(256 days)
The Hyper Source-unit Rotating Gamma System (SGS-1+) is a teletherapy device indicated for use in stereotactic irradiation of intracranial structures.
The Hyper Source-unit Rotating Gamma System (SGS-1+) consist of Main Mechanical System, Localization Device, Control System, Therapy Planning System (TPS) etc.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on demonstrating substantial equivalence to a predicate device and safety standards, rather than defining specific acceptance criteria for a novel performance claim. The key "acceptance criteria" here is that the proposed device must be Substantially Equivalent (SE) to the predicate device, the "Rotating Gamma System Infini™", in terms of safety and effectiveness.
The table in the original document (Table 3-1) serves as a comparison of technological characteristics to support this substantial equivalence. The "Acceptance Criteria" for each item can be inferred as "SAME" or "SIMILAR" to the predicate device, as explicitly stated in the table.
| Characteristic | Acceptance Criteria (compared to Predicate Device) | Reported Device Performance (Hyper Source-unit Rotating Gamma System (SGS-I+)) |
|---|---|---|
| Product Code | SAME | IWB |
| Regulation No. | SAME | 21 CFR 892.5750 |
| Class | SAME | Class II |
| Intended Use | SAME | Stereotactic irradiation of intracranial structures. |
| Category | SAME | Rotational |
| Treatment Bed Movement | SAME | 3-D movement |
| Collimator Diameter Sizes | SIMILAR | Φ 4mm, Φ8 mm, Φ12 mm, Φ 16mm |
| Number of Collimator Channels | SIMILAR | 152 |
| Target Positioning | SAME | Automated |
| Dose Distribution | SAME | Dose sculpturing through programmable arcs |
| Number of 60Co Sources | SIMILAR | 38 |
| Initial Overall Loading Activity | SIMILAR | 10600 Ci/3.922x10¹⁴Bq |
| Focus Dose-rate at Initial Loading | SAME | ≥ 3 Gy/min |
| Penumbra on Focal Plane | SIMILAR | ≤ 12 mm |
| Independent Dual Timer Accuracy | SIMILAR | ± 1s |
| Source Body Zero Position | SIMILAR | 0.01° |
| Collimator Selection Time | SIMILAR | 1s |
| Treatment Bed Travel | SIMILAR | X =400 mm; Y= 1057 mm; Z=300 mm |
| Treatment Bed Maximum Loading Capacity | SIMILAR | 135 kg |
| Treatment Bed Linear Travel Error (X,Y and Z) | SIMILAR | 0.1mm |
| Treatment Bed Traveling speed | SIMILAR | X, Z: 600mm/min; Y: 1000mm/min |
| Radiological Accuracy | SIMILAR | ≤1.0 mm |
| Overall Length | SIMILAR | 5656 mm |
| Overall Width | SIMILAR | 4171 mm |
| Overall Height | SIMILAR | 2943 mm |
| Overall Weight | SIMILAR | 30 T |
| Power Supply | SIMILAR | AC 480V±10% / 60Hz |
| Backup Power Supply | SAME | ≥ 30 min |
Beyond this, the response to the FDA's query (K 37) indicates that specific Precision/Reproducibility and Accuracy data was provided in a "Total positional precision and dose error test report." While the report itself is not included, the acceptance criteria for this would likely be specific numerical tolerances as verified by a clinical medical physicist.
2. Sample Size and Data Provenance (for test set)
The provided text does not contain information regarding a "test set" in the context of clinical or image-based studies. The study mentioned is a "Total positional precision and dose error test," which is an analytical non-clinical test, likely conducted on the device itself or test phantoms. Therefore, concepts like "sample size used for the test set" and "data provenance" (country, retrospective/prospective) are not applicable in this context.
3. Number of Experts and Qualifications (for establishing ground truth for test set)
Similar to point 2, the document does not describe a test set that would require expert-established ground truth. The "Total positional precision and dose error test report" was reviewed by a "registered Clinical Medical Physicist, JB Yu Zhang, PhD, DABR." This expert's role seems to be validation of the test report itself, not establishing ground truth for a clinical dataset.
4. Adjudication Method (for test set)
As there is no described test set requiring expert interpretation, there is no adjudication method mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or mentioned in the provided text. The submission focuses on demonstrating substantial equivalence through technical characteristics and non-clinical testing.
6. Standalone (Algorithm Only) Performance Study
Not applicable and not mentioned. The device described is a physical teletherapy system, not an AI algorithm.
7. Type of Ground Truth Used
For the "Total positional precision and dose error test report," the "ground truth" would be metrological standards or established physical parameters against which the device's precision and dose error are measured. This is an analytical (non-clinical) study.
8. Sample Size for the Training Set
Not applicable and not mentioned. This device is a physical medical device, not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable and not mentioned. As there is no training set, there's no ground truth to establish for one.
§ 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.