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The Hybrid Plasma Scalpel provides cutting and gas coagulation during open surgical procedure where monopolar electrosurgery (cutting and coagulation) is normally used. The Hybrid Plasma Scalpel is a monopolar handpiece used with compatible electrosurgical units.

The Canady Vieira Hybrid Plasma™ Scalpel is an accessory multi-functional electrosurgical handpiece used for open surgical procedures where monopolar radio frequency electrosurgical handpieces (cutting, coagulation) is normally used. The handpiece uses radio frequency (RF) monopolar electrosurgical current to cut or coagulate biological tissue. The handpiece can also combine argon gas with radio frequency monopolar cut or coagulation currents to produce a hybrid plasma cut, or argon plasma coagulation. The handpiece consists of three major components: Handle, Telescoping Nozzle, and Electrode. The insulated handle encases the radio frequency (RF) current and gas tubing for controlling the flow of argon gas and activation of RF current for the device. RF current is activated by two push buttons yellow (standard CUT mode) and blue (standard COAG mode) which are top of the handle. Argon gas is delivered via the handle by activating a third push button (purple) which is also on top of the handle. The electrode tip has 4 modes of operation and as shown in the below table, this words appear depending on the mode of operation that is necessary. Depending on the RF current mode (CUT or COAG), the handpiece can function in the following argon modes: HYBRID PLASMA CUT – Argon gas is delivered through the handpiece while the attached electrosurgical generator is set in the CUT mode. Hybrid Argon Plasma Cut mode will cut and coagulate the tissue at the same time. ARGON PLASMA COAGULATION – Argon gas is delivered through the handpiece while the attached electrosurgical generator is set in the COAG mode. Argon Plasma Coagulation will coagulate the tissue. The Canady Vieira Hybrid Plasma™ Scalpel is an accessory that is used with the Argon 2 (CPC2) and Argon 4 (CPC4) generators, previously cleared by FDA. These generators provide a controlled flow of argon to the electrosurgical handpiece during Hybrid Plasma Cutting or Argon Plasma Coagulation modes. The Physician manually sets the flow rate on the Plasma coagulator. The telescoping nozzle can be extended or shortened over the electrode as desired when the surgeon is performing argon procedures.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Canady Vieira Hybrid Plasma™ Scalpel:

Acceptance Criteria and Reported Device Performance

Study Information

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

   • Clinical Studies: "No Clinical studies were performed for the submission of this 510(k)." Therefore, there is no test set in the context of clinical human data.
   • Biocompatibility Testing: The sample size for biocompatibility testing is not specified. Data provenance is not specified beyond meeting ISO 10993-1 and USP requirements.
   • Bench Studies: The sample sizes for bench testing (IEC 60601-1-2, IEC 60601-2-2, compatibility, cutting/coagulation, shelf life, sterility) are not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical studies were performed. For bench and biocompatibility testing, ground truth is established through adherence to standards and test protocols, not expert consensus in the human data sense.

3. Adjudication method for the test set: Not applicable. No clinical studies were performed requiring adjudication of human data.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. No clinical studies, and therefore no MRMC studies, were performed.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electrosurgical handpiece, not an AI algorithm. Its performance is assessed through its physical and electrical characteristics and ability to perform cutting and coagulation, not through an algorithm's standalone performance.

6. The type of ground truth used:

   • Biocompatibility: Adherence to established standards (ISO 10993-1, USP requirements).
   • Performance Testing (Bench Studies): Adherence to established electrical safety standards (IEC 60601-1-2, IEC 60601-2-2), functional performance (cutting, coagulation), and physical characteristics (shelf life, sterility, compatibility with generators). The "ground truth" here is the successful demonstration of compliance with these standards and functionalities.

7. The sample size for the training set: Not applicable. This is a medical device, not an AI algorithm that requires a training set.

8. How the ground truth for the training set was established: Not applicable. No training set was used.

Summary of the Study provided:

The submission for the Canady Vieira Hybrid Plasma™ Scalpel is based on a substantial equivalence pathway, primarily relying on comparisons to predicate devices and extensive bench testing and biocompatibility testing.

• Bench Studies: These studies confirmed the device meets electrical safety standards (IEC 60601-1-2 and IEC 60601-2-2), is compatible with specified electrosurgical generators, and can successfully perform cutting and coagulation, as well as demonstrating shelf life and sterility.
• Biocompatibility Testing: Conducted in accordance with ISO 10993-1 and USP requirements to validate patient-contacting materials.
• Clinical Studies: No clinical studies were performed. The safety and effectiveness claim is based on substantial equivalence to predicate devices, supported by the non-clinical testing. The argument is that the device does not raise new issues of safety and effectiveness compared to the already cleared predicate devices.

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The Canady Plasma Coagulator devices are intended to provide gas-enhanced coagulation during general surgery procedures. The Canady Plasma Coagulator devices are Argon Plasma Coagulation Unit designed for gas enhanced coagulation when used only with the Canady Plasma Electrosurgery Unit models and compatible monopolar and/or bipolar RF handpieces.

The Canady Electrosurgery Unit Generators are intended to cut and/or coagulate tissue when used with compatible monopolar and/or bipolar RF handpieces. The Canady Electrosurgery Unit Generators are capable of monopolar argon gas enhanced coagulation when used with Canady Plasma Coagulator and probes.

The Canady Plasma"M Electrosurgical Unit Series with Accessories is an High Frequency (HF) Electrosurgery Unit (ESU) used in combination with Canady Plasma™ Coagulators (Argon 2 and Argon 4) gas units and probes (Canady Plasma™ GIT probe and Canady Plasma™ TBS probe). The Canady Plasma (ESU) series combines (HF) voltage to electrically enhanced plasma gas (i.e. Argon) to produce a plasma gas stream. Current density upon arrival at the tissue surface from Canady Plasma Probes causes coagulation of the tissue. Canady Plasma (ESU) series is also a monopolar and bipolar RF surgical device for cutting and coagulation. It is used for tissue removal and coagulation in accordance with the operative procedure performed by the physician. The unit provides various cutting and coagulation modes to meet the physician flexibility performing the specific procedure with the device.

The Canady Plasma Electrosurgery Unit Model SS-200E is to only be used with the Canady Plasma Coagulator Argon 2. The Canady Plasma Electrosurgery Unit Model SS-601 Mca is to only be used with the Canady Plasma Coagulator Argon 4.

The provided 510(k) summary for the Canady Plasma Electrosurgical Unit Series (K100669) focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria and a study proving device performance (especially for AI/software-based devices) is not applicable or not provided in this document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: In submissions for devices like electrosurgical units, the "acceptance criteria" are typically met through adherence to recognized national and international safety and performance standards for electromedical equipment, as well as demonstration of equivalence to legally marketed predicate devices. The document explicitly states compliance with relevant NBR IEC standards. No novel performance claims requiring specific clinical acceptance criteria are being made.

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

• Sample size for test set: Not applicable. The submission does not describe a clinical study with a test set of data points for performance evaluation in the way one might for an AI/software device.
• Data provenance: Not applicable. The testing described (compliance with NBR IEC standards) is typically laboratory-based engineering and electrical safety testing, not based on patient data.

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

• Number of experts: Not applicable.
• Qualifications of experts: Not applicable.

Explanation: As no clinical test set with ground truth is described, this information is not relevant to this submission.

4. Adjudication Method for the Test Set:

• Adjudication method: Not applicable.

Explanation: No clinical test set is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC study: No.
• Effect size of human reader improvement with AI vs. without AI assistance: Not applicable.

Explanation: This device is an electrosurgical unit, not an AI-assisted diagnostic or clinical decision support tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

• Standalone study: No.

Explanation: This device is a physical electrosurgical unit, not an algorithm. Performance is assessed through compliance with standards and equivalence to predicate devices, used directly by a physician.

7. Type of Ground Truth Used:

• Type of ground truth: Not applicable.

Explanation: As this is an electrosurgical unit, the "ground truth" would relate to its physical and electrical characteristics as determined by engineering tests and adherence to standards, not clinical "ground truth" labels for a dataset.

8. Sample Size for the Training Set:

• Sample size for training set: Not applicable.

Explanation: This is not an AI/machine learning device, so there is no concept of a "training set."

9. How the Ground Truth for the Training Set was Established:

• How ground truth was established: Not applicable.

Explanation: As this is not an AI/machine learning device, there is no training set and thus no ground truth establishment for a training set.

Summary of Focus in this 510(k) Submission:

The K100669 submission for the Canady Plasma Electrosurgical Unit primarily focuses on demonstrating:

• Substantial Equivalence: The crucial aspect of this submission is showing that the device is "equivalent in intended use, technological characteristics, and performance characteristics to the named predicate devices." This is the cornerstone of a 510(k) submission.
• Intended Use: Clearly defining the intended use, which is for gas-enhanced coagulation and general tissue cutting/coagulation during surgery.
• Compliance with Standards: Adherence to recognized national and international safety standards for electromedical equipment (NBR IEC 60601-1, 60601-2-2, 60601-1-2). This indicates that the device has undergone electrical, mechanical, and electromagnetic compatibility testing to ensure it operates safely and effectively within expected parameters.

For physical medical devices like electrosurgical units, the regulatory pathway often relies on comparison to existing, legally marketed predicate devices and compliance with established safety and performance standards, rather than large-scale clinical trials establishing new performance metrics or comparative effectiveness studies involving AI.

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