Search Results
Found 3 results
510(k) Data Aggregation
(303 days)
ICS CHARTR EP 200 WITH VEMP
The ICS Chartr EP 200 with VEMP is indicated for auditory evoked potential testing as an aid in assessing hearing loss and lesions in the auditory pathway. The Vestibular Evoked Myogenic Potential is indicated for vestibular evoked potential testing as an aid in assessing vestibular function in adult patients. The device is to be used only by qualified medical personnel with prior knowledge of the medical and scientific facts underlying the procedure.
"Vestibular Evoked Myogenic Potentials (VEMPs) are short latency electromyograms (EMGs) evoked by high level acoustic stimuli recorded from surface electrodes over the tonically contracted sternocleidomastoid (SCM) muscle." Akin FW & Murnane OD (2001).
The ICS Chartr EP 200 with VEMP is used to test the auditory and vestibular functions of children and adults in a hospital, in an Ear, Nose and Throat Clinic or in an Audiology office. The ICS Chartr EP 200 system measures evoked potentials from the patient using repeated auditory stimuli and averaging EEG or EMG activity in order to abstract the response from the noise resulting in an analysis of the auditory/vestibular system functions.
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 preamp, which is connected to the hardware platform, which is connected to the PC via a USB cable - no hardware installation inside the PC is required. The PC and hardware platform are powered from the isolation transformer which is powered from the mains.
One added item as compared to the standard EP200 is the VEMP monitor. The Chartr EP (USB) VEMP monitor assesses the level of tonic EMG and displays if the level is adequate or inadequate. The monitor light will display the following based on the EMG level: Low (blue) -EMG level is below the Min value- Good (green) - EMG level is between Min value and the Max value - High (amber) - EMG level is above the Max value
Summary: VEMP is an evoked potential (EP) just like ABR obtained using any commercially available EP system. The unique feature with the ICS Chartr EP 200 is the ability to perform EMG monitoring during VEMP data collection.
The VEMP function of the EP 200 does not make a diagnosis. The diagnosis is made by a medical professional.
The provided text describes a 510(k) premarket notification for the ICS Chartr EP 200 with VEMP, an auditory and vestibular evoked potential testing device. It does not contain information about an AI/ML medical device. Therefore, a comprehensive answer to the user's request for acceptance criteria and study proving an AI/ML device meets them cannot be wholly extracted from the given text.
However, I can extract the information relevant to the device's validation and substantial equivalence, and then address the remaining points by stating the information is not present in the provided document.
Here's an attempt to answer the user's request based only on the provided text, highlighting what is available and what is not:
Based on the provided FDA 510(k) summary for the ICS Chartr EP 200 with VEMP:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define "acceptance criteria" in a quantitative table format for performance metrics relevant to an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating the reproducibility of VEMP waveforms and comparing the new device's features and safety/effectiveness to a predicate device.
The closest equivalent to "reported device performance" in the context of this device is the correlation values for VEMP waveform reproducibility.
Performance Metric (Reproducibility of VEMP Waveform) | Acceptance Criteria (Implicit) | Reported Device Performance (Correlation Values) |
---|---|---|
Normal Subjects (cVEMP) | (Implied to be "good" for clinical utility based on comparison to other EPs) | CORR R (entire window): 0.893448276 |
CORR L (entire window): 0.903448276 | ||
5-35ms CORR R: 0.914655172 | ||
5-35ms CORR L: 0.916206897 | ||
Patients with Disorders (cVEMP) | (Lower correlation expected due to absent/abnormal responses, but still demonstrably present when possible) | CORR R (entire window): 0.751964286 |
CORR L (entire window): 0.75637931 | ||
5-35ms CORR R: 0.775172414 | ||
5-35ms CORR L: 0.805 | ||
Normal Subjects (oVEMP) | (Implied to be "good" for clinical utility) | CORR R: 0.897 |
CORR L: 0.8915 | ||
4-20ms R: 0.926 | ||
4-20ms L: 0.93 |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Size:
- 60 normal cVEMP subjects
- 58 pathologic cVEMP subjects
- 20 normal oVEMP subjects
- Data Provenance: Studies were collected at two different facilities, one in the USA and one in Canada. The document states these were "clinical studies," implying they were prospective, but does not explicitly state "retrospective" or "prospective."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not present in the provided text. The device assesses auditory and vestibular function, and the "ground truth" seems to be the VEMP waveform itself and its reproducibility, rather than a clinical diagnosis established by experts. The diagnosis is stated to be made by a medical professional.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided text. The study focuses on correlation and reproducibility of waveforms, not on classification or diagnostic accuracy adjudicated by multiple readers.
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
- MRMC Study: No, an MRMC study was not done. This device is an evoked potential testing system, not an AI-powered diagnostic algorithm assisting human readers.
- Effect Size of AI assistance: Not applicable, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the context of AI/ML. The device's "performance" is its ability to reliably acquire and display VEMP waveforms. The clinical conclusion and diagnosis are explicitly stated to be made by a medical professional. "The VEMP function of the EP 200 does not make a diagnosis. The diagnosis is made by a medical professional."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" implicitly used for the reproducibility study is the VEMP waveform itself and its consistency across repeated measurements. The study aimed to demonstrate that the device could reliably produce these waveforms. For patients with disorders, the "pathologic" status serves as a descriptor for that cohort, with results indicating lower correlation due to the nature of their conditions (absent or abnormal VEMPs).
8. The sample size for the training set
This information is not present in the provided text. This is not an AI/ML device that requires a "training set" in the machine learning sense. Clinical studies presented were to confirm reproducibility, not to train an algorithm.
9. How the ground truth for the training set was established
This information is not present in the provided text, as it is not an AI/ML device with a training set and corresponding ground truth.
Ask a specific question about this device
(29 days)
ICS CHARTR EP 200
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.
Ask a specific question about this device
(95 days)
ICS CHARTR EP 200
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."
Acceptance Criteria (Implied) | Reported Device Performance (as stated in document) |
---|---|
Indication for use EP is "auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway." | "Indication for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway" (Identical to predicate devices). |
Compliance with EN 60601-1 (Electrical Safety) | "Designed to comply with EN 60601-1 (UL 2601)" (and other related standards like EN 60601-1-1, -1-4, -2-26, -2-40). |
Compliance with EN 60601-1-2 (EMI Compatibility) | "Designed to comply with EN 60601-1-2." |
Compliance with ISO 9001 and ISO 13485 (Quality Management Systems) | "Designed, developed and manufactured according to... ISO 9001:2000... ISO 13485:2003." |
Functional similarity to predicate devices | External hardware platform with USB connection to PC; no ASSR or OAE; minor software UI enhancements. These are described as differences, but the overall function (EP testing) is maintained and similar to predicates. |
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.
Ask a specific question about this device
Page 1 of 1