Search Results

The CellFX® Percutaneous Electrode System is intended for ablation of soft tissue in percutaneous and intraoperative surgical procedures. It is not intended for use in cardiac procedures.

The CellFX® Percutaneous Electrode System includes the CellFX Console, CellFX Percutaneous Electrode and Accessories: Percutaneous Adapter, pneumatic footswitch, and system software. The CellFX® Console is a proprietary energy-based platform for nanosecond Pulsed Field Ablation™ (nsPFA™) technology. nsPFA is a cell-specific, nonthermal ablation technology that delivers nanosecond-duration pulses of highamplitude electrical energy to tissue via bipolar electrodes. The pulses create nanopores in lipid membranes, which disrupt the ability of the cell and internal organelles to maintain cellular homeostasis - ultimately leading to regulated cell death (e.g., apoptosis). The electrode is provided sterile, for single use only.

The provided text is an FDA 510(k) summary for the CellFX® Percutaneous Electrode System. It describes the device, its intended use, and the data presented to demonstrate its substantial equivalence to predicate devices. However, the document does not describe an AI/ML medical device.

Therefore, many of the requested points, such as "number of experts used to establish ground truth", "adjudication method", "MRMC comparative effectiveness study", "standalone algorithm performance", "sample size for training set", and "how ground truth for training set was established", are not applicable to this device's submission and are consequently not present in the provided text.

The device discussed is an electrosurgical cutting and coagulation device that uses nanosecond Pulsed Field Ablation (nsPFA) technology. Its performance is demonstrated through various traditional medical device validation methods, including biocompatibility testing, electrical safety and EMC testing, bench testing, software verification and validation, pre-clinical animal studies, and a human safety study.

Here's an attempt to answer the applicable points based on the provided text, while explicitly stating when information is not present or not relevant due to the device type:

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

The document does not present a formal table of "acceptance criteria" against specific "reported device performance" values in a quantitative manner for most tests. Instead, it states that tests "met their respective acceptance criteria" or "passed". For the human safety study, a quantitative result is provided.

2. Sample sized used for the test set and the data provenance

• Test Set Sample Size:
  • Human Safety Study: Ten (10) subjects.
  • Pre-Clinical Animal Studies: "Two in vivo animal studies were conducted," but specific sample sizes for animals are not provided.
• Data Provenance:
  • The document implies the human safety study was conducted prospectively.
  • The geographical origin of the data (country) is not explicitly stated. Given the FDA submission, it's likely US-based or data accepted by the FDA.

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

• Not Applicable. This is not an AI/ML device requiring human expert annotation for ground truth. The "ground truth" for this device's performance is objective measurement (e.g., ablation zone reduction as measured by ultrasound in the human study, or physical/electrical parameters in bench testing, or pathological examination in animal studies).

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

• Not Applicable. This concept is specifically relevant to human labeling or ground truth establishment in AI/ML performance studies. It is not relevant to the validation tests described for this 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. An MRMC study was not done because this is not an AI/ML diagnostic or assistive device. The study performed was a human safety study of the device's direct clinical effect.

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

• Not Applicable. This is not an AI/ML algorithm. The device's performance is evaluated via its physical and biological effects.

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

• Human Safety Study: Outcomes data primarily, specifically "average of 95% reduction in ablation zones" (likely measured clinically, possibly via imaging like ultrasound, and "No serious adverse events were observed."
• Pre-Clinical Animal Studies: Likely involved pathological examination of ablated tissues for safety and effectiveness endpoints.
• Bench Testing: Engineering specifications and performance measurements.
• Biocompatibility/Electrical Safety: Standardized test methods specified by international standards (e.g., ISO, IEC).

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Ask a specific question about this device

The CRF Radiofrequency Ablation System is indicated for use in percutaneous, laparoscopic and intraoperative coagulation and ablation of tissue.

The CRF Radiofrequency Ablation System consists of an RF generator, active electrode, grounding pad, and peristallic punp for electrode cooling. This device is designed to cal tissue heating at the tip of the electrode causing coagulation and ablation of tissue. The CRF Generator supplies radiofrequency energy at 480 kHz while monitoring both the tissue imperature at the CRF electrode tip. The CRF Generator monitors the power, resistance, current and temperature during energy delivery to the paient.

The CRF Electrodes are sterile, single-use, hand-held for use in radiofrequency ablation procedures. The electrodes are surgically invasive, transient devices in patient contact typically for less than one hour. Cooling of the electrodes is provided by chilled sterile saline or water that is pumped through the electrode and out via outflow tubing. This is an enclosed system within the electrode and the saline does not contact. The CRF Generator automatically monitors impedance and temperature and adjusts RF output accordingly. The CRF Radiofrequency Ablation System is used in a healthcare facility or hospital setting.

This is a 510(k) premarket notification for a medical device (CRF Radiofrequency Ablation System), not an AI/ML device. Therefore, the traditional acceptance criteria and study designs relating to AI/ML performance metrics (such as sensitivity, specificity, AUC, MRMC studies, and expert adjudication as ground truth) are not applicable here.

The document describes the device's substantial equivalence to a predicate device based on non-clinical data.

However, to address the prompt's structure as best as possible within the context of the provided document, I will reframe some of the categories to fit the information given, focusing on the comparisons and testing performed for this physical medical device.

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

The document does not explicitly present "acceptance criteria" in the traditional sense of numerical thresholds for AI/ML performance (e.g., sensitivity > X%). Instead, the "acceptance" for this 510(k) submission relies on demonstrating substantial equivalence to a predicate device through various non-clinical tests and comparing technological characteristics. The reported device performance is presented as compliance with standards or successful demonstration of equivalence in specific tests.

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

• Sample Size for Test Set: Not applicable in the context of an AI/ML device for which this question is typically posed. For this medical device, various non-clinical tests were conducted:
  • Mechanical, Electrical, EMC: Implied to be on a sufficient number of device units to establish compliance with standards. Details on the exact number of units are not provided but are typically part of a detailed testing report not fully included in this summary.
  • Benchtop Ablation: Performed using an "ex vivo tissue model." The number of tissues or ablation cycles is not specified.
  • Usability, Biocompatibility, Sterilization, Packaging/Shelf Life, Software: Applied to the device and its components.
• Data Provenance: Not applicable in the AI/ML sense. All data appears to be from prospective non-clinical testing conducted specifically for this submission by the manufacturer or authorized labs (e.g., benchtop tests, lab tests for electrical safety, biocompatibility, etc.). Country of origin of data is not specified but would typically be where the manufacturing and testing facilities are located.

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 is not an AI/ML device requiring expert-established ground truth for image interpretation or diagnosis. Ground truth for this device is established through compliance with engineering standards (e.g., electrical safety, mechanical requirements) and observed physical outcomes in benchtop models (e.g., ablation performance). The "experts" involved are likely engineers, quality assurance personnel, and regulatory affairs specialists who conduct and interpret the non-clinical tests.

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

Not applicable. This device does not involve a diagnostic task requiring human-expert adjudication for a test set.

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

Not applicable. This is not an AI/ML device, and no MRMC study was conducted. No human "readers" are involved with the device in this capacity.

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

Not applicable. This is a physical medical device, not an algorithm. Therefore, "standalone" performance for an algorithm is not relevant. The device operates with a human operator (surgeon/clinician) in a "human-in-the-loop" manner by design, but its performance is evaluated in non-clinical settings without directly assessing human improvement from an AI perspective.

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

The "ground truth" for this device's assessment of substantial equivalence relies on:

• Compliance with codified U.S. and international standards (e.g., IEC 60601 series, ISO 11135, ASTM F1980-16, ISO 10993-1).
• Direct measurement and observation of physical characteristics and performance in laboratory and benchtop settings (e.g., electrical parameters, ablation zone size in ex vivo tissue, material properties, sterilization efficacy).
• Comparison to the established characteristics and performance of a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This device does not involve AI/ML algorithms that require a "training set."

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

Not applicable. As there is no training set, there is no ground truth established for it.

Ask a specific question about this device

The Cool-tip™ Switching Controller is to be used with the Cool-tip™ RF System and is intended for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue, such as the partial or complete ablation of non-resectable liver tumors, and osteoid osteoma tumors within bone.

The Cool-tip™ Switching Controller (CTSW Control) is an adjunct device for the Cooltip™ RF Ablation Generator. Power from the generator is routed to the controller and allows the physician to ablate lesions with one single Cool-tip electrode or one cluster electrode, or simultaneously with two or three single pre-placed electrodes. The controller sequentially switches power between the electrodes. Power is applied to the first electrode until the tissue impedance rises to the target value (30 percent above the baseline value), or until 30 seconds have elapsed. Then power is switched to the next electrode. Power is switched repeatedly until the selected procedure time is reached. The controller does not alter the basic functions available on the generator. The controller has the same timing, temperature measurement, and impedance measurement functions available on the generator. The controller does not change the power available at the electrodes compared to the generator without the controller. The indications for use and the control mechanisms for the Switching Controller remain the same as for the generator. The Switching Controller is an accessory that allows for the simultaneous activation of multiple electrodes. Activation of multiple electrodes during a single treatment session is a convenience for the physician and allows for the ablation of multiple lesions simultaneously, or for the ablation of one large tumor when the electrodes are placed 2 cm apart. Placing three single electrodes in close proximity produces a cluster electrode where the physician is controlling the cluster spacing. The controller automates the manual function of cauterization of the electrode track by controlling the temperature during electrode removal. The front panel of the Switching Controller contains an on/off power switch, activation switches for ablation and cauterization, ablation timer displays and buttons, three (3) electrode ports for the connection of selected electrodes, three (3) buttons for activating selected electrode channels, three (3) temperature probe displays with adjacent green bars to indicate the activated electrode channel, and three (3) current/watts displays for each electrode channel. The Cool-tip™ Switching Controller is comprised of the following components: Switching controller, Cable, which delivers power from the generator to the controller. The Switching Controller is connected to the Cool-tip RF generator by a dedicated cable that delivers power from the generator to the switching controller. The Switching Controller cannot direct power to the electrodes without the generator.

The Cool-tip™ Switching Controller is an adjunct device for the Cool-tip™ RF Ablation Generator, designed to facilitate the simultaneous activation of multiple electrodes. It routes power from the generator, allowing the physician to ablate lesions with one single electrode, one cluster electrode, or simultaneously with two or three pre-placed electrodes. The controller sequentially switches power between electrodes until the selected procedure time is reached. It also automates the manual function of cauterization during electrode removal.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for a specific performance metric (like accuracy, sensitivity, or specificity). Instead, the acceptance is based on the device demonstrating safety and efficacy comparable to a predicate device. The key performance aspect is the ability of the switching controller to produce similar therapeutic effects (lesions) as the predicate device when using various electrode configurations.

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

The study involved preclinical testing on bovine liver, both ex vivo (outside the body) and in vivo (in a living organism). The document does not specify a precise numerical sample size (e.g., number of livers, number of ablation procedures, or number of electrodes tested).

However, the data provenance is clearly stated as bovine liver, indicating an animal model. The study is described as "preclinical testing," implying it's a prospective study designed to compare the new device to the predicate.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the test set. The comparison of lesion characteristics likely involved direct measurement and observation rather than expert consensus on a diagnostic outcome.

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

No, an MRMC comparative effectiveness study was not conducted. This device is an accessory to an existing RF ablation system and its performance demonstration focuses on the equivalence of the generated lesions, not on diagnostic accuracy involving human readers.

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

This question is not applicable in the context of this device. The Cool-tip™ Switching Controller is a hardware accessory that automates power delivery for RF ablation electrodes. It does not involve algorithms for interpretation or generate diagnostic outputs that would have a "standalone performance" in the typical sense of AI/software. Its performance is intrinsically tied to its interaction with the RF generator and electrodes.

7. The Type of Ground Truth Used

The ground truth for this study was based on the characteristics of the lesions produced by the RF ablation. The statement "lesions produced... are comparable" implies a physical assessment of ablation zones (e.g., size, shape, completeness) as the reference for comparison. This would likely involve macroscopic and/or microscopic examination of the ablated tissue.

8. The Sample Size for the Training Set

The document does not mention a training set. This is not a machine learning device, so the concept of a training set as used in AI development is not applicable here.

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

As there is no training set for this hardware device, this question is not applicable.

Ask a specific question about this device