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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.

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

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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