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The Dolphin Neurostim™ OT C is indicated for temporary relief of pain associated with sore and aching muscles in the back, arms, and legs due to strain from exercise or normal household and work activities.

The Dolphin Neurostim™ OTC (DNS) is a handheld, battery powered (9V) Transcutaneous Electrical Nerve Stimulators (TENS), specifically designed for the temporary relief of muscular pain. It combines the electrical characteristics of TENS with point stimulation delivered through a metal probe tip (cathode or anode). There is a metal ground on the device and an ancillary wrist strap that plugs into the device (cathode or anode). The device has two modes of operation. In search mode it locates points of low resistance in a predetermined area. In treatment mode it applies a low-frequency (2.4-3.0 Hz) Direct Current to the skin.

This document (K133789) is a 510(k) premarket notification for the Dolphin Neurostim™ OTC, a Transcutaneous Electrical Nerve Stimulator (TENS) device. The purpose of this document is to establish substantial equivalence to predicate devices, not typically to present detailed clinical study results establishing performance against specific acceptance criteria.

Based on the provided text, the device's acceptance criteria are primarily related to manufacturing quality, electrical safety, and performance as a TENS device, demonstrated through factory testing rather than a clinical efficacy study. The submission focuses on demonstrating substantial equivalence to predicate devices based on design, intended use, and technological characteristics.

Here's an attempt to answer your questions based on the available information:

1. A table of acceptance criteria and the reported device performance

   The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in the context of a clinical study or a specific performance standard that would be met by a clinical trial. Instead, it discusses the device meeting its "product specification" through "factory tests." The table below reflects what is implied to be the performance criteria (i.e., being similar to predicate devices in key aspects) and the reported characteristics of the Dolphin Neurostim.

   Acceptance Criteria (Implied by equivalence claims)	Reported Device Performance (Dolphin Neurostim™ OTC)
   Intended Use: Relief of pain associated with sore or aching muscles of the lower back, arms or legs due to strain from normal exercise or normal household and work activities.	Indicated for temporary relief of pain associated with sore and aching muscles in the back, arms, and legs due to strain from exercise or normal household and work activities.
   Technological Characteristics: Deliver TENS waveform to patients; Stimulation current delivered to electrodes applied to skin.	Delivers TENS waveform; Stimulation current delivered to electrodes applied to skin.
   Material: Plastic case with electrodes constructed of metal.	Plastic case with electrodes constructed of metal.
   Output Waveform Design: Provide electrical stimulation to the body to relieve pain. (Predicate has single non-programmable microcurrent mode, pulsed monophasic.)	Single non-programmable milliamp mode, delivering a pulsed biphasic waveform that provides electrical stimulation to the body to relieve pain.
   Electrical Safety Limits: (Implied to be below safety limits, as the predicate also states "Below safety limit" for these parameters).	Maximum average power density: 0.116 watts/sq cm. Maximum current density: 0.21 amps/sq cm. Maximum charge per pulse: 0.00044 coulombs.
   Regulatory Classification: Class II, Over-The-Counter (OTC).	Class II, OTC.
   Quality Systems: Conformance to quality systems, design, development, testing, and production procedures.	"Benefited from design, development, testing and production procedures that conform to Quality Systems."
   Factory Tests: Verification of accurate and calibrated energy pattern over useful life.	"A series of factory tests are conducted to verify the intended signals are accurate and can maintain a calibrated energy pattern over its useful life."
   Substantial Equivalence: No substantial differences to predicate device(s) that raise new questions of safety or effectiveness. (Demonstrated by comparison in the document).	Claimed substantially equivalent to Painmaster MCT Patch (K130114) and TENS Pro 900 (K023726). The document explicitly states, "The differences between these systems are incidental and not significant."

2. Sample size used for the test set and the data provenance

   The document explicitly states, "Testing has confirmed this device meets its product specification. A series of factory tests are conducted to verify the intended signals are accurate and can maintain a calibrated energy pattern over its useful life."

   This indicates that the "test set" was likely a sample of manufactured devices (or the prototype), subjected to technical/electrical performance verification, rather than a clinical test set involving human subjects. Therefore, there is no sample size in terms of human patients, nor is there data provenance in terms of country of origin or retrospective/prospective type, as it was not a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

   This information is not applicable. The testing described is factory-level technical verification, not clinical evaluation requiring expert ground truth for diagnostic accuracy or efficacy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   This information is not applicable, as there was no clinical test set requiring adjudication.

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. The Dolphin Neurostim™ OTC is a TENS device, not an AI-powered diagnostic or assistive technology. Therefore, no MRMC comparative effectiveness study was performed in this context.

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

   This information is not applicable. The device is a physical TENS unit, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   The "ground truth" for the factory tests would be the pre-defined product specifications and engineering standards for electrical devices (e.g., specific voltage, current, waveform parameters, durability, and safety limits).

8. The sample size for the training set

   This information is not applicable. The Dolphin Neurostim™ OTC is a physical medical device that performs TENS. It is not an AI/machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established

   This information is not applicable, as there is no training set for this type of device.

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