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The GSI Corti series is indicated for testing of cochlear function in infants, children and adults by measuring otoacoustic emissions (OAEs). The OAEs are generated by a series of clicks that are directed into the ear canal. Otoacoustic emissions are low level audio-frequency sounds that are produced by the cochlea as part of the normal-hearing process. Available evidence suggests that otoacoustic emissions are generated by the cochlea's outer hair cells and that the presence of OAEs. is an indication that the outer hair cells are vidence indicates that these emissions normally occur with normal hearing, or at most, mild hearing loss (usually 30-40 dB HL). The majority of hearing-impaired individuals will be identified by a simple OAE test.

Corti test system provides rapid measurement and documentation of Distortion Product Otoacoustic Emissions (DPOAEs) or Transient Evoked Otoacoustic Emissions (TEOAEs) at several frequencies.

The system consists of the instrument, probe, printer, single-use eartips replaceable probe tubes and other accessories. The Corti instrument contains the hardware and software for generating the test stimuli, measuring and displaying the OAEs, and storing the results until they are printed. The plastic housing contains circuit boards that provide the signal processing and display the test results. The instrument also contains a rechargeable lithium-ion battery to power the device. The instrument uses a liquid-crystal display (LCD) and three light-emitting diodes (LEDs) to provide a visual display of test status to the operator. Four push buttons located on the keypad of the device allow the user to control testing and printing, and to reset test protocols.

The Probe houses the speaker and microphone which produce test stimuli and measure the sound pressure level (SPL) present in the sealed ear canal. Interface of the instrument to the ear canal is accomplished through disposable eartips, which fit onto the probe tube. The disposable eartips are color coded to facilitate easy selection by size.

Distortion Product Otoacoustic Emissions (DPOAEs) are acoustic signals that can be detected in the ear canal of a person with normal outer hair cell function, subsequent to stimulation of the auditory system with a pair of pure tones at frequencies f1 and f2. The resulting emission of interest is the distortion product tone at the frequency 2f1-f2.

The Corti instrument generates a series of test tones, directs them into the ear canal, and then measures the level of the DPOAE tone generated by the cochlea. By using different test frequencies, the Corti device provides an estimate of outer hair cell function over a wide range of frequencies.

Transient Evoked Otoacoustic Emissions (TEOAEs) are acoustic signals that can be detected in the ear canal of a person with normal outer hair cell function, subsequent to stimulation of the auditory system with a series of wideband clicks.

The Corti instrument generates a series of clicks, directs them into the ear canal, and then analyzes the spectrum of the returning signal, separating the noise and emission. By using band pass filters, the Corti device provides an estimate of outer hair cell function over a wide range of frequencies

Here's a breakdown of the acceptance criteria and the study details for the GSI Corti device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format, nor does it provide specific numerical performance values for the GSI Corti that are directly compared against such criteria. Instead, it states that the device was validated to ensure it provides equivalent diagnostic results to an "equivalent device" (the ERO-SCAN predicate device).

The "criteria" are implied by adherence to international standards and the demonstration of "substantial equivalence."

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

• Sample Size: "A selection of test subjects" with a targeted population of approximately 80% normal hearing and 20% having a range of impairment (from complete impairment to mild hearing impairment). The exact number of subjects is not specified but is referred to as "the subject ears."
• Data Provenance: Not explicitly stated, but it's a clinical validation study, implying prospective data collection in a controlled environment. The country of origin for the data is not mentioned.

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

This information is not provided in the document. The study compares the GSI Corti against a predicate device (ERO-SCAN), suggesting that the "ground truth" might be established by the results of the predicate device or by standard audiological assessments. However, the details of how the truth was established (e.g., specific expert audiologists or independent clinical diagnoses) are missing.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not an MRMC study or an AI-assisted interpretation device. The GSI Corti is an audiological device that measures otoacoustic emissions. The study compares the performance of the new device to a predicate device, not the performance of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a way. The "performance" being evaluated is of the device itself (GSI Corti) in measuring OAEs and providing diagnostic results, in comparison to another device (ERO-SCAN). There isn't a human interpreting the device's output and that output then being compared to a human baseline. The device's output is directly compared to the predicate device's output.

7. The Type of Ground Truth Used

The "ground truth" for the clinical validation was effectively the diagnostic results obtained from the predicate device (ERO-SCAN) and the known hearing status of the subjects (approximately 80% normal hearing, 20% impaired). The study aimed to determine if the GSI Corti provided "equivalent diagnostic results" to the ERO-SCAN, suggesting the ERO-SCAN's output served as the reference for equivalence.

8. The Sample Size for the Training Set

This information is not applicable or not provided. This is a device validation study, not a machine learning model training study. The device's algorithms are built into the hardware/software and are not "trained" on a dataset in the typical sense of AI/ML.

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

This information is not applicable or not provided as it's not a machine learning model training study.

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The GSI Novus is intended to be used for the measurement and automated analysis of auditory evoked responses (auditory brainstem responses, ABR) and/or otoacoustic emissions (distortion product, DPOAE and transient evoked, TEOAE). These measures are useful in the screening evaluation, documentation and diagnosis of auditory and hearing related disorders. The auditory evoked response (ABR) measurement is intended for newborns and infants up to 6 months of age. The otoacoustic emissions (DPOAE and/or TEOAE) measurement is intended for use in patients of all ages.

The GSI Novus is intended to be used by a healthcare professional such as an ENT doctor, nurse or audiologist or by a trained technician under the supervision of a professional. The device is intended to be used in a hospital, clinic, or other facility with a suitable quiet testing environment.

The device is audiometric equipment used for testing of inner ear and auditory brainstem abnormalities.

Novus features a touch-screen display and user-friendly software in a compact hardware design. Novus can be purchased with various licenses allowing you to perform different hearing screening tests.

Novus uses auditory brainstem response (ABR) technology to screen patients for hearing loss. A modified click stimulus, the CE-Chirp", of 35 dB nHL is delivered into the patient's ear while electrodes placed on the patient's head measure EEG activity.

The EEG is processed and analyzed automatically using the Novus's response detection algorithm. When a response is detected, the screening is stopped automatically and a Pass result is assigned to the test ear. When no response is detected after 3 minutes of EEG activity has been processed, a Refer result is assigned.

Auditory brainstem response (ABR) test produces a short acoustic stimulus and measures via transcutaneous electrodes the auditory evoked potentials from the inner ear, the auditory nerve and the brainstem.

Distortion product otoacoustic emissions (DPOAE) technology uses pairs of pure tones presented in sequence to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal.

Transient otoacoustic emissions (TEOAE) technology uses a click stimulus to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal. The response can be divided into frequency bands for assessment.

The Novus consists of a handheld unit that utilizes a touchscreen display and a rechargeable battery. A simple cradle is included to support charging of the device's battery. The device supports Bluetooth® communication with a label printer for the purpose of printing screening results.

This document does not contain an acceptance criteria table or a study proving the device meets specific acceptance criteria in the format requested. The document is a 510(k) premarket notification letter from the FDA to Grason-Stadler Inc. for their GSI Novus device. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed clinical trial results or specific performance metrics against pre-defined acceptance criteria.

However, based on the provided text, I can extract information related to the device's intended use, general performance claims, and the type of non-clinical testing performed to support its safety and effectiveness.

Here's an attempt to answer your questions based only on the provided text, noting where information is explicitly not present:

Acceptance Criteria and Device Performance Study for GSI Novus (K172403)

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

The document does not provide a table of explicit acceptance criteria with corresponding device performance metrics. Instead, it asserts that the GSI Novus meets performance specifications by complying with international standards and through non-clinical design verification and validation. The "reported device performance" is primarily qualitative, stating that the device is "safe and effective" and that its performance characteristics are comparable to predicate devices.

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

The document explicitly states: "No clinical tests were performed" and "Summary of Clinical Testing: Not applicable. Not required to establish substantial equivalence." Therefore, there is no test set sample size, data provenance, or information on retrospective/prospective studies from clinical testing. The "data collection" mentioned in Phase 2 refers to data collected during non-clinical verification and validation activities.

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)

Since no clinical tests were performed and no "test set" in the context of human data was used to establish ground truth for clinical performance, this information is not applicable and not provided.

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

Not applicable, as no clinical test set was used for ground truth establishment.

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 document states "No clinical tests were performed." Furthermore, the GSI Novus is described as an auditory testing device with an automatic response detection algorithm ("Novus's response detection algorithm"), implying it functions as a standalone diagnostic aid rather than an AI assistance tool for human "readers" (in the typical sense of image interpretation).

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

Yes, the device relies on an automated analysis algorithm. The description mentions:

• "The EEG is processed and analyzed automatically using the Novus's response detection algorithm."
• "When a response is detected, the screening is stopped automatically and a Pass result is assigned to the test ear. When no response is detected after 3 minutes of EEG activity has been processed, a Refer result is assigned."
• "The detailed information about the validation and verification of PASS/REFER algorithms for the OAE and ABR modules is provided in the GSI Novus Manual, e.g., PASS/REFER Criteria, Sensitivity and Specificity etc."

This indicates that a standalone algorithm performance was assessed for the automated PASS/REFER results during the non-clinical design verification and validation activities, although specific performance metrics (like sensitivity, specificity) are referenced as being in the manual but not provided in this document.

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

For the non-clinical verification and validation of the "PASS/REFER algorithms," the "ground truth" would have been established by comparing the algorithm's output to expected or reference values derived from recognized audiological principles and potentially a "gold standard" reference measurement or simulation. The document mentions "Phase 3 then went into the algorithm descriptions for each TEOAE, DPOAE and ABRIS measurements modes," implying that the ground truth for validating the algorithms themselves would be based on established audiological standards and the device's ability to accurately detect "responses" or "no responses" against these standards. Specifics of how this "ground truth" was established (e.g., against a known simulated signal, against a predicate device's output, or against expert analysis of raw data) are not detailed here.

8. The sample size for the training set

The document does not mention a "training set" or "training data" in the context of machine learning, nor does it specify any sample size for such a set. Given the context of a 510(k) for an audiometer with an automated algorithm, it's possible the algorithm logic was developed based on established audiological principles and signal processing, rather than a large-scale data training approach commonly associated with AI/ML.

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

Not applicable, as no training set is described or referenced in the document.

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The Grason-Stadler Inc. model GSI 70 AudioPath™ Hearing Screener is similar to and predicated upon the Grason-Stadler Inc. model GSI 60 Otoacoustic Emissions/Screening Audiometer, the GSI 37 Auto Tymp Middle Ear Analyzer, and the GSI 17 Pure Tone Screening Audiometer. The purpose of this device is to detect as well as track hearing loss and abnormal middle ear conditions in all ages of patients (from premature infants through adults). The instrument has combined a battery of testing capabilities such as Otoacoustic Emission Screening, Tympanometry, and Pure Tone Audiometry within one hand held instrument. The device is intended to be used by trained personnel within a medical or school environment. This device is not intended for use in prescribing or fitting assistive listening devices such as hearing aids, cochlear implants or wireless microphones, or to diagnose the causes of detected hearing losses.

The Grason-Stadler Inc. model GSI 70 AudioPath™ Screener is similar to and predicated upon the Grason-Stadler Inc. model GSI 60 Otoacoustic Emissions/Screening Audiometer, the GSI 37 Auto Tymp Middle Ear Analyzer, and the GSI 17 Pure Tone Screening Audiometer. The purpose of this device is to detect as well as track hearing loss and abnormal middle ear conditions in all ages of patients (From premature infants through adults age). The instrument has a battery of testing capabilities such as Otoacoustic Emission Screening, Tympanometry, and Pure Tone Audiometry. The device is intended to be used by trained personnel in a medical or school environment. This device is not intended for use in prescribing or fitting assisstive listening devices such as hearing aids, cochlea implants or wireless microphones.

This 510(k) summary does not contain a typical "study" that would demonstrate the device meets specific performance acceptance criteria in a quantitative sense as might be expected for an AI/ML device. Instead, it argues for substantial equivalence primarily based on technological characteristics and safety.

The document does not provide a dedicated study with quantitative acceptance criteria and results for the GSI 70 AudioPath™ Screener's effectiveness in detecting and tracking hearing loss. Instead, it asserts its effectiveness by stating it is "equivalent or better in effectiveness" than its predicate devices, which are individual audiometric products.

Here's a breakdown of the requested information based on the provided text, highlighting the absence of some details for this particular submission:

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

Since this is a 510(k) for a medical device that combines existing technologies rather than introducing a new diagnostic AI/ML algorithm, the acceptance criteria are focused on safety and functional equivalence to predicate devices, rather than performance metrics like sensitivity or specificity for hearing loss detection.

• EMI EN55011 (Group 1 Class B requirements for medical equipment, conducted and radiated emissions).
• IEC801-2 (ESD Susceptibility).
• IEC801-3 (Radiated Electromagnetic Field Susceptibility).
• IEC801-4 (Conducted Susceptibility to Line Transients). |
  | CE Mark Compliance | Conforms with provisions of European Council Directive 93/42/EEC concerning medical devices. |
  | Functional Equivalence (Audiometry) | "Tones are presented by a miniature speaker within the probe which if perceived is indicated by the patient using a response switch. Tone quality and frequency specified per ANSI S3.6." (Functionally equivalent to GSI 17 which uses a speaker headset). |
  | Functional Equivalence (Tympanometry) | "Same as GSI 37" (Tones presented during pressurization of the ear by a miniature pump; response recorded by a microphone; tone quality and frequency controlled by ANSI S3.39). |
  | Functional Equivalence (OAE Probe Design & DSP Software) | "Same as GSI 60" (Two speakers and a microphone present and record response from cochlea; uses GSI 60 DSP Software). |
  | Overall Effectiveness | "Equivalent or better in effectiveness for the detection and tracking of hearing loss and abnormal middle ear conditions in all ages of patients (from premature infants through adults)" compared to the combined individual predicate devices (GSI 60, GSI 37, GSI 17). This is an assertion of equivalence rather than a quantitative performance metric from a study. |

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: The document does not describe a clinical study with a "test set" in the context of diagnostic performance (e.g., for sensitivity/specificity) for the GSI 70 AudioPath™ Screener itself. The submission relies on the established performance and safety of its predicate devices and the technical comparison to demonstrate substantial equivalence.

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 / Not Provided: No such ground truth establishment by experts for a specific test set is mentioned for the GSI 70 AudioPath™ Screener in this summary.

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

• Not Applicable / Not Provided: No adjudication method is described as there's no clinical performance study presented that would require it.

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: No MRMC study was conducted or reported. This device is not an AI-assisted diagnostic tool for interpretation by human readers. It's a screening instrument.

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

• Yes, implicitly, but not as an AI/ML algorithm: The device itself performs the audiometry, tympanometry, and OAE screenings standalone. Its "performance" is based on its ability to generate tones, measure responses, and process signals according to established audiological standards (ANSI S3.6, ANSI S3.39 for the respective functions) which are derived from the predicate devices. There isn't an "algorithm" in the modern AI/ML sense being evaluated independently, but rather the integrated functionality of the hardware and embedded software. The provided text doesn't offer quantitative standalone performance metrics like sensitivity/specificity for hearing loss detection from a new study for the combined device.

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

• Not Applicable / Not Provided for this specific device: For the predicate devices, the "ground truth" would implicitly be the established audiological standards for detecting hearing loss and middle ear conditions. The current submission for the GSI 70 relies on the equivalence to these predicate devices rather than generating new ground truth data to validate new performance claims.

8. The sample size for the training set

• Not Applicable / Not Provided: There is no mention of a "training set" as this device does not utilize a machine learning model that would require one.

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

• Not Applicable / Not Provided: As there is no training set mentioned, this information is not relevant.

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The Grason-Stadler Inc. model GSI SA60 Otoacoustic Emissions/Screening Audiometer is similar to and predicated upon the Grason-Stadler Inc. model GSI 60 Otoacoustic Emissions/Screening Audiometer. The GSI SA60 is to be used as part of an audiometric test battery. The purpose of this device is to assess the status of cochlear function by presenting an acoustic stimulus (i.e. the primary tone pair) to evoke an otoacoustic emission (i.e. the distortion product) which is measured. The GSI 60 and the GSI SA60 utilize a probe containing a microphone and two (2) independent speakers (one for each primary tone) to present the acoustic stimulus and measure for the presence of an evoked otoacoustic emission.

The Grason-Stadler Inc. model GSI SA60 Otoacoustic Emissions/Screening Audiometer is similar to and predicated upon the Grason-Stadler Inc. model GS1 60 Otoacoustic Emissions/Screening Audiometer. The GSI SA60 is to be used as part of an audiometric test battery. The purpose of this device is to assess the status of cochlear function by presenting an acoustic stimulus (i.e. the primary tone pair) to evoke an otoacoustic emission (i.e. the distortion product) which is measured. The GSI 60 and the GSI SA60 utilize a probe containing a microphone and two (2) independent speakers (one for each primary tone) to present the acoustic stimulus and measure for the presence of an evoked otoacoustic emission.

Here's an analysis of the provided text regarding the GSI SA60 DPOAE System, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain detailed information about a comprehensive clinical study to prove the device meets specific performance acceptance criteria in the way a clinical trial report would. Instead, it relies on the predicate device's established effectiveness and similarities between the new and predicate device.

Acceptance Criteria and Reported Device Performance

• IEC 601-1 (medical electrical equipment)
• UL2601 (medical electrical equipment)
• CSA 601-1-M90 (medical electrical equipment)
• Preliminary design review with competent test laboratory indicates design will meet requirements for IEC 601-1 class 1, type B medical instrument. |
  | Information Technology Equipment Safety Standards (for companion notebook computer): | Specified to meet:
• IEC 950
• UL1950
• CSA 950
• CE mark |
  | Electromagnetic Compatibility (EMC) Standards: | Certified to:
• EMI EN55011 (Group 1 Class B requirements for medical equipment, conducted and radiated emissions)
• IEC801-2 (ESD Susceptibility)
• IEC801-3 (Radiated Electromagnetic Field Susceptibility)
• IEC801-4 (Conducted Susceptibility to Line Transients)
• CE Mark (Conforms with provisions of 89/336/EEC Electromagnetic Compatibility Directive) |
  | Effectiveness (Cochlear Function Assessment): | Equivalent or better in effectiveness compared to the predicate device (Grason-Stadler Inc. model GSI 60 DPOAE system).
  Rationale: Operates in the same manner as the GSI 60, with the primary difference being enhanced portability due to direct compatibility with a notebook computer without a docking station. |
  | Intended Use: | To be used as part of an audiometric test battery to assess the status of cochlear function by presenting an acoustic stimulus to evoke and measure an otoacoustic emission. |

Study Details (Based on the 510(k) Summary)

Given that this is a 510(k) submission, the "study" referred to is primarily the comparison to the predicate device and the demonstration of equivalent performance and safety characteristics. A traditional "study" in the sense of a large-scale clinical trial with acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity) is not described.

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

   • Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of a performance study. The evaluation appears to be based on engineering testing for safety and EMC, and a functional comparison demonstrating operational equivalence to the predicate device.
   • Data Provenance: Not specified.

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

   • Not applicable for the type of evaluation described. No human expert "ground truth" was established for a clinical performance test set. The effectiveness claim rests on the established performance of the predicate device.

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

   • Not applicable.

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 study was done. This device is an Otoacoustic Emissions/Screening Audiometer; it directly measures physiological responses, not an AI-interpreted image or signal that requires human reader adjudication.

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

   • The device itself is a measurement instrument. Its performance is inherent to its design and how accurately it can acquire and process the otoacoustic emissions. The "effectiveness" is linked to its ability to perform this measurement, which is directly compared to the predicate device's ability to do the same. So, in a sense, its standalone functional equivalency to the predicate device was evaluated.

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

   • The "ground truth" for the effectiveness claim is the established clinical performance and safety of the predicate device (GSI 60 DPOAE system). The new device is stated to operate "in the same manner" and is thus "equivalent or better in effectiveness." For safety and EMC, the ground truth is adherence to international and national standards.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense.

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

   • Not applicable.

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