(107 days)
Apex is an add-on microMLC system. It is an accessory to the linear accelerator used for radiation therapy and it is intended to shape the X-ray field both in static (fixed) or dynamic mode with rotating gantry as a function of the gantry angle. It is provided to assist the radiation oncologist to deliver radiation to the target tissue while sparing the surrounding normal tissues.
This Traditional 510(k) describes modifications made to the add-on DMLC accessory for the Elekta range of digital linear accelerators. The primary reason for these enhancements is to improve the leaf resolution - Apex 11 has a reduced leaf width of 2.5mm and increased field size. The add-on MLC Apel M consist of a 112 leaves individually controlled and monitored having a 2.5mm thickness at the isocenter and a field size of 120 mm x 140 mm.
The provided document {0} is a 510(k) summary for the Elekta Apex microMLC, an add-on accessory for linear accelerators used in radiation therapy. This submission focuses on modifications to improve leaf resolution (2.5mm leaf width and increased field size) compared to its predicate device, the DMLC IV (K001163). The core of the submission revolves around demonstrating substantial equivalence to the predicate device.
Based on the information provided, the document describes the device, its intended use, and its technological characteristics but does not contain information about specific acceptance criteria, performance studies, sample sizes, ground truth establishment, or comparative effectiveness studies (MRMC or standalone) in the manner typically associated with clinical performance evaluation of medical devices where diagnostic accuracy or similar metrics are assessed.
The document is a regulatory submission for a device that shapes radiation beams. The evaluation of such devices primarily focuses on their technical performance in shaping the beam accurately and safely, rather than a clinical study evaluating diagnostic accuracy or treatment efficacy as might be seen with an AI-powered diagnostic tool.
Therefore, for most of the requested points, the answer derived from the provided text will indicate that the information is "Not provided in the document."
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device: The functionality for the Apex™ is equivalent to its predicate device DMLC IV (K001163) in safety and effectiveness. The fundamental technical characteristics are the same as those of the predicate device. | The primary reason for enhancements is to improve leaf resolution – Apex has a reduced leaf width of 2.5mm and increased field size. The add-on MLC Apex™ consists of 112 individually controlled and monitored leaves, having a 2.5mm thickness at the isocenter and a field size of 120 mm x 140 mm. |
Study Details
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided in the document. The 510(k) summary provided here is a technical and regulatory declaration of substantial equivalence, not a report of a clinical performance study with a test set of data. The "study" mentioned mainly refers to the comparison against the predicate device based on technical specifications and functional equivalence.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided in the document. There is no indication of a "test set" with a ground truth established by experts. The device's function is to shape radiation beams, and its performance is typically evaluated through engineering tests and phantom studies rather than expert-labeled clinical data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided in the document. No test set or expert adjudication is described.
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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:
- No MRMC study was done, or at least, it is not mentioned in this document. This device is a radiation therapy accessory (a microMLC), not an AI-powered diagnostic tool that assists human readers. Its function is mechanical beam shaping.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided in the document. The device is a physical component (microMLC) that operates as an accessory to a linear accelerator, not a standalone algorithm. Its performance is inherent to its mechanical and control accuracy.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided in the document. No such "ground truth" as typically understood for diagnostic or prognostic AI devices is relevant or described for this device in this submission. The "ground truth" for a microMLC would relate to its physical accuracy in beam shaping, measured through dosimetry and mechanical verification, not clinical outcomes or expert consensus on clinical images/data.
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The sample size for the training set:
- Not applicable / Not provided in the document. This document describes a physical medical device, not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable / Not provided in the document. As above, no training set or its associated ground truth is relevant or described for this device submission.
§ 892.5710 Radiation therapy beam-shaping block.
(a)
Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.(b)
Classification. Class II.