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The Plasmage system is a radiofrequency based professional device exciting an electrical plasma discharge between a metal tip and the patient skin. The discharge deposit thermal energy in the skin and results in removal and destruction of skin lesions and the coagulation of skin tissue. The device is operating in monopolar mode only. The device consists of a console with touch LCD screen and graphic user interface, handpiece with integrated cable, single use electrodes, and foot pedal.

AI/ML Overview

The provided document describes the Plasmage System, an electrosurgical cutting and coagulation device, and its substantial equivalence to a predicate device (Bovie Derm 941/942) for 510(k) clearance.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion / Aspect	Acceptance Criteria (Implied from Predicate Equivalence)	Reported Device Performance and Evidence
Indications for Use	Removal and destruction of skin lesions and the coagulation of skin tissue (identical to predicate).	The Plasmage System has the same Indications for Use: "Removal and destruction of skin lesions and the coagulation of skin tissue." This is a subset of the predicate's indications, implying it meets the necessary performance for this specific use.
Mechanism of Action	Creates a small area of thermal damage using RF energy for coagulation or tissue evaporation (similar to predicate).	The Plasmage system is a radiofrequency based device exciting an electrical plasma discharge, depositing thermal energy in the skin. The action is "predominantly thermal and related to absorption of the energy provided and heating the tissue in the area of energy application." Histology study shows "similar size and shape of thermal damage profile created by these devices."
Tissue Interaction	Causes thermal damage profile suitable for skin lesion removal and coagulation (similar to predicate).	Histology study on ex vivo porcine skin evaluated thermal damage profile (shape and size) at min, recommended, and max power. The study demonstrated "similar histological and thermal effect on skin tissue" between the subject and predicate devices.
Safety - Electrical & EMC	Meets appropriate electrical safety and EMC testing requirements per FDA recognized consensus standards (similar to predicate).	The Plasmage System "meets appropriate electrical safety and EMC testing requirements per FDA recognized consensus standards." Specific standards listed: AAMI ANSI ES 60601-1:2005(R)2012, IEC 60601-1-2:2014.
Safety - Biocompatibility	Meets biological evaluation of medical devices standards.	Complies with ANSI AAMI ISO 10993-1:2018 (Biological evaluation of medical devices).
Safety - Software	Meets medical device software lifecycle standards.	Complies with ANSI AAMI IEC 62304:2016 (Medical device software Software life cycle processes).
Safety - Risk Management	Applies risk management to medical devices.	Complies with ISO 14971:2007 (Application of risk management to medical devices).
Operational Principles	Operator control of treatment duration, visual observation of tissue effect, and training for appropriate power/tip movement speed (similar to predicate).	"The exposure level in both devices is controlled by an operator by selecting power and then controlling exposure duration by visually observing tissue effect and/or training the operator to maintain the combination of power and tip movement speed appropriate for selected clinical procedure." Similarities are highlighted.
Differences (RF Freq, Voltage, Power, Size, Weight)	Differences do not raise additional safety or effectiveness concerns, and performance is equivalent for proposed indications.	The document explicitly states: "The subject has different output power, RF frequency and applicators. However, these differences do not raise additional safety or effectiveness concerns. Performance tests as listed in the following section Hand I demonstrated the subject device has equivalent performance as the predicate device for the proposed indications for use." Specific values are listed in the comparison table.

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

Test Set (Histology Study): The document states the study was performed on "ex vivo porcine skin." It does not specify the exact sample size (e.g., number of skin samples, number of lesions treated, or number of pigs).
Data Provenance: The data is from an ex vivo study, meaning it was conducted on biological tissue outside of a living organism. The country of origin is not specified. It is an experimental/prospective study in the sense that the testing was specifically designed and performed to evaluate the device.

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

The document mentions a "histology study has been performed to evaluate shape and size of thermal damage profile... The tissue damage was evaluated with Nitro Blue Tetra Chlorine (NBTC) histological evaluation."
It does not specify the number of experts who evaluated the histology slides or their qualifications. It simply states the evaluation was done.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the histology study. It implies a direct histological evaluation was performed, presumably by a single expert or a team without a formal adjudication process described in the text.

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

No, an MRMC comparative effectiveness study was not done. The document describes a bench-top histology study comparing the thermal effects of the subject device to a predicate device, not a human reader study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to this device. The Plasmage System is a hardware medical device (an electrosurgical unit), not an AI or algorithm-based software device. Its performance is evaluated based on its physical interaction with tissue, not an algorithm's output.

7. The Type of Ground Truth Used

The ground truth for the performance study (histology) was established through histological evaluation using Nitro Blue Tetra Chlorine (NBTC) staining. This method allows for the assessment of tissue viability and thermal damage, serving as an objective measure of the device's effect on tissue.

8. The Sample Size for the Training Set

This question is not applicable as the Plasmage System is a hardware device, not a machine learning or AI algorithm that requires a training set.

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

This question is not applicable for the same reason as above (no training set for a hardware device).

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