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System-Arms, Type 390, Model E60 is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation ("EMS") through skin contact electrodes for the purpose of exercising the muscles of the upper arms.

Indications for use: Toning of the triceps muscles of the upper arms.

System-Arms, Type 390, Model E60 is intended for over-the-counter use.

System-Arms, Type 390, Model E60 is a two-channel, battery powered muscle stimulation system. The System-Arms accessory pack consists of two arms garments (left and right arm), four straps, a pack of 4 adhesive backed gel based electrodes, instructions for use (manual and separate quick start guide) and a carry pouch. The hand-held control unit, which may be purchased separately, is interchangeable between all the System models from Slendertone® range of garments (i.e. System-Abs Type 390, Model E10/X10, System-Shorts Type 390, Model E20, System-Mini, Type 390, Model E30 and System Arms Type 390, Model E60).

The four equal sized electrodes (approx. size 50 x 50 mm) are attached to the inner surface of the garments to cover stainless steel studs by using the electrode outlines to ensure correct placement. The garments are connected to the control unit by leads and an over-molded SATA 7-pin connector, which also incorporates the EEPROM (ID chip) device.

As with the predicate System-Abs, 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 combination, the data is read, identifying the specific garment type and also the stimulation parameters. The appropriate signals are then delivered to the garment electrodes. Three programs in total (beginner, intermediate and advanced) are available to the System-Arms user. All internal connections are over-molded to prevent moisture ingress and the user has no access to the wiring or connectors within the garments 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-Abs, System-Arms cannot be used when charging.

For purposes of hygiene, the garment may be cleaned and instructions for device care are included in the user manual

Acceptance Criteria and Study Details for System-Arms, Type 390, Model E60

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria for the device beyond the successful completion of a clinical trial demonstrating efficacy and compliance with referenced safety standards. However, the overall acceptance criterion for this 510(k) submission is "Substantial Equivalence" to the predicate device, System-Abs, Type 390, Model E10/X10.

• EN 60601-1-2:2001 (Electromagnetic compatibility)
• CISPR 22:2003 & CFR 47 Part 15:2005 (Radio disturbance)
• DIN EN 60601-1:1996; EN 60601-1:1990+A1:1993+A2:1995; 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 (Safety of nerve and muscle stimulators)
• Battery Charger complies to safety standards IEC 60950 and UL 1950.
  The manufacturer is registered to IS EN ISO 13485:2003. |
  | Effectiveness: Demonstration of "toning of the triceps muscles of the upper arms." | A single-blind, prospective, randomized, controlled trial titled "The effect of triceps brachii electrical muscle stimulation training on muscle strength, arm anthropometrics, triceps brachii skinfold and psychometric measures" was conducted. The study concluded that the proposed device, System-Arms, "delivers effective toning component of the therapy." (Specific quantitative results, such as percentage improvement in muscle strength, firmness, or tone, are not detailed in this summary.) |
  | Substantial Equivalence: Similar technological characteristics and intended use to a legally marketed predicate device. | The device is deemed substantially equivalent to System-Abs, Type 390, Model E10/X10. Both devices use identical electronic hardware. The principal physical differences are the garment type, and the number, size, and positioning of the electrodes, which are adapted to target different muscle groups (upper arms vs. abdomen). The predicate device was shown to be effective for the improvement of strength, firmness, and tone of the abdominal muscles. The System-Arms device demonstrated effective toning for the triceps. |

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify the exact number of participants in the clinical trial. It only states that a "single-blind, prospective, randomized, controlled trial" was conducted.
• Data Provenance: The trial was prospective. The country of origin of the data is not explicitly stated, but given the manufacturer's location in Ireland and the European Union's CE mark mentioned, it's plausible the study was conducted in Europe.

3. Number of Experts and Qualifications for Ground Truth

• The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication Method

• The document does not specify an adjudication method for the clinical trial results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done as this device is a muscle stimulator and not typically evaluated using MRMC studies. The study described is a clinical trial assessing the device's direct effect on muscle toning/strength.

6. Standalone (Algorithm Only) Performance

• Not applicable. This device is a muscle stimulator used directly by the human, so there isn't a "standalone algorithm" performance that would be evaluated outside of human interaction. The clinical trial assesses the device's performance when applied to human users.

7. Type of Ground Truth Used

• The ground truth in the clinical trial appears to be established through objective measures such as "muscle strength, arm anthropometrics, triceps brachii skinfold" and "psychometric measures." These are direct measurements of physiological and perceived effects, rather than expert consensus on an image or pathology.

8. Sample Size for the Training Set

• Not applicable. This is a hardware device (muscle stimulator) that does not involve a "training set" in the context of machine learning algorithms. The device's programs (beginner, intermediate, advanced) are pre-programmed and are not "trained" on data supplied by the user during operation.

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

• Not applicable. As stated above, there is no "training set" in the context of machine learning for this device. The device's parameters are likely based on established physiological principles of electrical muscle stimulation and potentially prior research or development from the manufacturer.

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