(11 days)
Fixation and (re)positioning of the head- and neck area of the patient during radiotherapy and diagnostics.
Positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics.
Positioning of the lower abdomen of a patient during radiotherapy and diagnostics.
Positioning of hip and lower extremities of a patient during radiotherapy and diagnostics.
Fixation and (re)positioning of the patient during radiotherapy and diagnostics.
The submission describes several types of immobilization systems and cushions for radiotherapy and diagnostics:
- Head and shoulder positioning and immobilization systems (Baseplates): Posifix 1,2,4,5,7 head and neck systems, Positilt head inclination system, Posifix Pediatric, Headsupports, Blocks and wedges, Shouldersupport cushion. These are designed to position and reposition the head and neck.
- Head and shoulders immobilization systems (Extensionplates): Posifix-EXT systems, Shoulderretractor, Couchtop Cover. These are intended to position the head and neck outside the couch.
- Lung and thorax immobilization systems: Thorawedge, Posirest, Posiboard, PET-armsupport. These are for positioning the patient for irradiation in the lung and thorax area.
- Pelvis and lower extremities immobilization systems (Bellyboard system): Bellyboard, Prone thorax support cushion for Bellyboard. These are developed to reduce irradiated small bowel volume in gynaecological patients.
- Pelvis and lower extremities immobilization systems: Posifix-12, Multifix, Combifix-system (Baseplate with Kneefix and Feetfix), Multi Purpose Support cushions. These are for positioning of hip and lower extremities.
- Repovac Cushions: Vacuum cushions filled with polystyrene beads that can be made vacuum to follow and keep the contour of a patient for reproducible positioning.
- Posicast immobilization systems: Thermoplastic mask material for patient immobilization.
The provided text is a 510(k) summary for Sinmed Radiotherapy products, including immobilization systems for various body parts and Repovac cushions. The document states that "No comparative investigations are performed" and "No clinical comparative tests are necessary" because the Sinmed devices are stated to be "substantially equivalent" to predicate devices, or in one case, "exactly the same" as a previously registered device. Therefore, it does not describe a study that proves the device meets specific acceptance criteria in terms of performance metrics.
Instead, the submission focuses on establishing substantial equivalence to legally marketed predicate devices, implying that the acceptance criteria are met by virtue of this equivalence and the known function of the predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed device performance metrics (e.g., accuracy of immobilization in mm, reproducibility over time, specific clinical outcomes) for the Sinmed devices. The primary "performance" reported is that they are technologically equivalent and function in the same way as the predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Intended Use: Similar to predicate device (Fixation and (re)positioning during radiotherapy and diagnostics for various body parts) | Functions for the same purpose as predicate device; "exactly the same" as predicate in one case. |
| Technological Characteristics: Similar materials, design, dimensions, possible adjustments, couch fixation, accessories, and compatibility as predicate devices. | "Same kind of construction and materials are used," "all features can be found." |
| Safety and Effectiveness: Assumed to be safe and effective due to substantial equivalence to predicate devices, which are legally marketed. | No specific safety or effectiveness data beyond material biocompatibility tests (cytotoxicity reports mentioned as enclosed in Chapter 11, but not detailed here). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states that "No comparative investigations are performed" and "No clinical comparative tests are necessary." Therefore, there is no test set sample size and no data provenance from a clinical study for performance evaluation. The data provenance mentioned refers to the predicate devices and their existing registrations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no comparative investigation or clinical study with a test set was performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no comparative investigation or clinical study with a test set was performed.
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
Not applicable. The devices are physical immobilization systems, not AI-powered diagnostic tools, so MRMC studies and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as the devices are physical immobilization systems, not algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Ground truth, in the context of this 510(k) submission, is established by substantial equivalence to legally marketed predicate devices. This implies that the predicate devices' established safety and effectiveness, based on their prior clearances and clinical experience, serve as the "ground truth" for what constitutes acceptable performance and safety for similar devices. The document refers to "clinical experience" with both predicate and proposed devices to argue that they "function in the same way."
8. The sample size for the training set
Not applicable, as the devices are physical immobilization systems, not machine learning models requiring training data.
9. How the ground truth for the training set was established
Not applicable, as the devices are physical immobilization systems, not machine learning models.
§ 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.