(92 days)
PLASMA IQ is used in the removal and destruction of skin lesions and coagulation of tissue.
PLASMA IQ utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of an electrical arc. The arc between the electrode tip and the skin is created by a radio frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas particles in the air. A straight active electrode made of 316L stainless steel is available with the system. The handheld device is cordless and is charged in a docking/charging station prior to use.
Here's an analysis of the provided text regarding acceptance criteria and study information for the Plasma IQ device:
Based on the provided text, the Plasma IQ device (K223222) is stated to be the exact same device as the predicate device (K212329), with the only change being an amendment to the labeling to remove a contraindication. Therefore, the device meets the acceptance criteria by being identical to a previously cleared device.
The document explicitly states: "No performance testing data was provided in this submission other than what was provided in the predicate (K212329) to establish substantial equivalence." and "The Plasma IQ that is subject to this submission is the same device that was cleared in K212329. No changes have been made to this device."
This means that all acceptance criteria and study details would be found in the K212329 submission, not in this current K223222 document. Since the K223222 document merely refers to the predicate for performance data, the details you've asked for related to clinical studies are not present here.
Therefore, many of your requested points cannot be answered from this specific document.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
As stated, no new performance testing data was provided in this submission (K223222). The device's performance is accepted by virtue of its substantial equivalence to the predicate (K212329), which would have had its own acceptance criteria and performance data. The table below presents the comparative technical specifications provided for substantiating equivalence, which implies the acceptance of these specifications being met.
| Feature | Acceptance Criteria (Predicate K212329) | Reported Device Performance (Plasma IQ K223222) |
|---|---|---|
| Indications | Used in the removal and destruction of skin lesions and coagulation of tissue. | Used in the removal and destruction of skin lesions and coagulation of tissue. |
| Mode of Operation | Plasma | Plasma |
| Output | Monopolar | Monopolar |
| Power Supply | 110 - 250 VAC, 50/60 Hz | 110 - 250 VAC, 50/60 Hz |
| Frequency | 40 kHz | 40 kHz |
| Max Output Power | 5 W | 5 W |
| Output Impedance | 54,000 | 54,000 |
| System Components | Handpiece with electrosurgical generator, Charging Station, two active electrode designs. | Handpiece with electrosurgical generator, Charging Station, two active electrode designs. |
| Electrical Safety Standards | Complies with EN60601-1, EN60601-1-2, EN60601-2-2 | Complies with EN60601-1, EN60601-1-2, EN60601-2-2 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided K223222 document, as no new performance testing was conducted for this submission. This data would be found in the K212329 submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided K223222 document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided K223222 document.
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
This information is not available in the provided K223222 document. The device is for physical tissue treatment, not AI-assisted reading.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not available in the provided K223222 document. The device is a physical electrosurgical unit, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not available in the provided K223222 document. Clinical ground truth for electrosurgical devices often involves direct observation of treatment effectiveness (e.g., lesion removal, tissue coagulation) and safety endpoints.
8. The sample size for the training set
This information is not available in the provided K223222 document.
9. How the ground truth for the training set was established
This information is not available in the provided K223222 document.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.