(32 days)
The MLCi2 Multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.
This Special 510(k) describes modifications to the MLCi multileaf collimator for use as an accessory for the Elekta range of medical digital linear accelerators. These modifications provide the following improvements;
- . Improved x-ray performance (peak and average leakage).
- Improved repeatability of leaf edge position.
- . The ability for leaves to interdigitate.
The provided document is a 510(k) summary for the Elekta MLCi2, a multileaf collimator, and the FDA's clearance letter. This document does not describe a clinical study with acceptance criteria and reported device performance in the manner typically associated with studies assessing diagnostic accuracy or clinical outcomes for AI devices.
Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (MLCi) for a hardware modification, which is a different type of regulatory submission.
Here's an analysis based on the information provided, highlighting why many of your requested points are not applicable or cannot be answered from this specific document:
1. Table of acceptance criteria and the reported device performance
The document does not present acceptance criteria and reported performance in a table format for clinical efficacy. The "performance" described is in terms of technical improvements over its predecessor, not clinical outcomes.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Technical Improvements) |
|---|---|
| Technical characteristics are substantially equivalent to the predicate device, MLCi (K963624). | - Improved x-ray performance (peak and average leakage). |
| Safety and effectiveness are comparable to the predicate device. | - Improved repeatability of leaf edge position. |
| Functionality is equivalent to the predicate device. | - Ability for leaves to interdigitate. |
| - Leaf height increased by 6.5%. | |
| - Leaf profile and attitude changed to reduce leakage. | |
| - Leaf guidance improved to allow interdigitation. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission is for a hardware modification of a medical device (multileaf collimator) and does not involve a "test set" of patient data in the context of evaluating a diagnostic or AI device's performance. The "test" performed would likely be engineering verification and validation testing to confirm the stated technical improvements and safety.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As above, there is no "test set" requiring ground truth established by experts in this type of submission. Performance is measured against engineering specifications and comparison to the predicate device's technical capabilities.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No test set or expert adjudication is described.
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
- Not Applicable. This is not an AI device, and no MRMC study was performed or described. The MLCi2 is a hardware component for radiation therapy.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. The MLCi2 is a mechanical accessory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. No explicit "ground truth" for clinical performance is mentioned. The "truth" in this context refers to engineering specifications met and performance comparable to the predicate device.
8. The sample size for the training set
- Not Applicable. This is not an AI device, and therefore, no training set data is relevant to this submission.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set is relevant.
Study that proves the device meets the acceptance criteria:
The document describes this as a Special 510(k) submission for modifications to an existing device (MLCi to MLCi2). The "study" (or rather, the basis for approval) is the demonstration of substantial equivalence to the predicate device (MLCi, K963624).
The core of the "proof" is that:
- The MLCi2 has fundamental technical characteristics that are the same as the predicate device.
- The modifications (improved x-ray performance/leakage, improved leaf edge position repeatability, ability for leaves to interdigitate, increased leaf height, changed leaf profile/attitude, improved leaf guidance) are described and are considered improvements that do not raise new questions of safety or effectiveness.
- The functionality of the MLCi2 is equivalent to its predicate device. This is typically presented through comparison charts and engineering data (though not detailed in this public summary).
In essence, the study is a technical comparison and verification process, rather than a clinical trial or AI performance study. The FDA's clearance letter confirms their agreement that substantial equivalence has been demonstrated, allowing the device to be marketed.
§ 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.