(268 days)
"EnerVive™" is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
"EnerVive™" is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the "EnerVive training programs are designed for injured or ailing muscles and it's use on such muscles is contraindicated.
The "EnerVive™' electrical impulses allow triggering action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.
The various types of muscle work that "EnerVive™ can impose on the stimulated muscles are able to improve or facilitate muscle performance. "EnerVive™ may therefore be considered a technique of muscle training.
EnerVive™ is the latest product offering from Slendertone, a division of Bio-Medical Research Ltd. It is a portable two-channel; battery operated neuromuscular electronic stimulation system. The device uses the principles of Neuromuscular Electrical Nerve Stimulation (NMES) and is intended for over the counter use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. It is not intended as a therapy for any medical condition.
The two channels may be operated independently when each lead wire is attached to the unit and to the supplied butterfly-shaped electrode pads. Detailed diagrams for correct pad placement are available as part of the instructions for use.
EnerVive™ stimulates action potentials in the motor nerves supplying muscle. Different patterns of muscle activity can be imposed on the target muscle, depending on the timing and intensity of the stimulation signal. EnerVive™ contains 6 programs for exercise warm-up, muscle performance improvement and exercise recovery.
Included in the product pack are an ergonomically designed EnerVive™ control unit, 4 adhesive pads (2 pairs), 1 x 9 volt battery (6F22), a belt clip, 2 lead wires, travel pouch and instructions for use.
The provided document describes the Slendertone EnerVive™ device, a neuromuscular electrical stimulation system. The information focuses on its regulatory submission (510(k)), comparison to a predicate device, and general safety and effectiveness.
However, the document does not contain specific acceptance criteria or a dedicated study section that outlines performance metrics with numerical results for the EnerVive™ device itself. It refers to existing research literature on Neuromuscular Electrical Stimulation (EMS) to establish the general effectiveness of the technology and mentions a further clinical data study [8] to detail the effectiveness of a dual electrode design.
Based on the provided text, I can infer some aspects and highlight what is missing:
Acceptance Criteria and Device Performance (Inferred/Missing)
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safety: Device operates without adverse events and complies with relevant electrical and medical device safety standards. | "There were no adverse events during this study." Compliance with EN 60601-1-2:2001, EN 60601-1 (1990) + A1 (1993) + A2 (1995) +A13 (1996) + Corrigenda (July 1994), D IEC 60601-2-10 (1987), and risk management to I.S. EN ISO 14971 2001 AMD 1 2003. |
| Effectiveness (General): Technology is known to facilitate or improve skeletal muscle performance. | Established by reference to "large body of research literature on EMS extending over several decades." (e.g., Alon G. 1991, Baker et al. 2000, Bax et al. 2005, etc.) |
| Effectiveness (Specific to EnerVive™ dual electrode design): Effective muscle contractions are elicited by the device's specific electrode design. | "The results showed that effective muscle contractions were elicited when a group of healthy adults used EnerVive™." |
| Technological Equivalence: Output specifications and basic unit characteristics are comparable to a legally marketed predicate device. | "Comparison in basic unit characteristics and output specifications for the device and the predicate have been compiled... Slendertone EnerVive™ uses the same technology as the predicate device i.e. low frequency pulsed electrical stimulation..." |
Study Details for EnerVive™ Dual Electrode Design (Study [8])
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Sample Size used for the test set and the data provenance:
- Sample Size: 6 subjects.
- Data Provenance: The study was performed in "Bio-Medical Research Institute, Galway, Ireland." The data is prospective as it describes a study being conducted specifically for this device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts or their qualifications for establishing ground truth in study [8]. It only lists the authors of the study: "Ciaran Byrne, MSc., Eta Tierney."
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Adjudication method for the test set:
- The document does not specify any adjudication method for the test set.
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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, an MRMC comparative effectiveness study was not conducted. This device is a muscle stimulator, not an AI-powered diagnostic device that involves human readers or AI assistance in interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not directly applicable. The device itself is a standalone (algorithm only, in the sense of an electronic circuit), but its "performance" is measured by its physical effect on human muscle, not an interpretative task where standalone performance of an algorithm would be compared to human performance. The study assesses the device's ability to elicit muscle contractions.
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The type of ground truth used:
- The ground truth for this specific study [8] appears to be direct observation/measurement of muscle contractions elicited in healthy adults due to the device's stimulation. This is inferred from the statement: "The results showed that effective muscle contractions were elicited when a group of healthy adults used EnerVive™."
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The sample size for the training set:
- The document does not mention a "training set" in the context of device development or any machine learning aspects, as this is a physical medical device rather than an AI/software algorithm that would typically have training and test sets. The studies referenced are for validating the efficacy of EMS technology and the specific design of the EnerVive™ device.
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How the ground truth for the training set was established:
- As there is no "training set" mentioned in the context of an algorithm, this question is not applicable. The underlying principle of stimulating muscle is based on decades of established physiological understanding and research, as referenced in the bibliography.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).