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Found 2 results
510(k) Data Aggregation
(36 days)
- Solstice™ SRS Immobilization System (when used with customizable cushion):
The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the 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), to support treatment planning.
- Solstice™ SRS Immobilization System (when used with headrest):
The device is indicated to position and/or immobilize adult and pediatic patients undergoing radiation therapy of the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT), to support treatment planning.
- Solstat™ Immobilization System & Solstice™ Thermoplastic Mask:
The device is indicated to position and/or immobilize adult and pediatic patients undergoing radiation therapy of the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT) Magnetic Resonance (MR) Imaging, to support treatment planning.
The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and the locking level allows the bowl to be tilted up to 10º in relation to the baseplate at infinite intervals. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can immobilize the patient to under 1 millimeters. The provider can correct the patient position for simulation and treatments by tilting the device.
The Static Head Fixation (Solstat) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and cannot be tilted. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can reproduce the patient position to under 3 millimeters within a treatment cycle.
The Open-Face Thermoplastic mask is comprised of a thermoplastic mask bonded with a frame. The frame has five swivel clamps that allow secure attachment onto either the Solstice or Solstat device. When heated, the thermoplastic mask can be formed around the patient anatomy and allows the Region of Interest (ROI) to be capture by camera systems, allowing Surface Guided Radiation Therapy to occur via camera systems. The same mask will be used throughout the course of the treatment. The Open-Face style mask is ideal for Surface Guided Radiation Therapy (SGRT) via camera systems.
The Solstice Immobilization device and Solstat Immobilization device are reusable devices that are provided non-sterile. Solstat and Solstice thermoplastic are single-patient reusable and is provided non-sterile and manufactured of non-magnetic materials. The devices are used in a healthcare facility/hospital. All devices are intended to be used on adult and pediatric patients.
The provided text describes premarket notification K182079 for the Solstice™ SRS Immobilization System/Solstat™ Immobilization System/Solstice™ Thermoplastic Mask. It does not contain information about a study proving the device meets acceptance criteria in the manner requested, particularly regarding clinical effectiveness studies involving human readers or expert consensus on ground truth.
However, it does provide acceptance criteria related to device performance in terms of patient immobilization accuracy, which is substantiated by non-clinical testing.
Here's an attempt to extract and frame the available information in the requested format, clearly stating where information is "Not Applicable" or "Not Provided" based on the document:
Device: Solstice™ SRS Immobilization System / Solstat™ Immobilization System / Solstice™ Thermoplastic Mask
Purpose of Testing (Non-Clinical): To substantiate the immobilization performance for Stereotactic Radiosurgery (SRS) and Stereotactic Radiotherapy (SRT), and suitability for Surface Guided Radiation Therapy (SGRT) and MRI compatibility.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Goal) | Reported Device Performance |
|---|---|
| Solstice SRS Immobilization System: Intrafraction movement during a 5-minute scanning window is less than 1.000mm. | "intrafraction movement during a 5-minute scanning window to the 99.73% Confidence Interval is less than 1.000mm." (Page 8) |
| Solstice SRS Immobilization System: Intrafraction movement during a 30-minute scanning window is less than 1mm. | "intrafaction movement during a 30 minute scanning the 95.45% confidence intervals is less than 1mm." (Page 8) |
| Solstat Immobilization System: Reproduce patient position to under 3 millimeters within a treatment cycle. | "When used with customizable cushion and thermoplastic mask, the system can reproduce the patient position to under 3 millimeters within a treatment cycle." (Listed as a feature/performance characteristic in comparison table, Page 6) - Note: This is stated as a capability, the document does not explicitly state a study proving this specific 3mm reproduction. It is more of a design claim based on the features. |
| Solstat Immobilization System & Open-Face Thermoplastic Mask: Suitable for Surface Guided Radiation Therapy (SGRT) | "Solstat, and the Open-Face thermoplastic mask can be used for Surface Guided Radiation Therapy (SGRT) as the Region of Interest (ROI) is able to be seen by the camera system." (Page 8) - Note: This is stated as a capability based on testing with VisionRT's AlignRT system. |
| Solstat Device: MR Safety (RF heating, magnetically induced torque, magnetically induced displacement force) | "The Solstat device was tested for image artifact using ASTM Standard F2119-07 as guidance and is considered MR Safe." (Page 7) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for the non-clinical tests. The data points presented for the Solstice device are statistical confidence intervals (99.73% and 95.45%), but the raw number of measurements or repetitions for these tests is not provided.
- Data Provenance: Non-clinical testing data; likely internal laboratory testing (MEDTEC Inc. dba CIVCO MEDICAL SOLUTIONS). The country of origin and whether it was retrospective or prospective is not specified, but non-clinical tests are generally prospective.
3. Number of Experts Used to Establish the Ground Truth and Qualifications
- Not Applicable / Not Provided. The "ground truth" for these performance claims appears to be derived from physical measurements using camera systems (e.g., VisionRT's AlignRT system) and standard test methods (e.g., ASTM F2119-07 for MR safety), rather than human expert interpretation of medical images.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided. This concept (2+1, 3+1, none) typically applies to human reader studies where expert disagreement on ground truth needs resolution. Here, it's about physical performance measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study was not conducted as this is a device for patient immobilization and positioning, not an AI image analysis device requiring human-in-the-loop performance evaluation.
6. Standalone (Algorithm Only) Performance
- Not Applicable. The device itself is a physical immobilization system. The "performance" relates to its mechanical stability and ability to maintain patient position, measured non-clinically. It does not employ an algorithm in the sense of AI for diagnostic or clinical decision support.
7. Type of Ground Truth Used
- Physical Measurements and Standard Test Methods.
- For Solstice: Intrafraction movement measured by camera systems (e.g., VisionRT's AlignRT system).
- For Solstat MRI safety: Compliance with ASTM F2119-07.
8. Sample Size for the Training Set
- Not Applicable / Not Provided. There is no "training set" in the context of this physical device's non-clinical performance evaluation. This concept is relevant for machine learning models.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Provided. See point 8.
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(14 days)
CIVCO Patient Positioning Devices are used to aid in the support and positioning of patients during MR, radiological, and other procedures.
The MR & Radiological Patient Positioning devices are used to aid in patient positioning and immobilization during radiotherapy procedures. The following models of the Patient Positioning Devices are included in this submission: . Bellyboard 126000 Bellyboard, which includes the following: 301101 Bellyboard Cushion o SBRT Accessories MTSBRT011 SBRT Patient Transfer System, which includes the following: MTSBRT012 Gurney Plate Assembly MTSBRT032 Transfer System Trans Slot MTSBRT033 Transfer System Longitudinal Slot MTSBRT014 Ski Assembly 20-CFHN-017 Type-S Strap Devices are sold non-sterile and may be reused for multiple patient or single patient use if set-up for a single patient. The proposed devices are non-implanted devices i that are large in size and manufactured of non-magnetic and plastic materials.
The provided text describes the regulatory submission for CIVCO MR & Radiological Patient Positioning Devices and their testing for MR compatibility. It is a 510(k) summary, not a study report for a novel AI device with specific performance metrics like those typically found in clinical trials. Therefore, much of the requested information (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study details) is not applicable or cannot be extracted directly from this document.
However, I can extract the acceptance criteria and reported device performance related to MR compatibility, as well as general information about the testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (General Category) | Reported Device Performance/Outcome |
|---|---|
| RF heating | Devices passed acceptance criteria. |
| Magnetic induced torque | Devices passed acceptance criteria. |
| Magnetically induced displacement force | Devices passed acceptance criteria. |
| Image artifact (specifically for SBRT Patient Transfer System) | Image artifact was observed in a specific area. (Device labeled MR conditional to account for this.) |
| Biocompatibility | Completed for patient contacting materials (implied satisfactory, as overall conclusion is substantial equivalence and safety/effectiveness). |
| Safety & Effectiveness in MR environment | Demonstrated that changes in design and materials do not affect safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of patient cases or device units tested in a clinical performance manner. The testing was non-clinical and focused on the device itself for MR compatibility.
- Data Provenance: The testing was non-clinical, involving direct device testing following ASTM standards. It is not patient or country-specific data but rather laboratory/device performance data. Therefore, it's neither retrospective nor prospective in the typical clinical study sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This was non-clinical engineering and materials testing for MR compatibility, not a study requiring expert clinical assessment for ground truth.
4. Adjudication Method for the Test Set
- Not applicable. This was non-clinical engineering and materials testing, not a study requiring adjudication of expert interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission concerns MR compatibility of patient positioning devices, not diagnostic or AI performance with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
- The "ground truth" here is objective physical measurements and observations against established engineering standards (ASTM F2182-9, F2119-07, F2052-06, F2213-06) for MR compatibility, along with biocompatibility testing results.
8. The Sample Size for the Training Set
- Not applicable. This document does not describe an AI/machine learning study with training sets.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This document does not describe an AI/machine learning study.
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