(88 days)
The Mini Multileaf Collimator is a conformal radiation therapy and radiosurgery device that delivers a shaped X-ray beam from a radiation therapy source. The Mini Multileaf Collimator is attached to a linear accelerator and consists of a series of pairs of tungsten leaves that collimate radiation delivery to a target based on a treatment plan generated by planning software. The device is used to help the clinician deliver well-defined target volumes of radiation while sparing the surrounding tissues and organs. The Mini Multileaf Collimator should only be used for fixed field X-ray treatments.
The Mini Multileaf Collimator is a conformal radiosurgery device that is a line to The Mini Multical Oonlinator to erapy linear accelerator (Linac). The Mini Multileaf Collimator mounted to a standard racines that determines the collimator aperture shapes at different gantry positions along the arc around the target area. Radiation is delivered at a constant rate.
The Mini Multileaf Collimator consists of three parts: (1) the user console, (2) the control cabinet and (3) the collimator mechanism.
The control cabinet with the user console serve as the control station for the operator and are I he control cabinet will the user console. The control cabinet contains the PC, an interface board located the power supply. The PC consists of a specified configuration of a CPU, motherboard, and the power supply. The F & consisted interface between the operator and the planning system software that contains the treatment positioning data. The PC also serves as the master for the control and verification system. The data received from the planning system software is processed and transferred to the micro-controllers (MC) on the control and verification boards.
The operator at the console initiates position adjustment. The PC then starts all the MC's I'm operator at the consore innussion of the leaves, comparing the values of the control system with those of the verification system.
The collimator mechanism is fitted to the accessory holder of the Linac gantry. It consists of 80 I it conmitte that position the fitted to theaves via a rack and pinion mechanism. A potentioneter is directly connected with each tungsten leaf to retrieve information on the leaf position. Independent potentiometers for verification are also included in the driving units.
The provided document is a 510(k) summary for a medical device called the "Mini Multileaf Collimator," submitted in 2001. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data for new safety and effectiveness claims. Therefore, the document does not contain the kind of specific performance data, acceptance criteria, ground truth details, or comparative study results you've requested that would typically be found in a study proving device meets acceptance criteria.
The document states that the new device has "minor differences" from its predicate and that "All tests were executed with all acceptance criteria met." However, it does not provide any specific details about what those acceptance criteria were, what tests were conducted, or the reported performance data from those tests.
Based on the provided text, I cannot complete most of the requested fields. Here's what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "All tests were executed with all acceptance criteria met." (No specific performance metrics are provided) |
2. Sample size used for the test set and data provenance:
- Not specified. The document mentions "Verification, Validation and other testing activities" but does not detail the nature of these tests, their sample sizes, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The document does not describe a test set with human-established ground truth in the context of device performance. This is typically relevant for AI/diagnostic devices, not for a collimator's mechanical and electronic performance.
4. Adjudication method for the test set:
- Not applicable/Not specified. As above, no such test set 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:
- No. This is not an AI device. It's a mechanical device (multi-leaf collimator) for radiation therapy. An MRMC study would not be relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is hardware with control software, not a standalone algorithm in the AI sense. Its function is to be integrated with a linear accelerator and planning software, with a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. Given the nature of the device (a mechanical collimator controlled by software), "ground truth" would likely refer to physical measurements of leaf positions, field shapes, and consistency with treatment plans, validated against engineering specifications. However, these details are not provided.
8. The sample size for the training set:
- Not applicable/Not specified. This is not an AI device that undergoes "training" in the machine learning sense. The software is deterministic and based on treatment planning data.
9. How the ground truth for the training set was established:
- Not applicable/Not specified. See point 8.
In summary: The provided 510(k) pertains to a hardware device (a multileaf collimator) and primarily focuses on demonstrating substantial equivalence to a predicate device based on engineering changes and subsequent testing. It explicitly states that "All tests were executed with all acceptance criteria met," implying successful verification and validation, but it does not provide the specific details of these tests, acceptance criteria, or performance data that you have requested. It is not an AI/diagnostic device, so many of your questions regarding ground truth, expert readers, and AI performance are not applicable to this document.
§ 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.