(29 days)
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.
| Acceptance Criteria (Implied by 510(k) for device modification) | Reported Device Performance (as stated in the submission) |
|---|---|
| Intended Use Equivalence: The modified device has the same intended use as the predicate device(s). | Indications for Use: "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." (Identical to predicate K031986). This claim is explicitly stated on page 1 of the 510(k) summary and the "Indications for Use" enclosure. |
| Technological Characteristics Equivalence: Key technological characteristics are substantially similar or modifications do not raise new questions of safety or effectiveness. | ASSR Protocol: "ASSR added." (Implemented from predicate K031986, which "Included" ASSR). |
| Software based electrode switching: "Implemented." (Not available on predicates K031986 or K083399). This is a minor software enhancement. | |
| Hardware implementation: "Identical to K083399." (PC-based system with external hardware platform and peripherals (USB interface)) | |
| Software: "Windows XP" (Same as predicate K083399) | |
| Power source: "Mains" (Same as predicates) | |
| Safety and EMC Compliance: The modified device complies with recognized safety and electromagnetic compatibility standards. | Safety (Unchanged): The ICS Chartr EP 200 "complies with" a list of specific safety standards (e.g., EN 60601-1, UL 60601-1, EN 60601-1-2 regarding EMC, etc.). This implies testing was done to verify compliance of the device as modified. |
| Effectiveness Equivalence: The device continues to be effective for its intended use, leveraging established technologies. | Effectiveness (Unchanged): "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 statement asserts that the inherent effectiveness of the technology has been previously established with 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.
§ 882.1900 Evoked response auditory stimulator.
(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).