(310 days)
SagiPlan is a Brachytherapy Treatment Planning System used by medical professionals.
SagiPlan is used for the creation of treatment plans for remote afterloader based HDR brachytherapy.
SagiPlan will calculate a proposed treatment course based on imported clinical images and other user entered data. SagiPlan also supports the evaluation of clinical images in calculating the local and global doses to organs at risk and target volumes. SagiPlan especially supports the SagiNova Brachytherapy Remote Controlled Afterloading Device from Eckert & Ziegler BEBIG GmbH.
SagiPlan is a software package which runs on a Windows - based PC and is used by medical professionals to create a radiation therapy plan based on imported medical images and the input manually entered by the operator.
The software offers tools to enhance imported images and offers contouring of the planned target volume and organs at risk. The isotopes used in the calculations match those which are normally used in High Dose Rate (HDR) remote afterloaders.
The main use of SagiPlan is to calculate the required dwell times at the predetermined dwell positions in a uniform way so that the Planning Target Volume (PTV) is treated with the prescribed dose while sparing the Organs At Risk (OAR).
SaqiPlan can reconstruct one or more applicators.
Based on the contoured target volume and the prescription dose. SagiPlan will calculate the optimal dose distribution for the tumor volume. Evaluation tools are available to qualify the proposed treatment. The therapy planning is then transferred from the SagiPlan software to the brachytherapy afterloader radiation device.
The SagiPlan software is intended to be used with the SagiNova and the MultiSource Brachytherapy Remote Controlled Afterloading Devices from Eckert & Ziegler BEBIG GmbH.
The SagiPlan System comprises subjoined listed subsystems:
- . Personal Computer to execute the SagiPlan software.
- . Monitor to visualise the treatment planning process.
- . Keyboard to enter treatment data.
- . Mouse to select objects on the screen
The PC is used to execute the SagiPlan software and runs under Windows 7. The hard disk stores patient data and the built in DVD-RW is used for making backup of the Patient Data. The PC can be connected to the hospital network to import Patient Image Data.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the SagiPlan device.
It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with specific acceptance criteria and performance metrics for a novel technology. Therefore, many of the requested details about specific performance outcomes and detailed study methodologies are not present in this document.
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative acceptance criteria or a detailed "reported device performance" table in the way one might expect for a new algorithmic device with specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the substantial equivalence argument relies on the device having the same technological characteristics and same intended use as a legally marketed predicate device.
Table 1: Absence of Explicit Quantitative Acceptance Criteria and Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative metrics (e.g., sensitivity, accuracy thresholds). The document focuses on demonstrating substantial equivalence to a predicate device with established performance. | Not explicitly stated as quantitative outcomes (e.g., "achieved X% accuracy"). The document asserts that the device has the same technological characteristics and intended use as the predicate, implying similar performance. |
Study Information (Based on Available Text)
Given the nature of a 510(k) summary for a brachytherapy treatment planning system, the "study" described is primarily a comparison of technological characteristics and intended use against a predicate device, rather than a clinical trial or performance study against a ground truth.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: The document does not describe a "test set" in the context of evaluating an AI or algorithmic performance against real-world data. The evaluation is a comparison of design and intended function.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable / Not Provided: There is no mention of experts establishing a ground truth for an evaluation dataset.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No adjudication method is mentioned as there's no described test set or expert evaluation.
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 document does not describe an MRMC study. The SagiPlan is a treatment planning system, not an AI-assisted diagnostic tool for human readers in the traditional sense of an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Kind of, but not a "performance study" in the modern sense: The "study" here is a technical comparison by the manufacturer to demonstrate that the SagiPlan software (algorithm) functions in a manner substantially equivalent to the predicate device. This isn't a direct standalone performance validation against a ground truth dataset, but rather an assertion of functional equivalence. The software itself, without human input, calculates treatment plans based on user-entered data and images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Provided: No explicit "ground truth" for a performance evaluation is mentioned. The "truth" in this context is implicitly the established and accepted functionality and outputs of the legally marketed predicate device, HDRplus. The SagiPlan is deemed "substantially equivalent" if its characteristics align with this predicate.
8. The sample size for the training set
- Not Applicable / Not Provided: The document does not describe an AI/ML model that undergoes a "training" phase with a dataset. It describes a software package that performs calculations.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: As there's no described training set, there's no ground truth establishment for it.
Summary of the "Study" from the Document:
The "study" described is entirely focused on a Substantial Equivalence (SE) determination under Section 510(k) of the Federal Food, Drug, and Cosmetic Act. For the SagiPlan device, this involves:
- Identification of a Predicate Device: HDRplus (K123263) from the same manufacturer.
- Comparison of Intended Use: SagiPlan and HDRplus have the "same intended use" (creation of treatment plans for remote afterloader based HDR brachytherapy).
- Comparison of Technological Characteristics: The document states SagiPlan has the "same technological characteristics" as the predicate, relying on a computer system, monitor, keyboard, mouse, and optionally a film scanner or frame grabber, running on Windows. It also states the differences "do not concern the basic principle of operation nor does it adversely affect the safety or effectiveness of the device."
Essentially, the "study" is a regulatory comparison showing that the design and stated function of SagiPlan are sufficiently similar to an already cleared device, implying that its performance and safety are also similar, without requiring new clinical performance 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.