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The NESS L300 Foot Drop System is intended to provide ankle dorsiflexion in individuals (adults and pediatrics) who have foot drop following an upper motor neuron injury or disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot. The NESS L300 may improve gait, facilitate muscle re-education, prevent or retard disuse atrophy, maintain or increase joint range of motion, and increase local blood flow.

The L300 Foot Drop System consists of Control Unit and Intelli-Sense Gait Sensor.

I'm sorry, but this document does not contain the information requested regarding acceptance criteria and studies proving the device meets those criteria. The provided text is a 510(k) Summary and an FDA clearance letter for the Bioness L300 Foot Drop System, focusing on its substantial equivalence to predicate devices and expanded indications for use. It outlines the device description, indications for use, and regulatory information, but does not detail specific performance acceptance criteria or the results of a study designed to demonstrate them.

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The NESS L300 is intended to provide ankle dorsiflexion in individuals with drop foot following an upper motor neuron injury or disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot; thus, it may improve the individual's gait. The NESS L300 may also facilitate muscle reeducation, prevent/retard disuse atrophy, maintain or increase joint range of motion and increase local blood flow.

The NESS L300 neuroprosthesis device consisting of a heel sensor, control unit (waist mounted or neck strap or in pocket) and below the knee orthosis containing electrodes and a controlled stimulation unit. The heel sensor detects "heel off" and "heel contact" events during gait. It transmits signals to the stimulator, which initiates/ pauses the stimulation accordingly, thus activating the foot Dorsiflexors to ensure proper foot clearance during the swing phase, and proper foot placement during the stance phase. The NESS L300 comprises of 4 main parts: 1. A lower leg orthosis with integrated stimulation unit (stimulator) and electrodes, RF communication and rechargeable battery. 2. A waist mounted (or in-pocket) control unit (CU), including a PDA interface, RF communication and AAA rechargeable battery. 3. Foot sensor, with RF communication and non-rechargeable coin battery. 4. PDA HP iPAQ hx4700 Pocket PC. The PDA is intended to be used by the clinician for configuring the control unit with the functional parameters as appropriate for every patient.

The provided text is a 510(k) summary for the NESS L300 device, which is an external functional neuromuscular stimulator. The document declares substantial equivalence to predicate devices and outlines the device's technical specifications and indications for use.

However, the provided text does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, or details such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for either training or test sets.

The document states: "The evaluation of the NESS L300 does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate device." This implies that the device was deemed equivalent based on its design and intended use being similar to already cleared devices, rather than through a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria.

Therefore, I cannot provide the requested table and detailed information based on the given input because the necessary data is not present in the provided 510(k) summary. The summary is focused on establishing substantial equivalence, not on detailing a performance study with specific quantitative results against acceptance criteria.

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