(114 days)
Smart Segmentation Knowledge Based Contouring provides a combined atlas and model based approach for automated and manual segmentation of structures including target volumes and organs at risk to support the radiation therapy treatment planning process.
The Smart Segmentation Knowledge Based Contouring was most recently cleared as the Varian Smart Segmentation Knowledge Based Contouring, K133227.
Smart Segmentation - Knowledge Based Contouring is a software only product that provides a combined atlas and model based approach to automated segmentation of structures together with tools for manual contouring or editing of structures. A library of already contoured expert cases is provided which is searchable by anatomy, staging, or free text. Users also have the ability to add or modify expert cases to suit their clinical needs. Expert cases are registered to the target image and selected structures propagated. SmartSegmentation Knowledge Based Contouring supports inter and intra user consistency in contouring. This product also provides an anatomy atlas which gives examples of delineated organs for the whole upper body, as well as anatomy images and functional description for selectable structures.
The provided text does not include a detailed study that proves the device meets specific acceptance criteria with quantifiable metrics. It primarily states that "Verification and Validation testing demonstrate that the product met defined user needs and defined design input requirements."
However, based on the information provided, we can infer some aspects and construct a response that highlights what is present and points out what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. It generally states that the device "met defined user needs and defined design input requirements" and "perform at least as well as the predicate device."
Without a detailed performance study, specific numerical acceptance criteria and reported device performance cannot be extracted.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Validation testing was performed on a production equivalent device, under clinically representative conditions by qualified personnel." However, it does not specify:
- The sample size used for the test set.
- The data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide this information. It states that "a library of already contoured expert cases is provided" and that users can "add or modify expert cases to suit their clinical needs." However, this refers to the creation and customization of the atlas, not the establishment of ground truth for a structured validation test set.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for establishing ground truth for a test set.
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
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human reader improvement with AI assistance. The device is described as "a combined atlas and model based approach for automated and manual segmentation... to support the radiation therapy treatment planning process," implying it assists, but no study on the impact of this assistance on human readers is provided.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document states that "Smart Segmentation - Knowledge Based Contouring is a software only product that provides a combined atlas and model based approach to automated and manual segmentation of structures." It implies the device can perform automated segmentation. However, it does not present a standalone performance study with specific metrics that would quantify its performance without human intervention or interaction. It focuses on the combined approach and support for the planning process.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document refers to an "expert case library" which contains "already contoured expert cases." This implies the ground truth for an internal atlas/model is likely based on expert contours. However, for any formal validation or test set, the specific method for establishing ground truth is not detailed.
8. The Sample Size for the Training Set
The document refers to an "expert case library" that serves as the basis for the atlas and model. It allows users to "add or modify expert cases." However, it does not specify the sample size used for the original training/creation of the underlying atlas and model. It only mentions: "New expert cases for Nasopharynx, Tonsil, Base of Tongue, Hypopharynx, Larynx" for the updated version.
9. How the Ground Truth for the Training Set Was Established
The ground truth for the "expert case library" is established by "already contoured expert cases." This suggests that expert delineation/contouring was the method. The document states that users can also "add or modify expert cases," allowing for clinical customization of this "ground truth." However, the specific process, number of experts, or adjudication for the original expert cases used for model training is not detailed.
§ 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.