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TENS stands for Transcutaneous Electrical Nerve Stimulation. The Ultima NEO TENS system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.

EMS stands for Electrical Neuromuscular Stimulator. The Ultima NEO EMS system is indicated for:

• Relaxation of muscle spasm; .
• Increasing local blood circulation and muscle re-education; ' .
• Prevention or retardation of disuse atrophy; .
• Prevention of venous thrombosis of the calf muscles immediately . after surgery;
• Maintaining or increasing range of motion. .

MIC stands for Microcurrent Stimulation. The Ultima NEO MIC system is used to provide symptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain.

IF stands for Interferential Stimulation. The Ultima NEO IF system is indicated for:

Symptomatic relief of chronic intractable pain. .

A portable TENS/EMS/MIC/IF combo device for pain relief or muscle re-education.

Features:

• Innovative design
• · Large LCD display
• · Dual output isolated channels
• · One rechargeable lithium battery
• · Adjustable frequency, pulse width, and timing parameters
• 18 different modes
• · Timer option
• · Doctor lock/unlock facility
• · Open circuit detectors
• Non-volatile

The Ultima NEO is a multi-system electrotherapy device, combining TENS, EMS, MIC, and IF functionalities. The document provided is a 510(k) summary, which focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a performance study with acceptance criteria and results in the typical academic sense.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided as this type of detailed clinical study information is generally not included in a 510(k) summary for devices demonstrating substantial equivalence through technological comparison to predicates.

Instead, the submission relies on the assertion that its technological characteristics, intended use, and safety comply with relevant standards and are substantially equivalent to already marketed and cleared devices.

Here's an attempt to address the prompt based on the provided text, highlighting what is implicitly or explicitly stated and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary for substantial equivalence, formal acceptance criteria and a detailed comparison table of quantitative performance metrics against these criteria are not provided. The "performance" assessment is based on the device's functional equivalence and compliance with established safety standards.

The document implicitly "accepts" the performance of the predicate devices as a benchmark. The reported device performance is described qualitatively as being "almost the same substantially" or "very similar" to the predicate devices in terms of features and operational parameters.

No quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or other clinical outcomes) are presented.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: Not applicable/not provided. No clinical "test set" in the traditional sense was used to evaluate the device's performance against specific clinical outcomes. The evaluation is primarily based on technological comparison and compliance with standards.
• Data Provenance: Not applicable. The "data" here refers to the design specifications, software logic, and electrical characteristics of the Ultima NEO and its predicate devices. The information is derived from the device designs and established standards.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable/not provided. There was no explicit "ground truth" derived by experts for a clinical test set in this context. The review process involves regulatory bodies and their internal experts assessing the submission's claims of substantial equivalence.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not provided. No clinical test set requiring adjudication was conducted.

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

• Was an MRMC study done? No. This type of study is not relevant for this device, which is an electrical stimulator.
• Effect Size: Not applicable.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

• Was a standalone study done? Not applicable in the context of an "algorithm-only" or AI device. The device is a physical electrotherapy unit. The "performance" is assessed through engineering testing and comparison to the predicate devices' specifications and intended use.
• The document states that the new device passes "the same tests of applicable recognized international consensus standards" as the predicate devices, indicating that its standalone (physical/electrical) functionality meets established safety and performance benchmarks.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable for clinical efficacy. For device safety and functional performance, the "ground truth" is derived from:
  • Compliance with recognized international consensus standards: The document lists several IEC, ISO, and UL standards (e.g., IEC 60601 series for medical electrical equipment, ISO 14971 for risk management).
  • Substantial equivalence to predicate devices: The functional specifications, intended use, and safety profiles of the already cleared predicate devices serve as the benchmark for "truth."

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not involve machine learning or AI that would require a "training set" in the conventional sense. The "training" for this type of device is the engineering design and manufacturing process that ensures it meets specifications.

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

• How Ground Truth Established: Not applicable. As there is no training set, there is no ground truth for a training set. The design principles and safety considerations are based on established medical device regulations and engineering best practices.

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