(90 days)
The 120 Leaf MLC is indicated for use with the Mitsubishi EXL series linear accelerators to provide the ability to adjust the field shape to conform to tumor shapes. It can be a substitute for conventional customer blocks.
This submission is intended to be applicable to the 120 Leaf multileaf collimator system (MLC) which can be used on Mitsubishi linear accelerators for external beam radiotherapy. The MLC system is design to provide the ability to adjust the field shape to conform to tumor shapes. It can be a substitute for conventional customer provided blocks. The MLC system consists of the collimator, the Local Control Equipment (LCE) located in the treatment room, and Multi Leaf Controller Unit (MLCU).
The collimator consists of three sets of jaws which determines the field size and shape. The top (Y-direction) jaws consist of a pair of monoblocks just like conventional accelerator therapy collimators. The middle (X-direction) jaws also consist of a pair of monoblocks. These jaws move in tandem and determine the field length.
The lower set of jaws consist of 60 pairs of leaves (120 leaves). Each pair of leaves is independently driven by a stepping motor. Each pair of leaves can be independently set to provide irregular-shaped field settings.
This 510(k) summary for the Mitsubishi 120 Leaf MLC (K973963) does not contain specific acceptance criteria or a detailed study proving the device meets those criteria in the way a typical diagnostic or AI-driven medical device submission would.
The document describes a medical device, a Multileaf Collimator (MLC), which is an accessory for linear accelerators used in radiation therapy. The submission focuses on demonstrating substantial equivalence to predicate devices, primarily by highlighting the increased number of leaves (from a previous Mitsubishi MLC) and its intended use to conform to tumor shapes, substituting for conventional blocks.
Therefore, many of the requested sections regarding acceptance criteria and performance study details cannot be extracted from the provided text because such information is not present.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in the document. For a device like an MLC, typical acceptance criteria would relate to leaf positional accuracy, speed of movement, repeatability, leakage radiation, and field shaping capabilities. However, these are not quantified or presented as acceptance criteria in this submission.
- Reported Device Performance: Not explicitly stated or quantified in terms of specific performance metrics against acceptance criteria. The document only describes the device's function and intended use.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable/not reported. This submission does not describe a clinical performance study with a test set of patient data. The device is hardware for radiation therapy delivery, not an imaging or diagnostic algorithm.
- Data Provenance: Not applicable/not reported.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: Not applicable. No ground truth establishment related to clinical outcomes or diagnoses is described or required for this type of device submission.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was an MRMC study done? No. This type of study is relevant for diagnostic or AI-assisted interpretation devices, not for a hardware accessory like an MLC.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only) Performance Study:
- Was a standalone study done? No. This device is a mechanical accessory, not a standalone algorithm.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not applicable. The purpose of this device is to shape radiation beams, not to make diagnoses or predictions that would require a "ground truth" in the clinical sense (e.g., pathology for a lesion, patient outcome for a prognosis). Its performance would be evaluated against engineering specifications and physics parameters rather than clinical ground truth derived from patient data.
8. Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This device is a hardware component and does not involve machine learning or AI that would require a "training set" of data.
9. How Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable.
Summary based on the provided text:
The provided 510(k) summary for the Mitsubishi 120 Leaf MLC (K973963) is a premarket notification for a radiation therapy accessory. It focuses on demonstrating substantial equivalence to previously marketed devices (Mitsubishi multileaf collimator and a Varian multileaf collimator) by highlighting its technological characteristics (increased number of leaves) and intended use.
The document does not contain information about specific acceptance criteria or a detailed clinical performance study as would be expected for a diagnostic device or a device incorporating artificial intelligence. The regulatory review process for such a device would likely have focused on engineering specifications, safety, and performance data from bench testing or preclinical studies, rather than human-reader studies or clinical ground truth establishment, which are not detailed in this public summary.
§ 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.