(90 days)
.decimal's Aperture manufacturing service manufactures the ring and solid core apertures for intensity modulation of external beam proton radiation therapy. The apertures are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.
The .decimal Proton Aperture is a Brass Core encased in a reusable steel ring (or material with similar attenuating properties) with a 2D hole cut from it, which defines the area that is to be treated with a proton beam. The design for a .decimal Proton Aperture is generated out of a customer's treatment planning system (TPS) or physician's specifications and is unique to each patient. The device functions as a beam shaping block. The apertures are inserted into the gantry's snout to shape and focus the beam as it exits the gantry en route to the targeted area. As radiation is passed through the gantry, the beam passes through aperture and it will be blocked. The opening of the aperture where there is no brass, the radiation will pass through targeted area defined by the radiation therapy professional.
The provided text does not contain specific acceptance criteria, reported device performance metrics, or details about a study that quantitatively measures the device's performance against such criteria.
The document states:
- "Clinical testing was not performed as part of the development of this product. Clinical testing is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. Clinically oriented validation test cases were written and executed in house by .decimal personnel where Proton Apertures were deemed safe and effective for clinical use. The tests show that .decimal Proton Apertures performed as well as the predicate device."
- The device is a ".decimal Proton Aperture," which is a physical device (a brass core encased in a steel ring) used to shape proton beams in radiation therapy. Its performance is related to its physical dimensions and ability to block radiation as designed by a treatment planning system.
Therefore, many of the requested categories of information are not present in the provided text, as this is a 510(k) summary for a physical medical device, not an AI/software-as-a-medical-device (SaMD) that typically relies on the detailed performance studies described in your query.
Here's an attempt to answer based on the available information, with many points noted as "Not applicable" or "Not provided":
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance "as well as the predicate device" (K121657) | Tests show .decimal Proton Apertures performed as well as the predicate device. |
| Deemed "safe and effective for clinical use" | Clinically oriented validation test cases executed in-house deemed them safe and effective. |
| Manufactured to customer's treatment planning system (TPS) design | The device is described as being "designed by the customer's treatment planning system" and "unique to each patient." |
| Blocks radiation from critical structures/healthy tissue, guides to targeted area | Intended Use and Indications for Use confirm this function. |
2. Sample size used for the test set and the data provenance
Not provided. The text mentions "clinically oriented validation test cases" but does not specify the sample size or their provenance. Given it's a physical device, these "test cases" likely refer to physical prototypes or manufactured units rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/SaMD (e.g., radiologist consensus on images) is not relevant for this physical device. "Clinical use" and "safety and effectiveness" were "deemed" by ".decimal personnel."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method is described for a test set.
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. This is a physical radiation therapy beam-shaping block, not an AI system or software. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of typical AI/SaMD studies. For this physical device, "ground truth" would relate to its manufacturing accuracy and material properties, ensuring it matches the design output from the TPS. The document states "clinically oriented validation test cases were written and executed in house by .decimal personnel." This implies internal testing against design specifications and functional requirements.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device. No "training set" in that sense was used.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
§ 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.