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The DOOPANG(YPS-301BD) is indicated for:

• The acute treatment of migraine with or without aura in patients 18 years of age or older.
• The prophylactic treatment of episodic migraine in patients 18 years of age or older.

This product is a small, portable product that uses the principle of transcutaneous nerve stimulation. By attaching an electrode to the forehead, it transmits electrical stimulation to the upper branch of the trigeminal nerve transdermally. The electrode surface transmits electric current to the skin to generate action potentials on the nerves and adjusts the output mode (Program 1 and Program 2) to preventative treatment of episodic migraine(60Hz) and acute treatment of migraine(100Hz). Specially designed electrode of this product allows contact with the trigeminal nerve endings associated with migraine headaches. The electrodes give nerve stimulation to the orbital upper branch (V1) inside the forehead skin and transmit it to the trigeminal nervous system. This electrical stimulation is transmitted percutaneously through a bipolar adhesive electrode located on the forehead to preventative treatment of episodic migraine(60Hz) or acute treatment of migraine(100Hz).

This FDA 510(k) summary (K232749) describes the "DOOPANG (YPS-301BD)" device, a transcutaneous electrical nerve stimulator for headache treatment. The summary demonstrates substantial equivalence to a predicate device, "Cefaly Dual" (K201895).

However, the provided text does not contain information about acceptance criteria for performance metrics, nor does it detail a study that proves the device meets such criteria in terms of clinical effectiveness. This type of device, a transcutaneous electrical nerve stimulator, typically relies on established efficacy of its mechanism and comparative safety and technical specifications rather than a novel clinical performance study with defined acceptance criteria for diagnostic output.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence in technological characteristics, indications for use, and safety, as opposed to proving a specific clinical performance metric with a dedicated pivotal study.

Here's what the document does provide, structured according to your request where applicable:

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

• Not explicitly provided in terms of clinical acceptance criteria like sensitivity, specificity, accuracy, or similar outcome measures for a diagnostic device. The comparison focuses on technical specifications to demonstrate equivalence.

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

• Not applicable / Not provided. The summary focuses on non-clinical testing (electrical safety, EMC, software validation, biocompatibility, cybersecurity, performance, usability) to demonstrate equivalence based on technical specifications and regulatory standards. There is no mention of a clinical test set with patient data for performance evaluation in the context of diagnostic accuracy or therapeutic outcome metrics.

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

• Not applicable / Not provided. No such clinical performance study is described.

4. Adjudication method for the test set

• Not applicable / Not provided. No such clinical performance study is described.

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

• Not applicable. This device is a direct-to-patient neuromodulation device, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This device is a direct-to-patient neuromodulation device. The software validation mentioned refers to the proper functioning of the embedded software control, not an AI algorithm for clinical interpretation.

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

• Not applicable / Not provided for clinical performance. For the non-clinical tests, "ground truth" would be defined by the specifications of the standards (e.g., IEC 60601-1 for electrical safety).

8. The sample size for the training set

• Not applicable / Not provided. No machine learning model or training set is mentioned for clinical performance.

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

• Not applicable / Not provided. No machine learning model or training set is mentioned for clinical performance.

Summary of Device Rationale from the Document:

The DOOPANG (YPS-301BD) device demonstrates substantial equivalence to the Cefaly Dual (K201895) predicate device primarily through:

• Identical Indications for Use: Both devices are indicated for acute treatment and prophylactic treatment of episodic migraine with or without aura in patients 18 years or older.
• Similar Technological Characteristics: The devices share comparable design, intended population, use environment, power source, channels, software programs (two fixed programs for acute and prophylactic treatment with similar frequencies and pulse widths), waveform, and output parameters.
• Minor Differences Not Adversely Affecting Safety or Effectiveness: Slight differences in session duration (1 minute) and maximum current density are considered insignificant. The slightly lower current density of the proposed device is even considered less risky.
• Compliance with Regulatory Standards: The device underwent non-clinical testing for electrical safety (AAMI/IEC 60601-1, 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 60601-1-6, 62366-1), home healthcare environment compatibility (IEC 60601-1-11), software validation, biocompatibility (ISO 10993-1), and cybersecurity. These tests confirm the device meets established safety and performance benchmarks for its classification.

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