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The intended use of the Smart USBLite device system is for the recording of auditory evoked potential, otoacoustic emissions, & auditory steady-state evoked potential data. The product is intended to be used as a diagnostic aid in auditory and hearing related disorders, as an objective measure of cochlear function, and as an adjunctive tool in the estimation of behavioral hearing thresholds on patients of all ages.

Smart USBLite is an auditory evoked potential and otoacoustic emission system that is capable of recording and measuring auditory evoked potential, otoacoustic emission, and auditory steady-state evoked potential data. The Smart USBLite system combines the following FDA 510(k) previously cleared devices into a repackaged, smaller-sized, single integrated unit: SmartEP (K904926), SmartScreener (K925648), SmartOAE (K964426), SmartTrOAE (K023859), SmartEP-ASSR (K031051), and Opti-Amp DC-Powered (K052060).

The Smart USBLite is an auditory evoked potential and otoacoustic emission system that records and measures auditory evoked potential, otoacoustic emission, and auditory steady-state evoked potential data. It combines several previously cleared predicate devices into a repackaged, smaller-sized, single integrated unit. The device is intended as a diagnostic aid for auditory and hearing-related disorders, an objective measure of cochlear function, and an adjunctive tool for estimating behavioral hearing thresholds across all patient ages.

The study presented does not include specific acceptance criteria with quantifiable metrics for performance, nor does it detail a standalone study proving the device meets particular performance thresholds. Instead, the submission relies on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and specifications. The "acceptance criteria" appear to be satisfied by the device's adherence to the same intended use, methodologies, and performance specifications as the established predicate devices, coupled with certification for electrical safety and electromagnetic compatibility.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit quantifiable acceptance criteria with corresponding reported performance metrics are not provided in the document. The submission focuses on claiming substantial equivalence to predicate devices. The "performance" is implicitly accepted if the new device's specifications are the same as the predicate devices or within acceptable limits for a repackaged unit.

However, the closest representation of "acceptance criteria" and "reported device performance" can be extrapolated from the "Specifications" table by comparing the "Predicate Devices" column to the "Device Under Current 510(k) Review (Smart USBLite)" column. The acceptance criterion for each parameter is implicitly the specification of the predicate device, and the reported performance is the "Same" or adjusted value for the Smart USBLite.

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

The document does not describe a "test set" in the context of clinical data or patient samples. The study is a technical comparison for substantial equivalence. The "test" in this context refers to engineering verification and validation activities to ensure the new device meets its design specifications and electrical safety standards; these do not typically involve patient data.

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. No "test set" involving expert-established ground truth for clinical performance is described. The comparison is based on technical specifications and adherence to safety standards.

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

Not applicable. There is no clinical test set requiring adjudication of ground truth.

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. This device is a measurement system, not an AI-assisted diagnostic tool for human readers, and no MRMC study is mentioned.

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

This is not an algorithm-only device. It is a hardware and software system for audiological measurements. The "study" for this submission is a declaration of conformance to design controls and safety standards, and a comparison of technical specifications to predicate devices. It states that "all verification and validation activities have been performed for the Smart USBLite device," and that "The results have demonstrated that all predetermined acceptance criteria have been met." However, no details of these specific verification and validation activities are provided in the summary beyond adherence to general standards (e.g., EN60601-1).

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

Not applicable in the clinical sense. The "ground truth" for the device's technical specifications and safety would be established by engineering standards, testing protocols, and comparison to the predicate devices' established performance. For example, the noise level specifications are a technical measurement, not a clinical "ground truth."

8. The sample size for the training set

Not applicable. This device is not an AI/ML device that requires a training set of data.

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

Not applicable. This device is not an AI/ML device that requires a training set.

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