(109 days)
The Encompass™ SRS Immobilization System provides noninvasive stereotactic head and neck immobilization by using a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning. a pationing and immobilization. The Encompass™ SRS Immobilization System allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy.
The Encompass™ SRS Immobilization System is a highly advanced, non-invasive immobilization solution designed for precisely targeted brain, head and neck treatments. The Encompass™ SRS Immobilization System consists of a posterior support of either a Fibreplast™ thermoplastic mask, or a Moldcare cushion which rests on a contoured surface. The Encompass™ SRS Immobilization System features the IntegraBite™, which reduces motion allowing for maximum dose to the tumor while minimizing radiation delivered to the surrounding healthy tissue. The Integrated Shim System™ enables quick and seamless 0.5 mm height adjustments of the thermoplastic mask for a fully customizable patient setup. The Encompass™ SRS Immobilization System is designed to optimize workflow efficiencies and improve patient outcomes.
The provided text describes the Encompass™ SRS Immobilization System and its performance studies to support its substantial equivalence to a predicate device. However, it does not explicitly define "acceptance criteria" in the way one might expect for a diagnostic or AI-driven medical device (e.g., sensitivity, specificity thresholds). Instead, the performance studies assess immobilization and workflow.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
As explicit acceptance criteria with numerical targets are not stated, I will infer them from the "verification, validation and safety requirements" and the "conclusions" of the studies.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Immobilization Performance (Sub-millimeter stability) | - Resting Conditions: Provides submillimeter stability under resting conditions, both with and without IntegraBite™. |
| Immobilization Performance (Intrafractionation Motion) | - Clinical Intrafractionation: Intrafractionation motion demonstrated to be less than 1mm/1°. |
| Workflow Efficiency (Mask Formation Time) | - Masks could be formed in under 5 minutes. |
| Workflow Efficiency (Total Mask Making Touch Time) | - Total touch time during the mask making workflow was 20 minutes or less. |
| Hardware Specifications Verification | - Verification of hardware specifications completed. |
| Ease of Use/Ergonomics | - Ease of use/ergonomics assessments completed. improved ergonomics are listed as a new feature. |
| Load Rating (IEC 60601-1 Ed. 3) | - Load rating per IEC 60601-1 Ed. 3 verified. |
| Aluminum Equivalence | - Verification of aluminum equivalence completed. |
| Deflection Requirements (IEC 60976) | - Verification of deflection requirements per IEC 60976 completed. |
| MRI Safety & Compatibility with Optical Tracking Systems | - Verification of MRI Safety and compatibility with optical tracking systems completed. |
| Compliance with Risk Management (ISO 14971:2007) | - Risk management ensured via a risk analysis in compliance with ISO 14971:2007, with identified hazards controlled via measures in development, testing, and product labeling. Adheres to recognized industry practices and standards, such as IEC 60601-1 for safety and performance risks. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Motion Studies: Healthy volunteers (number not specified).
- Intrafractionation Studies: Not specified, but conducted "at a clinical site."
- Workflow Studies: Not specified.
- Data Provenance: The text does not explicitly state the country of origin. The motion studies were conducted on "healthy volunteers," implying a prospective study. The intrafractionation studies were conducted "at a clinical site," also suggesting prospective data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts establishing ground truth in the context of diagnostic accuracy for this immobilization system. The "ground truth" for immobilization performance appears to be directly measured via tracking systems. For workflow studies, the assessment is observational.
4. Adjudication Method for the Test Set
Not applicable. The performance studies described involve direct measurement of physical parameters (motion, time), not subjective interpretation requiring adjudication among experts.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is an immobilization system, not a diagnostic imaging interpretation tool where human readers and AI would be compared. The study focused on the physical performance of the device itself.
6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) was done
Not applicable. The device is a physical immobilization system, not an algorithm. Its performance is inherent in its design and physical properties, tested in conjunction with human interaction (mask formation, patient use).
7. The Type of Ground Truth Used
- Motion Studies: Direct measurement of motion using tracking systems.
- Intrafractionation Studies: Direct measurement of intrafractionation motion, likely using external tracking or imaging.
- Workflow Studies: Timed observations of the mask-making process.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
§ 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.