(149 days)
Jiajian® CMN Stimulator 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.
Jiajian® CMN Stimulator is an electro-acupuncture device for acupuncture therapy, powered by 6 pieces of 1.5V batteries. It is composed of 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 Wave choosing knob, Frequency adjust knob, Intensity adjust knobs, and Timer. Jiajian® CMN Stimulator does not equip with acupuncture needles. The practitioners should select 510(k) cleared needles (with minimum diameter of 0.30mm and insertion depth of 15mm) for use.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Jiajian® CMN Stimulator:
Overview:
The document provided is a 510(k) Summary for the Jiajian® CMN Stimulator, an electro-acupuncture device. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (ES-130, K081943) by comparing technical characteristics and compliance with recognized safety standards. The document does not describe a clinical study for performance or effectiveness in the way an AI/ML device submission would. Instead, the "study" demonstrating it meets acceptance criteria refers to technical testing against safety standards and a comparison of its electrical output parameters to those of the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for an electro-acupuncture stimulator, the "acceptance criteria" are primarily established by compliance with recognized electrical safety and EMC standards, and by demonstrating that its operational parameters are either within established safe limits or are substantially equivalent to a legally marketed predicate device without raising new safety or effectiveness concerns.
| Feature / Criteria (Derived from Substantial Equivalence and Standards) | Acceptance Criteria (Predicate Device K081943 or Safety Standards) | Reported Device Performance (New Device: Jiajian® CMN Stimulator) | Assessment |
|---|---|---|---|
| Intended Use | For use in the practice of acupuncture by qualified practitioners. | Same as predicate. | Met |
| Power Source | DC 9V battery, Type 6F22 | DC 1.5Vx6, Type R14 (different but both DC) | Met (Equivalent) |
| Method of Line Current Isolation | N/A for DC current | N/A for DC current | Met |
| Patient Leakage Current (Normal Condition) | Not Stated (Predicate) | 2μΑ | Met (Within implicit safety limits) |
| Patient Leakage Current (Single Fault Condition) | Not Stated (Predicate) | ≤50μΑ | Met (Within implicit safety limits) |
| Waveform | Biphasic Asymmetric biphasic square wave | Biphasic Asymmetric biphasic square wave | Met |
| Maximum Output Voltage @500Ω | 18.0V ±15% | 24.4V ±10% | Differs (Higher), justified by overall charge and safety. |
| Maximum Output Current @500Ω | 36.0mA ±15% | 48.8mA ±10% | Differs (Higher), justified by overall charge and safety. |
| Pulse Duration | 100μs | 200μs ±10% | Differs (Higher), justified by overall charge and safety. |
| Frequency | 1~500Hz | 1~100Hz | Differs (Lower upper limit). |
| Net Charge @500Ω | 0µC | 0µC (+ and - pulses cancel) | Met |
| Maximum Phase Charge, (µC) | 7.2µC | 17.8µC | Differs (Higher), justified as within safety limit. |
| Maximum Current Density (r.m.s.) | 25.5mA/cm2 | 12.6mA/cm2 | Met (Lower, thus safer). |
| Maximum Average Power Density | 0.24W/cm2 | 0.18W/cm2 | Met (Lower, thus safer). |
| EMC Compliance | IEC 60601-1-2 | IEC 60601-1-2 | Met |
| Electrical Safety (General) | IEC 60601-1 | IEC 60601-1 | Met |
| Electrical Safety (Nerve/Muscle Stimulators) | IEC 60601-2-10 | IEC 60601-2-10 | Met |
| Stimulus Parameters Stability (Reduced Battery) | Not explicitly stated for predicate; implied stability. | Not significantly affected (less than ±10%) | Met (Specific test performed for new device.) |
Note on "Acceptance Criteria" for this device: For this type of electro-acupuncture stimulator pursuing 510(k) clearance, acceptance criteria are generally met by (1) demonstrating compliance with recognized safety standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2) and (2) showing that differences in technical specifications from the predicate device do not raise new questions of safety or effectiveness. There isn't a "performance" criterion in the sense of a clinical outcome effectiveness measure for these devices in a 510(k) context.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of clinical trial/performance data. The "test set" here refers to the device itself being subjected to electrical and mechanical testing for safety standards compliance. There is no mention of human subject data or a test set of data points derived from patients.
- Data Provenance: The 'data' proving compliance comes from internal testing by the manufacturer (Wuxi Jiajian Medical Instrument Co., Ltd), likely performed in China, against the specified international standards. This is not derived from patient studies, retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. There is no "ground truth" established by experts in the context of a clinical test set for this 510(k) submission. The evaluation is technical and regulatory, centered on compliance with engineering standards and comparison to a predicate device.
4. Adjudication Method for the Test Set
Not applicable. There is no expert adjudication process described for the technical testing of the device for safety standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic imaging devices or devices where human interpretation/performance is augmented by AI. This device is a therapeutic stimulator, and its clearance relies on technical safety and equivalence to an existing device, not a comparison of human interpretation.
6. Standalone (Algorithm Only) Performance Study
No. This is not an AI/ML device, so a standalone algorithm performance study is not applicable. The "standalone" performance here would refer to the device operating according to its technical specifications.
7. Type of Ground Truth Used
The "ground truth" for this submission are the established international safety standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2) and the technical specifications of the cleared predicate device (ES-130, K081943). The device's performance is compared against these benchmarks to establish substantial equivalence.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI/ML training set.
N/A