(26 days)
ClearVue, a breast radiation therapy patient support, is an accessory for medical linear accelerator radiation therapy systems. ClearVue is intended to be used to position and reposition patients for breast radiation therapy. ClearVue may be used with CT and MR scanners to acquire images for radiation therapy planning.
ClearVue is a prone-breast table top attachment, which allows for multi-angle access to the treatment anatomy. This device is compatible with mainstream linear accelerators as well as compatible with most existing CT scanners. ClearVue is placed on top of the existing treatment or imaging modality couch. ClearVue does not have motors for mechanical motion. ClearVue is compatible with both left and right breast patients by the use of variable inserts. An optional support cushion is used should one find it necessary to tilt the patient. ClearVue passes through a standard CT opening with the patient on top (these range from 70 to 85 cm in diameter). The distance between the layer on which the patient rests and the layer which rests on the therapy system couch is 18 to 30 cm to accommodate most breast sizes. The table is made from carbon-fiber to minimize thickness and radiation absorption. A soft, cushion lining is attached to the patient layer for comfort.
This looks like a 510(k) premarket notification for a medical device called the "ClearVue Prone Breast Treatment Table." Based on the provided text, this document declares the device to be substantially equivalent to a predicate device, meaning it does not require a new study to prove its efficacy or safety. The document uses a comparison chart rather than a study with acceptance criteria and device performance metrics.
Here's a breakdown of why the requested information cannot be fully provided from the given text:
- No new study was performed: This is a 510(k) submission, which aims to demonstrate "substantial equivalence" to an already cleared predicate device (Bionix RT-6025 Prone Breast System). It does not involve a new clinical or performance study with defined acceptance criteria for the new device itself. Instead, it compares the characteristics of the new device to the predicate.
- No 'algorithm' or 'AI' is involved: The ClearVue is a physical medical device (a prone breast treatment table), not a software or AI-driven diagnostic tool. Therefore, terms like "algorithm only performance," "AI assistance," "effect size," and "ground truth" (in the context of diagnostic accuracy) are not applicable.
- Ground truth and experts for a physical device: For a physical support table, the "ground truth" isn't about diagnostic accuracy based on expert consensus, pathology, or outcomes data in the way it would be for an AI model. Instead, it's about physical properties, safety, and functionality, which are assessed through engineering specifications, materials testing, and intended use validation.
However, I can extract information related to the comparison with the predicate device, which serves a similar purpose to demonstrating equivalence in a 510(k):
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) for a physical device demonstrating substantial equivalence, direct "acceptance criteria" and "reported device performance" in the typical study sense (e.g., sensitivity, specificity for an AI) are not present. Instead, the comparison to the predicate device serves as the basis for acceptance. The table below outlines the characteristics compared, with the predicate device's characteristics acting as the de facto "acceptance criteria" for the new device to claim equivalence.
| Characteristic | Acceptance Criteria (from Predicate Device - Bionix RT-6025) | Reported Device Performance (ClearVue) |
|---|---|---|
| Intended Use | To position and re-position patients for breast radiation therapy; may be used with CT/MR for planning. | Same (ClearVue Prone Breast Treatment Table, a breast radiation therapy patient support, is an accessory for medical linear accelerator radiation therapy systems. ClearVue is intended to be used to position and re-position patients for breast radiation therapy. ClearVue may be used with CT and MR scanners to acquire images for radiation therapy planning.) |
| Connection to accelerator patient table | Locks to table | Rests on table with high friction feet to prevent movement. An optional fixture locks to the table. |
| Prone position for breast treatment | Same | Same |
| Patient cushion | Massage-style face cushion supports the head with openings for air flow. | Cushioned body and head support |
| Contralateral breast protection | Same | Same |
| Comfortable foam support during treatment | Same | Same |
| Height | 9" | 7" to 12" |
| Weight | 18 pounds | 28 pounds |
Study Proving Device Meets Acceptance Criteria:
The "study" proving the device meets the acceptance criteria is the 510(k) Premarket Notification itself, specifically the section detailing the "Comparison to the predicate device." The conclusion explicitly states: "The Clear Vue is substantially equivalent to the Bionix RT-6025 Prone Breast System with respect to intended use, safety, and effectiveness." This "substantial equivalence" is the regulatory standard that allows the device to be marketed without a new clinical efficacy study.
2. Sample size used for the test set and the data provenance:
- Not applicable. No clinical or performance test set, in the sense of patient data or algorithm evaluation, was used or reported in this 510(k) for the ClearVue device. The evaluation is based on characteristic comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no "test set" and thus no "ground truth" established by experts in the context of diagnostic accuracy for this physical medical device in this filing. The regulatory body (FDA) reviews the comparison document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As there was no test set in the traditional sense, no adjudication method was used.
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:
- No. This is a physical support device, not an AI or imaging diagnostic tool, so an MRMC study is not relevant or applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. ClearVue is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this 510(k) submission, the "ground truth" for the device's acceptability is the characteristics and performance of the legally marketed predicate device (Bionix RT-6025 Prone Breast System). The company demonstrates that its new device is "substantially equivalent" in its intended use, design, and performance characteristics to that predicate. This is a regulatory "ground truth" for market clearance, rather than a clinical ground truth for diagnostic accuracy.
8. The sample size for the training set:
- Only applicable if a new study or design validation was performed for the device, beyond the scope of a typical 510(k) summary provided here. For a physical device, "training set" might refer to engineering prototypes or design iterations, but this information is not disclosed in the provided 510(k) summary. Given the nature of a 510(k) (substantial equivalence), no new "training set" for performance evaluation in the typical sense of machine learning or clinical trials is required or described here.
9. How the ground truth for the training set was established:
- Not applicable for the reasons stated above (physical device, no AI/algorithm, focus on substantial equivalence to a predicate).
§ 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.