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The DEKA SIMON device is intended for

• Prevention or retardation of disuse atrophy
• Maintaining or increasing range of motion
• Muscle re-education
• Relaxation of muscle spasms
• Increasing local blood circulation
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

The DEKA SIMON is a device provided with 4 applicators by 2 electrodes each intended to employ EMS (Electrical Muscle Stimulation) technologies for various medical applications.
The DEKA SIMON consists of:

• an AC/DC power supply unit,
• EMS driving electronic board
• CPU controller;
• user interface with LCD touch screen,
• 4 EMS applicator with interconnecting cables
  The modifications to the device consist of a restriction of indications for use (removal of TENS mode), a restyling of the device (chassis, cover plastics and GUI) and of modifications to the applicator (different dimensions).
  The indications for use of the modified device, as described in the labelling, has been restricted to those referred to EMS mode only as a result of the modifications. Labelling itself has been updated also to include general improvements that have been implemented since predicate device clearance and considered as minor changes.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested. The document is a 510(k) summary for the DEKA SIMON device, primarily focused on establishing substantial equivalence to a predicate device (DEKA PHYSIQ, K202079).

It discusses the device's technical specifications and how they compare to the predicate, and lists the types of performance data submitted (Electrical safety and electromagnetic compatibility, Software Validation and Verification Testing) and the standards followed. However, it does not provide:

• A table of acceptance criteria and reported device performance specifically for a clinical or performance study.
• Sample size used for a test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications.
• Adjudication method.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results from a standalone (algorithm only) performance study.
• Type of ground truth used.
• Sample size for a training set.
• How ground truth for the training set was established.

The "Performance Data" section solely lists the types of engineering and software tests conducted for safety and essential performance, not clinical or performance studies for effectiveness. The conclusion states that the device is "as safe, as effective, and performs as well as the legally marketed predicate device (K202079)" based on technological characteristics and indication for use comparison, implying that no separate clinical performance study was deemed necessary for demonstrating substantial equivalence for this particular modification (a Special 510(k)).

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