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The CloudTMS Edge for OCD is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

The CloudTMS Edge for OCD is a repetitive transcranial magnetic stimulation (rTMS) system. This computerized medical device produces non-invasive, repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex for the treatment of Obsessive-Compulsive Disorder (OCD).
It can be used in patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories of research institutions.General functionalities provided by the system are: - Single pulse stimulation (motor threshold detecting)

• Repetitive stimulation (therapy)
• Patient's data entering
• Stimulation algorithm editing
• Review of stimulation history
• Treatment report generation and printing
• Operation with list of treatment (selection for review, removal, etc.).
  The CloudTMS Edge for OCD principle of operation is based on the discharge of high voltage capacitor (1.8 kV) through stimulation coll; the pulsed magnetic field generated by the discharge current (up to 10 kA) penetrates through neuromuscular tissues nearby to induce electrical currents in cortical neurons.

This document describes K233742, CloudTMS Edge for OCD, a transcranial magnetic stimulation (rTMS) system intended as an adjunct treatment for adult patients with Obsessive-Compulsive Disorder (OCD).

Based on the provided text, there is no clinical study that explicitly defines acceptance criteria and then presents device performance against those criteria in a table. The submission relies heavily on a comparison with a predicate device (CloudTMS for OCD, K221129) and asserts substantial equivalence based on technological and operational similarities, and non-clinical testing.

Here's an attempt to extract and synthesize the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, a formal table of acceptance criteria and device performance from a clinical study is not provided in this document. The document focuses on demonstrating substantial equivalence to a predicate device through technological comparison and non-clinical testing.

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

Since no clinical study comparing the device to acceptance criteria is described, there is no information on the sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). The document primarily discusses non-clinical testing for safety and electromagnetic compatibility.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as no clinical study with a ground truth established by experts is described for this device in the provided text.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical study requiring an adjudication method is described.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not described or performed according to the provided text. The document focuses on the device itself and its equivalence to a predicate, not on how human readers might improve with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study of an algorithm was not described or performed in the provided text. The device is a physical rTMS system, not an AI algorithm requiring standalone performance evaluation in the usual sense.

7. Type of Ground Truth Used

No ground truth (expert consensus, pathology, outcomes data, etc.) was established or used for the CloudTMS Edge for OCD in the context of a clinical performance study as described in this document. The document relies on predicate device equivalence and non-clinical testing for safety and electrical characteristics.

8. Sample Size for the Training Set

This information is not applicable. The device is an rTMS system that produces magnetic fields, not an AI algorithm that would require a training set.

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

This information is not applicable as there is no training set mentioned for this device.

Summary of Device Evaluation in the Document:

The evaluation of the CloudTMS Edge for OCD, as presented in this 510(k) summary, is based on demonstrating substantial equivalence to its predicate device, CloudTMS for OCD (K221129). The key points of the evaluation are:

• Identical Indications for Use: The subject device has the exact same indications for use as the predicate.
• Technological Comparison: The design, operational characteristics, and technological characteristics are nearly identical, with minor modifications.
  • Both systems are rTMS systems, produce non-invasive, repetitive pulsed magnetic fields to induce neural action potentials in the prefrontal cortex for OCD treatment.
  • Both use the same mechanism of action, coil (DCC-03-125-C), and software.
  • Operational procedures, including system setups, motor threshold determination, coil positioning, and treatment stimulation parameters, are identical.
  • Minor modifications in the subject device: automatic voltage detection (110V/220V), upgraded power supply for faster charging, obsolescence replacement for cooled coil connections, and improved graphical user interface. These modifications are asserted to have no known impact on safety or efficacy.
• Non-Clinical Performance Characteristics:
  • Electrical/mechanical/thermal safety and electromagnetic compatibility were verified through testing against IEC 60601-1:2005/(R)2012 and IEC 60601-1-2:2014. (These standards implicitly define some acceptance criteria for these aspects).
  • Biocompatibility characteristics are identical to the predicate because the same patient caps are used.
  • Characteristics of electric and magnetic fields are identical to the predicate (due to the same double cone coil and treatment parameters), including linearity of output, biphasic sinusoidal waveform, pulse width and intensity, magnetic field spatial distribution, and magnetic field strength gradient.
• Conclusion: The device "does not introduce any new safety or effectiveness considerations" compared to the predicate, and all modifications are minor and have no known impact on safety or efficacy.

In essence, the "study" proving the device meets acceptance criteria is a comparison to a legally marketed predicate device, supplemented by non-clinical testing to recognized safety and performance standards for medical devices (IEC 60601 series). No new clinical performance data for efficacy was presented, as the submission relies on the established efficacy of the predicate device.

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The CloudTMS for OCD is intended to be used as an adjunct for the treatments suffering from Obsessive-Compulsive Disorder (OCD).

The CloudTMS for OCD is a repetitive transcranial magnetic stimulation (rTMS) system. This computerized medical device produces non-invasive, repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the bilateral dorsomedial prefrontal cortex (DMPFC) for the treatment of Obsessive-Compulsive Disorder (OCD).

The CloudTMS for OCD principle of operation is based on the discharge of high voltage capacitor (1.8 kV) through stimulation coil; the pulsed magnetic field generated by the discharge current (up to 10 kA) penetrates through neuromuscular tissues nearby to induce electrical currents in cortical neurons. In the OCD treatment protocol, the repetitive transcranial magnetic pulses are applied at a frequency of 20 Hz.

The CloudTMS for OCD consists of the following main components:

• . Mobile console
• Cooling unit .
• Extra power supply unit ●
• System software with GUI ●
• Treatment chair*
• Head support system*
• Coil DCC-03-125-C for both MT and treatment ●
• K8 Coil fixture
• K3 flexible arm coil positioning system ●
• Data Management System ●
• Trolley with casters .
• (* optional)

The acceptance criteria and study proving the device meets these criteria are described below.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The provided document describes a non-clinical performance study to demonstrate substantial equivalence to a legally marketed predicate device (Tonica Electronik A/S, MagVenture TMS Therapy System for Treatment of OCD, K193006). The study primarily focused on comparing the technological characteristics of the new device (CloudTMS for OCD) with the predicate device.

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

No test set of patient data was used. This was a non-clinical study focused on device characteristics and substantial equivalence, not a clinical trial with patient outcomes. Therefore, data provenance is not applicable in this context.

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 ground truth was established by experts for a test set of patient data, as this was a non-clinical substantial equivalence submission.

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

Not applicable, as no external test set requiring adjudication was used.

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 was not an AI-assisted diagnostic device, and no MRMC study was conducted.

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

Not applicable, as this is a medical device, not an algorithm, and the focus was on hardware and operational parameter equivalence.

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

For this substantial equivalence application, the "ground truth" was the established and legally marketed predicate device (K193006) and its characterized technological parameters as specified in its FDA clearance. The new device's performance was compared against these established specifications.

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.

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

Not applicable, as no training set was used.

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The Neurosoft TMS is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

The Neurosoft TMS is a repetitive transcranial magnetic stimulation (rTMS) system. This computerized medical device produces non-invasive, repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex for the treatment of Maior Depressive Disorder.

The Neurosoft TMS principle of operation is based on the discharge of high voltage capacitor (1.8 kV) through stimulation coil; the pulsed magnetic field generated by the discharge current (up to 10 kA) penetrates through neuromuscular tissues nearby to induce electrical currents in cortical neurons.

The Neurosoft TMS consists of the following main components:

• Main unit of the magnetic stimulator
• Cooling unit
• Extra power supply unit
• Coils
• Cooled figure-of-eight coil FEC-02-100-C
• Cooled figure-of-eight coil AFEC-02-100-C
• Figure-of-eight coil FEC-02-100 (optional)
• Figure-of-eight coil AFEC-02-100 (optional)
• K8 coil holder
• K3 flexible arm for coil positioning
• Trolley with casters

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is not present as well, as this is a 510(k) summary, which often relies on comparison to predicate devices rather than de novo clinical studies for performance.

Important Note: The provided document is a 510(k) premarket notification summary for a medical device (Neurosoft TMS). Such submissions typically demonstrate substantial equivalence to a previously cleared predicate device, rather than proving direct clinical efficacy through new, large-scale clinical trials. Therefore, information regarding clinical effectiveness studies, particularly those involving human readers, ground truth establishment through expert consensus or pathology, and detailed statistical performance metrics like sensitivity/specificity for AI algorithms, are generally not present in these types of documents for TMS devices. The focus here is on non-clinical performance (safety, electrical, mechanical) and a comparison of technical specifications.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criteria for the Neurosoft TMS are primarily based on demonstrating substantial equivalence to its predicate devices, especially its own prior version (Neurosoft TMS K160309) and the MagVita TMS Therapy System (K171481). The key "performance" demonstrated relates to its technical specifications matching or being comparable to these cleared devices, and changes not introducing new safety concerns.

Table of Acceptance Criteria and Reported Device Performance

• Magnetic Field Intensity: 120% of the MT
• Frequency: 10 Hz
• Train duration: 4 sec
• Inter-train interval: 11-26 sec (Modified from fixed 26 sec in K160309, comparable to MagVita)
• Number of trains: 75
• Magnetic Pulses per Session: 3000
• Treatment Session Duration: 18.8 min-37.0 min (Due to variable inter-train interval)
• Sessions/week: 5
• Treatment Schedule: 5 daily sessions for 6 weeks
• Area of brain to be stimulated: Frontal Cortex |
  | Device Components | Comparable components (Main unit, Cooling unit, Power supply, Coils, Coil holders, Flexible arm, Trolley). | Lists identical and optional coils (FEC-02-100-C, AFEC-02-100-C, FEC-02-100, AFEC-02-100). "The Neurosoft TMS and the predicate devices have the same components..." |
  | Coil Specifications | Comparable coil designs (figure-of-eight, air core, cooling methods) and parameters (Inner/Outer diameter, Area, Inductance, Amplitude in SMT units, Waveform, Active pulse width, Max initial dB/dt). | Detailed specifications for all listed coils provided, showing close similarity to K160309 and comparable ranges to MagVita. |
  | Safety Standards | Compliance with relevant electrical safety and quality standards (e.g., IEC 60601-1, ISO 13485, ISO 14971). | "Complies with IEC 60601-1 and IEC 60601-1-2."
  "Company complies with DIN EN ISO 13485: 2012, ISO 10993-1: 2009, ISO 14971: 2007." |
  | Non-clinical Performance | Satisfactory performance in required non-clinical tests as demonstrated for the predicate device (K160309). | "The non-clinical performance testing of Neurosoft TMS has been tested as required, and cleared by the FDA earlier on K160309. These tests demonstrate that the Neurosoft TMS is safe and effective for use in treatment of Major Depressive Disorder." |
  | New Safety Concerns | The modifications (e.g., variable inter-train interval) should not introduce any new safety considerations. | "On the basis of the only modification of the treatment parameter, the Neurosoft TMS does not introduce any new safety considerations in comparison to the predicate device. All other identified differences between the two systems are minor and without any known impact on safety or efficacy." |

Study Information (Based on the Provided Document):

The document primarily refers to non-clinical performance data and relies on the substantial equivalence paradigm rather than a new clinical study for this specific 510(k) submission.

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

   • No specific sample size for a "test set" or clinical trial is provided. The document refers to "non-clinical performance testing."
   • Data Provenance: Not specified in terms of country of origin. The testing is described as having been "tested as required, and cleared by the FDA earlier on K160309," implying the data underpinning the original clearance (and now referenced) would be from the manufacturer's internal testing as part of their regulatory submissions. The nature of these tests (e.g., electrical, mechanical, EMC) would be retrospective from the previous submission perspective.

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

   • Not applicable / Not specified. As this is a 510(k) for a TMS device based on substantial equivalence and non-clinical data, there is no mention of a ground truth established by human experts for performance evaluation in the context of an AI/human reader study. The "ground truth" for a TMS device's safety and effectiveness is typically established through a combination of regulatory standards, engineering principles, and clinical data from predicate devices or general scientific consensus on the treatment.

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

   • Not applicable / None specified. No clinical test set involving human readers or expert adjudication is described in this document.

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 MRMC study was done or reported in this document. This device is a direct treatment device (rTMS system), not an imaging analysis or diagnostic AI tool that would typically involve MRMC studies.

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

   • Not applicable. This device is a hardware system for direct medical treatment; it is not an algorithm for diagnostic interpretation in the way AI/ML software as a medical device (SaMD) might be evaluated for standalone performance. The "algorithm" here refers to the internal programming of the TMS device to deliver stimulation according to parameters.

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

   • For the device's fundamental function (producing magnetic fields of specific parameters), the "ground truth" would be physical measurements and engineering specifications.
   • For the device's clinical indication (treatment of MDD), the "ground truth" used for prior clearances (and thus for this substantial equivalence claim) would be the clinical evidence supporting the predicate devices' efficacy (which may have originally involved clinical trials measuring patient outcomes or expert clinical assessments of depression severity). This document itself does not detail new outcomes data.

7. The sample size for the training set:

   • Not applicable / Not specified. This document does not describe a machine learning model with a "training set."

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

   • Not applicable. As no machine learning training set is described.

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The Neurosoft TMS is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

The Neurosoft TMS is a repetitive transcranial magnetic stimulation (rTMS) system. This computerized medical device produces non-invasive, repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex for the treatment of Major Depressive Disorder.

This document describes a 510(k) premarket notification for the Neurosoft TMS device. The core of this submission is to demonstrate substantial equivalence to predicate devices, namely the Tonica Electronik A/S MagVita TMS Therapy System and the Magstim Company Limited Rapid2 Therapy System. The document does not describe an acceptance criteria study with direct device performance measurement against these criteria, but instead relies on showing feature-by-feature similarity to already-approved predicate devices.

Therefore, the requested information elements cannot be fully populated as they would typically apply to a clinical trial or performance study against predefined metrics. However, an interpretation of "acceptance criteria" and "reported device performance" in this context would be the comparative features and specifications between the Neurosoft TMS and its predicate devices, as presented in Table 5-1.

Here's an analysis based on the provided text, addressing the points where information is available or can be inferred:

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

In the context of a 510(k) submission showing substantial equivalence, the "acceptance criteria" are implied by the characteristics of the predicate devices. The "reported device performance" is the Neurosoft TMS's specifications, which are presented as being equivalent, or not raising new safety/efficacy concerns, compared to the predicates.

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 primarily describes non-clinical performance data for the Neurosoft TMS focusing on electrical safety, EMC, biocompatibility, software verification/validation, risk analysis, and magnetic field characteristics. There is no mention of a "test set" in the context of a clinical study, as the submission relies on substantial equivalence to predicate devices, which are already approved for clinical use.

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. This document does not describe a clinical study where ground truth would be established by experts.

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

Not applicable. As no clinical test set is described, no adjudication method would be required.

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 Repetitive Transcranial Magnetic Stimulation (rTMS) system, a treatment device, not an image analysis or diagnostic aid involving human readers or AI.

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

The document describes non-clinical performance data for the Neurosoft TMS:

• Electrical safety and electromagnetic compatibility testing (compliant with AAMI/ANSI ES 60601-1:2005/(R)2012 and IEC 60601-1-2: 2007).
• Biocompatibility evaluation of coils (meet ISO 10993-1 (2009)).
• Software verification and validation testing (performs as intended and in accordance with specifications, described in section 16, not provided here).
• Risk analysis (compliance with ISO14971).
• Magnetic field characteristics (plots and acoustic output measurements conducted as per FDA guidance).

These are performed on the device itself and its components, representing "standalone" performance in terms of its technical and safety specifications.

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

For the non-clinical tests:

• Electrical safety/EMC: Ground truth is defined by the requirements of the cited standards (e.g., AAMI/ANSI ES 60601-1, IEC 60601-1-2).
• Biocompatibility: Ground truth is defined by the requirements of ISO 10993-1 (2009).
• Software verification/validation: Ground truth is the defined software specifications and requirements.
• Magnetic field characteristics: Ground truth is derived from physical measurements and comparison to established parameters of predicate devices and FDA guidance.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based diagnostic device that requires a training set of data.

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

Not applicable. No training set is involved.

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The Neuro-Audio system is indicated for use in the recording and analysis of human physiological data used for the diagnosis of auditory and hearing-related functions. It is intended as an aid to healthcare professionals trained and skilled in audiology. The system assists in the evaluation and diagnosis of ear disorders in humans using evoked potentials (EP), electrocochleography (ECochG), auditory brainstem response (ABR), auditory steady-state response (ASSR), otoacoustic emission (OAE) and pure tone audiometry (PTA).

The device is intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories.

The patient group includes all ages and genders.

The Neuro-Audio system provides for audiology biopotentials recording and input to personal computer (PC) by 1-2 channels, and measurement, calculation and analysis of its parameters. It can be used in patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories of the research institutions for auditory tract study and brain functional state study.

General functionalities provided by the system are:

• biopotentials acquisition by 1-2 channels in any unshielded room
• auditory stimulation
• electrocochleography (ECochG) acquisition
• auditory brainstem response (ABR) acquisition (air and bone conduction)
• middle- and long-latency auditory evoked potentials (AEP: MLR, LLR) acquisition
• cognitive evoked potentials (MMN, P300) acquisition
• auditory steady-state response (ASSR) acquisition
• otoacoustic emission study using transient evoked otoacoustic emission (TEOAE) and distortion product otoacoustic emission (DPOAE)
• spontaneous otoacoustic emission study (SOAE)
• pure tone audiometry (PTA; air and bone conduction)
• exam report generation
• review, store, and print of the recorded traces, results of their analysis and exam reports.

In addition, the Neuro-Audio system provides the healthcare professional with:

• A means of adjusting or activating all of the unit's settings and controls.
• Multiple ways in which a user can carry a task, such as from a menu, using the mouse or the keyboard or by double-clicking on an icon.
• Configurable function keys and fields that enable the user to customize the interface to meet their requirements.
• Single-stroke keyboard function keys for key tasks carried out during a patient examination.

The Neuro-Audio system is a medical device intended for recording and analyzing human physiological data related to auditory and hearing functions. The provided document, a 510(k) summary, outlines the process of establishing its substantial equivalence to predicate devices, focusing on non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Neuro-Audio device are primarily based on compliance with established industry standards for medical electrical equipment and audiometric devices. The device's performance is reported as successfully meeting these criteria through hardware and software tests and validations.

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

The document does not explicitly mention a "test set" in the context of human subjects or a clinical study for performance evaluation. The performance evaluation was focused on compliance with technical standards through hardware and software testing. Therefore, sample sizes for human subjects or specific data provenance (country of origin, retrospective/prospective) are not applicable in the context of this 510(k) summary, as it states "No clinical testing was conducted to support this submission."

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

This information is not applicable. Since no clinical testing was conducted and the performance evaluation focused on compliance with technical standards, there was no "test set" requiring ground truth established by human experts in the sense of clinical diagnosis or interpretation.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical test set requiring adjudication was used.

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

There is no MRMC comparative effectiveness study reported in this document. The submission explicitly states, "No clinical testing was conducted to support this submission." The device's substantial equivalence is based on non-clinical performance testing and comparison to predicate devices' technical specifications and functionalities, not on human reader performance with or without AI assistance. This device is described as assisting healthcare professionals who are "trained and skilled in audiology," implying it is a tool for their use, but not an AI diagnostic system itself, and no "AI assistance" effect size is mentioned or relevant to this submission.

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

This information is not applicable in the context of a standalone "algorithm" performance as might be seen with AI. The Neuro-Audio is described as a system that records and analyzes data for diagnosis and is intended as an aid to healthcare professionals. Its performance is evaluated based on its technical compliance and ability to perform specific functions (e.g., biopotential acquisition, audiometry) in line with established standards, not as a standalone diagnostic algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance evaluation is primarily the established industry standards (e.g., IEC 60601-1, IEC 60645 series) for medical electrical equipment and audiometric devices. The device's hardware and software tests and validations confirmed its compliance with these technical specifications and performance requirements.

8. The Sample Size for the Training Set

This information is not applicable. The Neuro-Audio system is not described as an AI/ML device that requires a "training set" in the machine learning sense. Its performance evaluation relies on traditional engineering verification and validation testing against defined technical standards and comparison to predicate devices, not on a machine learning model's training data.

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

This information is not applicable as there is no mention of a training set for an AI/ML model. The "ground truth" for the device's functionality is the adherence to the technical specifications outlined by the relevant IEC standards for audiometric equipment and general medical device safety and performance.

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The Focus is intended for use by a healthcare provider to perform nerve conductions and EMG studies as an aid in the evaluation of patients with diseases of muscle and nerves. The machine can also use electrical stimulus or sound stimulus for evoked potentials (EP) studies.

The Focus is a 2-channel neurodiagnostic testing system designed to enable reliable recording, display and documentation of electrophysiological information from the human nervous and muscular systems in a clinical environment. The system enables the healthcare provider to perform evoked potentials, nerve conductions and needle EMG studies as an aid in the evaluation of patients with central and peripheral nervous system symptoms. The device provides functionality for the Electromyography (EMG), Nerve Conduction Studies (NCS), and Evoked Potential (EP) testing for a range of clinical applications and has a fast, intuitive and flexible graphical user interface (GUI) that conforms to a Windows philosophy. The Focus EMG Device consists of a handheld electronic unit, a stimulator unit with steel electrodes and felt pads, and a footswitch.

The TeleEMG Focus EMG Device is intended for use by healthcare providers to perform nerve conduction and EMG studies, and for evoked potentials (EP) studies using electrical or sound stimulus.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a neurodiagnostic testing system (hardware and software) and not an AI/ML device making diagnostic claims, the acceptance criteria are based on compliance with established medical device safety and performance standards rather than specific diagnostic accuracy metrics. The "reported device performance" refers to the successful completion of these compliance tests.

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

The document explicitly states: "No clinical testing was conducted to support this submission."
Therefore, there is no test set in the sense of patient data for clinical evaluation, and no data provenance in that context. The testing was non-clinical (hardware, software, and safety standard compliance).

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 testing was performed, there was no "test set" requiring expert-established ground truth. The acceptance criteria were based on engineering, safety, and performance standards.

4. Adjudication method for the test set

Not applicable. No clinical 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

Not applicable. This device is a diagnostic electromyograph machine, not an AI-assisted diagnostic tool that interprets or analyzes data to improve human reader performance. Its function is to acquire and display electrophysiological data for a healthcare provider to interpret.

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

Not applicable. The device is a hardware and software system for data acquisition and display, designed for human-in-the-loop use by a healthcare provider. It does not perform standalone diagnostic interpretation.

7. The type of ground truth used

For the non-clinical performance testing, the "ground truth" would be the specifications defined by the relevant international standards (IEC 60601 series, IEC 62471) and the functional specifications and design requirements internally established for the device itself. For example, for noise levels, the ground truth is that the device noise should be less than 0.6 µVrms, or for the LED goggles, the luminance should be below the 10,000 cd/m² admissible limit.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product that relies on a "training set" of data in the conventional sense. Its software performs signal acquisition, processing, and display based on established algorithms and embedded logic, not learned patterns from a large training dataset.

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

Not applicable, as there is no training set.

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