(30 days)
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.
| Parameter | Acceptance Criteria (Predicate Device Specification) | Reported Device Performance (Smart USBLite) |
|---|---|---|
| Intended Use | Stimulate, record, & process auditory evoked potentials, auditory evoked potential screening, elicitation and measurement of otoacoustic emissions, and auditory steady-state evoked potentials. Diagnostic aid for auditory and hearing related disorders, objective measure of cochlear function, adjunctive tool for estimation of behavioral hearing thresholds. | Same |
| Indications for Use | Recording & analysis of physiological data for diagnosis of auditory/hearing-related disorders; determination of cochlear function. | Same |
| Target Population | All Ages | Same |
| Design | External box housing circuitry connected to personal computer via USB. | Same |
| Materials | Assorted electrical components, circuit boards, sound transducers, microphone, electrodes, disposable probe ear tips. | Same |
| Sterility | None required | Same |
| Biocompatibility | Completely Biocompatible | Same |
| Anatomical Site | Ear canal, arms, and head | Same |
| Energy Delivery | Stimulation of the ear with sound signals | Same |
| Where Used | Clinical Setting | Same |
| Safety | Meets EN 60601-1 | Same |
| Operating Temperature | 15°C to 40°C | Same |
| Storage Temperature | 5°C to 50°C | Same |
| Relative Humidity | 15% to 90% (at 40°C Non-Condensing) | Same |
| Atmospheric Pressure | None Specified | Same |
| Mode of Operation | Continuous | Same |
| Type of Protection | Class I (IEC 601) | Same |
| Degree of Protection | Type B (IEC 601) | Same |
| Protection Against Fluids | IPX0 - Ordinary Equipment (IEC 601) | Same |
| Degree of Mobility | Portable Equipment | Same |
| Vibration and Shock | N/A | Same |
| Expected Lifetime | 10 Years from date of manufacture | Same |
| Power Supply | External medical grade power supply (3 Outputs: +15V, -15V, +5V) OR Internal medical grade power supply (3 Outputs: +15V, -15V, +5V) | External medical grade power supply (1 Output: +5V (2A)) |
| Rated Input Current | 1.3 Amps or 2.0 Amps | 0.5 Amps |
| Rated Frequency | 50-60 Hz | Same |
| Rated Input Voltage | 100-240 VoltsAC | Same |
| Rated Max Input Power | 40 Watts | 10 Watts |
| Fuse Type | N/A (External Power Supply) or Time Lag Fuse (IEC 60127-2 compliant) | N/A (External Power Supply) |
| Fuse Rating | N/A (External Power Supply) or 1.6 Amps, 250 VoltsAC | N/A (External Power Supply) |
| Patient Isolation | 4000Vdc, 10 Mega Ohms | Same |
| A/D Resolution | 16 bit | Same |
| Artifact Rejection | Programmable | Same |
| Input Channels | SmartEP, SmartScreener, SmartEP-ASSR: 1-4 Channels; SmartOAE, SmartTrOAE: 1-2 Channels | Smart USBLite (EP, Screener, ASSR): 1 Channel; Smart USBLite (DPOAE, TrOAE): 1 Channel |
| Gain | SmartEP, SmartScreener, SmartEP-ASSR: Variable (30k-300k); SmartOAE: Fixed (100); SmartTrOAE: Fixed (100) | Smart USBLite (EP, Screener, ASSR): Fixed (100k); Smart USBLite (DPOAE): Same; Smart USBLite (TrOAE): Same |
| Lowpass Filter | SmartEP, SmartScreener: Variable (30-5000 Hz); SmartOAE: 100 kHz; SmartTrOAE: 5000 Hz; SmartEP-ASSR: Variable (30-5000 Hz) | Smart USBLite (EP, Screener): Fixed (1500 Hz); Smart USBLite (DPOAE): Same; Smart USBLite (TrOAE): Same; Smart USBLite (ASSR): Fixed (300 Hz) |
| Highpass Filter | SmartEP, SmartScreener, SmartEP-ASSR: Variable (1-500 Hz); SmartOAE: 200 Hz; SmartTrOAE: 450 Hz | Smart USBLite (EP, Screener, ASSR): Fixed (30 Hz); Smart USBLite (DPOAE): Same; Smart USBLite (TrOAE): Same |
| Filter Slope | SmartEP, SmartScreener, SmartEP-ASSR: 6 dB/octave; SmartTrOAE: 24 dB/octave | Smart USBLite (EP, Screener, ASSR): 12 dB/octave; Smart USBLite (TrOAE): Same |
| Notch Filter | 50/60Hz | Same |
| Noise Level | SmartEP, SmartScreener, SmartEP-ASSR: 0.33 μV RMS (1-3000 Hz), 0.12 μVpp for 1024 averaged sweeps; SmartOAE, SmartTrOAE: 40 μV RMS | Smart USBLite (EP, Screener, ASSR): 0.13 μV RMS (30-1500 Hz), 0.1 μVpp for 1024 averaged sweeps; Smart USBLite (DPOAE, TrOAE): Same |
| Input Impedance | Opti-Amp DC Powered: 5 MegaOhms | Same |
| CMR Ratio | Opti-Amp DC Powered: 117 dB at 60Hz, 110 dB at 1kHz | Same |
| Auditory Stimuli Types | Clicks, Pure Tones, Multifrequency Stimuli, Tone Bursts | Same |
| Duration | 25-5000 µsec or Continuous | Same |
| Envelopes | Linear, Blackman, Gaussian, Hanning, Rectangular, Triangular, Trapezoidal, Exact Blackman, Cosine, Cosine Squared, Cosine Cubed | Same |
| Intensity | 0-125 dB SPL (EP/Screener), 55-80 dB SPL (OAE), 60-90 dB SPL (TrOAE), 0-80 dB SPL (ASSR) | Same |
| Repetition Rate | 1-100 Hz or Continuous | Same |
| Test Frequencies | 500-16,000 Hz | Same |
| Presentation | Monaural or Binaural (EP/Screener/ASSR); Monaural (OAE/TrOAE) | Same |
| Masking | White Noise Programmable | Same |
| Transducers | Insert Earphones, Bone Vibrator, Headphones, Sound Field, Ear Probe | Insert Earphones, Headphones, Ear Probe |
| Analysis Window | Variable (up to 2.5 msec) or Fixed (25.6 msec, 102.4 msec, 2.5-22.5 msec) | Same |
| Artifact Rejection Threshold | User Selectable or Automated/Fixed | Same |
| Measured Values | Response Level, Noise Level, Signal to Noise Ratio, Response Latency, Frequency | Same |
| Computer Type | Personal Computer | Same |
| Operating System | Microsoft Windows 2000 or XP | Same |
| Interface Connection | USB (Universal Serial Bus) | Same |
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.
§ 882.1900 Evoked response auditory stimulator.
(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).