(146 days)
DART-12 is intended to assist the radiation oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
DART-12 is a tertiary Micro Multi Leaf Collimating (MMLC) system. It performs the same functions as beam shaping blocks, circular or cut blocks collimators for Conformal and "step and shoot IMRT" treatments, and it also performs "dynamic arcs" and "dynamic IMRT" treatments.
DART-12 is a LINAC based Micro-Multi-Leaf-Collimator (MMLC), used in radiation treatment.
It enables shaping the Linac beam according to target geometrical and clinical requirements.
The device is composed of the MMLC module, the Linac interface module, the Workstation (with DART-12 Control Software), and the Distribution module.
The device operates in conjunction with a Linac, a treatment couch, and any additional equipment required in radiation treatment.
The MMLC apertures, (defined in treatment data file), are generated by positioning the motor-driven leaves. The motors, controlled by DART-12, bring the leaves to specified positions. The DART-12 control software operates as a sequential linear process, where the apertures are performed one by one.
To form a desired aperture, DART-12 Control Software calculates leaves motion from knowledge of their current positions (measured) and desired destination (delivered by treatment plan).
DART-12 displays an image reflecting the leaves current position. Numeric indication of each leaf position is available.
DART-12 three operation modes are: Step-and-Shoot, Dynamic Arc. and dynamic IMRT.
The provided 510(k) summary for DART-12, K052705, does not contain information about specific acceptance criteria or a dedicated study demonstrating the device's performance against such criteria.
Instead, the document focuses on:
- Substantial Equivalence: The primary strategy for clearance is to demonstrate substantial equivalence to previously cleared predicate devices (AccuLeaf v2.1 (K040553) and BrainLAB MMLC (K020860)). The summary states that "The Dart-12 is substantially equivalent to its predicate devices as the basic features design and intended use are the same or similar. The minor differences in design dimensions and features between the Dart-12 and its predicate devices raise no issues of safety and efficacy as these differences have no effect on the performance, function or intended use of DART-12."
- Compliance with Voluntary Standards: The device complies with several IEC (International Electrotechnical Commission) standards, which are general safety and performance standards for medical electrical equipment.
Therefore, I cannot provide the requested table or detailed study information because it is not present in the provided text.
Here's a breakdown of why each specific point you requested cannot be fully addressed based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Information in text: The text mentions "No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act." It then lists voluntary standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4).
- Missing Information: There are no specific acceptance criteria (e.g., leaf positioning accuracy within X mm, repetition accuracy within Y, etc.) or quantitative performance metrics reported for DART-12. The IEC standards are general safety and performance standards, not specific acceptance criteria for the clinical performance of an MMLC in terms of radiation delivery accuracy.
2. Sample size used for the test set and the data provenance
- Information in text: Not found.
- Missing Information: No details are provided about any test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Information in text: Not found.
- Missing Information: This information would typically be part of a clinical performance study, which is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information in text: Not found.
- Missing Information: As no test set or expert review (ground truth establishment) is mentioned, no adjudication method would be detailed.
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
- Information in text: Not found.
- Missing Information: DART-12 is described as a LINAC based Micro-Multi-Leaf-Collimator. It is a hardware and software system for shaping radiation beams, not an AI-assisted diagnostic or decision-support tool for human readers. Therefore, an MRMC study related to human reader improvement with AI assistance would not be applicable to this device's function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information in text: Not found.
- Missing Information: While DART-12 has control software that calculates leaf motion, the document does not describe a standalone performance study in isolation from the LINAC or clinical use. The "performance" assessment relies on substantial equivalence and compliance with engineering standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Information in text: Not found.
- Missing Information: Since no specific performance study establishing a ground truth is described, this information is not available.
8. The sample size for the training set
- Information in text: Not found.
- Missing Information: The description of DART-12 doesn't indicate it utilizes machine learning models that would require a "training set" in the common sense (e.g., for AI/deep learning). Its software appears to be based on deterministic algorithms for leaf motion calculation.
9. How the ground truth for the training set was established
- Information in text: Not found.
- Missing Information: As no training set is indicated, this information is not applicable.
§ 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.