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The PlaDuo is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Argon handpiece is intended for the removal and destruction of skin lesions and the coagulation of tissue.

The PlaDuo System is an electro-surgical device for use in dermatological applications. The device utilizes nitrogen and argon gas to be used separately to generate the desired power level to patients. The effect of the device is achieved by heating the outer layer of the skin so that part or all of it becomes non-viable and there is controlled damage to the underlying skin.

The PlaDuo system consists of a system console with wells for 2 gas tanks, footswitch, 2 handpieces, and tip with 3 interchangeable guides.

This document describes the FDA's 510(k) clearance for the ShenB Co Ltd's PlaDuo System. The system is an electrosurgical device that uses nitrogen and argon gas to generate plasma for dermatological and general surgical procedures.

Based on the provided text, the device meets acceptance criteria through various performance tests, including:

1. IEC 60601-1:2005 + A1:2012: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
2. IEC 60601-1-2:2014: Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests.
3. IEC 60601-2-2:2017: Medical Electrical Equipment - Part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories.
4. IEC 62304:2006+A1:2015: Medical Device Software Life Cycle Processes.
5. EN ISO 14971:2012: Medical Devices - Application Of Risk Management To Medical Devices.
6. Biocompatibility testing (cytotoxicity, irritation, and sensitization) per ISO 10993-1:2018 for patient-contacting materials (space guides).
7. Software verification and validation testing in accordance with FDA's guidance.
8. Thermal testing on ex vivo tissue specimens to verify the performance of the argon gas.

Table of Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample sizes used for the test set and data provenance:

   • The document mentions "thermal testing on ex vivo tissue specimens." It specifies "skin and in liver models" and "muscle" as the tissue types. However, the exact sample size (number of specimens or tests) is not provided.
   • Data provenance: "ex vivo tissue specimens." The country of origin is not specified. The study's nature is likely prospective as it involves new testing for the modified device.

2. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

   • The document does not specify the number of experts or their qualifications used to establish ground truth or interpret the thermal testing results. The conclusion about "desirable clinical treatment effect" based on thermal damage profiles implies expert assessment, but details are absent.

3. Adjudication method for the test set:

   • Since the thermal testing is described as direct measurement of physical effects ("measurable thermal damage," "traceable thermal effect"), a human adjudication method in the sense of consensus reading (2+1, 3+1) is not applicable in the same way it would be for image interpretation. The method of assessing "consistent thermal damage profiles" and comparability to predicate devices would likely rely on quantitative measurements and engineering/biomedical expertise, but no specific adjudication method is mentioned.

4. 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:

   • No MRMC study was done. This device is an electrosurgical tool, not an AI interpreting medical images. The evaluation focuses on the safety and performance of the electrosurgical function itself, particularly its thermal effects, rather than how it assists human interpretation or decision-making in a diagnostic context.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This question is not applicable as the device is a piece of hardware with integrated software for control, not an AI algorithm to be evaluated in a standalone diagnostic capacity. The "software verification and validation testing" confirms the software's functional performance, which is a component of the device's overall standalone performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the thermal testing, the ground truth was observed thermal damage profiles on ex vivo tissue, measured directly. The comparison was made against profiles produced by predicate and reference devices, implying their established effectiveness provides a benchmark. It's a physical/biophysical ground truth.

7. The sample size for the training set:

   • The document describes a 510(k) submission for a physical medical device, not an AI/machine learning model that typically has a "training set." Therefore, the concept of a training set sample size does not apply in this context.

8. How the ground truth for the training set was established:

   • As this is not an AI/ML device, the question of establishing ground truth for a training set is not applicable.

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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.

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.

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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.

This document is a 510(k) Premarket Notification from the FDA regarding the Plasma IQ device. It primarily focuses on demonstrating "substantial equivalence" to previously cleared predicate devices, rather than presenting a performance study for a novel AI or diagnostic device.

Therefore, many of the requested elements for describing the acceptance criteria and study that proves a device meets acceptance criteria (especially those related to AI algorithm performance, human reader studies, and ground truth establishment for image analysis) are not applicable to this document. This document describes a device for direct physical interaction (removal and destruction of skin lesions, coagulation of tissue) using electrosurgery, not an AI or diagnostic tool.

However, I can extract information relevant to the device's technical specifications and the basis for its clearance.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance (as inferred from Substantial Equivalence)

For a device like Plasma IQ, "acceptance criteria" for FDA clearance through the 510(k) pathway are primarily demonstrating substantial equivalence to a previously cleared predicate device. This means the new device is as safe and effective as the predicate. The "study" proving this largely involves comparing technical specifications and intended use.

Inferred Acceptance Criteria for Substantial Equivalence:

• Identical Intended Use: The device must have the same indications for use as the predicate.
• Similar Technological Characteristics: Key physical and operational characteristics must be substantially similar.
• No New Questions of Safety/Effectiveness: Any differences must not raise new safety or effectiveness concerns.

Table of Acceptance Criteria (as demonstrated by comparison to predicates) and Reported Device Performance:

Study Details (as related to Substantial Equivalence for this type of device)

1. Sample sizes used for the test set and the data provenance:

   • N/A. This submission is for an electrosurgical device cleared via the 510(k) pathway, primarily demonstrating "substantial equivalence" to predicate devices. It states: "No performance testing data was provided in this submission other than what was provided in the predicate (K192813) to establish substantial equivalence."
   • The "study" here is a comparison of technical specifications, safety standards compliance, and intended use to predicate devices. The data provenance is implied to be existing documentation and specifications of the predicate devices.
   • The intent of this specific K212329 submission was to amend labeling to remove a contraindication, which was supported by clinical evidence (though not detailed here beyond this statement).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. This is not an AI/diagnostic device where expert "ground truth" for image data or clinical outcomes is established for a test set in the conventional sense. The "ground truth" for demonstrating substantial equivalence is the existing safety and effectiveness profiles of the cleared predicate devices, confirmed by technical comparisons.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • N/A. Not relevant for this type of 510(k) submission.

4. 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:

   • No. This is not an AI-assisted diagnostic device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This is a medical device for direct physical treatment, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this 510(k) clearance is the established safety and effectiveness of the predicate devices (K192813 and K201738) based on their prior FDA clearances and compliance with recognized standards (EN60601-1, EN60601-1-2, EN60601-2-2). The clinical evidence mentioned for the contraindication removal would refer to outcomes data from relevant studies, but these are not presented in this summary document.

7. The sample size for the training set:

   • N/A. This is not an AI/machine learning device that uses a "training set."

8. How the ground truth for the training set was established:

   • N/A. Not applicable, as there is no training set for this device type.

Conclusion stated in the document: "The Plasma IQ that is subject to this submission is the same device that was cleared in K192813. No changes have been made to this device. The Plasma IQ is substantially equivalent to the predicate device. The intent of this submission is to amend the labeling to remove a contraindication. This removal of the contradiction is supported by clinical evidence. There are no new questions regarding safety or effectiveness raised by the change in the labeling."

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