(51 days)
The MMLC is intended to assist the radiation oncologist team in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. This is accomplished through 31 pairs of opposing tungsten leaves, which allow the MMLC to shape the x-ray beam according to a treatment plan generated by a planning system such as the RSA XPlan software.
The MMLC is intended to assist the radiation oncologist team in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. With Radionics' XPlan Conformal Treatment Planning Software or any treatment planning system, the MMLC enables static conformal treatments to be performed with finely shaped field patterns. In this application, the MMLC performs the same function as customized beam shaping blocks, and circular or cut block collimators, which have been used for many years.
The Mini Multi-Leaf Collimator (MMLC) is a complete system consisting of an independent device that attaches to a Siemens linear accelerator (LINAC) for small field conformal radiosurgery or radiotherapy. Along with XPlan Conformal Treatment Planning Software, the MMLC enables static conformal treatments to be performed with finely shaped field patterns created by independently actuated leaves.
The subject of this submission, the software modifications for the MMLC VR1, is for use in an installation of a Siemens LINAC with the Lantis Verify and Record system and the PrimeView front end. This program coordinates MMLC settings with the Siemens software and hardware and assures that the MMLC is set correctly to the same field as the LINAC setting, and can abort treatment if the MMLC cannot be set correctly.
Here's an analysis of the provided text regarding acceptance criteria and the study performed, structured as requested. It's important to note that the provided text is a 510(k) summary and approval letter, which typically focuses on substantial equivalence rather than detailed performance studies with quantified acceptance criteria in the manner often sought for AI/ML device evaluations. As such, some of the requested information may not be explicitly present.
Acceptance Criteria and Study for MMLC VR1
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain a formalized table of acceptance criteria with corresponding performance metrics in the way one might find for an AI/ML diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the "performance" described relates to the system's functionality and its ability to correctly interface and coordinate with the Siemens LINAC.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software readiness for clinical use (general safety & effectiveness) | "Radionics Software Applications' MMLC VR1 system testing verifies that the software is ready for clinical use." |
| Correct functionality of the MMLC-Siemens interface | "A rigorous test of the functionality of the MMLC-Siemens interface was conducted using a Siemens LINAC, equipped with PrimeView and Lantis. The LINAC was equipped with the Radionics MMLC interface hardware (BCI box)." |
| Coordination of MMLC settings with LINAC settings | The software "coordinates MMLC settings with the Siemens software and hardware and assures that the MMLC is set correctly to the same field as the LINAC setting, and can abort treatment if the MMLC cannot be set correctly." (This implies successful coordination and safety abort functionality as criteria). |
| Equivalence to predicate device function for beam shaping | "In this application, the MMLC performs the same function as customized beam shaping blocks, and circular or cut block collimators, which have been used for many years." (This is a statement of functional equivalence to established methods, which is a core concept in 510(k)). |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the test set. It mentions "a rigorous test of the functionality of the MMLC-Siemens interface was conducted using a Siemens LINAC." This implies physical testing with at least one LINAC setup.
- Data Provenance: The testing was conducted using a "Siemens LINAC, equipped with PrimeView and Lantis" and "Radionics MMLC interface hardware (BCI box)." This suggests a controlled, prospective testing environment rather than retrospective data analysis from patient studies. There is no information about the country of origin of the data beyond the company's location (Burlington, MA, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not provided in a 510(k) summary for a device like the MMLC. The "ground truth" for this device is not based on expert interpretation of medical images or patient outcomes, but rather on the correct mechanical and software functioning of the radiotherapy equipment. The "experts" involved would likely be engineers, physicists, and radiotherapy professionals conducting the functional tests, but their specific number or qualifications are not detailed.
4. Adjudication Method for the Test Set
Not applicable. The testing described is functional verification of mechanical and software interfaces, not expert adjudication of clinical findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The MMLC is for beam shaping in radiotherapy, not for diagnostic interpretation by human readers. Its "effectiveness" is in its ability to accurately and safely shape radiation beams, not in improving human diagnostic performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The MMLC VR1's performance is inherently tied to its interaction with the LINAC and the treatment planning software, and ultimately, human operators oversee its use. The testing described is a standalone functional verification of the software and hardware integration, ensuring the algorithm (software modifications) correctly coordinates MMLC settings and safety functions. It's not a standalone diagnostic algorithm in the typical sense of AI/ML.
7. The Type of Ground Truth Used
The ground truth used for this device's validation is based on the correct and safe operational functionality and physical accuracy of the MMLC in shaping the X-ray beam as intended by the treatment plan and in coordination with the LINAC. This includes:
- Accurate setting of the MMLC leaves.
- Correct coordination between MMLC settings and LINAC settings.
- Effective abortion of treatment if MMLC settings are incorrect.
This is a technical ground truth rather than a medical/clinical ground truth (like pathology, expert consensus, or outcomes data).
8. The Sample Size for the Training Set
The document is a 510(k) summary for a hardware/software device primarily focused on mechanical functionality and software integration, not an AI/ML algorithm that learns from a "training set" of medical data. Therefore, the concept of a training set sample size, as typically understood for machine learning, does not apply here. The software modifications likely underwent traditional software development and testing cycles rather than machine learning training.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" and its associated ground truth is not applicable to this type of device and its submission. The software was likely developed against functional specifications and tested against expected operational behaviors, not 'trained' on patient data.
§ 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.