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(1) When using Electrical Muscle Stimulation (NMES), Revitive is intended:

· for users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankles/feet, NMES though the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping

• · to temporarily increase local blood circulation in healthy leg muscles
• · to stimulate healthy muscles in order to improve and facilitate muscle performance
• · to temporarily relieves 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
• · for relaxation of muscle spasm,
• · for increase of blood flow circulation.
• · for prevention or retardation of disuse atrophy,
• · for muscle re-education,
• · for maintaining or increasing range of motion, and
• · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• · Provide quadricep strengthening
• · Improve knee stability secondary to quadricep strengthening

(2) When using Revitive to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide:

• · symptomatic relief and management of chronic, intractable pain
• · relief of pain associated with arthritis

· 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 activities.

Not Found

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for the Revitive Medic Coach (Model Number 5575AQ). It outlines the device's indications for use and regulatory classifications, but does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.

Therefore, I cannot provide the requested information based on the input text.

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NMES:

• 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
• For relaxation of muscle spasm.
• Increase of blood flow circulation,
• Prevention or retardation of disuse atrophy,
• Muscle re-education.
• Maintaining or increasing range of motion,
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• For users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankles/feet, NMES through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping

TENS:

• For symptomatic relief and management of chronic intractable pain
• Relief of pain associated with arthritis
• 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 activities

Not Found

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a powered muscle stimulator (Revitive Medic Plus, Revitive Advanced 2).

It includes:

• Device Name and Regulation Information: Identifies the device, its regulation number, and product codes.
• FDA Clearance Statement: States that the device is substantially equivalent to legally marketed predicate devices.
• General Controls Provisions: Mentions various regulatory requirements like annual registration, listing, good manufacturing practice, and labeling.
• Indications for Use: Details the intended medical uses for the device (NMES and TENS applications).

However, it does not contain any information about:

1. Acceptance Criteria Table: There is no table outlining specific performance metrics and their required thresholds.
2. Reported Device Performance: No actual study results or performance data are presented.
3. Sample Sizes and Data Provenance: No details about the size of test or training sets, or where the data came from (country, retrospective/prospective).
4. Expert Ground Truth Establishment: No information about the number or qualifications of experts used for ground truthing.
5. Adjudication Method: No mention of how ground truth disagreements were resolved.
6. MRMC Study: No indication that a multi-reader multi-case study was conducted, nor any effect size for human readers' improvement with AI.
7. Standalone Performance: No results for the algorithm's performance without human intervention.
8. Type of Ground Truth: No description of whether ground truth was based on expert consensus, pathology, or outcomes data.
9. Training Set Sample Size and Ground Truth Establishment: No information about the training set or how its ground truth was established.

This document is primarily concerned with regulatory clearance based on substantial equivalence, not a detailed presentation of validation study results. To answer your request, a different type of document, such as a summary of safety and effectiveness (SSED) or a clinical study report, would be needed.

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NMES:

• 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
• For relaxation of muscle spasm,
• Increase of blood flow circulation,
• Prevention or retardation of disuse atrophy,
• Muscle re-education,
• Maintaining or increasing range of motion, and
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

TENS:

• For symptomatic relief and management of chronic intractable pain

• Relief of pain associated with arthritis

• 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 activities

Not Found

I am sorry but the provided document is a 510(k) summary for a powered muscle stimulator (Revitive Medic Plus, Revitive Advanced 2) that specifies its indications for use and classification. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or detailed performance studies.

Therefore, I cannot provide the requested information based on this document.

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· 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.

Not Found

I am sorry, but the provided text only contains an FDA 510(k) clearance letter for the Revitive Medic, Revitive MV, and Revitive LV devices. This letter confirms that the devices are substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding:

• Specific acceptance criteria for performance.
• Details of any study proving device performance against acceptance criteria.
• Sample sizes, data provenance, ground truth establishment, or expert involvement in any study.
• Any multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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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.

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