(211 days)
exoplan is a medical software, intended to support the planing of dental implants using the visualization of the implant placement within images of the patient's anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient's anatomy as well as a virtual prosthetic proposal. exoplan allows the design of surgical guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representing the preoperative situation and approved implant positions. Alternatively, instead of optical surface data a second CBCT/CT dataset can be used. The software exports the planning and design results as geometrical data and a digital 3D model of the surgical guide to support the manufacture of a separate physical product.
exoplan does not extend or change indications of dental implants. Usage of a surgical guide designed with the software does not change the necessary due diligence required compared to conventional (non-guided) surgery.
The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets. exoplan shall not be used for any purpose other than planning dental implant placement or design of surgical guides.
exoplan is a standalone software application for the purpose of pre-operative implant planning and design of surgical guides to support the surgical intervention.
The software application runs on "off-the-shelf" PC hardware with Microsoft Windows 10 operating system (64 Bit), off-the shell GPU card and otherwise standard peripheral components.
The device allows importing 3D CT and optical scans from teeth, dental impression, or stone models) from compatible intraoral or desktop scanners. While the planning of implant position is mainly based on the information of the CT data, the design of a surgical quide is based on the STL data of the optical scan. Both modalities are registered to a common coordinate system to ensure that the implant positions defined by a user can be used for design of a surgical guide.
exoplan uses so called component libraries, which contain (e.g., physical dimensions, compatibility, etc.) provided by the original manufacturer of a component, and cover all components that can be used during treatment and necessary to consider during planning, e.g. implants, drills and drill sleeves. The libraries are digitally signed. This ensures that any modification of the content of a library will be detected by exoplan. The issue is then reported to the user and documented in the Implant Planning Report or the Surgical Protocol.
exoplan has no contact with the patient.
The provided text primarily focuses on the FDA 510(k) Summary for the "exoplan" device, describing its indications for use, device description, and a comparison to predicate and reference devices. It does mention "Non-Clinical Performance Testing" and that "Furthermore, accuracy tests were performed to verify that the planning results are as accurate as defined." However, it does NOT provide specific details about the acceptance criteria or the study that definitively proves the device meets those criteria, outside of a general statement about software verification, validation, and accuracy tests. It explicitly states, "Clinical testing is not a requirement and has not been performed."
Therefore, based on the provided text, I cannot fully answer all aspects of your request. I can only provide the information that is explicitly stated or strongly implied.
Here's an attempt to answer your questions based on the limited information available:
Acceptance Criteria and Device Performance Study for exoplan (K213302)
Based on the provided 510(k) Summary, specific quantitative acceptance criteria and detailed performance study results are not explicitly disclosed. The document generally refers to "Software verification and validation" and "accuracy tests."
1. A table of acceptance criteria and the reported device performance
The document states:
- "Each user requirement and each derived product requirement has an own acceptance criteria."
- "Furthermore, accuracy tests were performed to verify that the planning results are as accurate as defined."
However, no specific quantitative acceptance criteria or corresponding reported device performance values are provided in this document. The document only generally states that "the verification of the device has been completed" and that "the results of verification and validation ensure that the new device is as safe and as effective."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for any "test set" or "accuracy tests." It also does not provide any information regarding data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts or their qualifications used to establish ground truth for any test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention any adjudication method 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 explicitly states: "Clinical testing is not a requirement and has not been performed." Therefore, no MRMC comparative effectiveness study was conducted, and no effect size regarding human reader improvement with AI assistance is available.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes "accuracy tests" and "software verification and validation," implying a standalone evaluation of the algorithm's performance against predefined criteria. However, no specific data or metrics from such standalone performance are provided. The device (exoplan) is described as a "medical software, intended to support the planing of dental implants," indicating a human-in-the-loop use case.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document refers to "accuracy tests... to verify that the planning results are as accurate as defined." Given the nature of the device (dental implant planning software), the ground truth for these "accuracy tests" would most likely involve measurements against known physical or digital standards, or potentially comparisons to expert-derived ideal plans. However, the exact type of ground truth (e.g., physical phantoms, simulated anatomical models, or expert consensus on ideal implant placement) is not explicitly stated. Pathology or outcomes data would not typically be applicable to pre-operative planning software validation as it's not a diagnostic or outcome-predicting tool.
8. The sample size for the training set
The document does not mention a training set size. This is likely because the device, as described, is a software tool for planning and design, rather than an AI/ML model that would typically require a distinct training set (though verification and validation apply to all software).
9. How the ground truth for the training set was established
Since no training set is mentioned as applicable to this type of software according to the document, the establishment of its ground truth is not applicable/not described.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).