(76 days)
The Cura Collimator is a solid, machine-shaped brass aperture intended to shape an external radiation beam to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area. The Cura Collimator may be used as an accessory whenever external beam radiation therapy is indicated for the treatment of patients with localized tumors or other conditions susceptible to treatment by radition.
Cura Collimators are custom beam blocks with machined cutout to allow beam passage per prescription and sized to snugly fit the applicator or nozzle and block all remaining beam in the radiation therapy fraction delivery. The Collimator is made of high lead content brass with notch orientation to match radiation manufacturer use specifications. No software is included in this device.
Here's a breakdown of the acceptance criteria and study information for the Cura Collimator, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance Statement |
|---|---|
| Material performance | All tests PASSED |
| Machine tool instructions adherence to Treatment Plan direction | All tests PASSED |
| DICOM Network Transmission system integrity | All tests PASSED |
| Accuracy of delivered beam line field vs. treatment plan | Both Mevion and Washington confirmed the accuracy of the delivered beam line field versus the treatment plan. |
| Function as intended | Non-clinical test demonstrates that Cura Collimators function as intended. |
| Safety and Effectiveness | Non-clinical test demonstrates that Cura Collimators are Safe and Effective to accomplish their intended use. |
Study Information:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated as a number. The text mentions "Treatment plans were created at Washington University," and "Cura manufactured the Cura Collmators, based upon the communicated treatment plan." This implies multiple treatment plans were used to generate multiple collimators for testing. However, a specific count is not provided.
- Data Provenance:
- Country of Origin: United States (Washington University, St. Louis, Missouri).
- Retrospective or Prospective: Not explicitly stated. The description "Treatment plans were created... and transmitted to Cura" suggests a prospective setup for the purpose of this testing, where specific plans were generated to test the collimator manufacturing process and beam delivery.
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)
- Number of Experts: Not explicitly stated. The text mentions "Washington University, who physically compared the Cura Collimators to the actual treatment plan and conducted beam tests," and "Mevion Medical Systems, Inc. for physical inspection and beam test." This indicates at least two entities were involved in verification.
- Qualifications of Experts: Not explicitly stated beyond "Washington University" and "Mevion Medical Systems, Inc." It can be inferred that personnel involved in radiation therapy at these institutions (e.g., medical physicists, radiation oncologists, dosimetrists) would be qualified to perform such evaluations, but specific titles or years of experience are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not explicitly described in terms of a formal adjudication process (like 2+1). The text states "Both Mevion and Washington confirmed the accuracy," suggesting independent verification and agreement, but no formal adjudication rule is mentioned.
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
- MRMC Comparative Effectiveness Study: No. This device is a physical medical device (radiation beam-shaping block), not an AI algorithm or a diagnostic tool that involves human readers interpreting data. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical device, not a software algorithm. The "Cura Collimator" itself is the standalone product. The process involves a DICOM network transmission system and machine tools, but the primary device being evaluated is the physical collimator. The testing mentioned (material performance, machine tool adherence, network transmission integrity, beam accuracy) essentially evaluates the "standalone" performance of the manufactured collimator in fulfilling its function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth used was the "actual treatment plan." The manufactured Cura Collimators and the delivered beam line field were compared directly against these established treatment plans. This would involve precise measurements and physical comparisons to the prescribed radiation field.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that requires a training set. The device is manufactured based on design specifications and treatment plans, not trained on data.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this device.
§ 892.5710 Radiation therapy beam-shaping block.
(a)
Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.(b)
Classification. Class II.