Search Results

The Revitive IX (OTC) is intended to be used for electrical stimulation of the muscles of the lower leg for the purposes of supporting muscle function, and improving blood circulation. In addition Revitive IX (OTC) is intended to be used for electrical stimulation of sore and aching muscles to relieve pain. The device is intended for home use for 30 minutes per treatment with a maximum of 3 hours treatment time per day as required.

Revitive IX (OTC) is indicated for:

• To temporarily increase local blood circulation in healthy leg muscles
• To stimulate healthy muscles in order to improve and facilitate muscle performance. ●
• For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties.

The Revitive IX (OTC) consists of foot pads and/or electrode pads that deliver electrical stimulation to the lower limb muscles, electrode pads may also deliver electrical stimulation to muscles in the shoulder, waist, back and arms; an optional feature that allows for ankle movement during stimulation; a remote control; dust protectors for the electrode pads; and a user interface. Replacement electrode pads are available separately under 510(k) K132588.

Revitive IX (OTC) is a neuromuscular electrical stimulation (NMES) device that applies electrical impulses that are of sufficient intensity to produce an artificial contraction of the muscle tissue. The device delivers electrical stimulation to the lower limb muscles through foot pads and/or through electrode pads which may be positioned on the lower limb, waist, back or arms. The foot pads are made of conductive black nitrile butyl rubber (NBR) containing carbon, while the electrode pads are made from conductive carbon film coated with an adhesive hydrogel on a cloth backing. It has an optional IsoRocker™ feature that allows ankle movement during stimulation. When enabled, the lsoRocker™ allows Revitive IX (OTC) to tilt back and forth as the muscles contract and relax. The main body of the device is constructed from ABS plastic.

The Revitive IX (OTC) is intended for multiple uses in the home environment and is not provided sterile. The software included in the device controls the pulses generated by the device to stimulate the muscle. The software allows the device to generate various different shapes of pulses with different repetition rates, duration and magnitude. The Revitive IX (OTC) utilizes standard household AC/DC power supply with a 5V DC power adaptor.

The provided text describes the Revitive IX (OTC) device and its substantial equivalence to predicate devices, focusing on safety and performance, but it does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria.

The document is a 510(k) summary for an Over-The-Counter (OTC) powered muscle stimulator (Revitive IX), and typically these submissions demonstrate substantial equivalence to legally marketed predicate devices rather than proving performance against specific acceptance criteria for an AI algorithm.

However, I can extract the information that is present concerning performance testing and usability studies:

1. Table of Acceptance Criteria and Reported Device Performance

As stated, the document does not explicitly list "acceptance criteria" in the typical sense of a target performance metric for an AI system (e.g., sensitivity, specificity, AUC). Instead, it refers to compliance with safety and biocompatibility standards and successful usability testing.

The following information is NOT present in the provided text, as it pertains to AI/algorithm performance studies which are not described for this device.

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 (N/A) as no AI performance study is described.
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): N/A.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A.
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: N/A.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A.
8. The sample size for the training set: N/A.
9. How the ground truth for the training set was established: N/A.

Summary of what is available from the document:

The document describes performance data primarily related to meeting established medical device safety, EMC, and biocompatibility standards (e.g., ISO and EN standards). A usability study was also conducted to demonstrate safe and effective operation by intended users in a home environment for OTC use, following FDA human factors draft guidance. The device is a "Powered Muscle Stimulator" and the "software included in the device controls the pulses generated by the device to stimulate the muscle." However, this software is for device function control, not for an AI-driven diagnostic or treatment recommendation system that would typically have the AI-specific performance metrics requested. The submission is a 510(k) for substantial equivalence, implying that its safety and effectiveness are established by comparison to existing legally marketed predicate devices, supported by compliance with relevant standards and usability testing.

Ask a specific question about this device

The Revitive IX is indicated for:

• Relaxation of muscle spasms; .
• Prevention or retardation of disuse atrophy; ●
• Increasing local blood circulation; .
• Muscle re-education; .
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and .
• Maintaining or increasing range of motion. .

The Revitive IX consists of foot pads and/or electrode pads that deliver electrical stimulation to the muscles; an optional feature that allows for ankle movement during stimulation (IsoRocker); a remote control; and a user interface.

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and the supporting study:

The provided 510(k) summary for the Actegy's Revitive IX does not contain specific acceptance criteria or a dedicated study explicitly designed to prove the device meets pre-defined performance acceptance criteria in the way typically found for novel diagnostic algorithms or complex medical devices requiring clinical efficacy studies.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics, intended uses, and safety standards. The performance data mentioned refer to general safety and functional testing, not to specific clinical performance metrics with pre-defined acceptance thresholds.

Therefore, many of the requested fields cannot be directly answered from the provided text. I will address what information is available and indicate where information is absent.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this 510(k) is primarily centered around safety, electromagnetic compatibility, biocompatibility, and functional equivalence to the predicate device. There are no specific quantitative clinical performance metrics (like sensitivity, specificity, accuracy, etc.) provided in relation to the stated indications for use.

Study Details (Based on the provided text)

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

   • Sample Size: Not applicable/Not specified. This was not a study involving a "test set" of patients or data in the context of diagnostic or clinical performance. The "performance data" refers to engineering and safety verification.
   • Data Provenance: Not applicable/Not specified.

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

   • Not applicable. There was no "ground truth" to establish for a test set in a clinical performance context. The assessment was against engineering specifications and regulatory standards.

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

   • Not applicable. No test set for clinical performance was evaluated this way.

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. This device is a muscle stimulator, not an AI-powered diagnostic or assistive tool for human readers.

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

   • Not applicable as this is a physical medical device for muscle stimulation, not an AI algorithm. Its performance is measured directly by its electrical output and safety, not as an algorithm's classification accuracy.

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

   • Not applicable in the clinical sense. The "ground truth" for the performance data mentioned would be the relevant engineering standards (e.g., EN60601-1-2 for EMC) and the device's design specifications for electrical output and safety characteristics.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

   • Not applicable.

Summary of the Study:

The "study" or "performance data" referred to in the 510(k) submission for the Revitive IX comprises standard engineering and regulatory compliance testing. This includes:

• Biocompatibility testing: To ensure the materials in contact with the patient are safe.
• Electromagnetic compatibility (EMC) testing (EN60601-1-2:2007): To ensure the device operates correctly in its electromagnetic environment and does not interfere with other devices.
• Electrical Safety testing (EMDD (93/42EEC), UL 60601-1, CSA C22.2 No.601-1-M90): This covers aspects like patient leakage current, enclosure leakage current, and insulation.
• Functional performance verification: Confirming that the device's electrical output parameters (frequency, pulse type, voltage range) and operational features (channels, modes, controls) align with its design specifications and are comparable to the predicate device.

The overarching goal of these tests was to demonstrate that the Revitive IX is as safe and effective as its predicate devices and that its minor technological differences do not raise new issues of safety or effectiveness, thus justifying a finding of substantial equivalence. There was no clinical trial or algorithm performance study described in the provided document.

Ask a specific question about this device