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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 CLS001 Laser System is intended to effect stable, long-term or permanent hair reduction, in Fitzpatrick skin types I-VI, including sun tanned skin types. Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing after a treatment regime
The CLS001 Laser System is intended to effect coagulation and haemostatis of vascular lesions in Fitzpatrick skin types I-VI, including suntanned skin types.

The CLS001 Laser System is an analog, pulsed Nd: YAG laser utilizing the Nd: YAG crystal as the lasing medium. It operates at the wavelength of 1064 nanometers. Laser activation is controlled by a footswitch mechanism. Physically, the system weighs 66 pounds, is 13.8 inches high, 23.6 inches wide and 17.3 inches deep. The electrical requirements are 220/240 VAC single phase, 50/60 Hz and 8 amps.

Here's an analysis of the provided text regarding the acceptance criteria and study for the K112141 device:

Based on the provided 510(k) summary for the Castle Laser Systems Limited CLS001 Laser System, the following information can be extracted:

Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "Clinical Performance Data: none required." This indicates that the device's acceptance criteria for safety and effectiveness were established through substantial equivalence to predicate devices, rather than through new clinical performance studies demonstrating a specific level of clinical outcome (e.g., a specific percentage of hair reduction or lesion clearance).

Study Details

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

   • Sample Size: Not applicable. No clinical test set was used for this device's performance evaluation as clinical performance data was "none required."
   • Data Provenance: Not applicable for a clinical test set. The substantial equivalence argument relies on the established safety and efficacy of the predicate devices (Smartepil and Depilase Yag Lase Plus).

2. 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 requiring expert ground truth was performed for this device.

3. Adjudication method for the test set:

   • Not applicable. No clinical test set was performed.

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:

   • Not applicable. This device is a medical laser system, not an AI-assisted diagnostic or imaging device, and no MRMC study was conducted.

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

   • Not applicable. This is a medical laser system, not an algorithm, and the performance evaluated was substantial equivalence to predicate devices.

6. The type of ground truth used:

   • The "ground truth" for the device's performance is implicitly the established safety and effectiveness of the legally marketed predicate devices. The manufacturer argued that their device is substantially equivalent to these predicates. The specific type of ground truth (e.g., pathology, outcomes data) for the predicate devices' original clearances is not detailed in this document, but their prior clearance implies their performance met a certain standard.

7. The sample size for the training set:

   • Not applicable. There is no mention of a "training set" in the context of an algorithm or AI for this device. The regulatory submission relies on substantial equivalence.

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

   • Not applicable. No training set was used.

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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 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 SMARTEPIL Laser is indicated for benign vascular lesions and hair removal.

The SMARTEPIL Laser is a pulse Nd:YAG laser utilizing the Nd-YAG crystal as the lasing medium. It is a pulsed laser with a wavelength of 1064nm. Laser activation is either by a finger switch or a footswitch. Overall weight of the laser is 200lbs, and the size is 92cm x 40cm x 80cm (H x W x D). Electrical requirement is 220VAC, 13A, 50-60 Hz, single phase.

The provided 510(k) summary for the SMARTEPIL laser system does not contain information about acceptance criteria or a study proving the device meets them. The document explicitly states "Non-clinical Performance Data: None" and "Clinical Performance Data: None."

This is a pre-amendments 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical or performance data as would be required for more complex or novel devices today.

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the provided text.

The closest relevant information is contained in the "Conclusion" section of the 510(k) summary:

• Conclusion: "The SMARTEPIL Laser is another safe and effective device for dermatological vascular lesions and hair removal application." This statement serves as the overall conclusion, but it's not supported by specific performance metrics or studies within this document.

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