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The Boston Scientific RFG-X1 (GX1) Radiofrequency Generator is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. The Boston Scientific GX1 Radiofrequency Generator is used with separately approved Boston Scientific Radiofrequency Probes

The Boston Scientific GX1 Radiofrequency (RF) Generator is a 50W RF lesion generator that supplies electrical power to associated RF Probes. During RF energy delivery, power is continuously monitored and controlled, based on temperature and impedance measurements at the treatment site, to ensure proper operation. The GX1 Generator is a product line extension of the Boston Scientific G4 Radiofrequency Generator which is FDA approved under 510(k) K082051.

The GX1 Generator is a small, portable unit (14.3" W x 10.8" H x 12.5" D, 24lbs) that can accommodate line Voltage between 100 and 240 Volts. The GX1 Generator has advanced functionality and a Graphical User Interface (UI) equivalent to the Boston Scientific RF Generator, its predicate device.

The provided FDA 510(k) clearance letter describes a medical device, the Boston Scientific GX1 Radiofrequency Generator, and its performance testing. However, the document does not contain information related to acceptance criteria, a study proving the device meets those criteria, or details regarding AI/ML components.

The GX1 Radiofrequency Generator is a hardware device used to create radiofrequency lesions, not a software or AI/ML device that would typically have acceptance criteria based on diagnostic performance metrics (like sensitivity, specificity, AUC) and require a clinical study with a test set, ground truth, and expert adjudication.

Therefore, I cannot fulfill most of your request as the information is not present in the provided text.

Here's a breakdown of what can be extracted and what is missing based on the prompt's requirements:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as specific numerical targets for performance metrics like accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implicitly "Pass" for compliance with electrical safety standards, electromagnetic compatibility, and various design verification tests.
• Reported Device Performance:

• RF Output Voltage Measurement
• RF Output Current Measurement
• RF Output Impedance Measurement
• RF Ramp Rate Control
• Stimulation Output Voltage
• Stimulation Output Current
• Ablation Temperature Measurement
• Contact Quality Measurement | Pass |
  | Packaging Testing | Conform to ASTM D4169 Standard Practice for performance testing of shipping containers and systems | Pass |
  | Mechanical Testing | - Tamper Resistant screws
• Cleaning Test
• Drop Test
• Impact Test
• Flammability
• Overbalance
• Durable Labels
• Ingress Protection
• Operational conditions (Temperature, Pressure and Humidity) | Pass |
  | Lesion Size Comparison Test | Compare lesions size in homogenous tissue using G4 (Predicate) vs GX1 System | Pass |
  | Dimension and Weight | Meet dimensional and weight specifications per product specification | Pass |
  | Software Verification | - User Workflow and Information Display
• Touch Screen
• Error Display
• Report/Diagnose Logging
• Security
• Language Translation
• Therapy Template | Pass |

Missing Information (Not present in the provided document):

2. Sample size used for the test set and the data provenance: Not applicable for this type of hardware device testing. There isn't a "test set" in the context of clinical data for diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for hardware performance is typically established through engineering specifications, calibrated measurements, and adherence to international standards.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth used for these technical tests are established engineering specifications, physical measurements, and compliance with recognized industry standards (e.g., IEC standards for electrical safety and EMC, ASTM for packaging).
8. The sample size for the training set: Not applicable, as this is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The Boston Scientific GX1 Radiofrequency Generator underwent a series of non-clinical bench testing to demonstrate its performance, safety, and effectiveness. These tests included:

• Electrical Safety Testing: To ensure compliance with IEC 60601-1 and IEC 60601-2-2.
• Electromagnetic Compatibility (EMC) Testing: To confirm compliance with IEC 60601-1-2.
• Performance Testing: A range of specific tests covering RF power, voltage, current, impedance, temperature measurement/control, stimulation output, contact quality measurement, and lesion size comparison with the predicate device (G4 RF Generator) in "homogenous tissue."
• Packaging Testing: To ensure integrity during shipping.
• Mechanical Testing: Covering various physical durability and environmental factors.
• Software Verification: To confirm user interface, error handling, security, and other software functionalities.

All tests "Passed," indicating that the device met its design input requirements and compliance standards. The study's conclusion was that the GX1 Generator is substantially equivalent to its predicate device (K082051) based on indications for use, technological characteristics, and acceptable results from verification and validation testing.

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COOLIEF* Radiofrequency Generator (CRG) System is indicated for use to create lesions during neurological lesion procedures and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The CRG is to be used with only AVANOS* and Diros RF Probes and accessories, such as Cooled / Standard RF Pain Management Probes, Cannulas, and Introducers. Use of the CRG System is limited to the indications cleared under these devices and accessories.

COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)

The provided text is an FDA 510(k) clearance letter for the COOLIEF* Radiofrequency Generator. It does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner requested (e.g., performance metrics, sample sizes, ground truth establishment, or expert qualifications).

The letter primarily:

• Acknowledges receipt and review of the 510(k) premarket notification.
• Determines substantial equivalence to legally marketed predicate devices.
• Outlines general controls provisions and other regulatory requirements applicable to the device.
• Specifies the "Indications for Use" for the device.

Therefore, I cannot provide a response with the information requested in your bullet points as it is not present in the given document.

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The Racz Neurostat RF Generator is intended for lesioning of neural tissue. It is indicated for use in the peripheral nervous system. It is to be used with Epimed RF probes and cannula.

The Racz Neruostat RF Generator is a touchscreen controlled Radio Frequency (RF) Generator used to lesion neural tissue for pain management. It has 4 outputs for delivering RF from a single source into the patient, it includes functions for nerve stimulation (Sensory and Motor), Continuous Thermal RF Lesioning, Pulsed RF Lesioning and Pulsed Dose RF Lesioning. The RF Energy is transmitted via each individual probe and a Neutral Electrode when in monopolar mode; or between probes when running in bipolar mode. The device will monitor the patient's impedance, probe temperature, along with the voltage and current of the RF Energy during a procedure.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them, structured according to your requested information.

Based on the provided FDA 510(k) summary for the Racz Neurostat RF Generator (K232632), the information focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria that would typically be seen for a novel AI/software-based medical device.

The Racz Neurostat RF Generator is a radiofrequency lesion generator, a hardware device, and not an AI or software algorithm in the traditional sense that generates diagnostic output or assists human readers in interpretation. Therefore, many of the typical questions for AI/software performance studies (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not directly applicable or explicitly detailed in this type of submission.

The "acceptance criteria" discussed in this document are primarily related to safety, electrical performance, and functional equivalence to a predicate device, rather than diagnostic accuracy or clinical effectiveness in the way an AI algorithm would be evaluated.

Acceptance Criteria and Device Performance (as inferred from the 510(k) summary)

The "acceptance criteria" for a hardware device like this are generally satisfied by demonstrating compliance with recognized standards and functional equivalence to a legally marketed predicate device.

Detailed Study Information (Based on provided text):

As the device is a hardware RF generator with embedded software for control, the "study" is more akin to engineering testing and validation rather than a clinical trial assessing diagnostic performance.

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

• Test Set Sample Size: Not applicable/not specified in the context of an FDA 510(k) for a hardware device like this. The "test set" for this device refers to the specific physical units or simulated environments on which engineering and performance tests were conducted. These are not datasets of patient images or clinical data.
• Data Provenance: Not applicable. The "data" being generated and tested are electrical signals, temperature readings, and physical lesion formation, not patient-derived medical data. The tests are likely performed in a lab setting.

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

• Not applicable for this type of device. "Ground truth" for this device would be established by engineering specifications, physical laws, and recognized medical device standards (e.g., a specific power output measured by calibrated equipment, or a lesion size measured by a pathologist/engineer during comparative testing). There's no subjective expert interpretation required in the same way as for image-based diagnostics.

4. Adjudication method for the test set:

• Not applicable. The "adjudication" for this type of device involves comparing measured performance against engineering specifications and predicate performance, not resolving discrepancies between expert readings.

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. This type of study is relevant for AI systems that aid human interpretation (e.g., radiologists reading images). This device is a therapeutic generator, not a diagnostic aid.

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

• The device inherently operates as a "standalone" therapeutic device, meaning its core function (generating RF energy) does not require "human-in-the-loop" interpretation for its primary output. However, it is human-controlled to perform procedures. Performance testing was done on the device itself (hardware and embedded software), as detailed in the "Performance Testing" section.

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

• The "ground truth" for this device's performance would be established through a combination of:
  • Engineering specifications: (e.g., accurate power output, temperature control).
  • Measurement against calibrated standards: using specialized test equipment.
  • Physical demonstration: (e.g., the ability to generate a lesion of a certain size/shape in a controlled medium during "Comparative Lesion Testing").
  • Compliance with recognized standards: (e.g., IEC 60601 series).
  • Functional equivalence to predicate: demonstrating it performs the same functions as the already cleared predicate device.

8. The sample size for the training set:

• Not applicable. This device does not use machine learning in a way that requires a "training set" for an AI model.

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

• Not applicable, as there is no training set for an AI model.

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The NeuroOne OneRF Radiofrequency Ablation System is indicated for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures.

The OneRF™ Ablation System components consist of the:

• Radiofrequency (RF) Generator and Accessories
• Generator Interface Cable (GIC), Cart and Foot Pedal (optional)
• sEEG-RF Probe (with Universal Cable Assembly) and Ablation Accessories
• Temperature Accessory, Spacer Tubes, Stylet and RF Connector Box

The OneRF™ Ablation System uses radiofrequency ablation to create lesion (s) in an area of nervous tissue that the neurosurgeon has identified for ablation. This is accomplished by diagnostically locating the area to ablate using the implanted Stereoelectroencephalography (sEEG). Once the area of ablation is located, the generator and ablation accessories are taken to the patient with implanted sEEG(s). The sEEG(s) now function as an sEEG-RF Probe for RF ablation.

To perform the ablation the Temperature Accessory (TA) is inserted into the sEEG-RF Probe to the predetermined electrode contact location using the specified spacer tube. A stylet may be used to ensure the lumen is patent prior to inserting the TA. The universal cable assembly remains attached to the sEEG-RF Probe while its cables are disconnected from the diagnostic head box. One (monopolar) or two (bipolar) cables from the universal cable assembly are inserted into the radiofrequency connector box (RFCB) depending on the contact area(s) to be ablated. The TA is also connected to the RFCB is attached to the Generator Interface Cable which is attached to the Generator. Temperature and time are used to create lesion (s).

The provided text describes the NeuroOne OneRF Ablation System, a radiofrequency lesion generator and probe indicated for creating radiofrequency lesions in nervous tissue for functional neurosurgical procedures.

Here's an analysis of the acceptance criteria and study proving the device meets them, based solely on the provided text:

Important Note: The provided text is a summary from an FDA 510(k) premarket notification. It describes the device, its intended use, comparison to predicate devices, and a high-level summary of performance testing. It does not contain detailed pass/fail acceptance criteria values for most tests or granular study design information (e.g., specific sample sizes for particular experiments, expert qualifications, or detailed ground truth methodologies beyond "lesion size was determined"). The information here is inferred from the "Results and Conclusions" section, which consistently states "Pass" or "Met applicable requirements."

1. Table of Acceptance Criteria and Reported Device Performance

Given the lack of specific quantitative acceptance criteria in the provided text, the table below will list the tests performed and their reported outcomes, implying that the device met the (unstated) acceptance criteria for each.

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Intended for use for lesioning of neural tissue and for pain management. It is indicated for use in the peripheral nervous system. The APEX 6 is to be used with LCCS electrodes and cannulae and Conmed Thermogard Dispersive Electrodes.

The RF Innovations APEX 6 is a desktop RF lesioning generator which is used for the lesioning of neural tissue. The APEX 6 is a multi-lesioning, 6 channel portable generator that can provide continuous or pulsed RF output at 460 kHz, and monopolar or dual electrode modes. The device includes sensory and motor stimulation functions to fine tune electrode placement for procedures. Based on performance testing the device is designed to connect to LCCS FDA cleared lesioning probes which are inserted into patients for lesioning of neural tissue during medical procedures. Device features include a touch screen monitor incorporating microprocessor and graphics display for user interface as well as self-diagnostics, calibration checks, and recordkeeping functions.

This document is a 510(k) summary for the APEX 6 Lesioning Generator. It outlines the device's characteristics, its intended use, and how it compares to a predicate device (NeuroTherm NT 2000 RF Lesioning Generator) to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the supporting study, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details:

The provided document describes bench testing to demonstrate the substantial equivalence of the APEX 6 to its predicate device, primarily focusing on physical performance characteristics and safety standards. There is no clinical study (human-in-the-loop or standalone AI performance) described for this device, as it is a medical device generator and not an AI/Software as a Medical Device (SaMD).

Here's an breakdown of the specific points requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance: (See table above)

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

   • Sample Size: The document does not specify exact sample sizes for the "Lesion size" or "Comparison of treatment times" tests. It refers to "minimal, typical, and maximum energy delivery" for lesion size and "worse case conditions" for treatment times, implying a set of controlled experimental conditions rather than a large clinical "test set" in the common AI/SaMD sense. For "Every unit functional test," the sample size is "Every unit manufactured."
   • Data Provenance: The tests are described as "Bench testing," indicating they were performed in a laboratory or controlled environment. There is no information regarding country of origin or whether it's retrospective or prospective, as it's not a clinical data study.

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

   • This information is not applicable to the type of testing described. The "ground truth" for a device like a radiofrequency lesion generator is based on physical measurements (e.g., lesion dimensions, electrical parameters, time) and established engineering/safety standards. It's not about expert interpretation of medical images or clinical outcomes that would require human expert consensus for ground truth.

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

   • This is not applicable. Adjudication methods are typically used in clinical studies where multiple human readers interpret data, and significant disagreements require a tie-breaking mechanism or consensus. The tests described are bench tests with objective physical measurements.

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. This type of study is relevant for AI/SaMD devices where the AI assists human readers in diagnostic or screening tasks. The APEX 6 is a physical medical device generator, not an AI software.

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

   • While the APEX 6 itself performs functions autonomously (e.g., generating RF energy), the "standalone" concept usually applies to AI algorithms whose performance is evaluated independently of human input. No such "algorithm-only" performance study is described here, as the device's function is the generation and control of RF energy, which is evaluated through bench tests against physical parameters and predicate device performance. Software functions were validated, but this is different from a standalone AI performance study.

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

   • The ground truth for the bench tests was based on physical measurements (e.g., linear dimensions in millimeters, time in seconds, electrical parameters like impedance, voltage, current, power) and compliance with established international and national standards (e.g., IEC 60601 series, ANSI/AAMI, CAN/CSA).
   • For "Lesion size" and "Comparison of treatment times," the "ground truth" was derived from the performance of the legally marketed predicate device, used as a benchmark for substantial equivalence.

8. The sample size for the training set:

   • This information is not applicable. The device is not an AI/machine learning model that requires a "training set" in the sense of data used to train a statistical or learning algorithm. Its design and validation rely on engineering principles, product specifications, and comparisons to predicate devices.

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

   • This information is not applicable, as there is no training set for an AI/ML model for this device.

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This disposable electrosurgical return electrode with conductive adhesive gel is used in monopolar electrosurgical procedures for adult patients.

The Abbott Medical Grounding Pad is a dispersive electrode that is designed for use in monopolar electrosurgical procedures in adult patients. It is a single-use, non-sterile and disposable device. The Abbott Medical Grounding Pad is compatible with the lonicRF™ Generator and provides a path for radiofrequency (RF) energy produced at an RF electrode to return to the generator. The Abbott Medical Grounding Pad consists of a grounding pad component (also called a neutral electrode, dispersive electrode or return electrode) and an attached cable. The grounding pad component includes a conductive aluminum foil layer which acts as the neutral electrode that connects back to the generator. The aluminum foil layer is covered with a conductive hydrogel adhesive which is covered with a protective liner while it is packaged.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Abbott Medical Grounding Pad:

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device's performance against specific acceptance criteria in a clinical study. Therefore, some of the requested information (like effect size in MRMC studies, standalone algorithm performance, training set details) is not applicable or present in this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a numerical or percentage format typically associated with AI/software performance. Instead, it describes various non-clinical tests designed to show the device meets its performance requirements and specifications, thereby demonstrating substantial equivalence to the predicate.

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

• Sample Size: Not explicitly stated for each test, but implied to be sufficient for each specific test as per standards like ISO 10993-1 or IEC 60601 series. The testing involved physical devices (Abbott Medical Grounding Pad and some leveraging the predicate device).
• Data Provenance: The tests were non-clinical, involving laboratory testing of the physical device components and assembled device. There is no mention of country of origin for data as it's not a clinical data study. The nature of the studies is prospective in the sense that controlled tests were performed on the device to assess its compliance.

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

This information is not applicable as this is a non-clinical device submission. The "ground truth" for the non-clinical tests is established by industry standards (e.g., ISO 10993-1, IEC 60601 series) or the device's own internal specifications. Expert consensus or clinical diagnosis is not relevant here.

4. Adjudication Method for the Test Set

This information is not applicable as there is no human interpretation or decision-making being assessed, only objective physical, electrical, and biological performance.

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

No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the cognitive performance of human readers, sometimes with AI assistance, which is outside the scope of this medical device (a grounding pad).

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

No, a standalone algorithm performance study was not done. This device is a passive electrosurgical component (grounding pad), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for these non-clinical tests refers to the established requirements and standards:

• Industry Standards: ISO 10993-1 for biocompatibility, IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2 for electrical safety and electromagnetic compatibility.
• Device Specifications: Specific values like the $\ge$ 20N for cable tensile strength, and parameters for shelf life and operating environment.
• Predicate Device Equivalence: The primary "ground truth" for the overall submission is demonstrating that the subject device is substantially equivalent to the predicate device and that its differences do not raise new questions of safety and effectiveness.

8. The Sample Size for the Training Set

This information is not applicable as there is no AI algorithm being developed or "trained."

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

This information is not applicable as there is no AI algorithm or training set.

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The lonicRF™ Generator, in combination with approved compatible electrodes and cannulae, is an aid in the management of pain in the nervous system. Examples include, facet denervation, trigeminal rhizotomy, and related functional neurosurgical procedures.

The Abbott IonicRF™ Generator is a desktop radiofrequency (RF) lesioning generator, which is intended for lesioning of neural tissue in the peripheral nervous system as an aid in the management of pain.

The generator is portable and can be placed on a level surface using the countertop stand or mounted to a compatible roll stand using the optional pole mount.

The IonicRF™ Generator is a multi-lesioning, 4 channel portable generator that can provide continuous or pulsed RF output at 460 KHz, monopolar or dual electrode modes, and a Simplicity™ mode for large lesion creation. The generator includes sensory and motor stimulation functions to fine-tune electrode placement before procedures are performed. The generator is also designed to be compatible with all existing Abbott electrodes and cannulas.

Device features include a touch screen monitor incorporating microprocessor and graphics display for user interface, and recordkeeping functions. The user interface controls all functions of the generator. The generator incudes a dial on the front for control of stimulation level during stimulation and motor testing. The IonicRF™ Generator can be set on a flat surface or mounted on a pole with the accessory pole mount bracket.

The IonicRF™ Generator can be used with previously cleared Abbott RF Electrodes (K011387, K111576), and Cannula/Introducers (K042375, K000073) used with the predicate device.

The IonicRF™ Generator is a device intended for radiofrequency lesioning of neural tissue as an aid in pain management. The provided document does not contain acceptance criteria or study details in the typical sense of a clinical performance study for an AI/ML medical device. Instead, it demonstrates substantial equivalence to a predicate device (NeuroTherm NT2000 Lesioning Generator (K111576)) through non-clinical testing.

Here's the breakdown of the information available in relation to your request:

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

The document provides a comparison of technological characteristics between the IonicRF™ Generator and its predicate device, and a summary of non-clinical testing. These serve as the performance evaluation for substantial equivalence.

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

This document describes a medical device (radiofrequency generator), not an AI/ML software. Therefore, there isn't a "test set" in the context of image data or patient data for an algorithm. The "testing" refers to non-clinical verification and validation activities of the hardware and software. No specific sample sizes for these tests (e.g., number of devices tested, number of lesion creations) or data provenance (as it pertains to human-derived data) are detailed in this summary.

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. As this is a hardware device undergoing non-clinical testing for substantial equivalence, there is no "ground truth" establishment by medical experts in the way an AI/ML diagnostic algorithm would require.

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

Not applicable. There is no test set of patient cases requiring adjudication by experts.

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 device is a radiofrequency generator, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a radiofrequency generator, not an algorithm.

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

For the non-clinical testing, the "ground truth" is defined by the technical specifications, performance requirements, and established standards (e.g., IEC 60601-1, IEC 60601-1-2). For instance, for comparative lesion testing, the "ground truth" would be the expected characteristics of a lesion created by a radiofrequency generator, likely determined through validated experimental methods and comparison to the predicate.

8. The sample size for the training set

Not applicable. This device is a radiofrequency generator, not an AI/ML algorithm requiring a training set.

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

Not applicable. There is no training set for an AI/ML algorithm.

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COOLIEF* Radiofrequency Generator (CRG) System is indicated for use to create lesions during neurological lesion procedures and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The CRG is to be used with only Avanos RF Probes and accessories, such as Avanos TransDiscal Probes, COOLIEF*/Standard RF Pain Management Probes, Cannulas, Introducers, and Fluid Delivery Introducers. Use of CRG System is limited to the indications cleared under these Avanos devices and accessories.

The COOLIEF* Radiofrequency Generator (CRG) System uses controlled radiofrequency energy to generate heat that is used to create lesions in neurological tissues or to coagulate and decompress disc material to treat symptomatic patients with contained herniated discs. The following components of the predicate Pain Management Generator-TD (K072478), which must be used together, have been modified and are the subject of this 510(k): a) COOLIEF* Radiofrequency Generator (CRG), b) COOLIEF* Quad Pump Unit (QPU), and c) COOLIEF* Therapy Cables.

The provided text describes the 510(k) premarket notification for the COOLIEF* Radiofrequency Generator (CRG) System. It lists general and technological characteristics of the device and compares them to a predicate device, along with non-clinical performance data.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., minimum accuracy percentages). Instead, it lists various performance tests conducted and their successful completion, implying that "Pass" is the acceptance criterion for each test.

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

The document primarily discusses non-clinical testing (performance testing). For these tests, specific sample sizes are not explicitly stated. For example, "Therapy Cable Mechanical Testing" implies that multiple cables were tested, but the number is not provided. Similarly, for "Bench-Top Lesion Validation," the number of lesions or trials is not detailed.

No clinical data was used for this submission, therefore, none of the typical provenance information (country of origin, retrospective/prospective) applies.

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 section is not applicable as the submission relies on non-clinical performance data and engineering verification tests. The "ground truth" for these tests would be established by the expected technical specifications and standards (e.g., a flow rate of >18mL/min, successful completion of a software test protocol). It doesn't involve subjective expert review in the way medical image analysis or diagnostic decision-making would.

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

This section is not applicable as the submission focuses on non-clinical performance testing and engineering verification. Adjudication methods are typically used in clinical studies or studies involving expert interpretation where there might be disagreements on ground truth.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted and is not applicable to this submission. The device is a radiofrequency generator, not an AI-powered diagnostic or assistive tool for human readers. No AI assistance or human reader performance is mentioned.

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

This section is not applicable. The device is a hardware system (radiofrequency generator, pump, cables) and is not an algorithm or AI product capable of standalone performance.

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

The ground truth for the non-clinical performance tests is based on engineering specifications, established standards (e.g., IEC 60601 series), and expected functional performance. For instance, for "Quad Pump Unit Flow-Rate Verification," the ground truth is whether the measured flow rate meets the specified >18mL/min. For "Software Verification and Validation," the ground truth is compliance with the software requirements and absence of critical bugs. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for this type of submission.

8. The sample size for the training set

This section is not applicable. The submission describes a medical device (radiofrequency generator system), not a machine learning or AI model that requires a training set.

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

This section is not applicable as there is no training set for this device.

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The Polaris RF Ablation System is intended for the creation of radiofrequency lesions in nervous tissue.

The Polaris RF Ablation System includes the following components:

1. Polaris Radiofrequency Generator and Desk Stand
2. Polaris Pump, Pump Cable and Desk Stand
3. Polaris Standard Connector Hub / Polaris Cooled Connector Hub
4. Polaris Footswitch
5. Polaris Cooled RF Probe Kit:
   i. Polaris Cooled RF Ablation Probe
   ii. Polaris Tube Kit
   iii. Polaris Introducer
6. Polaris Single-Use RF Probe
7. Polaris Reusable RF Probe
8. Polaris RF Cannula
   The Polaris RF Ablation System is intended for the creation of radiofrequency lesions in nervous tissue. The system is designed to deliver controlled RF energy from the Polaris RF Generator to target tissues via the Polaris RF Probes for standard RF procedures or Polaris Cooled RF Probes for cooled RF procedures. RF energy is applied based on the configured RF generator settings to create the desired lesions in the target tissue. The generator also delivers low frequency stimulation pulses during procedures.
   During standard RF procedures, the Polaris RF Probe is used with a compatible Polaris RF Cannula to enable RF energy delivery via the active electrode to the target tissues. During cooled RF procedures with Polaris Cooled RF Probes, the system integrates a cooling mechanism by internally circulating water through the probes using the Polaris Pump Unit. This cooling results in minimal charring of the surrounding tissue and also prevents tissue from adhering to the electrodes. This allows for larger and more consistent ablation volumes to be achieved.

The document you provided is a 510(k) summary for a medical device, the Polaris RF Ablation System. It details the device's substantial equivalence to predicate devices, rather than establishing primary effectiveness through clinical trials with defined acceptance criteria for diagnostic output.

Therefore, the information requested for AI/ML device studies such as sample sizes for test/training sets, ground truth establishment, expert qualifications, and MRMC studies, is not present in this document, as it focuses on demonstrating product safety and performance against established standards and predicate devices.

However, I can extract the information relevant to performance testing based on the provided tables.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests conducted on different components of the Polaris RF Ablation System. The general acceptance criterion for all tests is "All samples passed the acceptance criteria," with the reported performance consistently stating that the device or its components met all relevant requirements and confirmed compliance with applicable standards.

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

The document does not specify exact sample sizes (e.g., number of units tested) for most of the performance tests. It mentions "All samples passed" for many tests, indicating that multiple units were likely tested for each category. No information on data provenance (country of origin, retrospective/prospective) is provided, as these are technical performance tests on the device itself, not clinical data.

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

Not applicable. This is a technical performance and substantial equivalence submission for a medical device, not an AI/ML diagnostic or prognostic device that requires expert-established ground truth for a test set. The "ground truth" here is compliance with engineering standards and predicate device performance.

4. Adjudication Method for the Test Set

Not applicable. As this is not an AI/ML diagnostic output, there is no adjudication method in the context of expert review. Test results are compared against predefined technical standards and requirements.

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

No. This document does not pertain to an AI/ML device that assists human readers, so an MRMC study is not relevant here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

No. The Polaris RF Ablation System is a physical medical device, not an algorithm, so a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to established engineering and medical device standards (e.g., IEC 60601 series, ISO 10993 series, ANSI/AAMI ISO 11607) and the performance characteristics of the legally marketed predicate devices. For mechanical and electrical tests, it's compliance with these standards. For lesion validation, it's the demonstration of "substantially equivalent ablation performance" compared to the predicate in a soft tissue model.

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 model, this question is not relevant.

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The Relievant RFG is intended to be used with RF probes FDA cleared as part of the Relievant INTRACEPT Intraosseous Nerve Ablation System for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.

The Relievant RFG is a universal AC powered, microcontrolled, bipolar RF generator intended to deliver RF energy to a targeted site. During RF energy delivery, power is continuously monitored and controlled, based on temperature and impedance measurements at the treatment site, to ensure proper operation. RF probes FDA cleared as part of the Relievant INTRACEPT Intraosseous Nerve Ablation System are used with the Relievant RFG.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Relievant Medsystems RF Generator:

The provided document describes the Relievant Medsystems RF Generator (RFG), a radiofrequency lesion generator. The acceptance criteria and testing detailed are primarily non-clinical performance tests aimed at demonstrating the device's substantial equivalence to a predicate device, rather than clinical efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes non-clinical performance testing, primarily bench testing and software validation. Therefore, there are:

• No "test set" in the traditional sense of patient data.
• No human "sample size" for these performance tests.
• The data provenance is laboratory testing of the device itself against established medical device standards and internal company requirements.

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

Since the testing described is non-clinical (electrical, mechanical, software, etc.), the "ground truth" is established by adherence to recognized medical device standards and internal specifications. This means:

• No external human experts were used to establish a "ground truth" for a patient-based test set.
• The "ground truth" is derived from engineering specifications and regulatory standards. Presumably, internal engineers and quality personnel with relevant expertise in these standards conducted and verified the testing.

4. Adjudication Method for the Test Set

Given that the performance testing is non-clinical and based on objective measurements against standards:

• There was no adjudication method (like 2+1 or 3+1 consensus) as this is typically applied to subjective human interpretation of patient data or images.
• The results are either a "Pass" or "Fail" based on whether the device meets the defined quantifiable specifications of the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No MRMC comparative effectiveness study was done.
• The device described is an RF Generator, a piece of medical hardware. It does not involve AI or human-in-the-loop performance improvement with AI assistance.
• The document explicitly states: "Substantial equivalence is not dependent upon clinical data and no clinical testing was performed."

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

• No standalone (algorithm-only) performance was done.
• As noted above, this device is hardware (an RF generator) and does not involve an algorithm for diagnostic or interpretative purposes.

7. The Type of Ground Truth Used

For the non-clinical performance testing, the "ground truth" used was:

• Engineering Specifications and Recognized Medical Device Standards: These include IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-2, IEC 62304, IEC 60601-1-6, IEC 62366-1, and FDA guidance documents for software and human factors.
• Relievant Specified Requirements: Internal requirements set by the manufacturer for mechanical testing.

8. The Sample Size for the Training Set

• Not applicable. This document describes non-clinical performance testing of a hardware device (RF Generator). There is no "training set" in the context of machine learning or AI that would produce diagnostic results.

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

• Not applicable. As there is no training set mentioned or implied for this medical device, there is no ground truth established for it.

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