(311 days)
The Jiajian® Pointoselect Digital is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.
Jiajian® Pointoselect Digital is a newly designed and easy to operate hand held stimulator. It is 9V battery powered device, with an LCD in the console. which can display the selected operation mode, intensity, frequency, pulse width, and battery level of the device, and so on. The device composes of a console, a hand held probe, a hand grip electrode, and lead wires. The hand probe can be used for treatment at individual sites. When using the hand probe, the patient must hold the hand grip electrode in order to electrically ground the device.
The provided text does not describe a study that proves the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy. Instead, it details a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device, the Jiajian® Pointoselect Digital, focusing on its substantial equivalence to a predicate device (Pointer Excel) based on technical characteristics and compliance with safety and biocompatibility standards.
Therefore, many of the requested categories (sample size, data provenance, ground truth, experts, adjudication, MRMC studies, standalone performance, training set) are not applicable or cannot be extracted from this document, as they relate to clinical studies or performance evaluations that are not present.
However, I can extract the acceptance criteria related to technical specifications and safety standards compliance and the reported performance based on the substantial equivalence discussion and safety and effectiveness section.
Here's the information that can be extracted based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" here are defined by the comparison to the predicate device and compliance with established safety/biocompatibility standards.
| Feature | Acceptance Criteria (Predicate Device K060517 Performance) | Reported Device Performance (Jiajian® Pointoselect Digital) | Notes |
|---|---|---|---|
| Intended Use | Symptomatic relief of chronic intractable pain, postoperative pain, and acute pain. | Symptomatic relief of chronic intractable pain, postoperative pain, and acute pain. | Met: Identical intended use. |
| Power Source | DC 9V battery, Type 6F22 | 9 Volt battery type 6F22 (Carbon-zinc), or 9 Volt battery type 6LR61 (Alkaline) | Met: Similar DC battery power source. |
| Waveform | Biphasic | Biphasic | Met: Identical waveform. |
| Shape | Asymmetric biphasic square wave | Asymmetric biphasic square wave | Met: Identical wave shape. |
| Net Charge | 0μC@500Ω | 0μC @500Ω, + and - pulses cancel | Met: Identical net charge. |
| Frequency Range | 1-16Hz | 2~18Hz | Met: Similar frequency range, subject to "differences would not raise new safety concerns." |
| Maximum Output Voltage | 11V ±15% @500Ω | 6.6V ±15% @500Ω | Different: Lower for new device. Document asserts "differences would not raise new safety concerns." |
| Maximum Output Current | 22mA ±15% @500Ω | 13.2mA ±15% @500Ω | Different: Lower for new device. Document asserts "differences would not raise new safety concerns." |
| Pulse Duration | 220μS | 60-120μS | Different: Shorter for new device. Document asserts "differences would not raise new safety concerns." |
| Maximum Phase Charge | 4.8μC@500Ω | 2.4μC@500Ω | Different: Lower for new device. Document asserts "differences would not raise new safety concerns." |
| Maximum Current Density (r.m.s.) | 10.35mA/cm²@500Ω | 12.08mA/cm²@500Ω | Similar: Slightly higher for new device. Document states "similar maximum output current density." |
| Safety Standard Compliance | IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 (for predicate) | IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 (for new device) | Met: New device was tested and found to meet these safety standards. |
| Biocompatibility Standards | ISO 10993-5, ISO 10993-10 (for predicate) | ISO 10993-5, ISO 10993-10 (for new device, specifically pointer probe) | Met: New device's pointer probe was tested and found to comply with these biocompatibility standards. Lead wires also tested to IEC 60601-1. |
| Battery Life Impact | Not explicitly stated | Stimulus parameters not significantly affected (less than ±10%) with reduced battery level. | Met: Specific testing for performance under reduced battery conditions. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. The document describes a comparison of technical specifications and compliance with standards, not a clinical trial or performance study involving patient data.
- Data Provenance: Not applicable, as no human subject data (retrospective or prospective) is discussed. The device is manufactured in Wuxi, Jiangsu, China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no mention of "ground truth" established by experts in the context of clinical performance or diagnostic accuracy. The assessment is based on engineering specifications and adherence to standards.
4. Adjudication method for the test set
- Not applicable. No adjudication method is described as there is no clinical test set requiring it.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (TENS) for pain relief, not an algorithm or AI system.
7. The type of ground truth used
- Not applicable. The document assesses the device against technical specifications and safety/biocompatibility standards, not against a "ground truth" derived from clinical outcomes or expert consensus.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. No training set is involved.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).