(14 days)
The Bionix Thigh and Foot Positioner 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 for receiving 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 SuProne Plus from Bionix Development Corporation is designed to be used for the positioning and re-positioning of patients for receiving radiation therapy.
Thigh Bolster and Foot Positioner: The Thigh Bolster and Foot Positioner consist of two parts, a thigh support and a footrest. The thigh support portion has a generally tent-like shape, with formed contours to support the thighs and calves. The thigh support portion is designed to interface with the Bionix Secure-Bar, allowing it to be secured to the radiation therapy treatment couch in an index-able fashion. The thigh support portion also has attachment points for interlocks that allow the use of low-melt thermoplastic during the patient immobilization procedure. The Thigh Bolster and Foot Positioner are constructed of a thermoformed thermoplastic ABS shell with an air core. The Thigh Bolster and Foot Positioner also have simple mechanical interlocks that allows the individual parts to be secured to the tabletop of the therapy couch. Other interlocks or clamps allow low-melt thermoplastic to be attached to the Thigh Bolster and Foot Positioner during the patient positioning process.
SuProne Plus: The SuProne Plus consists of a flat "headboard" comprised of a material with a carbon fiber/epoxy skin and a foam core that rests on a base-plate comprised of similar carbon fiber/epoxy composite material without the foam core. The headboard is designed to hold a patient's head in either the supine or prone position during treatment. An open area in the center of the headboard allows for prone positioning of the patient; during treatment, the patient's forehead and cheekbones rests on a foam cushion for support and comfort. For supine positioning, the patient's head rests on a thin plastic headrest for comfort. With both prone and supine positioning, low-melt thermoplastic may be used to further constrain patient movement. The headboard has clamps or other locking mechanisms that allow the low-melt thermoplastic to attach firmly to the device. The headboard rests on a base-plate made from a carbon fiber/epoxy resin composite material. This base-plate has three main elements: a base, side supports, and an upper frame that mates with the headboard. The base-plate base has simple mechanical interlocking systems that allow the device to be securely attached to the treatment couch tabletop using an attachment bar or similar device. The side supports of the base-plate provide rigidity and have semi-circular slots milled into the side support of the bas a rigid, open box-like design, and has locating pins that mate with the underside of the headboard. The sides of the upper frame have threaded pins that mate with the semi-circular slots in the side supports. These threaded pins allow the upper frame to move in an arcing fashion, following the semi-circular slots in the side supports. Tightening the threaded pins locks the upper frame at desired angle.
The provided document is a 510(k) Premarket Notification for two medical devices: the Thigh Bolster and Foot Positioner, and the SuProne Plus. This submission aims to demonstrate substantial equivalence to existing legally marketed predicate devices, rather than proving the device meets specific performance acceptance criteria through a study with detailed quantitative outcomes.
Therefore, the document does not contain the information requested in sections 1-9 of your query, as it describes a regulatory submission focused on substantial equivalence rather than a detailed performance study with acceptance criteria, sample sizes, expert adjudication, or MRMC studies.
Here's why the requested information is absent:
- No Acceptance Criteria or Reported Performance (Section 1): The document claims "similar properties as regards to stiffness, support strength, and minimal attenuation of the radiotherapy beam." However, these are qualitative statements of expected similarity to predicates, not specific measurable acceptance criteria with reported performance values as would be found in a performance study.
- No Test Set Sample Size or Provenance (Section 2): Since no performance study is detailed, there is no test set, sample size, or data provenance mentioned.
- No Experts for Ground Truth (Section 3): The submission relies on a comparison to existing devices, not on the generation of new ground truth for a test set.
- No Adjudication Method (Section 4): Not applicable as there's no diagnostic study requiring adjudication.
- No MRMC Study (Section 5): The document focuses on the physical characteristics and intended use of the devices, not on effects on human reader performance.
- No Standalone Performance Study (Section 6): The devices are patient positioning systems, not algorithms. Their performance is described in terms of their intended function (positioning and re-positioning patients for radiation therapy) and comparison to predicate devices, not as standalone diagnostic performance.
- No Ground Truth Type (Section 7): The "ground truth" here is the established safety and effectiveness of the predicate devices based on their long-term clinical use and FDA clearance. No new clinical ground truth is established for these devices in this submission.
- No Training Set Sample Size (Section 8): These are physical devices, not AI/ML algorithms that require training sets.
- No Ground Truth Establishment for Training Set (Section 9): Not applicable for the same reason as above.
The core of this 510(k) submission is the argument that the new devices are "substantially equivalent" to legally marketed predicate devices. This is achieved by comparing their design, materials, function, and intended use. The document repeatedly states:
- "This product is similar in design and function to existing patient positioning devices currently in use..."
- "The Bionix Thigh Bolster and Foot Positioner is substantially equivalent to the Med-Tec Dual Leg Positioner and Knee-and-Foot Lok in design, form, and function."
- "Based on the almost identical design and similar features...it is reasonable to expect that the two devices will have similar properties as regards to stiffness, support strength, and minimal attenuation of the radiotherapy beam, and should function in a substantially equivalent fashion..."
In summary, this document does not contain the information you requested because it's a regulatory submission demonstrating substantial equivalence through comparison, not a clinical trial or performance study with detailed acceptance criteria and quantitative results.
§ 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.