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510(k) Data Aggregation
(108 days)
The SANGRAY is an x-ray irradiation system intended for use in the irradiation of blood products packaged in transfusion bags to inactivate lymphocytes for the prevention of graft versus host disease (GVHD).
The X-ray irradiation system SANGRAY consists of a power supply (high-voltage generation unit), controller panel (console), and a shielded protection unit which contains two vertically opposed X-ray tube assemblies that generate X-ray beams. Blood products are placed into a tray and irradiated with the X-rays in a sample chamber. The system has a built-in dosimeter which measures the exposure dose in real time and ensures that the X-ray irradiation is stopped automatically when the preset dose is reached. If the power supply fails during the X-ray irradiation, the dosimeter keeps the integral dose value in memory, which allows the operator to continue the X-ray irradiation after power is recovered.
The provided text describes a 510(k) submission for the SANGRAY X-ray irradiation system. The document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a clinical study to prove the device meets specific performance criteria through a traditional clinical trial or AI algorithm validation study. Therefore, most of the requested information regarding acceptance criteria and studies proving the device meets them, especially in the context of AI, cannot be extracted from this document.
Here's what can be gathered, addressing your points where possible:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in the format of a clinical study or AI performance metrics. Instead, it presents a comparison of technological characteristics between the SANGRAY and two predicate devices (Rad Source X-ray Blood Irradiator, Model RS-3400 and Raycell X-ray Blood Irradiator). These characteristics serve as points of comparison to demonstrate substantial equivalence, rather than strict performance acceptance thresholds for a new, independent claim.
| Characteristic | Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (SANGRAY) |
|---|---|---|
| Irradiation Method | Similar to predicate: X-rays, two opposing tubes | Two opposing X-ray tube assemblies |
| X-ray Tube voltage | Similar to predicate: 150 kV or 160 kV | 150 kV |
| X-ray Tube Current | Similar to predicate: 25 mA or Not stated | 30 mA |
| Measurement Method | Minimum Dose: 15 Gy (for SANGRAY) | Minimum Dose: 15 Gy |
| Dose Rate | Similar to predicate: 5 Gy/min or 7 Gy/min | 5.7-7.9 Gy/min |
| Max/Min Dose Ratio | Less than 1:1.3 or 1:1.2 | Less than 1:1.5 |
| Radiation Safety | Pb shielding, interlocks | Pb shielding, interlocks |
| Radiation Leakage | Less than 5 µSv/h | Less than 1 µSv/h |
| Federal Regulatory Environment | Requires 510(k), comply with 21 CFR 1020.40 | Requires 510(k), comply with 21 CFR 1020.40 |
| Safety Standards Compliance | ANSI/AAMI ES 60601-1:2005+A2(R2012)+A1, IEC 60601-1-2:2007 | In compliance with these standards |
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 explicitly states: "6.8 Clinical Performance Test Summary: None." This indicates that no clinical performance study was conducted or presented in this submission. The "test set" in this context refers to non-clinical performance and safety tests, not a clinical data set for evaluating an AI algorithm or human reader performance. The provenance of such non-clinical test data is not detailed beyond compliance with specified safety standards.
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 no clinical performance study was conducted, there were no experts used to establish ground truth for a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical performance study was conducted.
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. The SANGRAY is an X-ray irradiation system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. SANGRAY is a medical device for irradiating blood, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance tests mentioned (Section 6.7), the "ground truth" would be established by physical measurements and engineering standards, comparing the device's output (e.g., dose, dose rate, leakage) against pre-defined specifications and regulatory limits. For example, radiation leakage is compared against a specified maximum (e.g., less than 1 µSv/h). There's no clinical ground truth in the sense of disease diagnosis or outcomes.
8. The sample size for the training set
Not applicable. SANGRAY is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. SANGRAY is not an AI algorithm.
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