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The intended use of the ES-130 is an ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

ES-130 is a palm-size ELECTRO-ACUPUNCTURE DEVICE equipped with three independent output channels. This unit has incorporated similar features as the predicate devices such as: Variable Frequency Settings & Similar Frequency Range, Variable Intensity Settings & Similar Output Range, Biphasic Pulse Waveform, Similar Pulse Shape & Pulse Charge, Battery Power & Portability.

The provided text discusses the ES-130 Electro-Acupuncture Device and its submission for FDA 510(k) clearance. The crucial point for your request is that no clinical testing or performance study with acceptance criteria was conducted for this device beyond non-clinical verification and validation testing, as explicitly stated in the document.

Therefore, I cannot populate a table of acceptance criteria and reported device performance based on a human-in-the-loop or standalone AI study from this document, nor can I provide information about sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, or training sets.

Here's a breakdown of what the document does state in relation to your questions:

1. Table of acceptance criteria and the reported device performance

No acceptance criteria for clinical performance are reported, as no clinical studies were performed. The "performance" described focuses on demonstrating equivalence to predicate devices based on technical specifications.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No clinical test set was used. "Non-clinical verification and validation testing was conducted on ES-130 device" but details on sample size or data provenance for these engineering tests are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set requiring expert ground truth was used.

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

Not applicable. No clinical test set requiring adjudication was used.

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. No MRMC study was done, as this is an electro-acupuncture device and not an AI-assisted diagnostic tool.

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

Not applicable. This device is not an algorithm or AI system. Its performance was assessed through non-clinical verification and validation to demonstrate technical equivalence to predicate devices, not as a standalone AI.

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

Not applicable. No clinical ground truth was established because no clinical studies were conducted. The "ground truth" for the submission was established by comparing the device's technical specifications and electrical outputs to those of three predicate devices.

8. The sample size for the training set

Not applicable. This device is not an AI/algorithm-based system requiring a training set.

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

Not applicable. This device is not an AI/algorithm-based system requiring a training set.

Summary of the Study Discussed in the Document:

The study referenced in the document is a non-clinical verification and validation testing of the ES-130 device. Its purpose was to demonstrate substantial equivalence to three legally marketed predicate devices (K051197: ACULIFE/Model SMW-01, K840983: Pulselife Model PL2, and Pre-Amendment: Model WQ-10B).

The submission states: "Using three similar predicate devices, detailed comparisons of specific ES-130 features and characteristics are contained in Section 8 of this submission... This side-by-side comparison demonstrates that the performance characteristics of the predicate devices encompass the entire range of performance characteristics of the proposed ES-130 device including frequency values, output intensity values, number of channels, supply voltage value, pulse width value, pulse charge value, delivered current density, and delivered power density."

Crucially, the document explicitly states: "Clinical testing was neither required nor conducted regarding the ES-130 submission." Therefore, there are no acceptance criteria or performance metrics related to human or clinical outcomes in this document. The device gained market clearance based on its technical specifications falling within the range of existing, legally marketed devices.

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