are based only on the information available in the provided text.
Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative performance metric format (e.g., minimum sensitivity or specificity). Instead, substantial equivalence is claimed based on the new device (CHARTR® EP with ASSR) operating on the same scientific principle, having comparable clinical purpose, patient population, and electrical/EMI safety standards as the predicate device (CHARTR® EP).
The key difference highlighted is in the interpretation method:
- Predicate (CHARTR® EP): Audiologist subjectively identifies responses.
- New Device (CHARTR® EP with ASSR): Algorithm objectively identifies responses.
The "reported device performance" related to this algorithmic identification is described as follows:
| Feature | Acceptance Criteria (Implied / Predicate Baseline) | Reported Device Performance (CHARTR® EP with ASSR) |
|---|---|---|
| Response Detection | Subjective identification by audiologist (standard of care for predicate) | Algorithm objectively identifies responses. Calculations performed on EEG samples provide periodic values for amplitude/phase of each response. A statistical algorithm calculates confidence. Response declared "present" when confidence reaches a predetermined threshold (i.e., 95%). "No response" declared if confidence not reached within a predetermined amount of time (i.e., 5 minutes). |
| Scientific Principle | Established principle of auditory evoked potentials. | Based on the same long-established principle; stimuli presented at fast rates evoke overlapping ("steady-state") brain responses, resulting in a stable sinusoidal EEG pattern. Detectable with computer algorithms, stable only if auditory system responds. |
| Clinical Purpose | Aid in detecting hearing loss and lesions in the auditory pathway. | Same. |
| Patient Population | Adults, children, and infants. | Same. |
| Electrical Safety | Designed to comply with EN 60601-1 (UL2601) | Same. |
| EMI Compatibility | Designed to comply with EN 60601-1-2 | Same. |
Study Details
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The 510(k) summary does not provide any specific sample size for a test set, nor does it detail the provenance of any data used for validation. The document describes the scientific principle of ASSR and mentions "Research studies have demonstrated..." but does not reference a specific study conducted for this 510(k) submission with participant numbers or data origin.
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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):
- This information is not provided in the 510(k) summary. The summary describes the algorithm's objective detection based on a statistical confidence threshold, rather than comparison against a traditional expert-adjudicated ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided. The device uses an algorithmic, statistical detection method (95% confidence threshold) rather than external expert adjudication for its output.
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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:
- No MRMC comparative effectiveness study is mentioned or summarized. The document highlights that the new device's algorithm replaces subjective interpretation by an audiologist with objective identification, rather than assisting a human reader.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The "Interpretation" section explicitly states that the CHARTR® EP with ASSR uses an "Algorithm objectively identifies responses." This suggests a standalone performance where the algorithm provides the final determination. The scientific principle details how the algorithm extracts responses and calculates confidence to make a "present" or "no response" declaration independently.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document does not explicitly state a specific ground truth used for validation of the ASSR algorithm in the context of this 510(k). The basis for "substantial equivalence" relies on the established scientific principle and comparison to the predicate, which relies on a human audiologist's subjective identification. The algorithm itself creates its own "decision" based on a statistical confidence threshold (95%), rather than being validated directly against an external, independent ground truth method in this summary. It mentions "Research studies have demonstrated" the comparability of these techniques, implying prior validation in the scientific literature.
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The sample size for the training set:
- This information is not provided. The document focuses on the operational principle of the algorithm rather than its development or training data.
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How the ground truth for the training set was established:
- This information is not provided.
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.