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Arasys Genius is intended for muscle conditioning to stimulate healthy muscles. The Arasys Genius is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the Arasys Genius programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The Arasys Genius is only offered under prescription given by a physician licensed in the state in which he or she practices. The Arasys Genius is intended to be operated by a trained professional who is always present to monitor treatment.

The Arasys Genius has the exact same technological characteristics, the same number of channels and the exact same frequencies as the predicate. Arasys Genius is made by UV Innovations by the same engineers and technicians that make the lon Magnum Genius K12315B. Arasys Genius has the exact same technology of the predicate, lon Magnum Genius K123158 with the exceptions. The Arasys Genius is a muscle stimulator with six ports just like the predicate and one output that is the same for all ports just like the predicate. The unit is designed for healthy men & women to provide muscle conditioning. Arasys Genius stimulator provides selections of different programs through manual adjustment of the three different frequencies of the device, 90 Hz, 100 Hz, in an identical fashion as the predicate. The Arasys Genius maximum output current is 100 ma which is equivalent to the maximum output current of the predicate. The Arasys has a maximum output voltage of 200 volts which is equivalent to the maximum output voltage of the predicate. An LCD display shows the balance treatment time in the same fashion as it happens with the predicate. The output signal is biphasic, rectangular and based on a voltage and current regulated technology as it does in the predicate. The unit is easy and simple to use. The Arasys has an identical indication for use just like the predicate as it is intended for muscle conditioning to stimulate healthy muscles. The Aras is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the Arasys Genius programs is designed for ailing muscles and its use on such muscles is contraindicated. The Arasys Genius is only offered under prescription given by a physioian licensed in the state in which he or she practices.

The Arasys Genius (K132179) device's acceptance criteria and the study proving it meets these criteria are described below:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document establishes substantial equivalence of the Arasys Genius to a predicate device, the Ion Magnum Genius (K123158), rather than setting specific acceptance criteria for a new type of performance. The acceptance criteria are, therefore, based on demonstrating that the Arasys Genius's technical characteristics, indications for use, and safety and effectiveness aspects are "equivalent" to those of the predicate device.

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

The provided document describes a 510(k) Premarket Notification for a muscle stimulator. This type of submission generally relies on demonstrating substantial equivalence to a previously legally marketed device (predicate device) rather than conducting new clinical trials with a test set of patients to prove efficacy and safety from scratch.

Therefore, there is no specific "test set" sample size in the traditional sense of a clinical study for product performance validation mentioned here. The device's performance is not demonstrated through a separate clinical trial on a patient cohort for this submission. Instead, the performance is inferred by demonstrating that its technical specifications and other characteristics are equivalent to the predicate device.

The data provenance for the information presented is the technical specifications and design choices of both the Arasys Genius and the predicate device (Ion Magnum Genius K123158), as well as compliance with relevant standards (e.g., IEC 60601-1:2005) and previous FDA clearances for components (e.g., K970426 for electrodes). This represents retrospective data derived from the design and manufacturing of the devices. The source is the manufacturer's internal documentation and comparisons. The country of origin for the manufacturing facility for Ion Genius, Inc. is the UK (UV Innovations Ltd, Enfield, Middlesex).

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

As explained above, this submission relies on substantial equivalence rather than a new clinical study with a "ground truth" derived from expert assessment of patient data. Therefore, no experts were explicitly used to establish ground truth for a test set in this context. The "ground truth" for the comparison is the established performance and safety profile of the predicate device, accepted by the FDA based on its own prior regulatory clearance (K123158).

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

Since there is no "test set" clinical study described, there was no adjudication method for a test set. The regulatory review process for 510(k) submissions involves the FDA reviewing the manufacturer's documentation and claims of substantial equivalence.

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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This type of study is not relevant to demonstrating substantial equivalence for a powered muscle stimulator in this context, especially as the device does not involve "human readers" or "AI assistance" in interpreting medical images or data.

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

No standalone algorithm performance study was done. The device is a hardware electrical muscle stimulator, not an algorithm, and its operation inherently involves a trained professional (human-in-the-loop).

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

The "ground truth" in this context is the established regulatory clearance and documented specifications of the predicate device, Ion Magnum Genius (K123158). The Arasys Genius demonstrates substantial equivalence by showing that its design, technical characteristics, materials, and intended use are identical or equivalent to this predicate, which has already been deemed safe and effective for its intended use by the FDA. There is no new clinical outcomes data or pathology review presented for the Arasys Genius in this submission to establish a new ground truth.

8. The sample size for the training set:

There is no "training set" sample size mentioned or implied in this 510(k) submission. Training sets are typically associated with artificial intelligence or machine learning model development. This device is an electrical muscle stimulator, and its development does not involve machine learning.

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

As there is no training set for an AI/ML model, this question is not applicable.

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Ion Magnum Genius is intended for muscle conditioning to stimulate healthy muscles. The Ion Magnum Genius is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Ion Magnum Genius programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The Ion Magnum Genius is only offered under prescription given by a physician licensed in the state in which he or she practices.

Ion Magnum Genius is a muscle stimulator with six ports and one output that is the same for all ports. The unit is designed for healthy men & women to provide muscle conditioning. Ion Magnum Genius stimulator provides selections of different programs through manual adjustment of the three different frequencies of the device, 90 Hz, 100 Hz which are within the same range as the predicate that offer a range from 1-120 Hz. The setting that the frequency button is turned shows which frequency the device is set on. The device delivers a voltage of 50 volts at 500 Ohms load and 100ma just like the predicate. It delivers a voltage of 200 volts at 10K Ohms just like the predicate. The Ion Magnum maximum output current is 100 ma which is equivalent to the maximum output current of the predicate. The Ion Magnum has a maximum output current of 200 volts which is equivalent to the maximum output current of the predicate. The device primarily treats abdominal muscles (ABS). LCD shows the balance treatment time. The output signal is biphasic, rectangular and based on a voltage and current regulated technology. The unit is easy and simple to use. Ion Magnum is suitable for use by all healthy adults. However as with other muscle stimulators some care is needed when using the Ion Magnum Genius [see contraindications and warnings in manual]

The provided text describes a 510(k) premarket notification for the "Ion Magnum Genius" muscle stimulator, asserting substantial equivalence to a predicate device, the "Compex Sport" (K01180). This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than conducting new clinical trials to prove efficacy from scratch. Therefore, the document does not describe a study that proves the device meets specific acceptance criteria in the way a clinical trial would. Instead, it focuses on demonstrating equivalence to a known device.

However, I can extract the relevant information from the document that functions as acceptance criteria for demonstrating that the device is "substantially equivalent" and the "reported device performance" to meet those criteria.

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

Acceptance Criteria and Device Performance (Demonstration of Substantial Equivalence)

Since this is a 510(k) submission, the "acceptance criteria" are effectively the characteristics of the predicate device, and the "reported device performance" is how the Ion Magnum Genius compares to these characteristics to establish substantial equivalence.

1. Table of acceptance criteria and the reported device performance:

Missing Information (Not provided in the document for this type of submission):

The following information is typically associated with clinical trials or specific performance studies, which are generally not required for a 510(k) submission when substantial equivalence is established through comparison to a predicate device. The document does not describe such studies.

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 as no clinical test set is described. The comparison is primarily based on technical specifications and claims of physical characteristics.

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. Ground truth, in the context of clinical studies, is not established for this 510(k) submission.

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, as this device is a muscle stimulator, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.

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

• Not applicable, as this device is a physical muscle stimulator and does not involve "algorithm only" performance separate from its physical application. The entire device performance is akin to "standalone" in that it performs its function. Some technical bench tests are mentioned (e.g., current leakage, electrical outputs) but these are for device specification verification, not a clinical efficacy trial.

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

• Not applicable in the clinical sense. The "ground truth" here is the technical specifications and established safety/efficacy profile of the predicate device. The Ion Magnum Genius demonstrates "truth" by having equivalent (or improved, i.e., current leakage, safety design changes) technical specifications.

8. The sample size for the training set

• Not applicable, as no machine learning/AI training set is described.

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

• Not applicable.

Summary of "Proof" in a 510(k) Context:

The "study that proves the device meets the acceptance criteria" in this 510(k) submission is the comprehensive comparison table and discussion of technological characteristics and intended use against the predicate legally marketed device. The manufacturer (Ion Genius, Inc.) asserts and demonstrates through specification comparison, and in some cases, risk assessment (e.g., for 6 channels vs. 4), that the Ion Magnum Genius is substantially equivalent to the Compex Sport, which is legally marketed and presumed safe and effective for its intended use. The FDA's issuance of the 510(k) clearance (K123158) confirms this finding of substantial equivalence based on the provided information.

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