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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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Aerosure is indicated for use as a Positive Expiratory Pressure (PEP) Device.

• · The use of Aerosure improves clearance of secretions
• · The use of Aerosure may reduce the need for postural drainage
• Aerosure facilitates opening of airways in patients with Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems
• · Aerosure may be used to prevent or reverse atelectasis
  · Aerosure may also be useful in the removal of mucus from the lungs of patients who have chronic bronchitis or bronchiectasis

Aerosure is intended for patients age 21 and above with Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems, and patients with atelectasis. All patients must be capable of following instructions for Positive Expiratory Pressure Therapy.

Aerosure may be used in hospital as well as the home after a period of training.

Aerosure is a small, battery powered device. It produces a rapidly alternating occlusion of airflow as a user breathes through the replaceable valve head (containing the powered rotating vane mechanism) which creates a general increase in resistance to breathing and a vibration of the respiratory tree and the associated structures, including the musculature. Frequency is adjusted by switching modes.

The provided document is a 510(k) summary for the Aerosure Medic device. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for clinical performance.

Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth establishment cannot be directly extracted from this document.

However, I can provide the available information based on what is presented:

Acceptance Criteria and Reported Device Performance

The document states that a variety of performance tests were conducted, and the device "functioned as intended" and "met its specifications." It also notes that performance bench test data demonstrated the Aerosure Medic is "substantially equivalent" to predicate devices and has "directly comparable basic characteristics and substantially similar output specifications." Crucially, it highlights that human factors and usability testing concluded the device is "reasonably safe and effective for the intended users, uses and use environments."

General Acceptance Criteria (Implied / Stated):

Missing Information (Not Present in the Document):

Due to the nature of this 510(k) summary, the following specific details are not provided:

1. Sample size used for the test set and the data provenance: The document mentions "performance data," "functional testing," "bench testing," and "usability testing," but it does not specify sample sizes for any of these tests or the data provenance (e.g., country of origin, retrospective/prospective).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed clinical performance results and ground truth establishment involving human experts are not described in this regulatory submission for substantial equivalence.
3. Adjudication method for the test set: Not applicable for the type of testing described (which is primarily bench, safety, and usability).
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device, and no MRMC study or AI components are mentioned.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm-only device; it's a physical medical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the tests described would be objective measures against engineering specifications, safety standards, and usability criteria. There is no mention of clinical ground truth (like pathology or outcomes) as a basis for device performance in this submission.
7. The sample size for the training set: Not applicable, as this is not a machine learned AI device.
8. How the ground truth for the training set was established: Not applicable.

Summary of Study Information (Based on Document):

• Type of Studies: Biocompatibility, Electromagnetic Compatibility, Medical Device Safety, Cleaning & Ingress Protection, Functional Testing, Bench Testing (comparison to predicates), and Usability/Human Factors Testing.
• Purpose of Studies: To demonstrate that the Aerosure Medic "functioned as intended," "met its specifications," is "substantially equivalent" to predicate devices, and is "reasonably safe and effective" for its intended users and uses.
• Methodology for Usability Testing: Followed FDA's human factors draft guidance for industry entitled, "Applying Human Factors and Usability Engineering to Optimize Medical Device Design (June 22, 2011)."

The document primarily serves to demonstrate that the Aerosure Medic's technological characteristics and performance are substantially equivalent to existing, legally marketed predicate devices, thereby supporting its 510(k) clearance for marketing.

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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.

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