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The DORADOnova MR3T system assists in reproducible patient positioning during radiation therapy planning and is utilized during treatment planning workflow. The DORADOnova MR3T system projects visual laser beams which can be positioned at specified coordinates via a control system. The position coordinates are typically chosen by the operator or provided by an external system (e.g. treatment planning system). The DORADOnova MR3T system is allowed to be used in MR environment with a magnetic field, less or equal to 3 Tesla.

Device Description

The LAP moving laser positioning system contains laser devices and a control system. The laser system is provided in a configuration that enables the movement of two projection planes by using an appropriate composition of motorized and fixed laser devices. The installation of the system is realized in a combined bridge solution.

AI/ML Overview

This FDA 510(k) summary (K173926) describes the DORADOnova MR3T system, a medical device used for reproducible patient positioning during radiation therapy planning. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with acceptance criteria for an AI/algorithm-driven device.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets them (especially those related to AI/algorithm performance, ground truth establishment, expert adjudication, and MRMC studies) are not applicable to this specific device and document, as it is a laser positioning system, not an AI-powered diagnostic or therapeutic device.

However, based on the provided text, I can extract the relevant performance specifications and how they were tested.

Device Name: DORADOnova MR3T (LAP moving laser positioning system)

Device Type: Medical charged-particle radiation therapy system (21 CFR 892.5050, Class II) - Specifically, a laser positioning system.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical positioning device and not an AI/algorithm, "acceptance criteria" are tied to its physical specifications and safety standards, largely demonstrated through bench testing and compliance with recognized standards.

Feature / Criterion	Acceptance Criteria (Stated or Implied)	Reported Device Performance / Characteristics
Intended Use	Must assist in reproducible patient positioning during radiation therapy planning and be utilized during treatment planning workflow, by projecting visual laser beams positionable at specified coordinates. Must be usable in MR environment (≤ 3 Tesla).	The DORADOnova MR3T system "assists in reproducible patient positioning during radiation therapy planning and is utilized during treatment planning workflow. The DORADOnova MR3T system projects visual laser beams which can be positioned at specified coordinates via a control system... The DORADOnova MR3T system is allowed to be used in MR environment with a magnetic field, less or equal to 3 Tesla." (Identical to intended use).
Functional Principle	Must use projection of visual light/laser lines on the patient's skin surface, with reflection aiding medical staff to determine patient's position.	"Projection of a visual laser lines on the patient's skin surface. Reflection of the laser lines aide's professional medical staff to determine the patient's position." (Similar to predicate/reference devices).
Patient Reference Position Information	Must allow coordinates for 3 laser intersection points to be manually input or imported from a treatment planning system for reproducible patient positioning.	"The patient reference position information is the coordinates for 3 laser intersection points. They are either manually input into the device by the operator or imported from the treatment planning system." (Similar to predicate/reference devices).
Positioning Accuracy	Must be comparable to or better than predicate/reference devices. Reference device: +/- 0.1 mm. Predicate device: max mean: 0.27mm; max std dev: 0.65mm.	+/- 0.1 mm (Matches reference device performance, superior to predicate device in terms of stated accuracy).
Resolution / Line Width	Must be comparable to or better than predicate/reference devices. Reference device: <1 mm at 4m distance. Predicate device: <1 mm.	0.5 mm (blue) at 4m distance; <1 mm (red&green) at 4m distance (Meets or exceeds criteria, blues is better than reference).
Compatibility with MR Environment	Must be safe and perform as intended in MR environments up to 3 Tesla.	"For use in hospital environment, including MRI environment up to and including 3 Tesla. MRI safety testing and labeling of the proposed device are in accordance with applicable ASTM standards. Bench testing in MR environment up to three Tesla did not show any negative impact on the performance of the proposed device." (Meets criterion).
Electrical Safety	Must comply with IEC 60601-1.	"The proposed device has been tested in respect to electrical and mechanical safety in accordance with IEC 60601-1..." (Complies).
EMC	Must comply with IEC 60601-1-2.	"...EMC in accordance with IEC 60601-1-2..." (Complies).
Laser Safety	Must comply with IEC 60825-1 and U.S. performance standard 21CFR 1040.10. Laser Class 2.	"...laser safety in accordance with IEC 60825-1. The proposed device complies with U.S. performance standard 21CFR 1040.10." and "Laser Class: 2." (Complies).
Bio-compatibility	Must have no contact with patient.	"No contact with patient." (Identical to predicate/reference devices, indicating compliance with the implicit "no patient contact" requirement for biocompatibility).

Study Details for DORADOnova MR3T Performance:

This device's performance demonstration relies on engineering specifications, adherence to international safety standards, and bench testing, rather than a clinical study in the typical sense for AI/diagnostic devices.

Sample Size Used for the Test Set and Data Provenance:
- Not applicable in the typical AI/diagnostic study sense.
- Performance testing described is focused on physical properties, safety, and compatibility. Tests were likely conducted on a defined number of device units or prototypes. Data provenance is implied to be from internal company testing conducted in Germany (location of LAP GmbH Laser Applikationen).
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. Ground truth for device performance (e.g., accuracy, resolution, safety compliance) is established through standardized engineering measurements and compliance with regulatory standards, not expert clinical interpretation of data.
Adjudication Method for the Test Set:
- Not applicable. This falls under engineering and regulatory compliance testing, not clinical diagnosis where adjudication is needed.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No. This is not an AI-assisted diagnostic or CAD device requiring MRMC studies. Its function is to project light for patient positioning.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- Not applicable. This is a physical system with an operator, not an AI algorithm. Its performance directly relates to its ability to project lasers with specified accuracy.
The Type of Ground Truth Used:
- Engineering/Physical Measurement Ground Truth: For parameters like accuracy, resolution, and line width, the ground truth is established by precise metrological measurements using calibrated equipment.
- Standard Compliance Ground Truth: For safety (electrical, laser, EMC, MRI), the "ground truth" is adherence to the specified international and national standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, 21 CFR 1040.10, ASTM standards for MRI safety).
The Sample Size for the Training Set:
- Not applicable. This device does not use machine learning or AI models that require a "training set."
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set.

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