(71 days)
The Bionix T-Form Extremities Immobilizer patient positioning system, developed and manufactured by Bionix Development Corp., 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 T-Form Extremity Immobilizer 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.
The T-Form Extremity Immobilizer from Bionix Development Corp. consists of a thermoformed patient support device with attachment areas for accessories. The T-Form Extremity Immobilizer is thermoformed from an ABS plastic material so that the resulting contoured shell is lightweight and thin-walled, providing low attenuation for unobstructed passage of the radiation therapy beam. The T-Form Extremity Immobilizer is specifically designed for immobilization of the upper and lower extremities.
The T-Form Extremity Immobilizer has a generally rectangular shape, with pre-formed areas that allows,the device to be securely attached to the treatment couch tabletop. Specifically, there are pre-formed depressions with threaded holes that allow the T-Form Extremity Immobilizer to screw onto an attachment bar that can lock onto the treatment couch tabletop. These pre-formed areas can be found on both the top and side of the device, allowing the T-Form Extremity Immobilizer to be used in either a longitudinal or transverse orientation to allow greater flexibility in patient positioning. This allows the T-Form Extremity Immobilizer to be repeatedly located in the same position on the treatment couch tabletop for each therapy session.
The T-Form Extremity Immobilizer has a central thermoformed depression to allow the use of optional vacuum cushions as part of the patient immobilization process. Vacuum cushions contain expanded polystyrene beads in an airtight vinyl bag, with a valve for attachment to a vacuum pump. In practice, the patient's extremity is positioned on the bag which is then evacuated using the vacuum pump. As the bag is evacuated, the polystyrene beads form a rigid cushion that accurately conforms to the contours of the patient's extremity, and also to the sides of the thermoformed depression. The latter allows the vacuum cushion to locate reproducibly onto the board, while the patient's extremity can be reproducibly located into the pocket formed into the vacuum cushion.
Attachment points for standard low-melt thermoplastic (used to restrain patients undergoing radiation therapy) are provided for use in immobilizing the patient's extremities. A simple mechanical interlocking system allows the attachment of the lowmelt thermoplastic to the T-Form Extremity Immobilizer. Low-melt thermoplastic has the property of becoming soft and pliable when warm so that it can be stretched over and molded to the contoured shape of an object, in this case the patient. As it cools, it becomes rigid, and retains the object's shape. For the T-Form Extremity Immobilizer two non-adherent plastic handles are used to hold the low-melt thermoplastic. Simple screwtightened clamps mounted on the surface of the T-Form Extremity Immobilizer are used to secure the non-adherent plastic handles to the board. The low-melt thermoplastic sheet is stretched over the patient's extremity in its pliable form; once molded to the patient's anatomy, the customized low-melt thermoplastic sheet can be placed over the patient and "locked down" to the T-Form Extremity Immobilizer to ensure proper positioning for every therapy session.
The Bionix T-Form Extremity Immobilizer has a thermoformed ABS shell that displays minimal attenuation of the radiotherapy beam. This is due primarily to the fact that the thermoformed shell is relatively thin. The device has an open, air filled core that is radiolucent. The resulting structure provides strength and rigidity, and is ideal for producing a device that reproducibly positions patients and yet does not interfere with the administration of therapeutic radiation. Patient positioning devices with this type of structure are common in radiation therapy. They come in many varieties and are manufactured by several companies; examples including Civco Medical Solutions.
In clinical practice, the Bionix T-Form Extremity Immobilizer is secured to the therapy couch tabletop by attachment to a lock-down bar. The patient's extremity is positioned on the T-Form Extremity Immobilizer as desired, either directly onto the board or with the use of a vacuum cushion that has been evacuated to conform to the patient's anatomy. Low-melt thermoplastic is heated, and then draped in its warm, pliable state over the patient's extremity, and then secured to the T-Form Extremity Immobilizer using the screw-down clamps. When it cools, the low-melt thermoplastic becomes rigid and retains the shape of the patient's extremity, allowing it to be positioned and re-positioned securely during the radiation therapy regimen. Radiation therapy is then administered in the usual fashion.
The provided document is a 510(k) summary for the Bionix T-Form Extremities Immobilizer. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, it does not contain information about specific performance acceptance criteria or a study designed to prove the device meets those criteria, as typically seen in clinical performance studies for diagnostic or AI-powered devices.
This document is a submission for a Class II medical device accessory (Extremity Immobilizer for radiation therapy), and its clearance is based on demonstrating substantial equivalence to legally marketed predicate devices, not on a clinical performance study with specific quantifiable metrics like sensitivity, specificity, accuracy, or effect sizes for human readers.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot:
| Information Requested | Description from the Document |
|---|---|
| 1. Acceptance criteria and reported device performance | Not Applicable / Not Provided in this type of document. The submission focuses on substantial equivalence to predicate devices (Multifix and HipFix) based on design, features, radiolucency, and function for patient positioning and re-positioning during external beam radiation therapy. There are no quantifiable performance metrics (e.g., accuracy, precision) or specific acceptance criteria for such metrics reported. The "performance" is implicitly deemed acceptable if it's "as well as" the predicate devices for the intended use. |
| 2. Sample size used for the test set and data provenance | Not Applicable. This document does not describe a test set or data for performance evaluation in the context of diagnostic or AI device studies. It's a physical medical device. |
| 3. Number of experts used to establish ground truth and qualifications | Not Applicable. This document does not describe a process for establishing ground truth as there's no diagnostic task or AI algorithm being validated with expert consensus. |
| 4. Adjudication method for the test set | Not Applicable. No test set requiring adjudication is described. |
| 5. Multi-reader multi-case (MRMC) comparative effectiveness study | No. This is not an AI-assisted diagnostic device. No MRMC study was done or is relevant to this type of device. |
| 6. Standalone (algorithm only) performance study | No. This device is a physical immobilizer, not an algorithm. |
| 7. Type of ground truth used | Not Applicable. No ground truth in the context of diagnostic accuracy is discussed. The "ground truth" for this device's effectiveness would be its ability to physically position and immobilize patients reliably, which is inferred through comparison to predicate devices and design principles. |
| 8. Sample size for the training set | Not Applicable. This device uses design control procedures and is compared to existing devices. There is no "training set" in the machine learning sense. |
| 9. How ground truth for the training set was established | Not Applicable. |
Summary of Device Comparison (from document):
The justification for acceptance appears to be based on the following comparison points to predicate devices (Multifix and HipFix by Civco Medical Solutions):
- Intended Use: The T-Form Extremities Immobilizer is for "positioning and re-positioning of patients for receiving external beam radiation therapy," which is identical to the predicate devices.
- Design Similarity:
- Uses a base-plate-like structure (thermoformed ABS plastic shell) for attachment to the treatment couch tabletop via a lock-down bar.
- Allows for reproducible positioning.
- Incorporates features for securing patient extremities.
- Allows use of vacuum cushions (optional for T-Form, integrated for HipFix).
- Utilizes low-melt thermoplastic sheets to conform to the patient's extremity for immobilization and proper positioning, similar to both predicate devices.
- Radiolucency: The T-Form's thermoformed ABS plastic shell is described as lightweight, thin-walled, and having low attenuation for the radiation therapy beam, achieving radiolucency similar to the carbon fiber/foam composite materials used in the predicate devices. The open, air-filled core also contributes to radiolucency.
- Function: The document states that the "similarity of design, features, radiolucency, and function indicate that the T-Form Extremity Immobilizer... will perform as well as the legally marketed Multifix and HipFix immobilization devices."
In essence, for this type of medical device clearance, the "proof" the device meets acceptance criteria is the demonstration of substantial equivalence to already cleared devices based on design, materials, and intended function. There isn't a "study" in the traditional sense of a clinical trial or performance evaluation with quantifiable metrics against a defined acceptance threshold for algorithms or diagnostic tools.
§ 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.