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The intended use of ACULIFE/Model SMW-01 is an ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. ACULIFE/model SMW-01 is intended for the stimulation at hands of patient.

The device consists of a battery powered portable instrument, with a basic power pack which is connected by conducting lead wire to two electrodes (one probe electrode and one big adhesive electrode) which make contact for hands stimulation. ACULIFE uses a 9V/DC battery or 9V adaptor as the supply power of the stimulation unit. It can be adjusted for the output amplitude, keep the memory of chosen amplitude, and set the operation time. The electrode combination and lead wire provide the electro-acupuncture stimulation for hand by or on the order of a qualified practitioner of acupuncture as determined by the states.

This 510(k) summary describes an electro-acupuncture device (ACULIFE/Model SMW-01) and does not contain detailed information about acceptance criteria, device performance metrics (e.g., accuracy, sensitivity, specificity), sample sizes for test/training sets, ground truth establishment, or human reader studies. The provided document focuses on demonstrating substantial equivalence to a predicate device through compliance with general safety and performance standards.

Here's an analysis based on the provided text, highlighting the absence of the requested information for an AI/device performance study:

1. Table of Acceptance Criteria and Reported Device Performance

Missing from the document: The document does not specify quantitative acceptance criteria for clinical efficacy or diagnostic accuracy (as would be expected for an AI-powered device). The performance data cited are primarily related to safety, EMC, biocompatibility, and electrical output characteristics, which are standard for an electro-medical device, not a device with a performance-based claim for AI.

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

• Sample Size for Test Set: Not applicable / Not provided. The performance data presented are for electrical safety, EMC, biocompatibility, and output characteristics, which typically involve laboratory testing, not a clinical "test set" in the context of AI performance evaluation.
• Data Provenance: Not applicable. The testing described is for engineering and safety standards, not clinical data.

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

• Not applicable. There is no mention of "ground truth" or expert review in the context of the performance data provided, as it pertains to safety and electrical characteristics of the device.

4. Adjudication Method for the Test Set

• Not applicable. There is no clinical test set or subjective assessment described that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The device is an electro-acupuncture stimulator, not a diagnostic or AI-assisted interpretation device that would involve human readers.

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

• Not applicable. This is not an AI algorithm; it's a physical electro-acupuncture device.

7. The Type of Ground Truth Used

• Not applicable. The "performance data" relate to compliance with established engineering and safety standards (e.g., electrical safety, EMC, biocompatibility), where the "ground truth" is defined by the requirements of those standards, not clinical outcomes or expert consensus.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI system that requires a training set.

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

• Not applicable. As this device does not utilize a training set, there is no ground truth establishment process for one.

Summary of Findings Regarding AI-Specific Information:

The provided 510(k) summary for the ACULIFE/Model SMW-01 electro-acupuncture device is typical for a traditional medical device prior to the widespread integration of advanced AI/ML functionalities. It focuses on demonstrating compliance with essential safety and performance standards for an electrical stimulator and substantial equivalence to a predicate device. None of the requested information pertaining to AI model performance, test/training sets, ground truth establishment, or human reader studies is present because the device described does not appear to be an AI-powered diagnostic or interpretive system.

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