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The SmartScreener-Plus2 device is indicated for use in the recording and automated analysis of human physiological data (auditory brainstem responses and/or otoacoustic emissions) necessary for the diagnosis of auditory and hearingrelated disorders. The device is especially indicated for use in the screening of infants to determine hearing loss.

Sites appropriate for use include the well-baby nursery, neonatal intensive care unit (NICU), mother's bedside, outpatient clinic, audiologist's office, or doctor's office. The device is simple to operate. It does not require special technical skills or interpretation of results by the device operator. Basic training with the device is sufficient to learn how to operate it.

The SmartScreener-Plus2 device can be used for patients of all ages, from children to adults, including infants and geriatric patients. It is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults.

The possible anatomical sites of contact are the patient's ear, ear canal, and/or external skin surrounding the ear (with the contact object being a sound delivery eartip, headphone cushion, or an acoustic ear coupler such as a circumaural ear cup, intra-aural ear bud, or supra-aural ear patch), the patient's head (with the contact object being a bone vibrator), and the patient's head, nape of the neck and shoulder (with the contact object being electrodes that are capable of measuring biopotentials).

The SmartScreener-Plus2 device is for prescription use.

The SmartScreener-Plus2 is a noninvasive device used to test for hearing and related neurological abnormalities. The device is especially indicated for use in the screening of infants to determine hearing loss.

The SmartScreener-Plus2 device records and detects auditory evoked potentials (AEPs) and otoacoustic emissions (OAEs) which are generated in response to a series of auditory stimuli delivered to the patient. AEPs are electrical signals produced by the patient's nourological activity and are picked up by electrodes attached to the patient's skin. The portion of the AEP that originates from the anatomical structures of the inner ear to the auditory brainstem is commonly called the Auditory Brainstem Response (ABR). Otoacoustic emissions are acoustic signals produced by the patient's inner ear and are picked up by a sensitive microphone located in an OAE probe. The SmartScreener-Plus2 device is capable of recording Transient Evoked OAEs (TEOAEs or TrOAEs), and Distortion Product OAEs (DPOAEs)

The SmartScreener-Plus2 uses advanced signal processing technology to separate AEPs and OAEs from background noise and other physiological activity. The device uses proven statistical algorithms to automatically determine if there is an AEP or OAE response present to the auditory stimuli delivered to the patient. A user, with device administrator approved password security clearance, is able to set the output level of the stimulus. AEP stimulus levels between 30 to 40 dB nHL, and TEOAE stimulus level of 85 dB SPL, and DPOAE stimulus levels of 65 and 55 dB SPL are commonly used for newborn hearing screening applications.

The SmartScreen-Plus2 device is simple to operate. It does not require any special technical skills or interpretation of results. Basic training is sufficient to learn how to use the device.

Here's an analysis of the provided text regarding the SmartScreener-Plus2 device, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary for a medical device submitted to the FDA in 2009. These summaries are designed to establish substantial equivalence to predicate devices, not necessarily to detail comprehensive clinical trial results in the same way a new drug application or a more recent medical device submission might. Therefore, some of the requested information, particularly regarding detailed study methodologies, sample sizes, and expert qualifications for ground truth establishment, is not explicitly present in this type of document.

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in terms of sensitivity, specificity, accuracy, or other performance metrics. Instead, "acceptance" is framed around demonstrating substantial equivalence to existing, legally marketed predicate devices. The core acceptance criterion for this 510(k) submission is that the SmartScreener-Plus2 device is as safe and effective as its predicate devices for its intended use.

The "reported device performance" is largely presented through a comparative table with predicate devices, highlighting similarities in design, materials, indications for use, and compliance with safety standards.

• Biocompatible (materials are completely biocompatible).
• No chemicals involved.
• No mechanical parts in contact with patient. |
  | Effectiveness (Functional Equivalence) | - Records and detects Auditory Evoked Potentials (AEPs) and Otoacoustic Emissions (OAEs) for diagnosis of auditory/hearing-related disorders and infant hearing screening.
• Uses advanced signal processing and proven statistical algorithms for automated response determination.
• Operates simply, without special technical skills or result interpretation.
• Stimulus levels (AEP: 30-40 dB nHL, TEOAE: 85 dB SPL, DPOAE: 65 and 55 dB SPL) are commonly used for newborn screening. |
  | Substantial Equivalence to Predicate Devices | - Target Population: Same (all ages).
• Where Used: Same (clinical setting).
• Anatomical Sites: Same (scalp, ear, and other skin sites).
• Sterility: Same (none required).
• Biocompatibility: Same (completely biocompatible).
• Design: Same (main hardware unit connected to patient cables/transducers and portable computer with software).
• Components/Materials: Same (main hardware unit, transducers, acoustic couplers, electrodes, cables, computer, printer, cart).
• Human Factors: Same (simple, easy-to-follow instructions and software user interface).
• Standards: Same (none known explicitly for performance, but electrical/thermal safety standards met).
• Energy Used/Delivered: Same (stimulation of auditory system).
• Chemical Safety: Same (no chemicals).
• Mechanical Safety: Same (no mechanical parts in contact with patient).
• Thermal Safety: Same (device not thermal in nature). |

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 document states: "The SmartScreener-Plus2 device specifications were verified and validated."
   • However, no specific details about a clinical test set sample size, data provenance, or whether the study was retrospective or prospective are provided in this 510(k) summary. This type of detail is often summarized or cross-referenced to internal validation reports, which are not publicly disclosed in the 510(k) summary.

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):

   • Not specified. The document focuses on the device's technical specifications and substantial equivalence, not a detailed clinical outcomes study involving expert interpretation for ground truth.

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

   • Not specified. Since no explicit clinical test set with human ground truth establishment is detailed, no adjudication method is mentioned.

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 comparative effectiveness study was not done or described. This device is an automated screening tool, not an AI-assisted interpretation tool for human readers in the traditional sense. It automates the analysis of physiological data (AEPs and OAEs) directly, with a "pass/refer" outcome, meaning it eliminates the need for complex interpretation by the device operator. The text explicitly states: "It does not require any special technical skills or interpretation of results."

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

   • Yes, implicitly. The device is designed for standalone automated analysis. The "Performance Testing" section states, "The SmartScreener-Plus2 device specifications were verified and validated." While specifics are absent, this verification and validation would inherently test the algorithm's performance in automatically determining the presence or absence of AEP or OAE responses. The device is marketed as not requiring "interpretation of results by the device operator," indicating its standalone analytical function.

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

   • The document mentions the device uses "proven statistical algorithms to automatically determine if there is an AEP or OAE response present." For this type of device, ground truth would typically be established by:
     • Physiological standards/biomarkers: The presence or absence of a physiological AEP or OAE response based on established audiology and neurophysiology principles, often confirmed by expert audiologists or neurophysiologists using gold-standard diagnostic equipment.
     • Clinical diagnosis/outcomes: Correlation of screening results with definitive diagnostic tests (e.g., full audiometry, follow-up examinations) to determine actual hearing status.
   • The specific method for establishing ground truth for validation is not detailed in this summary.

7. The sample size for the training set:

   • Not specified. This pertains to the internal development and calibration of the "advanced signal processing technology" and "proven statistical algorithms." The 510(k) summary does not include details on the training set for these algorithms.

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

   • Not specified. Similar to the training set size, the method for establishing ground truth for the training of the device's algorithms is not disclosed in this regulatory summary. It would typically involve large datasets of AEP and OAE recordings from individuals with known hearing status, often categorized by expert review or correlation with comprehensive diagnostic audiometric evaluations.

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