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510(k) Data Aggregation
(177 days)
General Positioning Devices: The device is indicated to aid in supporting and positioning adult and pediatric patients undergoing radiation therapy including electron, photon treatments. The device is also used during image acquisition to support treatment planning. Devices include Couchtops, Cushions, Cushions, and Accessories. The following are other positioning devices:
Head. Neck. and Shoulders Device is indicated to aid in supporting, positioning, and/or immobilization of adult and pediatric patients undergoing radiation therapy of the head, brain, neck, and spine including radiosurgery and electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. Devices include Overlays, Extensions, Thermoplastic Masks, and Cushions.
Support Garments: The device is indicated to aid in supporting adolescents undergoing radiation therapy including electron, photon treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age.
Breast Positioning Devices: The device is indicated to aid in supporting adult and adolescent patients undergoing radiation therapy of the breast and chest region including electron, photon treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age.
The CIVCO Positioning and Immobilization devices have been used for many years and were previously cleared under other 510(k) is to have these identical Class II products cleared for use in Proton Therapy environment.
The Head, Neck, and Shoulder Devices are used to treat cancer of the head, neck, brain and spine. Organs that are located in these anatomical regions are applicable.
The General Positioning Devices are used to treat cancer of the spine, thorax, breast, abdomen, pelvis and prostate. Organs that are located in these anatomical regions are applicable.
The Support Garments are used to treat cancer of the breast, thorax and abdominal area. Organs that are located in these anatomical regions are applicable.
The Breast Positioning Devices are used to treat cancer of the breast, thorax and abdominal area. Organs that are located in these anatomical regions are applicable.
The devices are intended for therapeutic treatment (including proton, photon, and electron beam therapy) and diagnostics (including CT and MR as indicated). The devices will be used in a variety of types of external beam radiation therapy including Intensity Modulated Proton Therapy (IMPT), Intensity Modulated Radiation Therapy (IMRT), Pencil Beam Proton Therapy (PBPT), Image Guided Radiation Therapy (IGRT), Volumetric Modulated Arc Therapy (VMAT), Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Stereotactic Body Radiation Therapy (SBRT), and Craniospinal Treatment.
The intended users of the devices are radiation oncology therapists, medical physicists, and oncologists. The provider selects the appropriate equipment based on a patient's individual clinical goals and unique constraints.
Thermoplastic mask, AccuForm Cushion, and Support Garment devices are single patient use. All devices are non-powered and static.
The subject devices are reusable or disposable as provided in product labeling, provided non-sterile, and are used in a healthcare facility/hospital. The devices are labeled for MR safety, as applicable.
This document is a 510(k) Pre-market Notification for medical devices, specifically Proton Positioning and Immobilization Devices. It is a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, primarily for the modified intended use/indications for use to include proton treatment and pediatric/adolescent use.
The document does not describe a study involving an algorithm or artificial intelligence (AI) with acceptance criteria in the traditional sense of a computer-aided diagnosis (CAD) or AI-driven diagnostic device. Instead, it describes non-clinical performance testing for physical medical devices. Therefore, many of the requested details about acceptance criteria, ground truth establishment, expert consensus, and multi-reader multi-case (MRMC) studies are not applicable to this type of device submission.
Here's an interpretation of the relevant information provided, framed as closely as possible to your request for acceptance criteria and study proof for a medical device:
Device Type: Physical Medical Devices (Positioning and Immobilization for Radiation Therapy)
Purpose of Submission: To expand the Indications for Use of existing, previously cleared devices to include proton treatment and pediatric/adolescent use.
1. Table of "Acceptance Criteria" (Performance Goals) and Reported Device Performance
Given that this is a 510(k) for physical positioning devices, the "acceptance criteria" are not quantitative performance metrics like sensitivity/specificity for an AI algorithm. Instead, they are functional performance goals related to the physical interaction with the proton beam and patient. The "reported device performance" is the confirmation that these functional goals are met.
| Acceptance Criteria (Performance Goal) | Reported Device Performance (Conclusion from Testing) |
|---|---|
| Primary Goal: Device will not perturb or impact the proton beam in a way that cannot be accounted for in the facility's proton treatment planning process. | Devices evaluated, including edge effects, were considered safe and effective for use with proton. The performance tests confirmed that these devices would not perturb or impact the proton beam in a way that cannot be accounted for in the proton treatment planning process. (No recognized threshold for proton attenuation; criteria based on non-perturbation given facility's planning capabilities). |
| Maintain safety and effectiveness with expanded use (proton treatment, pediatric/adolescent use). | The risk analysis confirmed the safety and effectiveness of similar devices used for pediatrics/adolescents and Proton Therapy, ensuring no new issues are raised. CIVCO devices were found to be safe and effective for use with adults, pediatrics, and/or adolescents in the Proton Therapy environment. |
| No additional biocompatibility issues with expanded use. | All devices are previously cleared and manufactured with the same or substantially equivalent material that was previously cleared, thus no additional biocompatibility testing is required. |
| Devices used in MRI environment maintain their MR safety. | Devices labeled for use in an MRI environment were previously cleared by predicate 510(k)s included in this submission. Therefore, no additional MR testing is required. |
| Mechanical function without software/electronics. | Confirmed: The devices are mechanical without the use of software or electronics. |
| Limited contact duration ( |
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(88 days)
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.
| Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (as claimed in submission) |
|---|---|
| Similar Design and Construction | "The Bionix VersaBoard is substantially equivalent to the Med-Tec S-Type Baseplate in design, construction, and function." |
| "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." | |
| Similar Functionality for Patient Positioning and Repositioning | "In clinical practice the VersaBoard again functions similarly to the Med-Tec S-Type Baseplate." |
| "The patient is positioned on the VersaBoard... allowing him to be positioned and repositioned securely during the radiation therapy regimen." | |
| Minimal Radiation Attenuation | "The carbon fiber/epoxy/foam composite structure of the board has a minimal attenuation factor." |
| "The foam core allows for almost no attenuation of the radiation beam during the treatment process." | |
| "Similar to that exhibited by the VersaBoard." (in comparison to other predicate devices) | |
| Strength and Stiffness for Patient Support | "The carbon fiber/epoxy skin provides strength and stiffness;" |
| "It is reasonable to expect that the two devices will have similar properties as regards to stiffness, support strength..." | |
| Compatibility with Radiation Therapy Couch & Thermoplastic Masks | "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." |
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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