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The device is intended to be used by clinicians in symptomatic relief of chronic intractable pain. Also, for post traumatic and post surgical pain relief.

The Z Tech Tens Device is designed to produce 0-60μc H-WAVE type pulse which is described as a bi-polar asymmetrical exponentially decaying impulse type waveform. It has a pulse width of approximately 1.5ms and and delivers a maximum frequency of 55Hz. Essentially the device originates an astable type pulse of controllable peak voltage, frequency and pulse width, which is amplified and passed to the output electrodes through an isolation transformer, which also eliminates any D.C. component in the output. The device also employs a recharging type circuit which effectively inhibits any patient use during the recharging of permanently installed ni-cad type batteries. The case which is of a lexan plastic type material. Front and rear controls are clearly marked as to their function for ease of patient use.

Here's an analysis of the provided text regarding the Z Tech Model F7 (TENS DEVICE) and its acceptance criteria and supporting study information:

This submission is a 510(k) premarket notification, which determines substantial equivalence to a predicate device, rather than a full premarket approval (PMA) that would typically involve extensive clinical trials with pre-defined acceptance criteria and detailed study reports. Therefore, much of the requested information regarding detailed study design, sample sizes, and expert ground truth is not explicitly available or applicable in the provided document format for a 510(k) submission.

The core of this submission is demonstrating technical identity and equivalent performance to the predicate device, the H-WAVE Model P-4 (TENS DEVICE).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not explicitly stated in terms of a formal clinical test set with a specific number of patients/cases. The "clinical experimentation" mentioned refers to the general body of knowledge and previous studies conducted on TENS devices, rather than a specific new clinical trial for the Z Tech F7.
• Data Provenance: The document refers to "clinical experimentation" generally, and cites articles like "Transcutaneous Neural Stimulation for Relief of Pain" by Mark Linzer and Doulin M. Long, along with an "N-S4 article." This indicates reliance on existing scientific literature and established clinical data for TENS devices, particularly the H-Wave, rather than new, primary data from a dedicated clinical study for the Z Tech F7. It implies a retrospective analysis of existing knowledge and a comparison of the Z Tech F7's technical specifications to those known to be effective and safe from prior studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document references general "clinical experimentation" and standards, implying that the "ground truth" for the efficacy and safety of TENS devices, in general, has been established by the scientific and medical community over time. There wasn't a specific "test set" with individually adjudicated ground truth as would be found in a diagnostic AI study.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Given the nature of a 510(k) for a TENS device relying on substantial equivalence to an existing technology, a formal independent adjudication of a new test set's ground truth by multiple experts is not part of the standard process described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No. This type of study (MRMC) is typically performed for diagnostic devices where human readers interpret medical images or data, and the AI's impact on their performance is being measured. This is a therapeutic device (TENS), and the submission focuses on technical equivalence and adherence to general performance standards, not on improving human reader interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable in the conventional sense for an AI algorithm. The device itself (the TENS unit) is a standalone therapeutic device. Its "performance" is its ability to generate the specified electrical waveform and deliver it safely and effectively for pain relief, matching the predicate. This is assessed through engineering analysis and comparison to established clinical efficacy for similar waveform parameters, not through a "standalone algorithm" performance study.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" here is based on established clinical efficacy and safety of TENS devices with specific waveform characteristics, derived from historical clinical experimentation and literature. It's not individual patient outcome data from a new trial for this specific device, but rather the understanding that devices producing certain electrical outputs (like the H-Wave) are known to be effective for pain relief. The Z Tech F7 simply demonstrates it produces those same effective and safe outputs.

8. Sample Size for the Training Set

• Sample Size (Training Set): Not applicable. This device is not an AI/machine learning algorithm requiring a "training set" in the computational sense. The "training" for its design and performance specifications comes from the established knowledge base and technical specifications of the predicate device (H-Wave) and general TENS technology.

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

• Ground Truth for Training Set: Not applicable, as there's no "training set" for an AI algorithm. The "ground truth" for the design principles of this TENS device is based on scientific research and clinical understanding of how specific electrical parameters (waveform, pulse width, frequency, charge) interact with the human body to achieve pain relief. This knowledge has been established through decades of research in electrophysiology and TENS therapy.

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