(78 days)
The Oncology Tech precision milled brass/aluminum compensators with tungsten fillings in the compensator walls are used for modulation of beam intensity during radiation therapy.
The Oncology Tech Mod1T Compensators for Radiation Beam Therapy are used for modulation of beam intensity during radiation therapy. Typically, a brass or aluminum round is used as a basis for the compensator. It is placed into the milling machine and worked into precise X, Y and Z dimensions. The new design of Oncology Tech Mod1T compensators mills out the compensator brass or aluminum walls and adds a high density material. The higher density of the fill material in the compensator walls provides for more attenuation and less radiation transmission at the field edges.
The provided text describes the Oncology Tech Mod1T Compensators for Radiation Beam Therapy and its substantial equivalence determination. However, it does not contain the specific details required to fully address your request regarding acceptance criteria and the study that proves the device meets those criteria.
Here's an analysis of what can and cannot be extracted from the provided document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document implies an acceptance criterion related to "improvement of the attenuation under the compensator walls" and "greater attenuation of the photon beam at the field edge and less dose outside the field." However, no specific quantitative acceptance criteria or thresholds are stated.
- Reported Device Performance: The document states: "The measurement results show an improvement of the attenuation under the compensator walls for both the 6X and 18X beams. The addition of the high density fill to the compensator walls at the field edge provides greater attenuation of the photon beam at the field edge and less dose outside the field."
- Quantitative results are referenced as being in "Appendix A, located within the step 20 clinical testing section of this submission," which is not provided in the input text. Without Appendix A, specific performance values cannot be extracted.
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: The document mentions "Each compensator was irradiated." The number of compensators tested is not explicitly stated.
- Data Provenance: Not specified. The description of the testing procedure (linear accelerator, Sun Nuclear profiler) suggests a controlled laboratory setting, but the location, whether it was retrospective or prospective, etc., is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a physical compensator for radiation therapy. Its performance is measured directly (attenuation), not diagnosed by experts. Therefore, there is no "ground truth" established by experts in the context of diagnostic performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. As above, this is direct physical measurement, not a diagnostic assessment requiring adjudication.
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 not an AI/diagnostic imaging device. It's a physical component used in radiation therapy.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm. The "study" described is a standalone physical measurement of the device's attenuation properties. The measurements were "recorded and compared to the brass compensator baseline."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" or reference for comparison was the "brass compensator baseline." The goal was to show improvement over this baseline in terms of attenuation.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above.
Summary of available information:
Acceptance Criteria and Device Performance:
| Criterion Category | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Attenuation | Implied: Improved attenuation under compensator walls and greater attenuation at field edge compared to predicate device. | "improvement of the attenuation under the compensator walls for both the 6X and 18X beams." "greater attenuation of the photon beam at the field edge and less dose outside the field." |
Study Details:
- Test Set Sample Size: Not explicitly stated (refers to "Each compensator").
- Data Provenance: Not specified (likely laboratory/controlled environment).
- Experts for Ground Truth: Not applicable (physical measurement).
- Adjudication Method: Not applicable.
- MRMC Study: Not applicable.
- Standalone Performance: Yes (physical measurement of device's attenuation properties).
- Type of Ground Truth: Comparison against "brass compensator baseline" (predicate device).
- Training Set Sample Size: Not applicable.
- Training Set Ground Truth Establishment: Not applicable.
Additional Study Information from the Text:
- Measurement Method: Sun Nuclear profiler in the transverse plane.
- Setup: Compensator locked in tray holder, linear accelerator gantry at 0°, collimator rotation at 0°.
- Irradiation: 100 monitor units of radiation.
- Comparison: Compared to a brass compensator baseline.
§ 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.