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The TENS is used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post surgical and post traumatic acute pain

The Fast Start® TENS device is a transcutaneous electrical nerve stimulator that provides a non-invasive, drug free method of controlling acute and principally long term intractable pain. The device projects mild electrical impulses that are transmuted through the skin via surface electrodes to modify the body's pain perception. The FastStart ® TENS is made up of the device, one 9 V alkaline battery, a set of electrodes, two lead wires, and a carrying case.

The provided text is a 510(k) summary for the "Fast Start® TENS" device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and reported device performance in the way a clinical trial or algorithm validation study would.

Therefore, many of the requested sections (sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set details) are not applicable or not available in this type of submission.

Here's a breakdown of what can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided 510(k) summary. The submission's core argument is about substantial equivalence to a predicate device, implying that its performance is acceptable if it functions similarly to the already approved predicate. No specific performance metrics or acceptance thresholds are detailed.

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

This information is not provided. This 510(k) summary does not describe a clinical study or a separate performance evaluation with a "test set" in the context of device performance against specific metrics. It relies on the similarities to the predicate device.

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

This information is not provided. The submission does not describe a process of establishing ground truth with experts for a test set.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not applicable/not provided. This device (Transcutaneous Electrical Nerve Stimulator) is a physical medical device, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is irrelevant to its approval.

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

This information is not applicable/not provided. As explained above, this is a physical device, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable/not provided. The submission argues for substantial equivalence based on technical characteristics and indications for use, not by comparing performance against a "ground truth" derived from patient outcomes or expert consensus.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is a hardware product, not a machine learning model, so there is no "training set."

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

This information is not applicable/not provided.

Summary of the Study and Device Acceptance (Based on K041092 Document):

The "study" in this context is the 510(k) premarket notification process itself, which aims to demonstrate that the new device is "substantially equivalent" to an already legally marketed device (the predicate device). Approval is based on meeting this substantial equivalence rather than explicit, new acceptance criteria and a performance study against those criteria.

• Acceptance Criteria (Implied): The primary "acceptance criterion" is that the new device (Fast Start® TENS) is substantially equivalent to the predicate device (Classic TENSTM, K020437) in terms of indications for use, technical characteristics, and device specifications. This means it should not raise any new questions regarding safety and effectiveness.
• Study That Proves Substantial Equivalence: The submission itself constitutes the "study." It does not present a clinical trial or performance data in the traditional sense. Instead, it makes a reasoned argument by:
  • Comparing Indications for Use: The Fast Start® TENS has the same indications for use as the Classic TENS: "symptomatic relief and management of chronic intractable pain, and/or as an adjunctive treatment in the management of post surgical and post traumatic acute pain."
  • Comparing Technical Characteristics and Device Specifications: The document states that "This device is similar to its predicate device, the Classic TENS, they both exhibit the same indications for use, technical characteristics and device specifications." It further mentions the Fast Start® TENS has "three modes of operation: Conventional, Burst, and Modulated" and "twelve pre-set and two customized programs," implying these are comparable or represent standard TENS functionalities also found in the predicate or are generally accepted.
  • Conclusion: The submission concludes that "Designed with the same performance standards as its predicate, the Fast Start ® TENS does not raise any new questions in regards to safety and effectiveness. The device contains three modes of operation... It is also equipped with twelve pre-set and two customized programs. The Fast Start TENS meets the mandatory performance standards."

In essence, the "proof" for this 510(k) is the detailed comparison to an already approved device, asserting that the new device is functionally and technically similar enough not to warrant new, extensive performance testing.

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