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"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)

Study Details for EnerVive™ Dual Electrode Design (Study [8])

1. 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.

2. 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."

3. Adjudication method for the test set:

   • The document does not specify any adjudication method for the test set.

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, 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.

5. 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.

6. 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™."

7. 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.

8. 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.

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System from Slendertone is intended for use by healthy persons to apply trans-cutaneous electrical muscle stimulation (EMS) through skin contact electrodes. Indications for used are as follows:

System-Abs, Type 390, E10/X10

• The improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.

System-Shorts, Type 390, E20

• Strengthening, toning and firming of the bottom and thigh region.

System-Abs and System-Shorts are the newest product offerings from Slendertone (division of Bio-Medical Research Ltd.). The products include an interchangeable, rechargeable handheld controller, which can be used with a garment from the System range, to exercise specific areas of the body. The System-Abs belt is used to exercise the abdominal muscles and the System-Shorts is used to exercise the bottom and thigh muscles.

The overall product consists of a garment (shorts for System-Shorts and belt for System-Abs), control unit, a pack of adhesive backed gel based electrodes (6 for System-Shorts and 3 for System-Abs), battery charger and instruction manual.

System is a two-channel EMS product and offers 7 programs to the user of the belt and 4 programs to users of the shorts. Electrodes are applied to the inner surface of the garment to cover the silver studs and the garment is fitted (sizing options are given for a best fit) using the hook and loop patches. Each System garment contains an ID chip, which is programmed to determine the different model types and treatment parameters and is connected to the electronic controller unit via a lead and connector. The control unit generates the required stimulation signals and the garment connects these signals to the skin electrodes. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit.

There is no current passed from side to side. Because the user has no access to the wiring or connectors within the garment, he/she cannot alter the current path and so the possibilities for misuse are greatly reduced.

The product cannot be used whilst in charge mode.

Materials:
(Belt): Outer -100% Nylon, Binding - 82% Nylon, 18% Elastane, Hook and Loop - 100% Nylon, Foam -- 100% Polyurethane

(Shorts): Outer -100% Nylon, Binding - 82% Nylon, 18% Elastane, Hook and Loop - 100% Nylon, Non-Elastic Hook and Loop - 100% Polyethylene, Foam - 100% Polyurethane, Stitch String - 100% Nylon.

This document is a 510(k) summary for muscle stimulator devices (System-Abs and System-Shorts). It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and conducting a new study to prove device performance against those criteria.

Therefore, the requested information elements related to specific acceptance criteria, a study proving performance against them, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable or not provided in this document.

However, I can extract information regarding the clinical and non-clinical tests that were performed to support substantial equivalence, which is a form of demonstrating safety and effectiveness.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as new, quantitative performance criteria for the proposed devices. The acceptance criteria for this submission revolve around demonstrating substantial equivalence to the predicate devices and compliance with relevant safety standards.
• Reported Device Performance: The document does not present new performance data for improvement of muscle tone or strengthening from the proposed devices themselves. Instead, it relies on the clinical information submitted for the predicate devices to support the stated Indications for Use.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not applicable. No new clinical studies were conducted for the proposed devices. The submission leverages previous clinical information.
• Data Provenance: The clinical information is from the original predicate submissions (K010335 for Slendertone Flex, Type 512, and K022855 for Slendertone Flex Bottom and Thigh Toning System, Type 511). The document does not specify whether these predicate studies were retrospective or prospective, or their country of origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable. No new clinical studies or ground truth establishment processes are described for the proposed devices.

4. Adjudication Method:

• Not applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

• No. This type of study is not relevant to a muscle stimulator device and was not performed.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done:

• Not applicable. These are physical muscle stimulator devices, not AI algorithms.

7. The Type of Ground Truth Used:

• For the predicate devices' clinical information, the "ground truth" would have been objective measurements of muscle tone/strength improvement or subjective assessments by participants or clinicians. The document does not detail the specific methodology for ground truth establishment for the predicate studies.

8. The Sample Size for the Training Set:

• Not applicable. No "training set" in the context of an algorithm.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable.

Summary of what was reported to demonstrate safety and effectiveness for the proposed devices in this 510(k) submission:

• Clinical Tests:
  • No new clinical studies were submitted.
  • The submission relies on clinical information from the original predicate submissions (K010335 and K022855) to support the Indications for Use.
• Non-Clinical Tests:
  • The proposed devices (System-Abs and System-Shorts) were designed and independently tested to comply with several international electrical safety and electromagnetic compatibility (EMC) standards:
    • EN 60601-1-2:2001 (Medical electrical equipment - EMC)
    • CISPR 22:2003 & CFR 47 Part 15:2005 (Radio disturbance characteristics)
    • DIN EN 60601-1:1996; EN 60601-1:1990+A1:1993+A2:1995 (General requirements for safety)
    • IEC 60601-1:1988, IEC 60601-1/A1:1991, IEC 60601-1/A2:1995 (General requirements for safety)
    • DIN EN 60601-2-10; IEC 60601-2-10 (Particular requirements for nerve and muscle stimulators)
    • Battery Charger complies with IEC 60950 and UL 1950 (Safety standards for information technology equipment, which the charger falls under).
• Risk Management:
  • A risk management plan was carried out according to EN ISO 14971:2001.
• Quality System:
  • Bio-Medical Research Ltd. is registered to IS EN ISO 13485:2003 (Quality management systems for medical devices).
• CE Mark:
  • The devices are CE marked in Europe and comply with the Medical Device Directive 93/42/EEC.

Conclusion:

This 510(k) submission primarily demonstrates substantial equivalence through a comparison of technological characteristics to predicate devices and adherence to recognized safety and EMC standards. It explicitly states that no new clinical studies were performed for the proposed devices, relying instead on the clinical evidence of the predicate devices. Therefore, a direct answer to "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of new clinical performance data is not provided in this document.

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