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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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