Search Results

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.

Ask a specific question about this device

Needle Stimulator (Model: RJNS6-1) is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Needle Stimulator (Model: RJNS6-1) is an electro-acupuncture device for acupuncture therapy, powered by 6 pieces of 1.5V batteries or AC 100-240V. It is composed of a LCD, a console and 6 channels of electrode cables with alligator type connectors. Only 3 channels at most could work together on single patient. The console has the operating elements of Channel selecting button, Setting button, Operation suspending switch button, Wave-selecting button, On/off switch, Mute button, Therapy time adjusting button, Output frequency adjusting button, Intensity adjust knobs, and Output indicator light. Needle Stimulator (Model: RJNS6-1) does not equip with acupuncture needles. The practitioners should select 510(k) cleared needles (with minimum diameter of 0.40mm and insertion depth of 16mm) for use.

The provided text describes the 510(k) submission for the "Needle Stimulator (Model: RJNS6-1)" and its substantial equivalence to a predicate device. However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/human-in-the-loop diagnostic system.

The device in question is an electro-acupuncture stimulator, and the FDA's review focuses on its electrical safety, performance parameters, and substantial equivalence to a legally marketed predicate device (K202861). The testing mentioned is related to electrical safety and electromagnetic compatibility (e.g., IEC 60601 standards), not diagnostic performance or AI assistance.

Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC study details, standalone performance, or ground truth establishment as these concepts are not applicable or mentioned in the context of this specific device's 510(k) submission as provided.

The document confirms the following:

• Device Name: Needle Stimulator (Model: RJNS6-1)
• Intended Use: An electro-acupuncture stimulator indicated for use in the practice of acupuncture by qualified practitioners.
• Regulatory Pathway: 510(k) Premarket Notification.
• Predicate Device: Needle Stimulator (Model: CMNS6-2), K202861.
• Performance Evaluation: Substantial equivalence based on non-clinical tests (electrical safety, EMC, etc.) according to recognized standards (ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10).

In summary, the provided text does not contain the specific information requested about acceptance criteria and a study proving an AI-powered device meets them. The evaluation described is for a non-AI medical device and focuses on electrical and functional equivalence.

Ask a specific question about this device

The Self-adhesive Electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.

The Self-adhesive electrode, lead wire type and snap button type, are non-sterile flexible structures, composed of materials commonly used in this application:
First layer: Non-woven fabric tape
Second layer: Polyurethane (PU) electrically conductive carbon cloth (Hebei Kangshengda Electronic Technology Co., Ltd)
Third layer: Biocompatible conductive hydrogel coupling media (ValueTrode Carbon, K970426), which has passed the required skin sensitivity testing criteria as specified in ISO 10993-10 and cytotoxicity testing criteria as specified in ISO 10993-5.
The electrodes are designed for single patient / multiple application use. It can be used for low-frequency or medium-frequency nerve or muscle stimulators, as the conduction film adhered to body skin.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Self-adhesive Electrode" (K213879), structured according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly list "acceptance criteria" for each parameter in the way a formal study report might. Instead, it demonstrates substantial equivalence to a predicate device (K090198) by comparing various characteristics and reporting that the new device met specific test standards or manufacturer requirements.

The table below presents the comparative data and implies the "acceptance criteria" are generally that the new device's performance is similar to or meets the standards met by the predicate device, or adheres to established industry standards for such devices.

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

The document does not specify a separate "test set" in terms of patient data. The evaluation relies on non-clinical bench tests performed on the "Self-adhesive Electrode" device itself.

• Sample Size: The document does not explicitly state the number of electrodes tested for each bench test. For example, it lists "Impedance test," "Conformability test," "Fluid tolerance test," "Peeling force test," and "Simulation use test" but doesn't provide the quantity of devices subjected to these tests.
• Data Provenance: The tests were "Bench tests" conducted on the proposed device. The country of origin for the device manufacturer is China (Bozhou Rongjian Medical Appliance Co.,Ltd., Anhui, China). The data is retrospective in the sense that these tests were completed before the 510(k) submission.

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

This information is not applicable as the study did not involve human interpretation or a "ground truth" derived from expert consensus on clinical data. The tests performed were objective bench tests against established standards and comparative measurements.

4. Adjudication Method for the Test Set

This is not applicable as there was no test set involving subjective human assessment or consensus building. The assessments were based on direct measurements and compliance with technical standards.

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

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

6. If a Standalone (Algorithm Only Without Human-in-the-loop Performance) Was Done

This is not applicable. The device is a self-adhesive electrode, a physical medical device, not an algorithm or software. Therefore, an "algorithm only" performance study is irrelevant. The compliance for the device involves physical and electrical characteristics.

7. The Type of Ground Truth Used

For this device, the "ground truth" or reference for performance and safety is established by:

• Established industry standards: Such as ISO 10993 series for biocompatibility, AAMI/ANSI ES 60601-1, and IEC 60601-2-2 for electrical safety and performance.
• Manufacturer's internal requirements: For tests like peeling force and simulation use.
• Predicate device characteristics: Demonstrating that the new device's properties (materials, dimensions, electrical impedance ranges) are similar to those of a legally marketed predicate device (K090198).

There is no clinical ground truth (e.g., pathology, outcomes data) as no clinical study was performed.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

This information is not applicable for the same reason as point 8.

Ask a specific question about this device