Search Results

The intended use of ACULIFE/Model IDOC-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 IDOC-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.

The provided documentation describes the 510(k) summary for the ACULIFE/Model IDOC-01 electro-acupuncture device. It does not contain information about a study proving the device meets specific performance acceptance criteria for diagnostic or clinical efficacy beyond electrical safety, EMC, biocompatibility, and output characteristics.

Here’s an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. The performance data listed (electrical safety, EMC, biocompatibility, output characteristics) are typically evaluated through engineering tests on a sample of manufactured devices, rather than a "test set" in the context of clinical or AI performance evaluation. The provenance of any data used for these engineering tests (e.g., country of origin, retrospective/prospective) is also not mentioned.

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

This information is not applicable to the type of performance data presented. The document describes compliance with technical standards and product specifications, which do not typically involve expert-established ground truth in the same way clinical or AI studies do.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported. This type of study is relevant for diagnostic devices where human readers interpret data, often with or without AI assistance. The ACULIFE/Model IDOC-01 is an electro-acupuncture device for stimulation, not a diagnostic device requiring human interpretation of medical images or other complex data.

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

This information is not applicable. The device is not an algorithm or AI system for standalone performance evaluation. It is a physical electro-acupuncture device.

7. The Type of Ground Truth Used

The ground truth used for the performance data mentioned (electrical safety, EMC, biocompatibility, output characteristics) is based on established international standards and the manufacturer's engineering specifications. For example, electrical safety is grounded in the pass/fail criteria defined by EN 60601-1. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI model requiring a training set.

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

This information is not applicable as the device is not an AI model.

Summary of what the document does describe:

The document primarily focuses on establishing substantial equivalence to a predicate device (Inno-Health Aculife Electro-Acupuncture/ model SMW-01, K051197) for regulatory clearance. This equivalence is based on the device's intended use and technological characteristics, and its compliance with relevant international standards for safety and performance (EN 60601-1, EN 60601-1-1, EN 60601-1-2, ISO 10993) and its own product specifications for output. There is no mention of clinical studies, performance studies involving human subjects beyond safety and biocompatibility, or AI-related performance evaluations.

Ask a specific question about this device