(140 days)
XPlan-2 is a stereotactic LINAC-based radiation treatment planning system. XPlan-2 localizes lesions to be treated using CT scans, and digitized angiographic film. XPlan-2 provides a stereotactic planning system for treatment of turnors at sites such as cranial, base of skull, head and neck. The conformal stereotactic radiation therapy treatments are delivered over multiple fractions.
The XPlan-2 system is a stereotactic radiation treatment planning system. The XPlan-2 system, like the XPlan-1 system, consists of treatment planning software, stereotactic hardware and extensive verification and quality assurance (QA) procedures to ensure the proper system and patient setup and the proper radiation delivery. XPlan-2 radiation treatment plans are designed with stationary or "static" radiation beams. These beams can be shaped with a range of field shaping devices, such that the shape of the radiation beam conforms to the irregular shape of the lesion. The ability to shape the radiation beam enables the user to treat irregularly shaped lesions, maximizing the radiation dose to the lesion, while minimizing the radiation dose to the surrounding normal tissue and critical structures. This premarket notification is intended to describe those additional features or modifications that have been made to the XPlan System and the new Radionics Head and Neck Localizer that is to be used with the XPlan-2.
Here's an analysis of the provided text regarding the acceptance criteria and study for the XPlan-2 and HNL devices:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Accuracy of repeat positioning with the HNL for head and neck region | ±3 mm |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for any test set or data provenance (e.g., country of origin, retrospective/prospective). The document focuses on the system's design validation and nonclinical tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The provided text does not mention the use of experts to establish ground truth for a test set. The validation described is focused on software and hardware performance against product requirements and equivalency to predicate devices.
4. Adjudication Method
The provided text does not describe any adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the device's technical specifications and substantial equivalence, not on human reader performance with or without the device.
6. Standalone Performance Study (Algorithm Only)
The provided text describes internal validation of the XPlan-2 software and the HNL, stating: "Nonclinical tests were conducted to demonstrate that XPlan-2 software meets all product requirements. This testing also demonstrates that the performance is substantially equivalent to the predicate devices cited above." This indicates that standalone performance testing was done for the algorithm and system, but it's evaluated against internal product requirements and substantial equivalence, not necessarily a separate "standalone" study in the clinical sense with specific metrics like sensitivity/specificity against ground truth (as might be expected for an AI diagnostic device). The primary performance metric mentioned is the HNL's repeat positioning accuracy.
7. Type of Ground Truth Used
For the HNL, the "ground truth" for its accuracy was likely established through physical measurements and engineering verification of its ability to repeatedly position and re-localize an object (e.g., a phantom representing a patient's head and neck) within a specified tolerance using the device's own internal quality assurance equipment and procedures. The text states: "The HNL system has quality assurance equipment and procedures to verify, prior to patient treatment, that the HNL is accurately positioned with respect to the patient's head and neck. Device testing confirms that the accuracy of repeat positioning with the HNL is ±3 mm in the head and neck region."
For the XPlan-2 software, the "ground truth" was likely defined by pre-established product requirements and expected computational outputs from the treatment planning algorithms, verified through nonclinical tests.
8. Sample Size for the Training Set
The provided text does not mention a training set sample size. This is a medical device submission focused on new features and substantial equivalence, not an AI model development submission that typically details training data. While the XPlan-2 uses a "Plus (+) Scatter Dose Model" and a "Site-Specific CT Intensity option," the origin or training of these models are not discussed.
9. How Ground Truth for the Training Set Was Established
The provided text does not mention how ground truth for any training set was established, as a training set is not discussed.
§ 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.