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Plexr Plus is used in the removal and destruction of skin lesions and coagulation of tissue.

Plexr Plus 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 high frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas particles in the air. A stainless steel straight disposable active sterilized tip is not available with the system and is not supplied by the company. Three cordless handpieces with three fixed powers are charged in a docking/charging station prior to use.

The provided document does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device.

The document is a 510(k) premarket notification for a medical device called PLEXR PLUS, which is an electrosurgical cutting and coagulation device. The focus of this submission is to demonstrate substantial equivalence to a predicate device (Plasma IQ), not to prove performance against specific acceptance criteria using a clinical study as would be typical for an AI/ML device.

Here's what the document does discuss regarding performance and comparison:

Performance Testing:
The document mentions that the following performance testing was conducted to prove compliance with performance requirements and support substantial equivalence:

• Electrical: Compliance with EN 60601-1 (Pass) and EN 60601-1-2 (Pass).
• Tissue Testing: Compare thermal spread of devices (Result: Equivalent).
• Packaging: Compliance with EN 22248 (Pass).

Substantial Equivalence:
The primary study presented is a comparison to a predicate device (Plasma IQ) to demonstrate substantial equivalence, not to meet specific performance acceptance criteria for a novel AI/ML function. The comparison charts highlight device characteristics and explain differences:

• Intended Use: Same
• Indications for Use: Same
• Mode of Operation: Same (Plasma, Radiofrequency energy ionizes air)
• Output: Monopolar (Same)
• Power Supply: Same power input parameters
• Frequency: PLEXR PLUS (80 kHz) vs. Plasma IQ (40 kHz). The document states: "The output frequency is substantially the same in the electromagnetic spectrum. The minimal difference does not impact the efficacy of safety at all."
• Max Output Power: PLEXR PLUS (2 W) vs. Plasma IQ (5 W). The document states: "The output power is not linear, and it is calculated as P=V²/R, so 3 W of difference is not impacting the efficacy and the safety of the device."
• Output Impedance: PLEXR PLUS (60,000 Ω) vs. Plasma IQ (54,000 Ω). The document states: "The output impedance is substantially the same."
• Wave Form: Sinusoidal for both with similar amplitudes and frequencies.
• System Components: PLEXR PLUS has three different wireless handpieces with fixed power each, while Plasma IQ has one wireless handpiece with two buttons for choosing fixed power. The document states: "The operation is the same, just the configuration is different."
• Tips/Raw Materials/Electrical Safety Standards: Same.

Missing Information:

The document does not provide the following information relevant to your request for AI/ML device study details:

1. A table of acceptance criteria and the reported device performance (for an AI/ML function): The "Tissue Testing" result of "Equivalent" is very broad and doesn't provide specific numerical performance metrics.
2. Sample size used for the test set and the data provenance: Not applicable to this type of device comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not explicitly stated beyond "Tissue Testing" leading to an "Equivalent" finding. This suggests some form of experimental comparison rather than a ground truth derived from expert consensus, pathology, or outcomes data in a clinical setting.
8. The sample size for the training set: Not applicable (this is not an AI/ML device).
9. How the ground truth for the training set was established: Not applicable.

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