(92 days)
The 3D Systems VSP® Bolus product is a device that will be placed on the skin of a patient as a radiotherapy accessory intended to help control the radiation dose received by the patient. VSP Bolus is generated using input from radiation therapy professionals and medical imaging data to produce a bolus that is specific to the patient being treated. The VSP Bolus product is verified and approved by the radiation therapy professional prior to use on the patient, and is intended for patients of all ages receiving radiotherapy treatment.
VSP Bolus was evaluated using 6 MV photons but has not been assessed for use with protons. electrons, or at orthovoltage X-rays.
Boluses are used in external beam radiation therapy (EBRT) to change the depth of the radiation dose delivery to overcome the skin-sparing effect. The bolus is generated in accordance with a clinical treatment plan. The patient-specific bolus conforms to the patient anatomy to reduces airgaps for complex patient contours. The bolus is produced with additive manufacturing in a soft elastomeric material to conform to the patient's skin. The bolus is placed on the patient and verified for fit and accordance to the treatment plan prior to a radiation dose delivery to the patient.
The provided document is a 510(k) summary for the VSP® Bolus, a device used in radiation therapy. It does not describe an AI/ML device or a study comparing AI assistance with human readers. Therefore, I cannot extract information related to AI/ML specific acceptance criteria or an MRMC study from this document.
However, I can provide the acceptance criteria and performance data for the VSP® Bolus as described in the document.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list "acceptance criteria" in a quantitative format for the VSP® Bolus. Instead, it describes performance characteristics and validation activities demonstrating the device's fitness for clinical use and substantial equivalence to a predicate device. The performance is primarily assessed through simulated use testing and biocompatibility.
| Criterion Type | Description / Reported Performance |
|---|---|
| Biocompatibility | - Cytotoxicity: Passed ISO 10993-5 (MEM Elution Test) |
- Sensitization: Passed ISO 10993-10 (Guinea Pig Maximization Test)
- Irritation: Passed ISO 10993-10 (Primary Dermal Irritation Test)
- Patient Contact Materials: Biocompatible for intact skin contact. |
| Simulated Use Testing | - Clinically relevant validation study performed. - VSP Bolus was deemed fit for clinical use by radiation therapy professionals. |
| Clinical Acceptance (Post-Manufacturing) | Each VSP® Bolus must be validated and approved by the radiation therapy professional through a CT scan prior to the first treatment fraction. |
| Performance (General) | - Clinically oriented validation test cases were written and executed. - VSP Bolus was deemed fit for clinical use by radiation therapy professionals. |
| Intended Use | The device is placed on the skin of a patient to help control the radiation dose received, generated using input from radiation therapy professionals and medical imaging data to produce a patient-specific bolus. Verified and approved by professionals prior to use. Intended for patients of all ages receiving radiotherapy. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "Clinically relevant validation study was performed." However, it does not specify the sample size for this simulated use test set, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective nature of the simulated cases).
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)
The document states that "VSP Bolus was deemed fit for clinical use by radiation therapy professionals." However, it does not specify the number of experts used or their specific qualifications (e.g., number of years of experience, specific certifications) for establishing this ground truth in the simulated use testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not explicitly describe an adjudication method for the simulated use testing. It only states that the device was "deemed fit for clinical use by radiation therapy professionals," implying a consensus or approval process, but no specific adjudication method (e.g., 2+1, 3+1) 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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study in the document. This device (VSP® Bolus) is a physical, patient-specific bolus used in radiation therapy and does not involve AI assistance for human readers in its described function or evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The VSP® Bolus is a physical device, not an algorithm. Therefore, a standalone (algorithm-only) performance study is not applicable and was not performed. The device requires human input (radiation therapy professional input, DICOM data) for its design and human verification/approval (radiation therapy professional) prior to use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the simulated use testing, the ground truth was established by the judgment and approval of "radiation therapy professionals" who "deemed [the device] fit for clinical use." This can be considered a form of expert consensus or professional judgment.
8. The sample size for the training set
The document describes performance testing for a physical device and states, "Clinical testing was not performed as part of the development of this product." It refers to "clinically relevant validation study" and "simulated use testing." There is no mention of a training set in the context of machine learning or algorithm development, as this is not an AI/ML device.
9. How the ground truth for the training set was established
As there is no mention of a training set or AI/ML components, this question is not applicable to the provided document.
§ 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.