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SmartEP is an evoked response testing and diagnostic device, that is capable of eliciting, acquiring, and measuring auditory, somatosensory, visual, and vestibular evoked myogenic potential data, as well as providing nerve stimulation and monitoring.

The intended use of the SmartEP device is to objectively record evoked responses from patients of all ages upon the presentation of sensory stimuli. The product is indicated for use as a diagnostic aid and adjunctive tool in sensory related disorders (i.e., auditory, somatosensory, visual, and vestibular) and in surgical procedures for inter-operative nerve monitoring.

The SmartEP system is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's, EP technologist's, surgeon's, or physician's office, operating room, or other appropriate setting.

The SmartEP device records evoked potentials by using delivery of auditory, somatosensory, visual, or nerve sensory stimuli and using signal averaging techniques to extract the evoked potential from the uncorrelated electrical activity of the brain (electroencephalography or EEG) and muscles (electromyography or EMG). The device has options for Auditory Evoked Potentials (AEPs), Somatosensory Evoked Potentials (SEPs), Visual Evoked Potentials (VEPs), Vestibular Evoked Myogenic Potentials (VEMPs), and nerve stimulation and monitoring. The SEP, VEP, and nerve stimulation and monitoring functionality. operating principles, and intended uses are the same as on the predicate SmartEP device. On the SmartEP device with VEMP modality, the AEP modality has been modified to facilitate VEMP recording and analysis with optional biofeedback. The VEMP features added are comparable to those found in the ICS Chartr 200 predicate device. The VEMP modality does not provide a diagnosis. Diagnosis is made by a medical professional.

The SmartEP device is a Windows OS personal computer (PC) based system composed of software modules, an external main hardware unit, an optional biofeedback box, and peripheral stimulus delivery and recording components and accessories. The biofeedback box, stimulation, and recording devices are connected to the main hardware unit which is connected to the PC via a Universal Serial Bus cable. Software on the computer is used for the user interface to facilitate test parameter specification and for data display and analysis purposes.

The SmartEP with VEMP device has an optional biofeedback hardware accessory (VEMP feedback box) or uses a computer monitor for indicating EMG levels during VEMP testing. The VEMP feedback box has LEDs that indicate that the measured EMG level is either below the minimum value set by the user (Low - orange LED), or is between the minimum and maximum values set by the user (Satisfactory green LED), or is above the maximum value as set by the user (High – orange LED). The computer monitor displays a bar graph and pictorial face that indicates that the measured EMG level is either below the minimum value set by the user (Low - small pink bar and sad face), or is between the minimum and maximum values set by the user (Satisfactory - medium green bar and happy face), or is above the maximum value as set by the user (High - large pink bar and sad face). Recording of VEMPs can be set to occur when the EMG level is within the user programmed satisfactory range.

The provided document describes the substantial equivalence determination for the SmartEP device, focusing on its Vestibular Evoked Myogenic Potential (VEMP) testing modality compared to a predicate device. The information primarily addresses performance testing related to VEMP repeatability and reproducibility, rather than a typical AI model's acceptance criteria based on sensitivity/specificity/accuracy or an MRMC study.

Therefore, many of the requested fields cannot be directly answered as they pertain to AI/machine learning evaluation paradigms which are not the subject of this 510(k) summary. However, I will answer all applicable points based on the provided text.

Acceptance Criteria and Device Performance (VEMP Modality Only)

The document does not explicitly state "acceptance criteria" in terms of pre-defined numerical thresholds for performance metrics like sensitivity, specificity, or accuracy, as this is not an AI/diagnostic algorithm in the conventional sense. Instead, the performance is demonstrated through comparisons of repeatability and reproducibility metrics (specifically, correlation values of VEMP waveforms) to a legally marketed predicate device. The general acceptance criterion is demonstrating that the SmartEP device's VEMP performance is "similar or higher" than the predicate device.

Table of Performance for VEMP Waveform Correlation (SmartEP vs. Predicate)

Reported Device Performance:
The document states: "The mean correlation values for both cVEMP and oVEMP recordings obtained the SmartEP with VEMP device for both test-retest repeatability and reproducibility are similar or higher than those reported for the ICS Chartr EP 200 with VEMP device." This generally indicates that the SmartEP device met the implicit acceptance criterion of performing comparably or better than the predicate device for VEMP testing.

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Study 1 (P1 latency from cVEMP): 215 normal subjects.
   • Study 2 (cVEMP and oVEMP waveforms): 10 adult normal subjects.
   • Data Provenance: The document does not explicitly state the country of origin. It describes the studies as "performed with using the SmartEP with VEMP device," suggesting they were conducted by or for the manufacturer. The studies appear to be prospective to evaluate the device's performance.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This device is an evoked potential system used to record physiological responses, not an AI diagnostic algorithm that produces an interpretation requiring expert ground truth for classification/detection tasks. The "ground truth" here is the physiological response itself, as measured by the device. Therefore, this question is not directly applicable to the type of device and study described.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable, as the "ground truth" is the recorded physiological signal, not an interpretation requiring human adjudication.

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. This is a medical device for measuring physiological responses, not an AI-assisted diagnostic tool that humans would use to interpret images or signals. The study focuses on the device's measurement consistency.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This device is a standalone measurement system. The "performance testing data" section describes the device's inherent ability to record VEMP waveforms repeatably and reproducibly, independent of a specific human interpretation loop for a diagnostic task.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The "ground truth" is the physiological VEMP response itself, measured by the device. The studies characterize the device's ability to consistently and accurately capture these responses (repeatability and reproducibility). There isn't a "diagnostic ground truth" in the sense of a disease state confirmed by a gold standard like pathology, as the device is for recording diagnostic data, not making the diagnosis itself. It is stated that "The VEMP modality does not provide a diagnosis. Diagnosis is made by a medical professional."

7. The sample size for the training set:
   Not applicable. This is not an AI/machine learning device that requires a "training set" to learn from data. It's a measurement instrument.

8. How the ground truth for the training set was established:
   Not applicable, as there is no "training set."

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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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The Smart Coupler is a passive, ear-coupling, sound-delivery device accessory intended for short-term, non-invasive use to support auditory evaluation studies (including use with audiometers, auditory evoked potential and otoacoustic emissions devices) on patients of all ages. The Smart Coupler is a biocompatible, non-sterile, single patient use, disposable device.

The Smart Coupler is a non-invasive, cutaneous, passive, sound-delivery device accessory that provides a coupling interface between the patient's ear and the auditory stimulator used during audiometric testing. The device is a biocompatible, non-sterile, single patient use, disposable device.

The anatomical sites of contact for the Smart Coupler are the external skin surrounding the ear (circumaural model), the external skin of the outer ear (supra-aural model), or the external skin of the ear canal (intra-aural model) with the contact object being a thin layer of medical-grade, biocompatible adhesive hydrogel, used for adhering the Smart Coupler device to the patient.

Here's an analysis of the provided 510(k) summary for the "Smart Coupler" device, focusing on acceptance criteria and the study to prove it, as requested.

It's important to note that the provided document is a 510(k) summary for a device accessory (an acoustic coupler), not a complex AI-powered diagnostic device. Therefore, many of the requested elements like "multi reader multi case (MRMC) comparative effectiveness study," "standalone algorithm performance," "number of experts," and detailed "training set" information are not applicable or described in the context of this type of submission. The focus for this device is on safety, biocompatibility, and functional equivalence to a predicate device, rather than diagnostic accuracy.

Acceptance Criteria and Device Performance for Smart Coupler (K073384)

The "Smart Coupler" is a passive device accessory. The "acceptance criteria" for a device like this primarily revolve around demonstrating substantial equivalence to a predicate device in terms of safety and effectiveness. This is achieved by showing similar performance characteristics and demonstrating that any new features (like an additional model or specific materials) do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The submission primarily refers to "performance testing of prototype devices to specifications."

• Test Sample Size: Not explicitly stated as a number of devices or subjects. The context suggests that the testing was primarily focused on material properties (biocompatibility) and functional validation, not clinical trials with a defined "test set" sample size in the traditional sense for diagnostic accuracy.
• Data Provenance: Not specified regarding country of origin or retrospective/prospective. Given the nature of the device (acoustic coupler), it is highly likely that the biocompatibility testing was conducted in a laboratory setting. Functional testing would have involved prototypes.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable in the context of this device. The "Smart Coupler" is an accessory; its "ground truth" is its ability to meet material safety standards and functionally couple an auditory stimulator. This is assessed via technical standards (ISO 10993) and engineering verification, not by expert interpretation of output.

4. Adjudication Method for the Test Set

• Not applicable. There is no "adjudication" necessary for this type of device's performance assessment.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, Effect Size

• No. An MRMC study is relevant for AI-powered diagnostic tools where human readers are interpreting images or data. This device is a passive accessory and does not involve human interpretation of its output in a diagnostic capacity.

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

• No. This device does not contain an algorithm. It is a passive, mechanical accessory.

7. The Type of Ground Truth Used

The "ground truth" for this device relates to its fundamental safety and functional attributes:

• Biocompatibility: Established by adherence to ISO 10993 standards (e.g., cell viability assays for cytotoxicity, visual assessment for skin irritation/sensitization).
• Functional Performance: Established by engineering specifications and physical testing to confirm its ability to serve as a coupling interface for auditory stimulators, consistent with the intended use and predicate device. This would likely involve acoustic measurements and fit testing.

8. The Sample Size for the Training Set

• Not applicable. This device does not use an algorithm or machine learning, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

• Not applicable. As there is no training set, there is no ground truth establishment for one.

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SmartEP is an evoked response testing and diagnostic device, that is capable of eliciting, acquiring, and measuring auditory, somatosensory, and visual evoked potential data, as well as providing nerve stimulation and monitoring.

The intended use of the SmartEP device is to objectively record evoked responses from patients of all ages upon the presentation of sensory stimuli. The product is indicated for use as a diagnostic aid and adjunctive tool in sensory related disorders (i.e., auditory, somatosensory, visual) and in surgical procedures for inter-operative nerve monitoring.

SmartEP is an evoked response system that is capable of eliciting, acquiring, and measuring auditory, somatosensory, and visual evoked potential data, as well as providing nerve stimulation/monitoring.
The feature modifications described in this 510(k) are to incorporate additional/expanded indications to the SmartEP device for somatosensory evoked potential, visual evoked potential, and nerve stimulation testing to the previously FDA cleared indications for auditory evoked potential testing. Specifically, additional hardware and software features have been added to the original SmartEP device system to objectively acquire somatosensory/visual evoked potentials upon the presentation of a somatosensory/visual stimulus, and to provide nerve stimulation/monitoring functionality.

The provided text describes a 510(k) premarket notification for the SmartEP device, seeking expanded indications for Somatosensory Evoked Potential (SEP), Visual Evoked Potential (VEP), and Nerve Stimulation/Monitoring. The core of the information regarding acceptance criteria and supporting studies is based on demonstrating substantial equivalence to predicate devices.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the equivalence of key specifications and intended use to legally marketed predicate devices. The "reported device performance" is a demonstration that the SmartEP's characteristics meet or are comparable to those of the predicate devices. The tables provided (Table E-1 and Table E-2) serve as the primary evidence for this.

Table 1: Acceptance Criteria and Reported Device Performance for SEP & VEP (Summarized from Table E-1)

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The IHS TM-Wick Electrode is intended for non-invasive use in acquiring electrocochleography (ECochG) data on patients of all ages, for the purpose of monitoring and recording in the diagnosis of cochlear and auditory disorders. The electrodes are biocompatible, non-sterile, single patient use, disposable devices.

IHS TM-Wick Electrodes are non-invasive, cutaneous devices used in the acquisition of electrocochleography (ECochG) signals from the tympanic membrane for the purpose of monitoring and recording. These extra-tympanic electrodes are inserted into the ear canal to make contact with the tympanic membrane for acquiring the ECochG data. The electrodes are biocompatible, non-sterile, single patient use, disposable devices.

The IHS TM-Wick Electrode is a non-invasive, TM ECochG electrode which is biocompatible, prewired, non-sterile, for single patient use, and disposable. The electrode features a fine Silver/Silver Chloride (Ag/AgCl) wire attached to a soft cotton tip (i.e., wick) pre-soaked in a highly conductive, low impedance electrode gel/saline solution, which is hypoallergenic, non-irritating, bacteriostatic, water soluble, non-staining, and non-gritty. The conductive gel reduces the impedance of the contact between the electrode surface and the skin. The Ag/AgCl wire is encased inside of a thin, soft, flexible silicone tubing which is resilient, stretchable, non-corrosive, and inert. This tubing's small size and characteristics provide for ease of insertion and removal, as well as patient comfort and safety.

The other end of the Ag/AgCl wire is permanently adhered to an electrode cable lead wire. The solder joint is then covered by a heat shrink tubing so as not to allow exposure of the lead wire, as well as to provide strain relief. The electrode cable lead is terminated on the opposite end using two industry standard 1.5mm (0.06in) molded DIN safety socket connectors, which are subsequently used to interface to the monitoring device. For electrical safety, these connectors do not allow accidental connection to an A/C wall electrical outlet.

The provided 510(k) summary for the IHS TM-Wick Electrode does not describe a clinical study in the traditional sense, with specific acceptance criteria related to accuracy, sensitivity, or specificity of diagnostic performance for the device itself. Instead, it relies on demonstrating substantial equivalence to a predicate device (Bio-Logic TM-ECochGtrode, K944314) by comparing technological characteristics and ensuring compliance with established safety standards.

Therefore, the "acceptance criteria" and "device performance" in this context refer to the device meeting the requirements established for substantial equivalence through a comparison of its specifications and materials with those of the predicate device, and demonstrating compliance with relevant biocompatibility and electrical safety standards.

Here's an breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a substantial equivalence submission for an electrode, the "acceptance criteria" are predominantly about meeting safety and functional equivalence to the predicate device, rather than diagnostic accuracy metrics.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not describe a test set or data provenance in the way one would for a clinical performance study involving patient data. The basis for safety and effectiveness is a comparison to a predicate device and compliance with established standards (ISO 10993, 21 CFR 898). No human subject data (prospective or retrospective) is mentioned in relation to proving the performance of the device for ECochG signal acquisition in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. No clinical test set with a ground truth established by experts is described in this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication method is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No. The document does not describe a MRMC study.

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

Not applicable. This is a physical electrode, not a software algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of diagnostic accuracy. The "ground truth" here is the established safety and performance profile of the predicate device and the biocompatibility and electrical safety standards. The new device is shown to be equivalent or compliant with these.

8. The Sample Size for the Training Set

Not applicable. No training set is described as this is not an AI/ML device related to diagnostic accuracy based on a dataset.

9. How the Ground Truth for the Training Set was Established

Not applicable. No training set is described.

In summary, this 510(k) submission for the TM-Wick Electrode focuses on demonstrating substantial equivalence to a legally marketed predicate device (Bio-Logic TM-ECochGtrode) by comparing their intended use, indications, target population, design, materials, and safety characteristics. The "study" involves a detailed comparison of specifications and confirmation of compliance with relevant engineering and biocompatibility standards, rather than a clinical trial with performance metrics like sensitivity and specificity.

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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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The intended use of the Opti-Amp DC-Powered is as a physiological signal amplifier. It is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate setting.

Opti-Amp DC-Powered is a bio-amplifier testing device (made up of a transmitter and receiver) that is capable of acquiring evoked potentials.

The provided text is a 510(k) summary for the Opti-Amp DC-Powered device, which is an evoked potential amplifier. It describes the device, its intended use, and its technological characteristics as compared to a predicate device.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The summary focuses on demonstrating substantial equivalence to a predicate device (Opti-Amp K914876) based on intended use and technological characteristics, specifically noting a change in power supply from batteries to a medical-grade power supply with additional protection. It does not include the type of performance data and studies requested in your prompt.

Therefore, I cannot provide the requested table and study details.

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The intended use of the SmartEP-ASSR product is for the recording of auditory steadystate evoked potential data. The product is intended to be used as a diagnostic aid in auditory and hearing related disorders and as an adjunctive tool in the estimation of behavioral hearing thresholds.

SmartEP-ASSR is a auditory evoked potential testing device that is capable of measuring auditory steady state responses (ASSR).

The provided text is a 510(k) summary for the SmartEP-ASSR device, which is an auditory evoked potential testing device. The summary primarily focuses on demonstrating substantial equivalence to a predicate device (Bio-logic MASTER Evoked Response System, K021895) through a comparison of technical specifications.

Based on the provided information, there is no detailed study described that establishes explicit acceptance criteria and proves the device meets those criteria in a quantitative performance study. The submission relies on demonstrating substantial equivalence by comparing technical parameters to a legally marketed predicate device. This type of submission usually implies that if the technical specifications are comparable or superior, and there are no new questions of safety or effectiveness, then the device is considered to meet the requirements for marketing.

Here’s a breakdown of the requested information, indicating where the text provides details and where it does not:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, no explicit acceptance criteria for diagnostic accuracy or performance metrics (like sensitivity, specificity, or agreement rates) are stated, nor is there a study detailing such performance. The provided table focuses on technical specifications for comparing the SmartEP-ASSR to its predicate device. This comparison is the primary method used to argue for "substantial equivalence."

The "acceptance criteria" can be inferred as the SmartEP-ASSR meeting or exceeding the technical specifications of the predicate device, thereby demonstrating substantial equivalence for its intended use. For instance, the noise level being 0.33 μV RMS is "better" than the predicate's 0.45 μV RMS, which would contribute to showing equivalence or improvement.

2. Sample size used for the test set and the data provenance
The document does not describe any clinical test set or data derived from study participants for performance evaluation. The submission relies solely on comparing technical specifications to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set with ground truth established by experts is described.

4. Adjudication method for the test set
Not applicable, as no clinical test set requiring adjudication is described.

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 an auditory evoked potential testing device, not an AI-assisted diagnostic imaging or interpretation tool for human readers. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The SmartEP-ASSR is a medical device for measuring physiological responses, not an algorithm being tested for standalone diagnostic performance in the absence of human interpretation. Its function is to acquire and process evoked potential data for trained personnel to interpret.

7. The type of ground truth used
Not applicable, as no clinical performance study requiring ground truth is described. The "ground truth" equivalent for this type of submission is the established safety and effectiveness of the predicate device and the technical measurements demonstrating the new device performs similarly.

8. The sample size for the training set
Not applicable, as this device does not utilize a machine learning algorithm that requires a training set in the context of the provided document.

9. How the ground truth for the training set was established
Not applicable, as no training set for a machine learning algorithm is discussed.

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The intended use of the SmartTrOAE device is to measure otoacoustic emissions, which allow the operator to get information on cochlear function without requiring a subjective response from the person being tested with the device. It is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate setting.

SmartTrOAE is an otoacoustic emissions testing device that is capable of measuring transient and spontaneous otoacoustic emissions produced by the inner ear.

This 510(k) summary does not contain the detailed information necessary to fully answer all aspects of your request. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a comprehensive study protocol and results for the SmartTrOAE device independently.

However, I can extract the available information regarding acceptance criteria and device performance based on similarity to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in terms of specific thresholds for performance metrics. Instead, it demonstrates substantial equivalence by comparing the technological characteristics of the SmartTrOAE to the predicate device, ILO88 (K890124). The implicit acceptance criterion is that the SmartTrOAE's performance in these listed parameters is similar enough to the predicate to be considered substantially equivalent.

2. Sample size used for the test set and the data provenance:

This document does not report on a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective). The substantial equivalence is based on comparing technical specifications and intended use with a predicate device. There is no mention of a clinical study with a test set for the SmartTrOAE's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This document does not report on any ground truth establishment by experts for a test set.

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

This document does not report on an adjudication method for a test set.

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:

This document does not report on an MRMC comparative effectiveness study. The SmartTrOAE is an otoacoustic emissions testing device, which typically provides objective measurements (otoacoustic emissions) and does not involve "human readers" in the interpretation of complex images or data that an AI might assist with.

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

This document does not explicitly detail a standalone performance study. The device itself is an "otoacoustic emissions testing device," implying it takes objective measurements. The intended use "without requiring a subjective response from the person being tested" suggests a standalone measurement capability. However, detailed performance metrics from such a study are not provided. The comparison is solely based on technical specifications.

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

This document does not describe a type of ground truth used as it does not present a formal clinical study for the SmartTrOAE. The basis for equivalence is the similarity in technical characteristics and intended use to a legally marketed predicate device.

8. The sample size for the training set:

This document does not report on a training set sample size. This type of device (otoacoustic emissions) typically uses established physiological principles and signal processing, rather than machine learning models that require a "training set" in the conventional sense of AI/ML devices.

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

This document does not report on the establishment of ground truth for a training set.

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The SmartOAE device is intended to be used for the purpose of determining the distortion product response of the human cochlea. The device is intended to be used by hearing health professionals to determine cochlear function. The test administered by the device does not require any patient behavioral response, such as pushing a button switch. The device delivers sound signals into the outer ear and subsequently records the sound in the outer ear which contain sounds produced by normal cochleas. The device also measures the level of sound near the distortion product frequency to estimate the noise level present while the test was performed.

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This looks like a 510(k) clearance letter from the FDA for a device called "SmartOAE." While it describes the device's intended use, it does not contain the detailed information about acceptance criteria, study design, or performance metrics that you've requested.

The document primarily states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It doesn't include a study summary or the specific data you're looking for.

Therefore, I cannot provide the requested information based on the provided text. To get this information, you would typically need to refer to the original 510(k) submission documentation, which is usually more extensive and includes the technical details and study reports.

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