(130 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety Standards: | Meets or designed to meet: |
- 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.
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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.
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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.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
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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.
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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.
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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.
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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.
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How the ground truth for the training set was established:
- Not applicable.
§ 874.3310 Hearing aid calibrator and analysis system.
(a)
Identification. A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.