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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:

Device Description

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.

AI/ML Overview

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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