(67 days)
ExacTrac 4.0 is a system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. The ExacTrac 4.0 system uses optical tracking of infrared reflecting markers and x-ray registration as the method of locating the position of the patient.
ExacTrac 4.0 is a Patient Positioning System. It is based on an imported isocenter from a planning system or on an isocenter imported from a simulator. It allows verification and, if necessary correction of the patient's position.
Correction of patient's position is based on a comparison of digital reconstructed images (DRR) calculated from a corresponding CT set (reference image) and x-ray images) . Structures on the images to be compared can be either anatomical landmarks or implanted internal markers.
For some applications (e.g. prostate tumors) the correction can alternatively be performed by using the ultrasound module. Here the correction of patient's position is based on a comparison of an outlined structure in the CT set (reference image) and perpendicular ultrasound images) .
This 510(k) summary does not contain a detailed study with acceptance criteria and reported device performance in the format requested. It primarily focuses on demonstrating substantial equivalence to a predicate device based on BrainLAB's internal verification and validation procedures, rather than presenting a specific, independently conducted study with metrics like sensitivity, specificity, or accuracy against a pre-defined ground truth and acceptance criteria.
The document states: "ExacTrac 4.0 has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system. The information provided by BrainLAB in this 510(k) application was found to be substantially equivalent with the predicate device ExacTrac 2.0 (K003285)."
Therefore, most of the requested information (points 1-9) cannot be extracted from the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify quantitative acceptance criteria (e.g., accuracy thresholds, precision targets) or reported performance metrics from a specific study. It only states that the device was "verified and validated" according to internal procedures.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not mention any specific test set, its size, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. No information on ground truth establishment or experts is present for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No test set or an adjudication method is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be provided. The device is a patient positioning system, not an AI-assisted diagnostic tool for human readers. No MRMC study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided definitively for formal study results. The device description implies standalone operation for positioning correction based on image comparison, but no specific performance study in a "standalone" context with metrics is detailed in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No specific ground truth type for performance evaluation is mentioned in the summary. The system works by comparing DRRs/CT set outlines with real-time X-ray/ultrasound images, implying an internal consistency check rather than external ground truth for a study.
8. The sample size for the training set
- Cannot be provided. No training set or its size is mentioned.
9. How the ground truth for the training set was established
- Cannot be provided. No training set or ground truth establishment method for it is mentioned.
Summary of what is available from the text:
The provided 510(k) summary focuses on establishing substantial equivalence to a predicate device (ExacTrac 2.0, K003285) rather than detailing a specific clinical performance study with explicit acceptance criteria and results. The validation of the device (ExacTrac 4.0) relies on BrainLAB's internal product design and development procedures, which are stated to prove safety and effectiveness. The core function involves comparing digital reconstructed images (DRR) from a CT set and X-ray images, or in some cases, outlined structures in a CT set with perpendicular ultrasound images, to ensure accurate patient positioning to the isocenter of a linear accelerator.
§ 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.