(200 days)
The Rotating Gamma System Infini™ (Infini™) is a teletherapy device indicated for use in stereotactic irradiation of intracranial structures.
The Rotating Gamma System Infini™ is a teletherapy device indicated for use in stereotactic irradiation of intracranial structures. The system is composed of four parts:
- 60Co Radiation sources
- Main unit (including mechanical system and electric system)
- Stereotactic system
- Treatment planning system
Here's an analysis of the MASEP Rotating Gamma System Infini™ based on the provided text, focusing on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for performance metrics (e.g., accuracy thresholds, precision values, specific dose delivery tolerances). Instead, it relies on demonstrating substantial equivalence to a predicate device.
The reported device performance is described in terms of its similarity to the predicate and passing various tests.
| Acceptance Criteria (Inferred from Substantial Equivalence and Testing) | Reported Device Performance |
|---|---|
| Intended Use: For stereotactic irradiation of intracranial structures. | The Rotating Gamma System Infini™ is a teletherapy device indicated for use in stereotactic irradiation of intracranial structures, which is the same intended use as the predicate device (Gamma Therapy System K041125). |
| Geometric Accuracy: Performance similar to predicate device. | "The performance of the subject Rotating Gamma System Infini™ is similar in both geometric accuracy... to the predicate device." Non-clinical testing was conducted to validate and verify that it met all design specifications. |
| Dosimetric Characteristics: Performance similar to predicate device. | "The performance of the subject Rotating Gamma System Infini™ is similar in both... dosimetric characteristics to the predicate device." Non-clinical testing was conducted to validate and verify that it met all design specifications. |
| Safety and Effectiveness: No new questions of safety or effectiveness associated with modifications. | "All safety and effectiveness testing (including risk analysis and performance testing) were conducted and completed with passing results." "For all design changes, a risk analysis and safety and effectiveness testing were performed. All testing that was conducted showed passing results." "Testing demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." |
| Compliance with Standards: Adherence to relevant international and national standards. | The device has been "tested to assure compliance to the requirements of various published standards, including IEC60601-1, IEC60601-2, ISO14971 and ISO 2919." |
| Software Validation: Major level of software concern. | "Performance testing, including software validation testing to a major level of software concern for the Rotating Gamma System Infini™ device, was conducted to verify that the operation of the entire Infini™ system along with its electrical control system has not been adversely affected by the device modifications." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a "test set" in terms of patient data or image datasets. The testing described is non-clinical, focusing on the device's physical and software performance. Therefore, information on sample size and data provenance for a test set in the context of clinical or imaging studies is not applicable from the given document.
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 the provided text describes non-clinical performance and engineering validation testing, not a study involving human interpretation of data where expert ground truth would be established.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3.
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
This information is not applicable. The MASEP Infini™ is a physical medical device (a radiation therapy system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a complete system for radiation therapy, not a standalone algorithm. Its performance is inherent in its physical and software operation, which was tested.
7. The Type of Ground Truth Used
For the non-clinical testing of this device, the "ground truth" would be established through:
- Engineering specifications and design requirements: The device's components and system operation are designed to meet certain physical and functional parameters.
- Physical measurements: Using calibrated equipment to confirm geometric accuracy, dose delivery, and other physical properties.
- Software validation protocols: Testing the software against predefined functional and performance requirements.
- Compliance with published standards: Meeting the criteria set forth in standards like IEC60601-1, IEC60601-2, ISO14971, and ISO 2919.
8. The Sample Size for the Training Set
This information is not applicable. The device is a hardware and software system for radiation therapy, not a machine learning model that requires a training set in the conventional sense. Its "training" involves engineering design, manufacturing processes, and calibration.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets acceptance criteria primarily consists of non-clinical performance testing, risk analysis, and software validation. The core argument for acceptance is substantial equivalence to an already cleared predicate device (MASEP Gamma Therapy System K041125), despite some modifications.
- Study Design: The approach was to demonstrate that modifications to the predicate device (changes in treatment bed movement, collimator sizes, number of sources, and source switching design) did not adversely affect safety or effectiveness and that the new device maintained similar performance characteristics to the predicate.
- Key Activities:
- Risk Analysis: Performed for all design changes.
- Safety and Effectiveness Testing: Conducted to ensure the device met specifications and was safe and effective.
- Performance Testing: Specifically looked at geometric accuracy and dosimetric characteristics, finding them similar to the predicate device.
- Software Validation: Performed "to a major level of software concern" to ensure the entire system and electrical control were not adversely affected by modifications.
- Standards Compliance Testing: Verified compliance with IEC60601-1, IEC60601-2, ISO14971, and ISO 2919.
- Conclusion: The non-clinical testing "validated and verified that the Rotating Gamma System Infini™ met all design specifications and is substantially equivalent to the predicate device." It confirmed that "any differences in their technological characteristics do not raise any new questions of safety or effectiveness."
§ 892.5750 Radionuclide radiation therapy system.
(a)
Identification. A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.(b)
Classification. Class II.