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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:

Study Details

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. How the ground truth for the training set was established:

   • This information is not provided.

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The ICS Medical Model VG-30 Video Goggles are intended to provide video signals of patient's eyes thus making it possible to observe, record, and measure eye movements during testing of vestibular function.

The ICS Medical Model VG-30 Video Goggle consists of two small video cameras mounted in a custom housing to be worn on the face of the patient to view the patients eyes. The goggles use infrared (IR) Illumination to allow the eyes to be viewed in total darkness, a feature produced by a cover that can be installed on the front of the goggle housing.

The provided document is a 510(k) summary for the ICS Medical Model VG-30 Video Goggle, which seeks to establish substantial equivalence to a predicate device (ICS Video Goggle, K991497). This type of submission focuses on comparing the new device's characteristics and performance to a legally marketed predicate, rather than presenting a detailed new performance study with acceptance criteria in the typical sense of a clinical trial.

Therefore, the requested information elements related to specific acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable or not explicitly detailed in this 510(k) summary because the submission relies on demonstrating substantial equivalence.

Here's an analysis based on the provided text, addressing the points where information is available or noting its absence:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria for performance in the typical sense (e.g., a specific sensitivity or specificity target). Instead, the "acceptance criteria" for a 510(k) submission are implicitly met by demonstrating substantial equivalence to the predicate device. This means showing that the new device is as safe and effective as the predicate.
• Reported Device Performance: The "performance" assessment is primarily a comparison of design and material specifications to the predicate device. The key performance claim is its ability to "provide video signals of patient's eyes thus making it possible to observe, record, and measure eye movements during testing of vestibular function," which is identical to the predicate's intended use.

2. Sample Size Used for the Test Set and Data Provenance

• Not Applicable / Not Provided: As this is a 510(k) submission for substantial equivalence based on design comparison, a "test set" in the context of clinical performance evaluation with a specific sample size is not described. The assessment is primarily based on engineering and material comparisons to the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable / Not Provided: No "ground truth" establishment by experts for a specific test set is described, as the submission focuses on device characteristics relative to a predicate, not a de novo clinical performance study.

4. Adjudication Method for the Test Set

• Not Applicable / Not Provided: No adjudication method is mentioned as there is no specific test set requiring such a process.

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: The device (Video Goggle) is an accessory for observing and recording eye movements; it is not an AI-powered diagnostic tool that assists human readers in interpretation. Therefore, an MRMC comparative effectiveness study regarding "human readers improving with AI" is not relevant to this device and was not performed.

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

• Not Applicable: This device is a video goggle, an accessory that provides video signals for human observation or subsequent analysis by other systems (e.g., a nystagmograph). It does not perform an "algorithm only" standalone diagnostic function, so no such performance study would be applicable or provided.

7. The Type of Ground Truth Used

• Not Applicable / Implicit via Predicate: The "ground truth" in this context is implicitly the established safety and effectiveness of the predicate device. The new device demonstrates substantial equivalence by showing it shares the same technological characteristics, intended use, and performs similarly to the predicate. There is no independent "ground truth" (like pathology or outcomes data) established for a new clinical performance study.

8. The Sample Size for the Training Set

• Not Applicable / Not Provided: This device is not an AI/ML-based algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

• Not Applicable / Not Provided: As there is no training set mentioned, the method for establishing its ground truth is also not applicable.

In summary, this 510(k) submission successfully demonstrated substantial equivalence by comparing the design, materials, and intended use of the new VG-30 Video Goggle to a previously cleared predicate device, rather than through a new clinical performance study with acceptance criteria and ground truth as might be seen for novel diagnostic devices.

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This device is used to observe, record and measure eye movements in patients during testing of vestibular function.

The CHARTR® ENG/VNG Diagnostic System is a computer based medical device consisting of a Computer utilizing the Pentium III processor, Windows 98 Operating System. Computer Monitor, two Display Monitors for viewing eve movements and utilizes the following accessories: Light Bar, Video Goggles, External Isolation Transformer. Video Distribution Amplifier. Caloric Stimulator. Color Printer, Patient Electrodes, and Interconnection Cables.

The provided text is a 510(k) summary for the ICS Medical CHARTR® ENG/VNG Diagnostic System, and a letter from the FDA determining substantial equivalence to predicate devices. This type of document is generally focused on regulatory approval based on equivalence to existing devices, rather than detailed studies proving performance against acceptance criteria for a novel device. Therefore, much of the requested information regarding specific study details (like sample sizes, expert qualifications, adjudication methods, or MRMC studies) is not present in the provided text.

Based on the information available:

Acceptance Criteria and Device Performance

The document does not explicitly state acceptance criteria in terms of quantitative performance metrics for the CHARTR® ENG/VNG Diagnostic System itself. Instead, the basis for approval is "substantial equivalence" to predicate devices. The "performance" reported implicitly is that the device "observes, records, and measures eye movements in patients during testing of vestibular function," which aligns with the intended use statement.

Study Details (Based on available information)

1. Sample sizes used for the test set and the data provenance:

• Not provided. The document describes a regulatory submission based on substantial equivalence to predicate devices, not a de novo study with a specific test set.

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

• Not provided. Ground truth establishment, if any, is not detailed.

3. Adjudication method for the test set:

• Not provided.

4. 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, an MRMC study was not described. The device is for recording and measuring eye movements, not an AI-assisted diagnostic tool for human readers in the context typically associated with MRMC studies in imaging.

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

• Not explicitly described as a standalone performance study. The device is a "computer based medical device" that utilizes accessories to "observe, record, and measure eye movements." Its performance is inherent in its function as a diagnostic system for vestibular function, rather than an "algorithm only" in the sense of an AI model being evaluated. The approval is based on its functional equivalence to existing devices.

6. The type of ground truth used:

• Not explicitly stated as a separate ground truth study. The basis for approval is substantial equivalence to established devices, implying that the "ground truth" is effectively the established performance and clinical utility of those predicate devices for their intended use.

7. The sample size for the training set:

• Not applicable/Not provided. This document does not describe the development or training of an AI model with a training set. It refers to a computer-based system, but not an AI/ML system in the modern sense.

8. How the ground truth for the training set was established:

• Not applicable/Not provided. As there is no mention of a training set, the establishment of its ground truth is not discussed.

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This device is used to record and visually display movements of the eyes including nystagmus.

The VEMR™ Eye Movement Recorder is used to observe or record eye movements on a video monitor or video recording tape respectively. This device consists of: patient eye goggles, a video image splitter/power-supply, a video tape cassette recorder (VCR) video monitor console, and a remote control accessory. There is also a built-in microphone in the eye goggles to provide simultaneous voice recording's on a video recording tape. The patient eye goggles are an opaque, facially worn device fitted with tiny video cameras, infrared light emitting diodes (LED's), and a microphone. The diodes illuminate the eyes for video cameras that produce video signals. These signals are processed by the image processor that essentially allows for simultaneous viewing the video images of both eyes on the video screen. The microphone allows for recording of voices to help document events recorded on video tape. The remote control accessory provides remote control of the various functions (e.g. play, record etc.) on the VCR/video monitor console.

The provided document describes the ICS VEMR™ Eye Movement Recorder, a device used to observe and record eye movements. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in terms of accuracy or efficacy for its intended use.

Instead, the document details:

• Substantial Equivalence: The device is deemed substantially equivalent to the House InfraRed/Video Electronystagmograph System.
• Description of the Device: Components and basic function.
• Intended Use: To record and visually display movements of the eyes including nystagmus.
• Technological Similarities and Differences to Predicate Device: A comparison table.
• Non-Clinical Tests: These tests focus on safety and electromagnetic compatibility, not clinical performance for its stated intended use.

Therefore, many of the requested sections regarding acceptance criteria and performance studies cannot be filled from the provided text.

Here's an analysis of what can be extracted and what is missing:

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

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

• Sample Size for Test Set: Not applicable. The document describes non-clinical safety and electromagnetic compatibility (EMC) tests, not performance studies on human subjects.
• Data Provenance: Not applicable for clinical performance. The non-clinical tests were likely conducted in a lab environment (e.g., GLP regulations for cytotoxicity and irritation tests, specific test facilities for EMI).
• Retrospective or Prospective: Not applicable.

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)

• Not applicable as no clinical performance study with expert-established ground truth is described.

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

• Not applicable as no clinical performance study requiring 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

• No MRMC study was done. The device does not perform any analyses or measurements; it is a recorder/viewer.

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

• No standalone performance study of an algorithm was done. The device is explicitly stated as a "stand-alone device that only permits viewing of the eyes and recording their movements on video tape. Our device does not perform any analyses or measurements of the images."

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

• Not applicable as no clinical performance study requiring ground truth is described.

8. The sample size for the training set

• Not applicable as there is no mention of an algorithm or AI that would require a training set.

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

• Not applicable as there is no mention of an algorithm or AI.

Conclusion:

The 510(k) submission for the ICS VEMR™ Eye Movement Recorder focuses on demonstrating substantial equivalence to a predicate device and proving safety and electromagnetic compatibility through non-clinical testing. It explicitly states that the device "does not perfom any analyses or measurements of the images," thus negating the need for clinical performance studies related to diagnostic accuracy, a typical requirement for AI/algorithm-driven devices. The acceptance criteria and "study" are primarily related to safety, electrical standards, and EMC, where the device "passed" or "meets the requirements" or "is not considered an irritant," etc.

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