(70 days)
System-Mini, Type 390, Model E30 is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation ("EMS") through skin contact electrodes for the purpose of exercising the gluteal muscles. Proposed indications for use are: Strengthening, toning and firming of the bottom. System-Mini, Type 390, Model E30 is intended for over-the-counter use.
System-Mini, Type 390, Model E30 is a two-channel, battery powered muscle stimulation system. It consists of a skirt-shaped garment which is available in small (24-38"), medium (36-45") and large (40-48") sizes for best fit, a pack of 4 electrodes and instructions for use and is used with the Slendertone® System rechargeable handheld control unit which may be purchased separately or used from an existing Slendertone® System device i.e. System-Abs, Type 390, E10/X10 or the predicate System-Shorts, Type 390, Model E20. The four equal sized electrodes (6 cm x 15 cm) are attached to the inner surface of the garment to cover stainless steel studs by using the electrode outlines to ensure correct placement. The garment is connected to the control unit by a lead and an over-molded SATA 7-pin connector, which incorporates an EEPROM (ID chip) device. As with the predicate System-Shorts, the ID chip contains the data that identifies the garment type and the stimulation parameters intended for that garment. The model number of the garment itself is displayed on the LCD at power-on and on a label on the garment. When the control unit is connected to the garment, the data is read, identifying the specific garment type and also the stimulation parameters. The appropriate signals are then delivered to the garment electrodes. There are four programs in total available to the System-Mini user and these are designated as "beginner", "intermediate", "advanced" and "expert". All internal connections are over-molded to prevent moisture ingress. The user has no access to the wiring or connectors within the garment and is unable to alter the current path. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit. As with the predicate System-Shorts, System-Mini cannot be used when in charge mode. For purposes of hygiene, the garment may be cleaned and instructions for belt care are included in the user manual.
The provided document details a 510(k) submission for the System-Mini, a muscle stimulator, and does not contain information about acceptance criteria or a study proving the device meets said criteria. The document focuses on demonstrating substantial equivalence to a predicate device (System-Shorts) rather than presenting performance metrics against predefined acceptance criteria.
The submission states: "No new clinical studies have been submitted as part of this Premarket Notification." Instead, the manufacturer relies on the equivalence to the predicate device, which was previously shown to be effective.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study, or effect size.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily addresses the technological characteristics, intended use, and a comparison to the predicate device to justify substantial equivalence for regulatory approval.
§ 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).