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Neurodyn V2.0 Stimulators are intended for:

As a FES device:

• Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait.

As a TENS device:

• Symptomatic relief of chronic (long term) intractable pain

• Symptomatic relief of post-traumatic acute pain and post-surgical pain
  As an Interferential and Premodulated device:

• Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain

As a Russian device:

• Temporary relaxation of muscle spasms - Prevention of disuse atrophy in post-injury type conditions -Increase local blood circulation - Muscle re-education

• Maintaining or increasing range of motion
  As a Burst Modulated Alternating Current (Aussie) device:

• Temporary relaxation of muscle spasms

• Prevention or retardation of disuse atrophy in post-injury type conditions

• Increase local blood circulation

• Muscle re-education

• Maintaining or increasing range of motion

• Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain

As a Microcurrent device:

• Symptomatic relief of chronic intractable pain - Symptomatic relief of post-traumatic acute pain

As a DC/Polarized device: -Relaxation of Muscle Spasm

As a High Voltage Pulsed current device:

• Muscle re-education
• Relaxation of Muscle Spasms
• Maintaining or increasing range of motion
• Increasing local blood circulation
• Prevention or retardation of disuse atrophy

Neurodyn Aussie V2.0 Stimulators are intended for:

As a Burst Modulated Alternating Current (Aussie) device:

• Temporary relaxation of muscle spasms
• Prevention or retardation of disuse atrophy in post-injury type conditions
• Increase local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain

NEURODYN v2.0 is a transcutaneous neuromuscular stimulator of four channels with independent controls for treatments with: AUSSIE CURRENT (with Medium Frequency Current modulated in Burst), RUSSIAN CURRENT (Medium Frequency Current modulated in Burst), FES CURRENT (Functional Electrical Stimulation),TENS CURRENT(Transcutaneous Electrical Nerve Stimulation), INTERFERENTIAL CURRENT (IFC-T), PREMODULATED INTERFERENTIAL CURRENT (IFC-B) BIPOLAR (Medium Frequency Current modulated in Amplitude), and with two independent control channels for the treatments with: MICROCURRENT (Microcurrent Electrical Neuromuscular Stimulation), DIRECT CURRENT /POLARIZED CURRENT and HIGH VOLTAGE PULSED CURRENT (High Volt Pulsed Current).

NEURODYN AUSSIE V2.0 transcutaneous neuromuscular stimulator is a four-channel stimulator with independent controls for current therapy used in AUSSIE CURRENT (Burst Modulated Medium Frequency).

This FDA 510(k) summary for the Neurodyn V2.0 and Neurodyn Aussie V2.0 powered muscle stimulators focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness is not directly available or applicable in the provided document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding device performance in the context of an effectiveness study. Instead, it provides a comparative table of technological characteristics between the new devices and their predicate devices. The "Performance" line in this table states "Identical" for both the new devices and the primary predicate (Neurodyn Multiwave; Neurodyn Aussie Sport), implying that the performance is considered equivalent due to identical technological characteristics for many modalities.

Key parameters from the "Technological Characteristics Comparison" considered for substantial equivalence, which implicitly act as performance criteria for the new device as 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):

No clinical test sets or human subject data were used or described in this 510(k) summary for performance evaluation. The substantial equivalence is based on engineering and performance characteristics comparison with predicate devices and compliance with international standards.

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

Not applicable. No ground truth based on expert consensus was established as no clinical test set was utilized for demonstrating effectiveness.

4. Adjudication method for the test set:

Not applicable. No test set requiring adjudication was 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 is not an AI-assisted diagnostic device, and no MRMC study was performed or referenced.

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

Not applicable. This is not an algorithm-only device. Its performance is compared based on physical and electrical characteristics to predicate devices.

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

Not applicable in the context of clinical performance data. The "ground truth" for substantial equivalence is primarily the established performance and safety profiles of the predicate devices and compliance with recognized industry standards.

8. The sample size for the training set:

Not applicable. No machine learning algorithm requiring a training set was mentioned.

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

Not applicable. No machine learning algorithm requiring a training set was mentioned.

Summary of Device Acceptance Approach:

The Neurodyn V2.0 and Neurodyn Aussie V2.0 gained FDA clearance (K210572) through the 510(k) premarket notification pathway. This pathway establishes substantial equivalence to a predicate device, rather than proving independent safety and effectiveness through de novo clinical trials.

The study that "proves" the device meets acceptance criteria, in this context, is primarily a non-clinical engineering and performance characteristic comparison study against legally marketed predicate devices, coupled with compliance to recognized international safety and performance standards:

• Predicate Devices: K131629 (Neurodyn Multiwave; Neurodyn Aussie Sport) and K031077 (Vectra Genesis).
• Methodology: A detailed comparison of the new devices' indications for use and technological characteristics (e.g., number of channels, current types, output ranges, safety features, input voltage, and construction materials) against the predicate devices.
• Performance "Proof": The document explicitly states "Performance: Identical" when comparing key aspects to the predicate devices. Differences in current ranges (e.g., TENS 0 to 120mA (Ipp) vs. Tens 0 to 80 mA for a predicate) are deemed not to interfere with performance because "the intensity does not have fixed parameter, it is according to the sensorial of each patient." This indicates that these parameters are within acceptable safe and effective ranges as evidenced by the predicates.
• Standards Compliance: The devices comply with IEC 60601-1 (general requirements for basic safety and essential performance), IEC 60601-1-2 (electromagnetic disturbances), and IEC 60601-2-10 (particular requirements for nerve and muscle stimulators). Non-clinical testing was performed to demonstrate compliance with these standards.

Conclusion from the document: "The Neurodyn V2.0 device and the predicate devices are substantially equivalent when comparing the indications for use, and technological properties. The differences shown in the comparison do not affect the substantial equivalence."

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Indications for FES waveform:

• Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait.

Indications for TENS waveform:

• Symptomatic relief of chronic (long term) intractable pain
• Symptomatic relief of post-traumatic acute pain and post surgical pain

Indications for Russian waveform:

• Temporary relaxation of muscle spasms
• Prevention or retardation of disuse atrophy in post-injury type conditions
• Increase local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion

The device NEURODYN II is a four output channel stimulator, operated in power supply 100 to 240 V, 50-60 Hz, with independent controls, graphic display backlit blue, mechanical contact keyboard and ABS cabinet with acrylic cover.
Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation) FES (Functional Electrical Stimulation) RUSSIAN CURRENT (Burst Modulated Medium Frequency)
Characteristics:
TENS: four 120mA peak to peak channels FES: four 120mA peak to peak channels RUSSIAN: four 120mA peak to peak channels Electrical Feed: 100 a 240V (50/60Hz) Input Power: 85VA Temperature Range During Transport and Storage: 41 to 122°F Environment Operating Temperature Range: 41 to 113°F

The device NEURODYN COMPACT is a two output channel stimulator. operated in power supply 100 to 240 V, 50-60 Hz, with independent controls, graphic display backlit blue, mechanical contact keyboard and ABS cabinet with acrylic cover.
Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation) FES (Functional Electrical Stimulation) RUSSIAN CURRENT (Burst Modulated Medium Frequency)
Characteristics:
TENS: four 120mA peak to peak channels FES: four 120mA peak to peak channels RUSSIAN: four 120mA peak to peak channels Electrical Feed: 100 a 240V (50/60Hz) Input Power: 85VA Temperature Range During Transport and Storage: 41 to 122°F Environment Operating Temperature Range: 41 to 113°F

The provided submission for the NEURODYN Compact and NEURODYN II devices does not include a detailed study proving the devices meet specific quantitative acceptance criteria. Instead, it relies on demonstrating substantial equivalence to previously cleared predicate devices (K121369 Neurodyn/Aussie Powered Muscle Stimulator by Ibramed and K021100 300 PV Complete Electrotherapy System by EMPI) based on similar indications for use, operating principles, hardware configuration, and compliance with recognized electrical safety and performance standards.

The acceptance criteria are implicitly defined by compliance with these standards and the established performance characteristics of the predicate devices.

1. Table of Acceptance Criteria and 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)

The submission does not describe a test set involving patient data or clinical trials. The "testing results" mentioned are non-clinical and relate to engineering and electrical safety compliance. Therefore, there is no sample size for a test set or information on data provenance in the context of clinical performance.

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. The submission focuses on non-clinical engineering and safety standard compliance, not clinical interpretation or ground truth established by medical experts for a diagnostic or treatment outcome.

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

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

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 powered muscle stimulator, not an AI-assisted diagnostic or imaging device. No MRMC study was performed or mentioned.

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

Not applicable. This device is a physical medical device, not an algorithm, and its performance inherently involves human-in-the-loop (e.g., a therapist or patient operating the device).

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

The "ground truth" in this context is adherence to recognized international electrical safety and performance standards (IEC 60601 series). These standards define acceptable electrical characteristics, safety mechanisms, and electromagnetic compatibility. The device's performance is measured against the specifications of these standards and comparison to predicate devices, rather than clinical outcomes or expert consensus on patient data.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

Not applicable, as there is no training set.

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Therapeutic Ultrasound:

• Pain relief .
• . Reduction of muscle spasms
• Localized increase in blood flow .
• Increase range of motion of contracted joints using heat and stretch techniques .

The Sonopulse Compact 1MHz is a therapeutic ultrasound device with a frequency of 1 MHz using a 7cm² transducer. The membrane panel provides both tactile and audio feedback when buttons are pressed. A guide provides a through set-up routine for the operator. The display will show which treatment has been chosen and when the output is active.

The Sonopulse Compact 3MHz is a therapeutic ultrasound device with a frequency of 3 MHz using a 7cm² transducer. The membrane panel provides both tactile and audio feedback when buttons are pressed. A guide provides a through set-up routine for the operator. The display will show which treatment has been chosen and when the output is active.

The provided document is a 510(k) summary for the Sonopulse Compact 1MHz and Sonopulse Compact 3MHz therapeutic ultrasound devices. It describes the devices' characteristics and compares them to a predicate device (Sonicator Plus 930). The submission aims to demonstrate substantial equivalence, not to prove that the device meets specific acceptance criteria through a clinical study.

Therefore, the document does not include information on acceptance criteria, reported device performance against those criteria, or a study design as typically associated with a clinical trial to prove device efficacy or safety.

Instead, the "testing results" mentioned in the document refer to non-clinical testing to ensure the device meets established safety and performance standards for medical electrical equipment.

Here's a breakdown of the requested information based on the provided text, highlighting what is not available:

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

   • Not available. The document does not specify quantitative clinical acceptance criteria (e.g., a certain percentage reduction in pain, or specific range of motion improvement) or report device performance against such criteria. The "testing results" refer to compliance with IEC standards for safety and general 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 applicable. The document describes non-clinical testing (IEC standards compliance), not a clinical trial with a "test set" of patients.

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 information pertains to studies where expert opinion is used to establish ground truth for clinical outcomes, which is not described in this document.

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

   • Not applicable.

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 is a therapeutic ultrasound device, not an AI-assisted diagnostic imaging device.

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

   • Not applicable. This refers to AI algorithms, which are not the subject of this submission.

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

   • Not applicable for clinical ground truth. The "truth" in this context is whether the device physically performs according to established engineering and safety standards (e.g., electrical safety, electromagnetic compatibility, ultrasonic output parameters).

8. The sample size for the training set

   • Not applicable. No machine learning or AI "training set" is mentioned or relevant to this submission.

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

   • Not applicable. No machine learning or AI "training set" is mentioned or relevant to this submission.

Summary of available information (Non-Clinical Testing):

The document provides information about non-clinical testing to demonstrate the safety and essential performance of the device in compliance with international standards.

• Study Type: Non-clinical testing for compliance with IEC standards.
• Standards Met:
  • IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment.
  • IEC 60601-1-2: Electromagnetic compatibility for medical electrical equipment.
  • IEC 60601-2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment.
• Testing Performed By: Implied to be by the manufacturer (IBRAMED) or a certified testing laboratory, as part of the submission for regulatory approval.
• Proof of Compliance: The submission states that "Both the subject and predicate devices comply with this standard" for each listed IEC standard.
• Goal: To demonstrate "substantial equivalence" to a legally marketed predicate device (Sonicator Plus 930) by showing similar technological characteristics and compliance with recognized safety and performance standards. The conclusion explicitly states: "The differences between the subject and predicate devices do not affect the safety or effectiveness of the proposed device."

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Neurodyn Multiwave - Indications for Use:
As a FES device:

• Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait.
  As a TENS device:
• Symptomatic relief of chronic (long term) intractable pain
• Symptomatic relief of post-traumatic acute pain and post-surgical pain
  As an Interferential and Premodulated device:
• Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
  As a Russian device:
• Temporary relaxation of muscle spasms
• Prevention or retardation of disuse atrophy in post-injury type conditions
• Increase local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
  As a Burst Modulated Alternating Current (Aussie) device:
• Temporary relaxation of muscle spasms
• Prevention or retardation of disuse atrophy in post-injury type conditions
• Increase local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
  As a Microcurrent device:
• Symptomatic relief of chronic intractable pain
• Symptomatic relief of post-traumatic acute pain and post surgical pain
  As a DC/Polarized device:
• Relaxation of Muscle Spasm

Aussie Sport - Indications for Use:
As an Burst Modulated Alternating Current (Aussie) device:

• Temporary relaxation of muscle spasms
• Prevention or retardation of disuse atrophy in post-injury type conditions
• Increase local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain

Neurodyn Multiwave and Aussie Sport Neuromuscular Stimulators are intended for the treatment of, relief of chronic (long term) intractable pain as adjunctive treatment of post-surgical and post-traumatic acute pain. Both devices have the same intended uses and incorporate the same technologies as the following predicate devices: Vectra Genisys K031077, Neurodyn/Neurpdun Aussie K121369 and 400PV Complete K021100.

The Neurodyn Multiwave Muscle Stimulator is a programmable device. It comes equipped with 5 preset clinical programs along with 10 user programs are adjustable and can be changed according to the patient's needs, doctor's recommendations and prescription settings.

The Aussie Sport Muscle Stimulator has four output channels with independent intensity controls. Thus, four different areas can be stimulated separately or together during a therapy session. It is adjustable and can be changed according to the patient's needs, doctor's recommendations and prescription settings. It generates the medium frequency alternate current(MFAC), burst modulated alternating current (Aussie)- type of sinusoidal current with a frequency carrying 1,000 Hz or 4,000 Hz and a burst duration of 4 ms or 2 ms, modulated in pulse trains (bursts) with a variable frequency from 1 to 120Hz.

The provided document is a 510(k) Summary for the Neurodyn Multiwave and Aussie Sport powered muscle stimulators. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a study with specific acceptance criteria and performance metrics for the device itself.

Therefore, the following information cannot be extracted from the document:

1. A table of acceptance criteria and the reported device performance: The document does not define specific performance acceptance criteria for the Neurodyn Multiwave or Aussie Sport devices, nor does it report their performance against such criteria. Instead, it relies on demonstrating that the device characteristics are "identical" to predicate devices.
2. Sample size used for the test set and the data provenance: No test set or associated data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No experts or ground truth establishment are discussed.
4. Adjudication method for the test set: No adjudication method is mentioned as there is no test set described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, an effect size of how much human readers improve with AI vs without AI assistance: No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance is discussed.
7. The type of ground truth used: No ground truth is specified.
8. The sample size for the training set: No training set is mentioned.
9. How the ground truth for the training set was established: No training set or ground truth establishment is discussed.

Summary of Device Comparison (as provided in the document - not an acceptance criteria table):

The document provides a "Device Comparison Table" to show substantial equivalence, not to present acceptance criteria and performance. The key points from this table are:

Conclusion: The 510(k) summary concludes that the Neurodyn Muscle Stimulators are substantially equivalent to the predicate devices based on similarities in indications for use, technological design, materials, and various performance characteristics. The argument made is that because the new devices are "identical" or sufficiently similar to cleared predicate devices, they do not raise new issues of safety or effectiveness. No specific study demonstrating the new device's performance against defined acceptance criteria is presented.

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As a TENS device:
Symptomatic relief of chronic (long term) intractable pain
Symptomatic relief of post-traumatic acute pain and post-surgical acute pain

As an Interferential and Premodulated device:
Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain

As a Russian device:
Temporary relaxation of muscle spasms
Prevention or retardation of disuse atrophy in post-injury type conditions
Increase local blood circulation
Muscle re-education
Maintaining or increasing range of motion

As an Burst modulated alternaing current (Aussie) device:
Temporary relaxation of muscle spasms
Prevention or retardation of disuse atrophy in post-injury type conditions
Increase local blood circulation
Muscle re-education
Maintaining or increasing range of motion

As a Microcurrent device:
Symptomatic relief of chronic intractable pain
Symptomatic relief of post-traumatic acute pain and post-surgical acute pain

Neurodyn and Neurodyn Aussie Neuromuscular Stimulators are intended for the treatment of, relief of chronic (long term) intractable pain as adjunctive treatment of post-surgical and post-traumatic acute pain. Both devices have the same intended uses and incorporate the same technologies as the predicate the Vectra Genisys K031077. The Neurodyn Muscle Stimulator is a programmable device. It comes equipped with 5 preset clinical programs along with 10 user protocols. The user programs are adjustable and can be changed according to the patient's needs, doctor's recommendations and prescription settings.

The Neurodyn Aussie Muscle Stimulator has four output channels with independent intensity controls. Thus, four different areas can be stimulated separately or together during a therapy session. It is adjustable and can be changed according to the patient's needs, doctor's recommendations and prescription settings. It generates the medium frequency alternate current (MFAC), burst modulated alternating current (Aussie)- type of sinusoidal current with a frequency carrying 1,000 Hz or 4,000 Hz and a burst duration of 4 ms or 2 ms, modulated in pulse trains (bursts) with a variable frequency from 1 to 120Hz.

The provided text details a 510(k) summary for the Neurodyn and Neurodyn Aussie Powered Muscle Stimulators, seeking substantial equivalence to the Chattanooga Vectra Genisys K031077. The document outlines essential performance metrics and demonstrates equivalency through non-clinical testing and comparison of device characteristics.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the typical sense of quantitative performance thresholds. Instead, it demonstrates substantial equivalence to a predicate device (Chattanooga Vectra Genisys K031077) by showing that the Neurodyn and Neurodyn Aussie devices share identical or very similar technological characteristics, intended uses, indications for use, safety, and effectiveness.

Therefore, the "acceptance criteria" are implicitly met by demonstrating this substantial equivalence through a detailed comparison, rather than by achieving specific numerical performance targets against a predefined standard.

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 describes a non-clinical test design focused on demonstrating substantial equivalence to a predicate device. This typically involves performance verification against a known, cleared device, rather than a test on a patient sample. The data provenance is derived from engineering and design specifications and testing performed by Ibramed, a company based in Brazil (Amparo - Sao Paulo - Brasil). The document does not specify whether this was a retrospective or prospective comparison, but the data itself (device specifications) would inherently be current/prospective for the new devices and historical/retrospective for the predicate device's cleared specifications.

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)

This type of information is not applicable to this submission. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate device (Chattanooga Vectra Genisys K031077). The assessment is based on comparison of technical specifications and performance against recognized standards, not on expert consensus regarding patient outcomes or diagnostic accuracy.

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

This is not applicable. There is no "adjudication" in the sense of resolving discrepancies between expert readings or interpretations. The comparison is between documented technical specifications and results of non-clinical engineering tests.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices, which is not the nature of a powered muscle stimulator. The submission focuses on demonstrating substantial equivalence of a therapeutic device based on its functional characteristics and safety.

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

This is not applicable. These are powered muscle stimulator devices, not algorithmic diagnostic tools. Their performance is inherent in their electrical output and physical characteristics, and they are operated by a human user (clinician or patient) as part of a therapeutic regimen.

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

The "ground truth" is the established safety and effectiveness of the legally marketed predicate device (Chattanooga Vectra Genisys K031077) and compliance with relevant international and national electrical safety and medical device standards (e.g., ISO 13485, IEC 60601 series). No clinical outcomes data or pathology samples were used as ground truth for this 510(k) submission.

8. The sample size for the training set

This is not applicable. As a medical device submission based on substantial equivalence to a predicate device and non-clinical testing, there is no "training set" in the context of machine learning or AI algorithms. The device design and manufacturing processes are likely informed by prior engineering knowledge and regulatory standards, but not a specific "training set" of data for an algorithm.

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

This is not applicable, as there is no training set mentioned or implied in the context of this 510(k) submission.

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