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510(k) Data Aggregation
(25 days)
The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the body, head, brain, and neck, including Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Surface Guided Radiation Therapy (SGRT) and electron, photon treatments. The device is also used during image acquisition, including Computed Tomography (CT), Magnetic Resonance (MR) Imaging, to support treatment planning.
TOTIM is a fully sealed, polyurethane foam cushion covered with microfiber polyester tissue for patient positioning and immobilization during simulation, planning and radiation treatment. The cushion shapes and molds around the patient after activation of the internal components. It maintains its formed shape during all sessions of radiotherapy treatment, enabling reproducibility of patient position. The device is molded at the back of the patient's body, parts of the body or the head in order to hinder the usual range of movement occurring with non-customizable supports.
The provided text is a 510(k) summary for the TOTIM Patient Cushion Immobilization System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive de novo clinical study data for new acceptance criteria. Therefore, a comprehensive description of acceptance criteria and a detailed study proving the device meets those criteria, as typically found in clinical trial reports or performance studies for novel devices, is not present in this document.
However, based on the information provided, we can infer some aspects related to performance and testing:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) summary, specific numerical acceptance criteria for performance metrics (like accuracy of immobilization) are not explicitly stated as they would be for a novel device. Instead, the performance is primarily demonstrated through the equivalence to the predicate device and the results of non-clinical testing.
| Feature | Implicit Acceptance Criteria (Inferred) | Reported Device Performance (from text) |
|---|---|---|
| Material Safety | Biocompatibility comparable to predicate and relevant standards. | Biocompatibility testing completed for patient-contacting materials in accordance with ISO 10993-5:2009, 10993-12:2012, and ISO 10993-10:2010. Device intended for limited contact duration (<24 hours) for surface devices (skin). |
| MR Compatibility | No significant MR image artifacts or safety concerns (RF heating, magnetically induced torque, magnetically induced displacement force). | TOTIM device tested with ASTM F2119-07 (Reapproved 2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants (Materials). Result: TOTIM is MR Safe. A scientific rationale was used to address RF heating, magnetically induced torque, and magnetically induced displacement force. |
| Immobilization | Ability to position and immobilize patients for radiation therapy with reproducibility, comparable to or improved over the predicate device. | "The cushion shapes and molds around the patient after activation of the internal components. It maintains its formed shape during all sessions of radiotherapy treatment, enabling reproducibility of patient position." "The device is molded at the back of the patient's body, parts of the body or the head in order to hinder the usual range of movement occurring with non-customizable supports." "The cushion system can reproduce the patient position within a treatment cycle: SRS/SRT, SGRT, MRI, ELETRON, PHOTON, PROTON and PROTON treatments." "The proposed TOTIM Patient Cushion device have been proven to reduce preparation time, especially for difficult set-ups." |
| User Safety | Reduced risk for operators during preparation and use. | "The advantages of having a closed system for both the external bag and the inner pouch allows operators greater safety and easy to use." "With Totim we eliminate the risk of the foam out of the outer bag, make the use more practical, less risk and fast because the components are already inside the pouch contained in the fully sealed closed bag." |
| Patient Comfort | Comparable or improved patient comfort compared to the predicate device. | "Furthermore, the cushion with respect to the predicate product being made of a microfiber is more comfortable for the patient." |
| Radiotransparency | Must be radiotransparent to allow for imaging during treatment planning and verification. | "Radiotransparent" (listed under Technical Characteristics) |
| Sterilization | Single-patient/single-use. | "Single-patient /single-use" (listed under Technical Characteristics) |
| Latex-free | Must be latex-free. | "Latex Free" (listed under Technical Characteristics) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical performance data involving patients, as this is a 510(k) submission primarily relying on non-clinical testing and substantial equivalence.
- For Biocompatibility testing: The sample size would refer to the materials tested, not human subjects. The provenance would be the materials themselves.
- For MR compatibility testing (ASTM F2119-07): The sample size refers to the device and materials tested, not patients.
There is no mention of prospective or retrospective patient data for performance evaluation in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts
This information is not provided because the submission relies on non-clinical testing and substantial equivalence. No ground truth in the sense of expert consensus on patient diagnostic or treatment outcomes is established for a "test set" from patient data.
4. Adjudication Method for the Test Set
Not applicable as there is no mention of a human-reviewed "test set" requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. The device is a physical patient immobilization system, not an AI diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. The device is a physical patient immobilization system, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests involved objective measurements and standards:
- Biocompatibility: Demonstrated by testing against ISO standards (ISO 10993-5, -10, -12), where the "ground truth" is compliance with these established safety benchmarks.
- MR Safety: Established by testing against ASTM F2119-07, where the "ground truth" is the quantitative measurement of artifacts and evaluation of safety against defined criteria.
- Material properties (Radiotransparency, Latex-free, Single-use): "Ground truth" is based on material specifications and manufacturing processes.
8. The Sample Size for the Training Set
Not applicable. The device is a physical product, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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