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The NESS Children System is intended for pediatric use for the following indications: maintenance or increase of range of motion, reduction of muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation.

The NESS Children System is a portable, one-channel electrical neuromuscular stimulator for personal use. The stimulator, which is powered by rechargeable nickel-cadmium batteries, serves surface electrodes held on to the limb by a splint. A selection of four splints for the hand and forearm, the arm, the thigh, or the leg is provided in three sizes each to fit children dimensions. A single channel of constant-voltage symmetrical biphasic Russian waveform stimulation is delivered to the muscles through surface electrodes. Microprocessor-controlled switching of the stimulation between these electrodes allows the muscles to be activated in combinations either cyclically or continuously. The stimulation is ramped up at the beginning and down at the end of each cycle. The electrode locations allow the NESS Children System to provide extension and flexion of the limb segment distal to that of the splint. The user can select from five stimulation programs by pressing the mode button on the control unit and can increase or decrease the stimulation intensity in ten discrete levels.

The provided document is a 510(k) summary for the NESS Children System, which is a powered muscle stimulator. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through a clinical trial or algorithm evaluation.

Instead, the document focuses on regulatory aspects for device clearance, specifically demonstrating substantial equivalence to a predicate device (NESS System, K022776). The core of a 510(k) submission is to show that a new device is as safe and effective as a legally marketed predicate device, not necessarily to prove it meets specific performance metrics against a defined set of acceptance criteria through a dedicated study with the elements you requested.

Therefore, I cannot populate the table or answer most of your questions based on the provided text. The document refers to "Performance Standards" but states "No performance standards have been established for powered muscle stimulators under section 514 of the FDC Act. No special controls apply." This further indicates that the 510(k) process for this device did not involve predefined performance acceptance criteria and a study to meet them in the way you've described for, for example, an AI/ML device.

Here's how I would respond to your request based only on the provided text, highlighting what is missing:

Acceptance Criteria and Device Performance Study for NESS Children System

The provided 510(k) summary for the NESS Children System does not include specific acceptance criteria or an efficacy study demonstrating quantitative performance against such criteria. The submission focuses on demonstrating substantial equivalence to a predicate device (NESS System, K022776) for regulatory clearance. This regulatory pathway typically relies on comparison to a legally marketed device rather than on meeting pre-defined quantitative performance metrics through a dedicated clinical study with the elements you've outlined.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not mentioned.
• Data Provenance: Not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not mentioned.

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

• MRMC Study Done?: No, an MRMC comparative effectiveness study is not mentioned or described. This type of study is more common for diagnostic imaging AI systems where human reader performance is a key metric.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done?: Not applicable, as this is a physical medical device (electrical stimulator), not an algorithm-only software device.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable for this type of device and regulatory submission. The submission focuses on safety and effectiveness comparable to a predicate device through device description and indications for use.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable, as this is a physical medical device. There is no mention of a "training set" in the context of an algorithm.

9. How Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: Not applicable.

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