(84 days)
The MLC Beam Shaper software utility provides the ability to create, view, and edit geometric information that will be utilized to form irregular treatment fields through automated changes of multiple leaves that conform to the specified treatment target generate treatment field shapes. The MLC Beam Shaper software is an accessory to the Siemens Multileaf Collimator with Lantis Record and Verify System for the Siemens Digital MEVATRON radiation treatment system.
Beam Shaper consists of a digitizer tablet for inputting leaf positions based on field shapes traced from an x-ray film or paper diagram to generate Multileaf Collimator leaf plans. In specifying field geometry, Beam Shaper utilizes leaf, jaw collimator, and gantry position information.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Siemens Multileaf Collimator Beam Shaper:
The provided text does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving device conformance.
Instead, this document is a 510(k) summary for a medical device (Siemens Multileaf Collimator Beam Shaper) from 1996. The purpose of a 510(k) is to demonstrate substantial equivalence to a predicate device, not necessarily to prove specific performance metrics against pre-defined acceptance criteria in the way a clinical trial or a detailed performance study might.
Here's what can be extracted and what is explicitly missing:
1. A table of acceptance criteria and the reported device performance
- Missing. The document states that "Performance tests were conducted and the results indicated that the device consistently performed within the design parameters and equivalently to the predicate device." However, it does not specify what those "design parameters" were, what the acceptance criteria for those parameters were, or the quantitative performance measurements.
2. Sample size used for the test set and the data provenance
- Missing. No details are provided about any specific "test set" used, its size, or its origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Missing. Ground truth establishment is not mentioned as part of any described testing.
4. Adjudication method for the test set
- Missing. No test set or adjudication method 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
- Missing. This device is from 1996 and is purely a software utility for creating and editing radiation therapy field shapes. It is not an "AI" device as understood in modern terms, nor is there any mention of human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing. While the device is "algorithm only" in the sense that it's software, the performance evaluation described is too vague to determine if "standalone" performance testing (e.g., accuracy of calculations) was conducted and how it was measured.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Missing. No ground truth is mentioned.
8. The sample size for the training set
- Missing. There's no mention of a "training set" as this is not a machine learning device.
9. How the ground truth for the training set was established
- Missing. Not applicable, as there's no training set.
Summary of Device and Performance Statement (from the document):
- Device Name: Siemens Multileaf Collimator Beam Shaper
- Intended Use: To create, view, and edit geometric information for forming irregular treatment fields through automated changes of multiple leaves that conform to specified treatment targets. It's an accessory to the Siemens Multileaf Collimator with Lantis Record and Verify System.
- Technological Characteristics: Substantially equivalent to the predicate device (Siemens Multileaf Collimator Hand Control K953894) with no significant changes in materials, energy source, or performance. Minor configuration/specification differences do not alter intended use or affect safety/effectiveness.
- Performance Evaluation Statement: "Performance tests were conducted and the results indicated that the device consistently performed within the design parameters and equivalently to the predicate device."
Conclusion:
The provided document serves as a regulatory submission demonstrating substantial equivalence rather than a detailed technical report with specific acceptance criteria and a comprehensive study protocol. Therefore, it does not contain the granular information requested regarding acceptance criteria, study methodologies, and performance metrics.
{0}------------------------------------------------
K9619C
SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitter's Information: | Dated: May 13, 1996 |
|---|---|
| AUG - 8 1996 | |
| Siemens Medical Systems | |
| Oncology Care Systems Group | |
| 4040 Nelson Avenue | |
| Concord, CA 94520 | |
| Contact Person: | Kenneth R. Michael, Pharm.D.Vice President Regulatory Affairs and Quality Assurance |
| Common or Usual Name: | Radiation therapy beam shaping block |
| Proprietary Name: | Siemens Multileaf Collimator Beam Shaper |
| Classification Names: | Radiation therapy beam shaping block - 21 CFR § 892.5710Class II, Product Code: RA 90 IXI |
| Predicate Device: | Siemens Multileaf Collimator Hand ControlK953894 |
Description of Device: Beam Shaper consists of a digitizer tablet for inputting leaf positions based on field shapes traced from an x-ray film or paper diagram to generate Multileaf Collimator leaf plans. In specifying field geometry, Beam Shaper utilizes leaf, jaw collimator, and gantry position information.
Statement of intended use: The MLC Beam Shaper software utility provides the ability to create, view, and edit geometric information that will be utilized to form irregular treatment fields through automated changes of multiple leaves that conform to the specified treatment target generate treatment field shapes. The MLC Beam Shaper software is an accessory to the Siemens Multileaf Collimator with Lantis Record and Verify System for the Siemens Digital MEVATRON radiation treatment system.
The intended use is the same the predicate device.
Statement of technological characteristics: The Siemens Multileaf Collimator Beam Shaper software does not have significant change in materials, energy source or performance characteristics compared to the predicate devices.
The intended use and the performance characteristics are the same as the predicate device and therefore we believe it is substantially equivalent to it.
Differences: The minor configuration and specification differences between the Siemens Multileaf Collimator Beam Shaper software and that of the MLC hand control does not alter the intended use or affect the safety and effectiveness of the Siemens Multileaf Collimator Beam Shaper when used as labeled.
?erformance Evaluation: Performance tests were conducted and the results indicated that the levice consistently performed within the design parameters and equivalently to the predicate levice.
dical Systems, Inc.
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4040 Nelson Avenue Concord, CA 94520
Tel: (510) 246-8200 FAX (510) 246-8284
§ 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.