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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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