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The ICS Chartr EP 200 is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.

The ICS CHARTR EP 200 is a PC-based svstem, which consists of software modules for installation on a PC, an isolation transformer, a hardware platform, pre-amp, a mains adapter, stimulation devices and recording devices. The stimulation and recording devices are connected to the pre-amp, which is connected to the hardware platform, which is connected to the PC via USB cable - no hardware installation inside the PC is required. This submission is for a modification to K083399. The same hardware is used but the software has the additional ASSR (Auditory Steady State Response) feature as implemented on the system described in K031986.

The provided document K092373 describes a software modification to an existing medical device, the ICS CHARTR EP 200, which is an Auditory Evoked Potential System. This submission focuses on adding the Auditory Steady State Response (ASSR) feature and minor software and user interface enhancements to an already cleared hardware platform. As such, the acceptance criteria and supporting study are primarily focused on demonstrating the equivalence of the modified device to a predicate device, rather than proving novel performance metrics in a clinical study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a modification to an existing device, the "acceptance criteria" are primarily established through substantial equivalence claims to predicate devices rather than novel performance benchmarks. The performance is assessed by comparing the new device's features and safety/effectiveness to those of the predicate devices.

2. Sample size used for the test set and the data provenance

The document does not describe a specific clinical "test set" with a sample size of patient data. This submission is a 510(k) for a device modification, focusing on documenting substantial equivalence through technical specifications, safety standard compliance, and a logical comparison to predicate devices, rather than a clinical performance study with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As noted above, there is no clinical "test set" and thus no ground truth established by experts.

4. Adjudication method for the test set

Not applicable. No test set requiring expert adjudication is described.

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

Not applicable. This device is not an AI-assisted diagnostic tool where human reader performance would be evaluated with and without AI. It is an auditory evoked potential system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This refers to the performance of the Auditory Evoked Potential (AEP) system itself in generating and processing auditory evoked potentials, particularly the new ASSR feature. The document implies that the ASSR algorithm's performance is accepted based on its implementation from the cleared predicate device K031986. The submission states: "The same hardware is used but the software has the additional ASSR (Auditory Steady State Response) feature as implemented on the system described in K031986." This suggests either:
* The original K031986 submission had data supporting the ASSR algorithm's standalone performance.
* The ASSR algorithm is a well-established and accepted method in the scientific community, and thus, its re-implementation in a new software simply needs to demonstrate correct functionality, not re-prove its fundamental performance characteristics.

The document does not explicitly describe a new standalone performance study for the modified device, relying instead on the established performance of the predicate device's ASSR feature and the device's compliance with electrical safety and EMC standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For an Auditory Evoked Potential system, the "ground truth" for its diagnostic performance would typically be established through comparison to:

• Clinical diagnosis: Established by an audiologist or medical doctor based on multiple tests and patient history.
• Behavioral audiometry: Pure tone audiometry, speech audiometry, which define the patient's hearing thresholds.
• Pathology/imaging: In cases of lesions in the auditory pathway, this could serve as anatomical ground truth.

However, the provided 510(k) summary does not detail any new clinical studies or the type of ground truth used for such studies for THIS submission. The statement "The ICS CHARTR EP 200 is an Auditory Evoked Response device for replacement of an existing product of a technology type that is available and accepted in the market" implies that the underlying technology's ability to detect hearing loss and lesions has been previously validated and accepted.

8. The sample size for the training set

Not applicable. This device is not described as using machine learning or AI that would require a "training set" of data in the typical sense. It is a signal processing and measurement device.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for a machine learning model.

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The ICS Chartr EP 200 is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.

The ICS CHARTR EP 200 is a PC-based system, which consists of software modules for installation on a PC, an isolation transformer, a hardware platform, pre-amp , a mains adapter, stimulation devices and recording devices, The stimulation and recording devices are connected to the pre-amp, which is connected to the hardware platform, which is connected to the PC via USB cable - no hardware installation inside the PC is required.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ICS CHARTR EP 200 device:

The provided text is a 510(k) summary for the ICS CHARTR EP 200, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a novel clinical study. As such, many of the requested data points for a traditional clinical study are not present in this document.

The "Effectiveness" section explicitly states: "The ICS CHARTR EP 200 is an Auditory Evoked Response device for replacement of an existing product of a technology type that is available and accepted in the market." This indicates that the regulatory pathway is based on similarity to already approved devices, not on proving new performance metrics.

1. A table of acceptance criteria and the reported device performance

Based on the 510(k) summary, formal "acceptance criteria" in the sense of specific performance targets (e.g., sensitivity, specificity, accuracy for a diagnostic device) and corresponding "reported device performance" from a dedicated study are not explicitly stated or provided.

Instead, acceptance is demonstrated by showing substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable because the device's technical characteristics and intended use are similar to those of devices already on the market.

The closest we get to "acceptance criteria" are the compliance with recognized electrical safety and EMI/EMC standards, and the statement of "Indication for use EP."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided. This document does not describe a clinical study with a "test set" sample size or data provenance in the way one would for a new diagnostic or prognostic device's performance evaluation. The device type (auditory evoked potential system) is well-established, and the focus is on demonstrating safety and efficacy through equivalence to existing technology, rather than a de novo clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. Since there's no clinical study described with a "test set" and corresponding "ground truth" to be established by experts for performance evaluation, this information is not present.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. As there is no clinical study described that involved expert adjudication of a test set, this information is not available.

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

Not applicable/Not provided. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance, particularly in image interpretation. The ICS CHARTR EP 200 is an auditory evoked potential system, not an AI-assisted diagnostic imaging device, and the submission is a 510(k) for substantial equivalence, not a new technology requiring such a study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable/Not provided. The device is an Auditory Evoked Potential System, which is inherently a human-in-the-loop diagnostic tool, used by clinicians to perform tests and interpret results. It is not an "algorithm only" device in the context of standalone performance evaluation like an AI diagnostic tool.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not provided. As no dedicated performance study is described, no specific "ground truth" for evaluating the device's diagnostic accuracy is mentioned in the document.

8. The sample size for the training set

Not applicable/Not provided. The device is not an AI/machine learning product that requires a "training set" in the conventional sense. Its development is based on established principles of auditory evoked potential measurement and engineering standards.

9. How the ground truth for the training set was established

Not applicable/Not provided. As there is no "training set" for an AI algorithm described, the method for establishing its ground truth is not relevant or mentioned.

Summary of the Study and Device Performance as Presented in the 510(k):

The provided document, a 510(k) summary, demonstrates the device's substantial equivalence to legally marketed predicate devices primarily through comparison of:

• Intended Use: Identical to predicates for auditory evoked potential testing.
• Technological Characteristics: Similar to predicates, with minor differences (e.g., external hardware, USB connection, lack of OAE/ASSR features present in some, but not all, predicates).
• Safety Standards: Compliance with recognized international and national electrical safety and EMI/EMC standards (EN 60601 series, UL, CAN/CSA).
• Quality Management Systems: Compliance with ISO 9001 and ISO 13485.

The submission relies on the established safety and effectiveness of the predicate devices in the market, rather than a new clinical study to establish performance against novel acceptance criteria. The "study" here is essentially the detailed comparison showing that the new device's features, intended use, and adherence to safety standards are sufficiently similar to approved devices.

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