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The Canady Helios Cold Plasma™ XL-1000CP™ Ablation System is indicated for the gas enhanced ablation of soft tissue using helium-based plasma.

The Canady Helios Cold Plasma™ XL-1000CP™ Ablation System produces a Helium-based cold plasma spray to deliver high frequency low energy current intended for the ablation of soft tissues.
The Canady Helios Cold Plasma™ XL-1000CP Ablation System includes the following items:

• Canady Helios Cold Plasma™ XL-1000CP SMART Electrosurgical Generator
• Canady Helios™ Cold Plasma Ablators
• Foot Pedal
• Trolley Cart
  The Canady Helios Cold Plasma™ XL-1000CP™ SMART Electrosurgical Generator is a transportable nonsterile electrical device compatible for use in the operating room environment. The Canady Helios Cold Plasma™ XL-1000CP SMART Electrosurgical Generator creates high frequency, short duration energy pulses with regulated Helium gas, which is delivered to the target tissue via the Canady Helios™ Cold Plasma Ablators. The Canady Helios™ Cold Plasma Ablators are sterile monopolar electrosurgical instruments intended for single use.

This document, K240297, is a 510(k) Premarket Notification for the Canady Helios Cold Plasma™ XL-1000CP™ Ablation System. It demonstrates substantial equivalence to a predicate device, not an AI/ML powered device. Therefore, the information requested about acceptance criteria, study details, ground truth establishment, sample sizes, and expert adjudication as pertains to AI/ML device performance is not applicable to this submission.

The document focuses on the safety and effectiveness of the electrosurgical ablation system itself, comparing it to an existing predicate device based on its intended use, technological characteristics, and performance testing against recognized standards.

Here's a breakdown of what is available in the document regarding the device's performance and acceptance, interpreted in a general sense rather than specifically for AI/ML:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide specific numerical acceptance criteria for performance; rather, it lists various tests conducted and generally states that the device "Met criteria." This is common for non-AI medical devices where performance is typically validated against engineering specifications and applicable standards, rather than statistical thresholds for diagnostic accuracy.

The document also notes in the Substantial Equivalence table:

• Performance: "Shown to ablate soft tissue at specified parameters." (For both subject and predicate device).

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

This information is not applicable as the document describes a traditional medical device (electrosurgical ablation system) and its performance validation, not an AI/ML-powered device requiring a test set for algorithmic performance evaluation. The "tests" mentioned are likely bench testing, in-vitro experiments, or potentially animal studies (though not specified), designed to verify physical and electrical properties, sterility, and basic function. Data provenance as typically understood for AI (e.g., country of origin of patient data, retrospective/prospective) is irrelevant here.

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

Not applicable. There is no "ground truth" in the AI/ML sense (e.g., clinical labels for images) established by experts for this type of device. Performance is assessed against engineering specifications, safety standards, and the ability to perform its stated function (ablation).

4. Adjudication Method for the Test Set:

Not applicable. No adjudication methods are described as there is no human interpretation of data for algorithmic ground truth establishment.

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

Not applicable. This type of study is relevant for AI/ML diagnostic or assistive technologies where human reader performance is a key metric. This is a therapeutic electrosurgical device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. As this is not an AI/ML device, the concept of a standalone algorithm performance test is not relevant.

7. Type of Ground Truth Used:

Not applicable in the AI/ML sense. For this device, "ground truth" refers to established engineering principles, safety standards (e.g., electrical safety, electromagnetic compatibility), and the physical outcome of the ablation process (e.g., tissue ablation effectiveness, thermal effect), verified through laboratory testing against specifications.

8. Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not an AI/ML device that learns from data.

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

Not applicable. Similar to point 8, there is no training set or associated ground truth for this type of medical device submission.

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The Canady Flex RoboWrist is intended for grasping, mobilization, transection, suturing, and/or electrocautery of tissue under direct and endoscopic visualization.

The Canady Flex RoboWrist is a motorized, hand-held laparoscopic surgery instrument available with hook, scissors, or needle holder end-effectors. The device includes a connector for an electrosurgical generator, which allows the option of using the mono scissors or hook for electrosurgery. The Canady Flex RoboWrist primarily intended for dissection, and/or suturing of tissue under direct and endoscopic visualization in minimally invasive surgical procedures for interventions such as laparoscopic (urologic, gynecologic) or thoracic surgeries.

The Canady Flex RoboWrist is composed of an instrument (with end-effectors) and a control unit, which provides power to the instrument. Three models of instruments are available: needle-holder, monopolar hook and monopolar scissors. An electrical cable is provided to connect the instrument to the control unit. It is also provided with a sterilization tray.

The provided text is a 510(k) summary for the Canady Flex RoboWrist, an endoscopic instrument. This document describes the device, its intended use, and how it demonstrates substantial equivalence to a predicate device. However, it does not include detailed acceptance criteria or a study that evaluates the device's performance against specific clinical or diagnostic metrics, as would be expected for an AI/ML-driven device with performance claims.

Instead, the document focuses on non-clinical performance data to demonstrate safety and effectiveness for a surgical instrument. The key takeaway is that this is not an AI/ML device and therefore the questions about AI-specific performance criteria, ground truth, expert adjudication, and MRMC studies are not applicable.

Here's an analysis based on the provided text, highlighting what is present and what is not:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in the typical sense for a medical device with performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it lists various non-clinical tests that were performed to evaluate conformance to product specifications.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The "test set" here refers to physical components of the device and its performance in a lab setting, not a dataset of patient images or clinical outcomes.

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)

Not applicable. This device is an endoscopic surgical instrument, not an AI/ML diagnostic or prognostic tool. "Ground truth" for this device would relate to engineering specifications, material properties, and functionality demonstrations performed by engineers and technicians, not clinical experts establishing diagnostic accuracy.

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

Not applicable. There is no clinical test set requiring adjudication in the context of an AI/ML device.

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

No. This is not an AI/ML-assisted device.

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

No. This is a surgical instrument operated by a human.

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

For the non-clinical tests, the "ground truth" is defined by the requirements and specifications of the referenced ISO and IEC standards (e.g., a material is cytotoxic or not based on ISO 10993-5 criteria; electrical safety is met if measurements are within IEC 60601-1 limits). For functionality, it's whether the device can successfully manipulate, cut, and suture tissue as intended.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. No training set is involved.

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The Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories is intended to provide gas-enhanced coagulation during general surgery procedures. The Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories is designed for gas enhanced coagulation when used only with the Canady Plasma Electrosurgery Unit and compatible monopolar and/or bipolar 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® SMART XL-1000™ Electrosurgical Generator (CPSXEG) with Accessories is a High Frequency (HF) Electrosurgery Unit (ESU) used in combination with electrosurgical probes. The CPSXEG 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. The CPSXEG 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, coagulation, hybrid plasma, and argon plasma modes to meet the physician's flexibility performing the specific procedure with the device.

The modified Canady Plasma Smart XL-1000™ ESU has the same intended use as the predicate SS-601/Argon 4 Canady Plasma® Electrosurgical Unit as well as the same performance specifications. The modified device has the same protective circuits as the predicate ESU which displays the equipment output error on the monitor screen with a graphic symbol so that the user can determine the cause of the error. The packaging, labeling (i.e. user manual) are the same.

The Canady Plasma® SMART XL-1000™ Electrosurgical Generator has a touch screen color monitor that provides the user with quick start, on screen tutorial and user manual as well as operational and settings. Various cutting, coagulation, bipolar, and plasma modes are the predicate unit, but the modified device has improved programmable software. When turned on, an APPS screen is displayed on the monitor screen. The user can decide which medical application is started by touching the particular application (i.e Pediatrics, orthopedics, endoscopy, gynecology). Upon activation of the device audio and visual error system malfunctions or user errors can be observed by the user. Once the device is activated, power in watts, gas flow rate, gas volume, PPM, and energy mode are displayed on the monitor screen.

The provided text describes a 510(k) premarket notification for the Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories. This is a submission to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria in a clinical context.

Therefore, many of the requested details, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable or available in this type of regulatory document.

The document focuses on non-clinical performance data and a comparison to a predicate device to establish substantial equivalence.

Here's the information that can be extracted relevant to acceptance criteria and performance:

1. A table of acceptance criteria and the reported device performance

The document does not present "acceptance criteria" in the typical sense of a clinical performance study with specific endpoints and thresholds. Instead, it demonstrates performance through the comparison of technological characteristics with a predicate device and extensive non-clinical testing.

The acceptance criteria for this submission are implicitly that the modified device should perform as specified, in accordance with the predicate device's specifications, and not raise new questions of safety or effectiveness. The reported "performance" is that it meets these expectations.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing described is non-clinical laboratory testing performed by the manufacturer, not a clinical trial or study with human subjects.

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 applicable/provided. The testing performed is non-clinical performance and safety testing of an electrosurgical generator, not a diagnostic device requiring expert interpretation for ground truth establishment.

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

This information is not applicable/provided. Adjudication methods are typically used in clinical studies involving interpretation of data/images, which is not the nature of this submission.

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 applicable/provided. The device is an electrosurgical generator, not an AI-assisted diagnostic or image interpretation tool. Therefore, MRMC studies and AI-related effect sizes are irrelevant to this submission.

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

This information is not applicable/provided. The device is a medical instrument (electrosurgical generator), not an algorithm that operates in a standalone capacity without human interaction in a clinical setting.

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

This information is not applicable/provided in the context of clinical ground truth. For the non-clinical performance testing, the "ground truth" would be the established engineering specifications and compliance standards (e.g., maximum power output, frequency deviation, electrical insulation integrity) which were measured and validated.

8. The sample size for the training set

This information is not applicable/provided. This is a hardware device with "improved programmable software," but the document does not describe it as an AI/ML device that undergoes a "training" process in the sense of predictive modeling.

9. How the ground truth for the training set was established

This information is not applicable/provided for the reasons stated in point 8.

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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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