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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.

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).

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The VersaBoard patient positioning system developed and manufactured by Bionix Development Corporation, Toledo, Ohio, is intended to be used for the positioning and re-positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases.

It is intended to be used by or under the direction of a licensed physician.

The Bionix VersaBoard is substantially equivalent to the Med-Tec S-Type Baseplate in design, construction, and function. The VersaBoard is flat and has a similar, generally torso-shaped contour. with an area specifically for the head, shoulders, and back. The head portion has a central open area where a thin plate of carbon fiber/epoxy is placed. This thin plate may have a waffle-like cutout, or a more sophisticated design that allows for the prone as well as supine positioning of the patient. The Bionix VersaBoard is manufactured according to the FDA Good Manufacturing Practice guidelines using standard methods and practices. The VersaBoard is constructed in the same manner as the S-Type Baseplate from Med-Tec, having a carbon fiber/epoxy/foam core composite structure) that is an accepted standard in radiation therapy. The carbon fiber/epoxy again provides stiffness and strength, while the foam core allows for almost no attenuation of the radiation beam during the treatment process. The VersaBoard also has simple mechanical interlocks that allow the board to be secured to the tabletop of the therapy couch. Other interlocks or clamps allow low-melt thermoplastic to be attached to the VersaBoard during the patient positioning process.

The provided document is a 510(k) Premarket Notification Summary for the VersaBoard Patient Positioning System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed acceptance criteria and studies as might be found in a De Novo submission or a PMA.

Therefore, many of the requested elements regarding acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment are not typically included or required in a 510(k) summary focused on substantial equivalence for a device like a patient positioning system.

Here's an analysis based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not define specific, quantifiable acceptance criteria or provide a table of reported device performance in the way a clinical study would for a novel therapeutic or diagnostic device. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The key "performance" metrics for patient positioning systems like the VersaBoard relate to their physical properties (strength, stiffness, minimal radiation attenuation) and their ability to reproducibly position patients without interfering with radiation therapy.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not applicable. The submission does not describe a clinical "test set" in the context of a performance study with patient data. It is a comparison of design and function of the device itself to predicate devices.
• Data Provenance: Not applicable. The "data" presented comprises descriptions of the device's design, construction materials, and intended use, along with comparisons to existing predicate devices. No patient or clinical data is provided or referenced from a specific country of origin, nor is it described as retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable. No ground truth was established by experts for a test set in the context of this 510(k) submission. The submission relies on the established safety and effectiveness of the predicate devices. The submitter, James Huttner M.D., Ph.D., as Vice President, New Product Development, is an expert in the field.

4. Adjudication Method for the Test Set:

• Not applicable. There was no test set requiring adjudication in the context of a clinical study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices to assess reader performance. The VersaBoard is a patient positioning system, not a diagnostic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. The VersaBoard is a physical medical device, not an algorithm. Therefore, "standalone" performance in the AI context does not apply. The device's function is inherently "with human-in-the-loop" as it is used by clinicians to position patients.

7. The Type of Ground Truth Used:

• Not applicable in the conventional sense of clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for this submission is effectively the established safety and effectiveness of the legally marketed predicate devices (Med-Tec S-Type Baseplate, Med-Tec Carbon Fiber Breast Board, Bionix Max 2 Deluxe TorsoBoard) as recognized by the FDA through prior clearances (K933227, K974703, K905007). The submission argues that since the VersaBoard is substantially equivalent in design, materials, and intended use, it inherently shares the "ground truth" of safety and effectiveness with these predicates.

8. The Sample Size for the Training Set:

• Not applicable. There is no concept of a "training set" for this type of physical medical device in a 510(k) submission.

9. How the Ground Truth for the Training Set was Established:

• Not applicable, as there was no training set.

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