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The Transcutaenous Electrical Nerve Stimulator (Model RJTENS-1) 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 of post surgical and post traumatic pain.

Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin to relieve pain. The device has 16 programs (12 standard programs and 4 editable programs). It is a battery-powered portable device, comprising electronic stimulatory module and accessories of lead wires, electrodes and 4x1.5V AAA alkaline batteries. Two outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes is 510(k) cleared device (K213879), Size 50*50mm.

The provided text describes the 510(k) summary for the Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1). Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly derived from its substantial equivalence to the predicate device (K202893). The "Comparison" column in the table indicates "Same" or "Similar" for most parameters, meaning the new device's performance aligns with the established performance of the predicate. Note 1 explicitly addresses the difference in deviation from amplitude, frequency, and pulse width.

Study to Prove Acceptance Criteria:

The study proving the device meets the acceptance criteria is a non-clinical bench test study.

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

• Sample Size: Not explicitly stated as "sample size" in the traditional sense for an AI/diagnostic study. For bench tests, it typically refers to the number of devices tested. This information is not provided in the document.
• Data Provenance: Not applicable in the context of clinical data for this type of submission, as no clinical data was included. For bench tests, the data would have originated from laboratory testing of the manufactured devices. The manufacturer is Bozhou Rongjian Medical Appliance Co., Ltd. in China.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• This information is not applicable/not provided. The assessment of these types of electrical stimulators primarily relies on objective physical and electrical measurements against established standards, not necessarily on expert interpretation of ambiguous data points.

4. Adjudication Method for the Test Set:

• This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are used for expert consensus in interpretive tasks (e.g., radiology reads), which is not the nature of the bench tests reported here.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not including in this submission."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

• Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator, not an AI algorithm. Its performance is evaluated through its physical and electrical characteristics according to safety and performance standards.

7. The Type of Ground Truth Used:

• The ground truth for this device's performance evaluation is established through compliance with recognized voluntary standards and objective physical and electrical measurements as defined by those standards.
  • ANSI AAMI ES60601-1: 2005/(R) 2012 And A1: 2012, C1: 2009/(R) 2012 And A2: 2010/(R) 2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1: 2005, MOD)
  • IEC 60601-2-10 Edition 2.1 2016-04, Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators
  • IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

8. The Sample Size for the Training Set:

• Not applicable. The device is an electrical stimulator, not an AI/machine learning algorithm requiring a training set.

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

• Not applicable, as there is no training set for this device.

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