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510(k) Data Aggregation
(84 days)
The RSVP Half Sphere Phantom™ is designed for verification of therapy dose delivery in radiation therapy machines, specifically the Leksell™ Gamma Knife sterotactic radiosurgery system. The phantom can also be used for periodic quality assurance evaluations and acceptance testing, and to perform reevaluations after equipment or software upgrades. The phantom works in conjunction with commercially available ion chambers, which are not manufactured by the Phantom Laboratory.
The RSVP Half Sphere PhantomTM was developed to provide localization and dose verification for radiation therapy machines, specifically the LeksellTM Gamma Knife stereotactic radiosurgery system. The phantom's design provides full simulation of the localization and irradiation sequences. The hemi-spherical shape is formed from a urethane material and filled with water to simulate the radiation absorption and scatter of human soft tissue.
Based on the provided 510(k) summary, here's an analysis of the acceptance criteria and the study conducted for the RSVP Half Sphere PhantomTM:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly define specific numerical acceptance criteria for performance metrics like accuracy, precision, or reproducibility. Instead, it relies on the device's design, manufacturing controls, and a scientific paper to demonstrate substantial equivalence and fitness for intended use.
However, based on the narrative, the implicit acceptance criteria relate to:
- Ability to simulate radiation absorption and scatter of human soft tissue: Achieved through the urethane material and water-filled design.
- Suitability for localization and dose verification in radiation therapy machines (specifically Leksell Gamma Knife): Demonstrated by comparison to the predicate device and the referenced study.
- Ease of position reproducibility for consistency monitoring: A stated advantage of the geometric shape.
- Manufacturing quality and calibration traceability: Ensured by adherence to ISO 9001:2000 and NIST traceability.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Simulates radiation absorption and scatter of human soft tissue. | The hemi-spherical shape is formed from a urethane material and filled with water "to simulate the radiation absorption and scatter of human soft tissue." |
| Suitable for localization and dose verification for radiation therapy machines (Gamma Knife). | "The RSVP Half Sphere PhantomTM was developed to provide localization and dose verification for radiation therapy machines, specifically the LeksellTM Gamma Knife stereotactic radiosurgery system." The phantom's design "provides full simulation of the localization and irradiation sequences." The device is intended for "verification of therapy dose delivery." |
| Enables simpler theoretical calculations and easier position reproducibility for QA. | "The geometric shape of the RSVP Half Sphere Phantom™ has the advantage, compared to the predicate device, of simpler theoretical calculations and easier position reproducibility which makes it ideal for consistency monitoring through periodic QA testing." |
| Manufactured according to quality standards and calibrated measurement equipment. | "During the creation of prototypes for the RSVP Half Sphere Phantom™ , as part of the development process, numerous measurements and pressure leak tests were conducted in accordance with the Phantom Laboratory's ISO 9001:2000 registered quality system. The measurement equipment used was calibrated with traceability to NIST." |
| Functionally equivalent to the predicate device for evaluating maximum delivered dose. | "The RSVP Half Sphere PhantomTM and the predicate device, RSVP PhantomTM , are both designed to evaluate maximum delivered dose to an identified location for radiation therapy machines. Both phantoms are formed from materials selected for strength and tissue like absorbency, filled with water to simulate human tissue, and mimic actual patient absorbed dosages." "This 510(k) application draws on conclusions made from the research and corresponding paper, 'Calibration of the Gamma Knife using a new phantom following the AAPM TG51 and TG21 protocols' by R. E. Drzymala and R. C. Wood." (Implies the phantom's utility in established calibration protocols). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a distinct "test set" in the context of clinical data for algorithmic performance. The validation relies on measurements taken during prototype development and the conclusions drawn from the referenced scientific paper. The number of measurements and pressure leak tests conducted during prototype creation is described as "numerous," but a specific numerical sample size is not provided.
- Data Provenance: The directly referenced study, "Calibration of the Gamma Knife using a new phantom following the AAPM TG51 and TG21 protocols" by R. E. Drzymala and R. C. Wood, would presumably be from a research setting, likely academic or institutional. The document does not specify the country of origin of this research or whether it was retrospective or prospective. The internal testing during prototype creation by The Phantom Laboratory would be prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided as the device is a physical phantom for calibration and quality assurance, not a diagnostic or AI-driven interpretative device. Therefore, clinical "ground truth" established by experts in the typical sense (e.g., radiologists interpreting images) is not applicable or discussed for this type of device. The "ground truth" for a phantom would be its physical properties and performance against established dosimetry protocols, which are typically verified by medical physicists or engineers. The referenced paper's authors (R.E. Drzymala and R.C. Wood) are presumably experts in medical physics or a related field, given the subject matter (AAPM TG51 and TG21 protocols).
4. Adjudication Method for the Test Set
This information is not applicable as the device is a physical phantom for calibration, not a device requiring human interpretation or consensus for its "ground truth" in the way a diagnostic AI would.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study is not relevant here. This device is a passive phantom used for calibrating and verifying radiation therapy machines, not an AI for image analysis or diagnosis that would assist human readers.
6. Standalone (Algorithm Only) Performance Study
No. This device is a physical phantom, not an algorithm. Therefore, "standalone" algorithmic performance is not applicable. Its "performance" is based on its physical properties and how accurately it facilitates dosimetry measurements when used with an ion chamber (which is a separate, commercially available product).
7. Type of Ground Truth Used
The "ground truth" implicitly used for the phantom's validation is based on:
- Physical principles and dosimetry protocols: Specifically, the AAPM TG51 and TG21 protocols mentioned in the referenced paper.
- Traceability to national standards: "Measurement equipment used was calibrated with traceability to NIST."
- Comparison to predicate device: Functional equivalence to the RSVP PhantomTM.
- Material properties: Selection of urethane and water to mimic human soft tissue radiation absorption and scatter.
8. Sample Size for the Training Set
Not Applicable. This device is a physical phantom and does not involve AI or machine learning that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set, this question is not relevant.
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