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Modius Stress is a non-invasive, home-use neurostimulation device that is indicated to treat the symptoms of Generalized Anxiety Disorder in adults aged 22 and older, when used for approximately 4 weeks. Durability of effect after 4 weeks has not been established.

Modius Stress is a non-invasive transdermal neurostimulation device to treat the symptoms of Generalized Anxiety Disorder. The proposed mechanism of the device is through a technology known as Cranial Electrotherapy Stimulation (CES). It consists of a battery-powered device designed to transcutaneously deliver low-level electrical energy (up to 1.5mA) to the skin behind the ears, over the mastoid processes. The delivery of this neurostimulation is through two self-adhesive electrode pads. These pads are placed on the skin behind each ear (mastoid area). The intensity of the electric pulse can be adjusted up or down by the user. When turned on, the device delivers a small electrical impulse, and adjustments to the stimulation level may be made using the up and down buttons on the device, which are located just above the power button. The device can also be paused by pressing the power button twice. When finished the user removes the device and disposes of the electrode pads after each use. When the device is not being used it can be charged through a micro-USB cable. For safety reasons, it is not possible to recharge the battery while the device is in use in stimulation mode. The key components of the Modius Stress include the Modius Stress device (plastic enclosure and printed circuit board assembly (PCBA), stimulation pads (K210448 and K132588), skin cleansing wipes (K121655) and charging accessories. The PCBA consists of a microcontroller, USB connector, transformer driver, IO expander and EEPROM memory. The embedded software within the device manages overall functionality of the device from Stimulation Control, Power Management, and user interaction (Indication LED and Audio tones).

The Modius Stress device is a non-invasive neurostimulation device indicated to treat symptoms of Generalized Anxiety Disorder (GAD) in adults aged 22 and older when used for approximately 4 weeks.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative performance table commonly seen for AI/ML devices (e.g., sensitivity, specificity, AUC thresholds). However, implicitly, the acceptance criteria for the clinical studies focused on demonstrating a significant reduction in GAD-7 scores compared to a sham control.

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Modius Sleep is a non-invasive, home-use neurostimulation device to treat chronic insomnia in adults aged 22 and older.

Modius Sleep is a low-risk non-invasive transdermal neurostimulation device to treat chronic insomnia. The proposed mechanism of the device is through a technology known as electrical vestibular nerve stimulation (VeNS).

It consists of a battery-powered device designed to transcutaneously deliver low-level electrical energy (up to 1mA) to the skin behind the ears, over the mastoid processes. The delivery of this neurostimulation is through two self-adhesive electrode pads. These pads are placed on the skin behind each ear (mastoid area). The intensity of the electric pulse can be adjusted up or down by the user. When turned on, the device delivers a small electrical impulse which stimulates the vestibular nerve. Adjustments to the stimulation level may be made using the up and down buttons on the device, which are located just above the power button. The device can also be paused by pressing the power button twice. When finished the user removes the device and disposes of the electrode pads after each use. When the device is not being used it can be charged through a micro-USB cable. For safety reasons, it is not possible to recharge the battery while the device is in use in stimulation mode.

The key components of the Modius Sleep include the Modius Sleep device (plastic enclosure and printed circuit board assembly (PCBA), stimulation pads (K210448 and K132588), skin cleansing wipes (K121655) and charging accessories. The PCBA consists of a microcontroller, USB connector (charging only), transformer driver, IO expander and EEPROM memory. The embedded software within the device manages overall functionality of the device from Stimulation Control, Power Management, and user interaction (Indication LED and Audio tones).

The provided text is a 510(k) Summary for the Modius Sleep device. It details a clinical study to demonstrate the device's safety and effectiveness for treating chronic insomnia. Here's a breakdown of the requested information based on the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for performance in a table format. However, it defines the primary effectiveness endpoint as a "change in the Insomnia Severity Index (ISI) score at Week 0 and Week 4 between the Modius Sleep group and sham control group." The study then reports the mean change and statistical significance. The implicit acceptance criterion is a statistically significant greater reduction in ISI score for the Modius Sleep group compared to the sham control.

Note: The table uses data from the "Complete case" analysis as it represents those who adhered to the intervention and showed a statistically significant difference in Model 1. Other models and ITT analyses are also provided in the document.

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

• Test Set (Participants with available data for analysis): 126 participants (61 in Modius Sleep group, 65 in Sham control group for complete case analysis). A total of 149 participants were enrolled and randomized (75 Modius Sleep, 74 Sham control).
• Data Provenance:
  • Country of Origin: United Kingdom (UK) and Hong Kong (HK). The UK site also included remote recruitment from the Republic of Ireland (ROI).
  • Retrospective or Prospective: Prospective. The study was a "4-week pivotal randomized controlled trial."

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense (e.g., radiologists interpreting images). Instead, the "ground truth" for insomnia diagnosis and severity (ISI scores) was established via self-reported patient outcomes and an online survey based on clinical diagnostic criteria (AASM ICSD and DSM-V) prior to enrollment. There is no information provided about the number or specific qualifications of experts involved in the initial diagnosis or ISI score evaluation for the study participants, beyond the general statement that "further information was collected by an online survey to establish that the participants had chronic insomnia at the time of enrolment as defined by ICSD and DSM-V."

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

Not applicable. This was a clinical trial evaluating a treatment device based on self-reported patient outcomes (ISI scores), not an AI device requiring reader adjudication of findings.

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 study evaluated a medical device for treatment of insomnia in a direct patient-use scenario, not an AI-assisted diagnostic tool for human readers.

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

This was a clinical trial of a medical device used by patients, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable. The device's performance is inherently tied to human interaction (patient use).

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

The "ground truth" for effectiveness was outcomes data based on the Insomnia Severity Index (ISI) scores, which are a validated patient-reported outcome measure for insomnia. The initial diagnosis of chronic insomnia for inclusion criteria was based on patient self-reporting via an online survey aligned with AASM (American Academy of Sleep Medicine) International Classification of Sleep Disorders (ICSD) and The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria.

8. The sample size for the training set

Not applicable. This clinical study evaluated the device's performance in a randomized controlled trial. There is no mention of a "training set" in the context of an algorithm or AI development.

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

Not applicable, as there was no training set in the context of an algorithm.

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EaseVRx is a prescription-use immersive virtual reality system intended to provide adjunctive treatment based on cognitive behavioral therapy skills and other evidencebased behavioral methods for patients (age 18 and older) with a diagnosis of chronic lower back-pain (defined as moderate to severe pain lasting longer than three months). The device is intended for in-home use for the reduction of pain and pain interference associated with chronic lower back pain.

EaseVRx is an immersive virtual reality (VR) system which delivers 3-D VR treatment that incorporates principles of cognitive behavioral therapy (CBT), other behavioral methods, and mindfulness strategies to treat patients diagnosed with chronic pain. It is a prescription-use device which uses preloaded software content on a proprietary hardware platform to deliver treatment. The EaseVRx device, shown in the figures below, consists of an off-the-shelf VR head-mounted display (Figure 1) with added Breathing Amplifier (Figure 2) and AppliedVR developed software. The Breathing Amplifier is a mechanical attachment added to the commercially available headset which enables diaphragmatic breathing exercises designed to enhance the user's engagement by amplifying the user's exhalation into the on-board microphone. The device is also marketed with an optional hand-held controller to aid in navigating the user interface.

Acceptance Criteria and Device Performance for EaseVRx

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for device performance. However, based on the identified risks and special controls, and the clinical study outcomes presented as evidence of effectiveness, the implicit acceptance criteria are related to:

• Clinical effectiveness: Demonstrating a clinically meaningful and statistically significant reduction in pain intensity and pain interference (activity, mood, sleep, stress).
• Safety: Acceptable adverse event profile with temporary, resolvable events.
• Technical Compliance: Meeting relevant electrical, biocompatibility, and software standards.

Here's a table summarizing the implicit performance criteria and the reported device performance, derived from the clinical study results:

2. Sample Size and Data Provenance

• Sample Size (Test Set): 188 subjects (patients with chronic low back pain, age 18 and older).
  • Treatment group: (b)(4) participants (derived from percentages, e.g., for pain intensity 66% of 188 = approximately 124, 41% of 188 = approximately 77. The specific group counts are redacted as (b)(4) in the table but the percentages confirm a distribution of the 188 subjects between the groups.)
  • Sham group: (b)(4) participants.
• Data Provenance: The document does not explicitly state the country of origin. It describes a "single-cohort, double-blinded... randomized clinical trial." This implies a prospective data collection, initiated for regulatory submission.

3. Number of Experts and Qualifications for Ground Truth

• Ground Truth for Clinical Study: No external experts were used to establish the "ground truth" for the primary clinical effectiveness endpoints. The ground truth was patient-reported outcomes (PROs) using standardized scales. Therefore, no information on the number or qualifications of experts for ground truthing is applicable here. The primary endpoints were measured using the Defense and Veterans Pain Rating Scale (DVPRS), which is a self-assessment tool.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Since the primary endpoints were patient-reported outcomes (DVPRS scores), there was no need for expert adjudication. The study collected direct patient responses.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study typically evaluates the performance of human readers (e.g., radiologists) with and without AI assistance for tasks like image interpretation. EaseVRx is a behavioral therapy device, and its primary endpoints are patient-reported pain and pain interference, not diagnostic accuracy involving expert readers.
• Effect Size of Human Readers with/without AI: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance: Not applicable in the traditional sense of an "algorithm only" performance study. EaseVRx is an interactive virtual reality system designed for human-in-the-loop use. Its effectiveness relies on the patient's engagement with the software content and the behavioral therapy it delivers. The clinical study did evaluate the device's performance in a standalone manner relative to a sham control, demonstrating the direct effect of the EaseVRx therapeutic program on patient outcomes when used as intended by the patient. However, this is not a "standalone algorithm" performance in the context of, for example, an AI diagnostic algorithm, where the algorithm provides an output without human intervention.

7. Type of Ground Truth Used

• Ground Truth Type: Patient-Reported Outcomes (PROs).
  • The primary effectiveness endpoints (average pain intensity and pain interference on activity, mood, sleep, and stress) were measured using the Defense and Veterans Pain Rating Scale (DVPRS).
  • Secondary endpoints also included PROs such as Patient's Global Impression of Change (PGIC), PROMIS physical function, PROMIS sleep disturbance, Pain Self-Efficacy Questionnaire (PSEQ-2), Pain Catastrophizing Scale (PSCS-4), Chronic Pain Acceptance Questionnaire (CPAQ-8), Patient satisfaction, and Positive and Negative Affect Scale (PANAS).

8. Sample Size for the Training Set

• Training Set Sample Size: The document refers to the clinical trial as an evaluation study for the device's effectiveness. It does not describe a separate "training set" for the device's software algorithm in the context of an AI/machine learning development pipeline. EaseVRx delivers preloaded software content based on established therapeutic principles (CBT, behavioral methods, mindfulness). The device's content is "designed to minimize triggers of emotional distress and motion sickness, as well as to induce relaxation and activation of the parasympathetic nervous system." This suggests content designed by experts, rather than an algorithm trained on patient data. Therefore, the concept of a separate "training set" for an AI model that could be assessed independently is not directly addressed or implied by the provided text.

9. How Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable. As discussed above, the document does not describe the development of an adaptive AI algorithm that would require a ground truth-labeled training set. The device utilizes preloaded, expert-designed therapeutic content.

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Cervella Cranial Electrotherapy Stimulator (CES) is indicated for treatment of insomnia, depression, or anxiety.

Cervella Cranial Electrotherapy Stimulator (CES) is a device that delivers small pulses of electrical current through patient's brain. The stimulator is powered by an internal rechargeable battery which provides a low-level constant current to the cranium via a pair of conductive electrodes placed bilaterally on the mastoid process. The electrodes are incorporated into earpads of stereo over-ear noise-cancelling headphones. The patient can use the audio (through a separate dedicated Bluetooth connection) and noise cancelling features of the stereo headphones during treatment (e.g. music listening). The stimulator is controlled via a software application (app) installed on the patient's smart device (e.g. smartphone). The app communicates with the device through a dedicated Bluetooth® LE connection that is independent of the optional Bluetooth connection for audio listening purposes. The patient uses the app to adjust the intensity level, frequency, and duration of the treatment. The app also allows the patient to automatically store the treatment history for review by the patient's healthcare provider.

This submission lacks specific acceptance criteria and detailed study results to demonstrate device performance against those criteria. The provided document is a 510(k) summary, which focuses on establishing substantial equivalence to predicate devices rather than proving a device meets specific, pre-defined performance acceptance criteria through clinical studies.

Here's an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in terms of clinical or technical performance metrics (e.g., specific reduction in anxiety scores, minimum current output accuracy, etc.) and then report the device performance against those criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices based on shared design, operating principles, and compliance with general safety and performance standards.

The table presented in the "IX. PERFORMANCE DATA DEMONSTRATING SUBSTANTIAL EQUIVALENCE" and "X. SUMMARY OF SIMILARITIES AND DIFFERENCES" sections compares the Cervella device's characteristics to its predicate devices, CES Ultra and Alpha-Stim CS. This comparison serves as the de facto "performance data" that the manufacturer presented for substantial equivalence, rather than a direct measurement against pre-defined acceptance criteria for a new clinical claim.

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

The document (a 510(k) summary) does not describe a clinical "test set" in the context of typical AI/ML performance evaluation (e.g., a cohort of patients whose data is used to validate an algorithm's diagnostic or therapeutic efficacy).

The performance data cited are primarily bench testing against electrical safety and performance standards for medical devices (ES60601-1:2005, IEC 60601-1-2, IEC 60601-2-10, IEC 62133). These tests do not involve patient data or clinical outcomes. Therefore, there is no information on sample size, country of origin, or whether it was retrospective or prospective data in the clinical sense.

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

Not applicable. As noted above, there was no clinical test set requiring expert ground truth establishment for diagnostic or therapeutic accuracy. The ground truth for electrical safety and performance standards is defined by the standards themselves, not by expert consensus on clinical data.

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

Not applicable, as there was no clinical test set requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. The Cervella device is a Cranial Electrotherapy Stimulator (CES), a standalone therapeutic device, not an AI-assisted diagnostic or interpretive tool that would typically be evaluated in an MRMC study with human readers. The document does not describe any such study.

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

The device itself is a standalone therapeutic device. Its core function – delivering electrical stimulation – is algorithm-driven in terms of current intensity, frequency, and duration programming, but it's not an "AI algorithm" in the typical sense of a diagnostic or predictive model. The performance data provided is mainly about its physical and electrical characteristics conforming to standards, not a standalone evaluation of an AI algorithm's diagnostic accuracy.

7. The type of ground truth used:

For the evaluation described, the "ground truth" was compliance with mandatory and voluntary medical device safety and performance standards (e.g., IEC 60601 series). These standards define the expected electrical output, safety features, and battery performance. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for the purpose of this 510(k) submission, as it focuses on substantial equivalence of physical and electrical parameters.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data in the typical sense to learn patterns or make predictions. Its operation is based on predefined electrical parameters.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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FM 10/C is indicated to be used for:

• CES for the treatment of insomnia, depression, or anxiety. .
• TNS for Symptomatic relief and management of chronic intractable pain and/or . as an adjunctive treatment in the management of post-traumatic and postsurgical acute pain.

FM 10/C is portable Cranial Electrical Nerve Stimulator. FM 10/C combines uniquely two proven therapies CES for the treatment of insomnia, depression, or anxiety and TENS for symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain. Thus FM 10/C offers a partnership between Transcutaneous Electrical Nerve Stimulation (TENS) and Cranial Electrotherapy Stimulation (CES). FM 10/C has three modes viz. (i) TENS Burst (ii) TENS Conventional and (iii) CES mode. It provides easy mode selection through slide switch and user can select any one of the available modes through it. TENS and CES modes will not operate simultaneously so, if CES Leads are inserted then TENS modes are automatically blocked for the user and vice versa. TENS mode is programmable and user will have the option to select pulse width and pulse rate using analog pots. In addition treatment time is also selectable using a slide switch options available are 30 minutes or continuous treatment time. FM 10/c is only battery operated, with low battery indication.

The provided document does not contain information about acceptance criteria or a study that proves the device meets those criteria. Instead, it is a 510(k) premarket notification summary for a medical device (Cranial Electrical Nerve Stimulator, Model FM 10/C).

This document mainly describes the device, its intended use, and compares its technical specifications to two legally marketed predicate devices (CES Ultra and ELECTRONIC PAIN RELIEVERS) to claim substantial equivalence. The FDA letter confirms the substantial equivalence determination.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on technical specifications of the new device and predicate devices.
2. Sample size used for the test set and the data provenance: No clinical testing or data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set or ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study is mentioned.
6. If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is an electrotherapy device, not an AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable, as no AI model or training data is discussed.
9. How the ground truth for the training set was established: Not applicable.

The document serves to demonstrate that the FM 10/C device is substantially equivalent to existing devices in terms of its technology and intended use, primarily through technical specification comparison and safety considerations (e.g., battery operation). It does not present results from performance studies or clinical trials to meet specific acceptance criteria.

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The "Elexoma Medic" is a battery operated portable cranial electrotherapy stimulator (CES) device that applies electrical current to a patient's head through electrodes clipped onto the patient's earlobes to treat insomnia, depression, or anxiety and The "Elexoma Medic" is a battery operated portable transcutaneous electrical nerve stimulator (TENS) device used to apply microcurrent through self-adhesive electrodes to a patient's skin for the symptomatic relief of intractable pain, chronic intractable pain, post-traumatic and postsurgical pain relief. The "Elexoma Medic" is a prescription device according to Federal law.

The "Elexoma Medic" is a battery operated portable cranial electrotherapy stimulator (CES) device that applies electrical current to a patient's head through electrodes clipped onto the patient's earlobes and a battery operated portable transcutaneous electrical nerve stimulator (TENS) device used to apply microcurrent through self-adhesive electrodes to a patient's skin.

The provided document is an FDA 510(k) clearance letter for the Elexoma Medic device. It states that the device is substantially equivalent to a legally marketed predicate device.

However, this document does not contain information about specific acceptance criteria for performance, nor does it detail a study proving the device meets particular performance metrics.

The letter focuses on the regulatory clearance process and substantial equivalence, not on the detailed technical performance study results. Therefore, I cannot provide the requested information based solely on this document.

To answer your questions thoroughly, I would need access to the 510(k) submission itself, which would include the performance data and methodologies used to demonstrate substantial equivalence.

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The CES Ultra is indicated for the treatment of insomnia. depression or anxiety.

The CES Ultra is a device designed to deliver therapeutic electrical and stimulation for cranial electrotherapy stimulation (CES) applications. The stimulator is powered by a standard 9-volt alkaline battery and delivers a single channel of low-level, constant current electrical stimulation to electrodes connected to the patient's skin via conductive lead wires. Stimulation current is applied to the patient via either standard self-adhering conductive electrodes placed on the head or conductive clip-type electrodes attached to the patient's ear lobes. The stimulator's user controls include: a rotary stimulation amplitude control which allows user adjustment of stimulation current and includes an integral power on/off switch; and a pushbutton timer selector switch which allows user selection of either continuous stimulation or timed stimulation sessions with automatic stimulation shut-off.

The provided text is a 510(k) summary for the CES Ultra™ Stimulator, which is a Cranial Electrotherapy Stimulator (CES). Based on the information provided, no specific acceptance criteria or a study proving the device meets those criteria were required or conducted for this 510(k) submission.

Here's a breakdown of why and what information is available based on your requested points:

1. A table of acceptance criteria and the reported device performance

Reasoning: The document explicitly states: "Neither nonclinical nor clinical testing was required to demonstrate the substantial equivalence of the CES Ultra to the designated predicate devices." This means no specific performance criteria linked to clinical outcomes were set for this submission. The basis for clearance was substantial equivalence to already marketed devices.

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

• Sample Size for Test Set: Not applicable, as no clinical or nonclinical testing was required or conducted to demonstrate substantial equivalence against specific performance criteria.
• Data Provenance: Not applicable.

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, as no clinical or nonclinical testing was required or conducted.

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

• Not applicable, as no clinical or nonclinical testing was required or conducted.

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

• No MRMC study was done. The device is a direct therapeutic device (Cranial Electrotherapy Stimulator), not an AI-assisted diagnostic or interpretation tool for human readers.

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

• Yes, in spirit, the substantial equivalence determination is a form of standalone evaluation. The FDA reviewed the device's technological characteristics (frequency, pulse width, amplitude) and compared them to those of legally marketed predicate devices to determine that the CES Ultra was "substantially equivalent." This means the device itself, based on its design and parameters, was deemed equivalent without needing a human-in-the-loop study.

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

• Ground Truth Type: The ground truth for this submission was the established safety and effectiveness of the predicate devices (NF-1 Mindpeace CES, K895175, and HP-1 Healthpax CES, K883812). The "ground truth" for the CES Ultra's substantial equivalence was that its stimulation parameters (frequency, pulse width, and amplitude) were "well within the established range of such parameters that are generally accepted as safe and effective for CES" as demonstrated by the predicate devices.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense. The "training" here refers to existing knowledge about CES devices from prior marketing clearances.

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

• Not applicable in the context of an AI/ML training set. The "ground truth" for establishing substantial equivalence was based on the prior regulatory clearances and established safety and effectiveness of the predicate CES devices. These predicates had previously gone through their own approval processes, which may have involved clinical studies or other data to establish their safety and effectiveness. The CES Ultra leveraged this existing "ground truth" by demonstrating its similarity to these already-approved devices.

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Application of electrical current to the head to treat insomnia, depression, or anxiety.

The NET-2000 Microcurrent Stimulator is a precision electronic instrument used for the treatment of anxiety, depression, or insomnia. The treatment is simple and can easily be selfadministered. The device consists of a microprocessor controller box and skin contact electrodes. The small controller box is a software controlled low-intensity output. Current ranges from 0-600 microamperes typically set at 0.5 Hz. Additional frequencies at 1.5 and 100 Hz are available for the physician's use. The waveform is a bipolar asymmetric rectangular shape. Duty cycle is 50% with a 0 net current. Timed treatment is set at 16.5 minutes.

The provided text describes the NET-2000 Microcurrent Stimulator, a device used for the treatment of anxiety, depression, or insomnia. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study (or lack thereof) based on the provided information:

1. A table of acceptance criteria and the reported device performance

The provided information does not explicitly state "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy. Instead, the submission relies on a comparison table to demonstrate the NET-2000's features are equivalent to its predicate device, the Alpha-Stim 100. This is the primary method of showing "performance" in this context.

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 any clinical study with a test set involving human subjects or data. The "performance testing" mentioned is comparative testing to the Alpha-Stim 100 and electrical safety and biocompatibility testing. This implies bench testing rather than clinical data from a sample size.

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 clinical data or human evaluation with a "ground truth" established by experts is mentioned for this device. The assessment is based on technical specifications and safety/performance standards.

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

Not applicable. As no clinical study with a test set is described, there is no adjudication method.

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 microcurrent stimulator, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant and not mentioned.

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

Not applicable. This section is typically relevant for AI/ML-based algorithms. The NET-2000 is a physical medical device; its "performance" is assessed through its electrical characteristics, safety, and functional equivalence to a predicate, not through an algorithm's standalone performance.

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

Not applicable. For this type of 510(k) submission and device, the "ground truth" for demonstrating substantial equivalence is primarily the technical specifications and established safety and effectiveness of the predicate device, alongside adherence to recognized electrical safety and biocompatibility standards. There is no mention of clinical outcomes data in terms of "ground truth" for the device's efficacy. The claim of "safe and effective" is based on the equivalence to a device already deemed safe and effective.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/ML device.

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

Not applicable. As there is no training set, this question is not relevant.

In summary:

This 510(k) submission for the NET-2000 Microcurrent Stimulator focuses on "substantial equivalence" to a predicate device (Alpha-Stim 100) based on technical specifications, indications for use, and a demonstration of electrical safety and biocompatibility. It does not present evidence from clinical trials or studies involving human subjects with a "test set" and "ground truth" as typically seen in submissions for diagnostic algorithms or devices requiring new clinical evidence of efficacy. The "study that proves the device meets the acceptance criteria" in this context refers to the comparative analysis of features, electrical safety testing, and biocompatibility testing, all demonstrating the NET-2000's similarity to the predicate and compliance with relevant standards.

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Treatment with the TESA device is intended to reduce the symptoms of depression, anxiety and insomnia.

The TESA is a transcranial electrotherapy stimulation device. Three electrodes are applied, one to the forehead and one behind each ear. TESA delivers low amplitude AC current for a desired time of 0 to 99:59 minutes. Treatment can be stopped by pressing the "current off" button. Either the operator or patient may press this button at any time. During treatment, peak current amplitude can be adjusted over the available range of 0 - 4 mA. Treatment parameters are monitored and controlled by a built in microprocessor. The display on the front of TESA indicates remaining treatment time and shows the current setting.

During treatment, a modulated high frequency square wave is delivered to the patient electrodes. The amplitude and duration of the positive and negative going portions of this waveform have been carefully designed to deliver no DC component. Moreover, the electrodes are AC coupled to the patient to insure no DC component in the event of device failure.

Additional safety features of the TESA device include rapid measurement of electrode impedance to insure good electrode contact and to maintain controlled current output over changing load conditions (e.g. when electrode contact changes). Detection of poor electrode contact causes the device to stop treatment and illuminate an electrode fault LED. Further treatment is blocked until electrode/skin impedance is restored to nominal range.

The provided document is a 510(k) Summary for the Transcranial Electrotherapy Stimulator-A (TESA). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study demonstrating the device meets such criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device, or efficacy for a therapeutic device).

The "Testing" section only states that:

• "Various tests of the hardware and software have been performed to verify that the device works as described in this document."
• "Verification procedures with pass/fail critcria were developed to ensure that the product met all the specified requirements."
• "As part of this vorification, a certified body will be used to determine that the device conforms to the recognized safety standards listed below."
• "The device will not be marketed until it has been tested and complies with the standards."

The listed standards (UL2601-1, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-10) are safety and electromagnetic compatibility (EMC) standards, not clinical performance standards for therapeutic efficacy.

Therefore, I cannot populate the requested table and information beyond acknowledging what is present in the document.

Here's what can be extracted based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

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

• Not provided. The document does not describe any clinical test set or data provenance.

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/Not provided. No clinical performance study using a test set requiring expert-established ground truth is described.

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

• Not applicable/Not provided. No clinical performance study using a test set 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 a therapeutic stimulation device, not an AI-assisted diagnostic or interpretation tool. No such study is mentioned.

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

• Not applicable. This is a hardware therapeutic device, not a standalone algorithm.

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

• Not applicable/Not provided. No clinical performance study requiring ground truth is described.

8. The sample size for the training set

• Not applicable/Not provided. No machine learning or AI training set is mentioned for this device.

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

• Not applicable/Not provided.

Summary of what is present:
The document details the device's technical specifications, indications for use, and declares its substantial equivalence to other legally marketed cranial electrotherapy stimulators based on similar current amplitudes and frequencies. It also lists the safety and EMC standards it intends to conform to. It does not provide data on clinical efficacy or specific performance criteria related to its stated indications for reducing symptoms of depression, anxiety, and insomnia. This type of information is typically required for higher-risk devices or when a new mechanism of action is being introduced, often necessitating a PMA (Premarket Approval) rather than a 510(k) which focuses on substantial equivalence to existing devices. Given this device is Class III, a PMA would generally be expected for demonstrating efficacy, but a 510(k) was allowed due to substantial equivalence to older, pre-amendment devices or reclassified devices.

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