(48 days)
The decimal Bolus product is a solid piece of material (rigid or rubber-like) that will be placed on the skin of a patient with the intended use and primary purpose of helping control the dose received by that patient when undergoing radiation therapy treatment. decimal Bolus devices are designed by radiation therapy professionals to a unique shape that is specific to each patient being treated. The device is intended to modify the dose delivered during a radiation therapy treatment. As this product is a simple general purpose bolus device, the intended patient population and indications for use are quite broad. The most common indications for use are for the treatment of patients receiving radiation therapy, which encompasses a wide range of potential disease types and locations. As such, these devices will be required to have a wide range of potential shapes, sizes, and material properties and each device must be tested and approved by the radiation therapy professional prior to use on a patient.
The decimal Bolus product is a solid piece of material (rigid or rubber-like) that will be placed on the skin of a patient with the intended use and primary purpose of helping control the dose received by that patient when undergoing radiation therapy treatment. decimal Bolus devices will be manufactured according to the unique, patient-specific shape requested by a clinical customer. Trained radiation therapy professionals will create the bolus device design. In the most common use case, the devices are designed to increase the dose that will be delivered at the patient's skin surface for the treatment of superficial tumors. In this case the decimal Bolus operates as a "build-up" region, which is necessary as radiation dose is typically at its maximum strength slightly below the entrance surface. Such treatments may occur anywhere on a patient's body. As such, these devices will be required to have a wide range of potential shapes and sizes and material properties.
The provided text details the FDA 510(k) clearance for the ".decimal Bolus" device, a custom-manufactured bolus for radiation therapy. However, the document primarily focuses on the regulatory aspects, device description, and a comparison to a predicate device. It explicitly states:
"Clinical testing was not performed as part of the development of this product. Clinical testing is not advantageous in demonstrating substantial equivalence, safety, or effectiveness of the device since testing can be performed such that no human subjects are exposed to risk."
Therefore, the document does not contain the information required to answer your questions about acceptance criteria and a study proving the device meets those criteria, as no clinical study was conducted. The non-clinical testing summary mentions "Clinically oriented validation test cases," but it does not provide specific acceptance criteria or detailed study results needed to complete the requested table and answer the subsequent questions.
Based on the provided text, I cannot describe:
- A table of acceptance criteria and the reported device performance: The document mentions "well-fitting bolus devices, with homogeneous material composition, performing as well or better than the predicate device in all areas tested," but does not quantify these "areas tested" or provide specific acceptance thresholds or metrics.
- Sample sizes used for the test set and the data provenance: No test set details are provided as no clinical study was performed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical study with human data requiring expert ground truth was conducted.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: The text explicitly states no clinical testing was performed, so no MRMC study was done.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an AI algorithm.
- The type of ground truth used: Not applicable, as no clinical study with human data requiring ground truth was conducted.
- The sample size for the training set: Not applicable, as no AI model or training set is mentioned.
- How the ground truth for the training set was established: Not applicable.
The document indicates that the substantial equivalence determination for the .decimal Bolus was based on its similarity to a predicate device (.decimal Bolus Compensator K091911) and the concept that the changes (flexible material, custom manufacturing) do not impact safety or risk, especially since clinical end-users are required to test and approve the devices prior to use. The "Non-Clinical Testing" section states that ".decimal personnel and hospital-based testing partners" executed "clinically oriented validation test cases," but no specifics on these tests (e.g., number of tests, specific metrics, acceptance criteria) are provided in this document.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.