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Jiajian® TENS is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment in the management of post surgical and post traumatic pain.

Jiajian® TENS, is Transcutaneous Electrical Nerve Stimulator for pain relief. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. It is a battery-powered portable device, comprising electronic stimulatory module and accessories of lead wires and 9 volt type 6F22 battery. When using this device, the physician should select and use 510(k) cleared electrodes. The area of electrodes must be larger than 8cm2. The electronic stimulatory module has the operating elements of (1) Display screen, 2 Menu keys, 3 Modification keys, 4 On/Off key, 5 Battery compartment and (6) Outlet socket. The display screen can show (a) battery power, (b) selected program, (c) lasting time or left time of a program, (d) current intensity for each channel, (e) program phase and (f) locking state. The menu key "P" is for selecting standard program or user-program, and for locking; the menu key "E" is for editing program when the device is not being locked. The modification key "3A" and "3B" are for intensity level adjustment during stimulation. The outlet socket is used to connect skin electrodes by lead wires. The device has 12 selectable programs, which can be grouped into 4 output modes, i.e. Normal mode (P1, P2, P3, P4, P5, P6), Burst mode (P7, P12), Rate & width modulation (P8), and Intensity modulation (P9, P10, P11).

The provided document is a 510(k) summary for the Jiajian® TENS device and primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study of the device's performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in the provided text.

However, based on the information provided, here's what can be extracted and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics (e.g., pain reduction scores, patient satisfaction). Instead, it focuses on demonstrating technical equivalence and compliance with safety standards as a basis for being "substantially equivalent" to a predicate device.

The table below summarizes the comparison of technical specifications between the new device and the predicate device. While not acceptance criteria in the sense of clinical study endpoints, these indicate the technical specifications that the new device meets and how they compare to the predicate.

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

• Not applicable. This document is a 510(k) submission for a TENS device, which typically relies on demonstrating substantial equivalence to a predicate device through technical and safety comparisons, rather than a clinical trial with a "test set" of patient data. The safety testing mentioned (IEC standards) would involve hardware testing, not human subjects.

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

• Not applicable. As above, no clinical "test set" with ground truth established by experts is described in this document.

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

• Not applicable. No clinical "test set" or adjudication method 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 Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, not an AI-assisted diagnostic or imaging interpretation tool. Therefore, an MRMC comparative effectiveness study involving human "readers" and AI assistance is entirely irrelevant to this device type.

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

• Not applicable. This device is a physical TENS unit, not an algorithm. Its "performance" is measured by its electrical output characteristics and compliance with safety standards, not by an algorithm's classification accuracy.

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

• Not applicable. Since this is a TENS device and the submission focuses on substantial equivalence and safety standards, the "ground truth" relates to compliance with engineering and electrical safety specifications defined by standards like IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10. This is verified through objective testing against these standards, not against clinical expert consensus or pathology.

8. The sample size for the training set

• Not applicable. There is no "training set" for this device as it does not involve machine learning or AI models.

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

• Not applicable. As there is no training set, there is no ground truth for it.

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