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510(k) Data Aggregation
(293 days)
The CygneX I System is intended to provide treatment planning and surface-guided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. atteriovenous malformations), tumors and conditions of the brain and base of skull (BOS).
The CygneX I System consists of therapeutic CygneX I Treatment Delivery Subsystem and the dedicated CygPlan I Treatment Planning Subsystem. The CygneX I Treatment Delivery Subsystem consists mainly of a Therapeutic Xray Generation Part, 6-Axis Manipulator Part, and X-ray Delivery Control Console Part. A linear accelerator with a variable collimator is incorporated in the X-ray head, the main portion of the Therapeutic X-ray Generation Part, which generates a very fine, highly- energized (6 MV) and controlled dose of X-ray beams. The variable secondary collimator is capable of delivering regular hexagonal fields, with the distances between the two opposite sides from 5mm to 30 mm, at 60 SAD. The CygPlan I Treatment Planning Subsystem provides the capability for forward and inverse planning from CT data. It provides a plan after physician approval, to the CygneX I Treatment Delivery Subsystem to deliver the treatment from the selected treatment nodes.
The provided text is a 510(k) summary for the Accuthera CygneX I System. It primarily focuses on demonstrating substantial equivalence to a predicate device (Accuray CyberKnife System) rather than detailing a specific study to prove acceptance criteria with quantitative results from a test set.
However, based on the information provided, I can infer and extract some details about performance testing and acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a direct "acceptance criteria" table with specific thresholds and numerical performance metrics from a study. Instead, it compares features and specifications of the CygneX I System to its predicate device (Accuray CyberKnife) in Table ES-1. The "Reported Device Performance" would be implied by the CygneX I column, with the "Consideration of the difference(s)" column indicating whether the CygneX I meets or exceeds the predicate's performance, or if the differences are not adverse.
Therefore, I'll adapt the request to present the key performance-related features and their comparison to the predicate. The "Acceptance Criteria" for these would implicitly be "comparable to or better than the predicate," or "achieves same level of safety and effectiveness."
| Feature/Metric | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (CygneX I System) | Consideration of Difference |
|---|---|---|---|
| Intended Use | Same as predicate | "The CygneX I System is a medical charged-particle radiation therapy system accelerating electrons intended to provide photon radiation for treatment." | Same |
| Indication for Use | Comparable to predicate to ensure safety and effectiveness | "The System is intended to provide treatment planning and surface-guided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. arteriovenous malformations), tumors and conditions of the brain and base of skull (BOS)." | No, but while it is less, it is included by the predicate. |
| Principles of Radiation Delivery | Same as predicate | Same principles of stereotactic radiotherapy, using a Linac mounted on a robotic arm. | Same |
| Patient Position Monitoring | Comparable safety and effectiveness to fluoroscopic imaging | Uses commercially available (510K cleared) positioning device for monitoring body surface movement (e.g., AlignRT PLUS) and mobile C-Arm imaging/fluoroscopic system (e.g., Philips Veradius Neo System, K133819, or equivalent) to confirm target position. | No, but same safety can be achieved by confirmation of the patient position using a device which can image the position of the target inside the patient. |
| Single dose & fractionated treatment | YES | YES | Same |
| X-band Accelerator | YES | YES | Same |
| X-ray energy | 6MV (Standing wave Linac) | 6MV (Standing wave Linac) | Same |
| Dose rate | 300 cGy/min (maximum BUILD UP) | 300 cGy/min (maximum BUILD UP) | Same |
| Isocenter floor height SAD | 127cm (nominal isocenter, system is not isocentric); 80cm | 130cm (nominal isocenter, system is not isocentric); 60cm | No, but it is only 3 cm higher. No, but it still treats the target to the prescribed dose. |
| Source Target positioning | Six-axis manipulator | Six-axis manipulator | Same |
| Patient Positioning device (Treatment Couch) | Stationary/Adjustable | CygneX I System does not include a Treatment Couch. It uses commercially available Adjustable Treatment Couch which complies with conditions specified by Accuthera Inc. | No, but same level of safety & effectiveness can be achieved by using a specified 510K cleared treatment couch. |
| Mechanical Isocenter accuracy | Less than 0.05cm radius | Sphere less than 0.05cm radius | Same |
| Dosimetry system reproducibility position | ±3% or 3MU whichever is greater at any fixed treatment node | ±2% or 1 MU whichever is greater at any fixed treatment node | No, but has improved specification. |
| Beam collimation | Fixed secondary collimators delivering circular field sizes of 5-60 mm diameter at SAD | Variable secondary collimator delivering regular hexagonal fields sizes, with distances between opposite sides of 5, 7.5, 10, 12.5, 15, 20, 25 and 30 mm at SAD. | Comparable field sizes up to 30 mm. |
| Target location reference | Patient's skull | Patient's skull | Same |
| Treatment Planning System | YES | YES | Same |
| Safety Interlocks | YES | YES | Same |
| Emergency Stop | YES | YES | Same |
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 states, "comprehensive nonclinical testing in accordance with FDA Recognized Consensus Standards as shown in the TAB 8-2 and in the TAB-14, and testing in accordance with our internal performance specifications as shown in the TAB-15 demonstrates that the minor differences do not adversely impact performance..."
This indicates that the "test set" for this device consisted of nonclinical testing, which typically involves physical measurements, bench testing, and simulations, rather than patient data. Therefore, the concept of sample size as applied to patient cases or data provenance (country of origin, retrospective/prospective) is not applicable in this context. The testing was conducted on the device hardware and software itself.
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)
Since this was nonclinical testing of a radiation therapy system, the "ground truth" was established by engineering specifications, recognized consensus standards (e.g., IEC standards for medical electrical equipment), and physics principles, rather than expert medical consensus on patient data. Experts involved would likely be qualified engineers (e.g., electrical, mechanical, software) and medical physicists with expertise in radiation therapy equipment and relevant standards. The number and specific qualifications are not detailed in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like "2+1" or "3+1" are relevant for resolving discrepancies in human readings or clinical assessments. As this was nonclinical testing against technical specifications and standards, an adjudication method is not applicable in the traditional sense. Test results were objectively compared against predefined engineering and performance specifications.
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 is applicable to diagnostic imaging devices where human readers interpret medical images, often with and without AI assistance. The CygneX I System is a medical charged-particle radiation therapy system used for treatment planning and delivery, not for diagnostic imaging or interpretation by human readers. Therefore, an MRMC study and the concept of "human readers improve with AI" are not applicable to this device's function as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a complex system involving "therapeutic CygneX I Treatment Delivery Subsystem and the dedicated CygPlan I Treatment Planning Subsystem." The "Summary of Performance Testing" refers to nonclinical testing, electromagnetic compatibility testing, functional performance characteristics testing, and software verification and validation testing. This implies that performance of the individual components and the integrated system (including the algorithm for treatment planning and control systems) was assessed in a standalone manner against its specifications. The entire system effectively operates without a human in the real-time control loop during radiation delivery, based on the pre-approved treatment plan. So, a form of "standalone" testing for the algorithmic and functional aspects was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the nonclinical testing of this device, the ground truth was based on:
- Engineering specifications and design requirements
- Performance metrics defined by recognized consensus standards (e.g., those referenced in TAB 8-2, TAB-14, and TAB-15, which commonly include IEC standards for safety and performance of medical electric equipment)
- Physics principles for radiation generation and delivery.
8. The sample size for the training set
The device is a radiation therapy system, not an AI/ML algorithm that requires a "training set" in the sense of a large dataset of patient images or clinical outcomes used to train a model. Therefore, the concept of a training set sample size is not applicable in this context. The "training" for such a system refers to its design, calibration, and verification against physics models and engineering principles.
9. How the ground truth for the training set was established
As the concept of a "training set" is not applicable, the method of establishing ground truth for it is also not applicable.
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