(184 days)
TOPSLANE DMLC is a dynamic multileaf collimator designed to be mounted on the linear accelerator. It is intended to shape the specific fields, either in static or dynamic mode, 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.
TOPSLANE DMLC is a dynamic multileaf collimator designed to be mounted on the various linear accelerator. It comprises multiple motorized tungsten leafs and By controlling each leaf to the designed position according to the software. treatment planning system (TPS), TOPSLANE DMLC is intended to shape the specific field, either in static or dynamic mode. TOPSLANE DMLC can perform different field shaping methods, such as Static Field Shaping, or Step and Shoot IMRT Field Shaping or Sliding Window IMRT Field Shaping.
This document is a 510(k) premarket notification for the TOPSLANE DMLC, a dynamic multileaf collimator. It is a regulatory submission to the FDA, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics in the way a clinical trial might.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not provided in this type of regulatory document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific quantitative acceptance criteria or detailed performance metrics in a tabular format as one would find in a clinical study report. Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device (m3 micro-Multileaf Collimator, K004022, K020860).
The primary "acceptance criterion" for this type of submission is that the FDA determines the device is "substantially equivalent" to legally marketed predicate devices. This is based on comparisons of design, construction, intended use, and performance characteristics.
The document states:
- "This device is similar in design and construction, and has the same intended use and performance characteristics to the predicate device."
- "It utilizes materials that are already in use in other medical devices."
- "No new issues of safety or effectiveness are introduced by using this device."
Therefore, a table of acceptance criteria and reported performance cannot be created from the provided text. The document asserts that its performance characteristics are comparable to the predicate, implying it meets the performance standards already established for such devices.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable / Not provided.
This 510(k) submission does not describe a test set or associated data provenance from a new clinical study. Instead, it relies on the known performance and substantial equivalence to existing predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable / Not provided.
No new test set requiring expert ground truth establishment is described in this submission.
4. Adjudication Method for the Test Set
Not applicable / Not provided.
No test set and adjudication are described.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done
No.
An MRMC comparative effectiveness study was not done, as this is a 510(k) submission seeking substantial equivalence for a physical medical device (a dynamic multileaf collimator), not an AI algorithm.
6. If a Standalone Performance (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable.
This document is for a physical device (TOPSLANE DMLC), not an AI algorithm. Therefore, "standalone performance" in the context of an algorithm is not relevant. The device's function is to shape radiation fields, which integrates into the larger radiation therapy workflow managed by radiation oncologists.
7. The Type of Ground Truth Used
Not applicable / Not provided for new data.
The "ground truth" here is effectively the established performance and safety profile of the predicate devices. The submission asserts that the TOPSLANE DMLC operates similarly, thereby inheriting the "ground truth" of safe and effective operation within the scope of its intended design.
8. The Sample Size for the Training Set
Not applicable.
This document is for a physical device, not a machine learning algorithm, so there is no concept of a "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
As this is not an AI algorithm, the concept of a training set and its ground truth establishment is not relevant.
§ 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.