(66 days)
The ImplantMaster system is indicated for use as a front-end software interface for the transfer of imaging information from a medical scanner such as a CT scanner. It is also indicated for use as a planning and simulation software for use by qualified dental professionals to aid them in the placement of dental implants and surgical treatment. ImplantMaster processes the dental professional's input information and the result is used as an input data for CAD or Rapid Prototyping System.
The ImplantMaster system is a software interface used for the transfer of imaging information from a medical scanner such as a CT scanner, processing it and planning dental implant placement and surgical treatment. The ImplantMaster processes output result is used as an input data for CAD or Rapid Prototyping System.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ImplantMaster device:
Based on the provided 510(k) summary, the information regarding specific acceptance criteria and detailed study results is very limited. This document is a summary and often refers to more detailed studies that would be available to the FDA during their review but are not publicly disclosed in this format.
Key takeaway: The provided document states that "Bench and clinical data demonstrate that the implant placement positively match the planning. No adverse affects have been detected." However, it does not provide the specific acceptance criteria or detailed results of these studies.
Therefore, many of the requested sections below cannot be fully answered definitively from the provided text alone.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria:
- Not explicitly stated in the provided 510(k) summary. The document mentions "The device has been designed verified and validated complying to 21CFR 820.30 regulations." and "Bench and clinical data demonstrate that the implant placement positively match the planning." However, specific numerical or qualitative targets for "positively match" are not provided.
Reported Device Performance:
- "Implant placement positively match the planning."
- "No adverse affects have been detected."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for the test set in the provided document. The term "Bench and clinical data" implies multiple tests, but no numbers are given.
- Data Provenance: Not specified. The submitter, I-Dent Ltd., is located in Hod Hasharon, Israel, so the data could originate from Israel or other regions where their studies were conducted.
- Retrospective/Prospective: Not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The intended use states the software is for "qualified dental professionals," implying that such professionals would be involved, but specific details about how ground truth was established are missing.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: Not mentioned or described in the provided document. The focus seems to be on the device's ability to match planning to actual placement, rather than comparing human reader performance with and without AI assistance.
- Effect Size: Not applicable, as an MRMC study is not mentioned.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: The statement "Bench and clinical data demonstrate that the implant placement positively match the planning" implies a standalone assessment of the software's output accuracy against physical results. The software functions as a planning and simulation tool for professionals, making its direct output accuracy important. However, the exact methodology to demonstrate this "match" and whether it was truly "standalone" from a performance perspective (i.e., not reliant on human interpretation to correct or adjust the output) is not detailed. The phrasing "processes the dental professional's input information and the result is used as an input data for CAD or Rapid Prototyping System" suggests the software's output itself is a key component, hinting at a standalone performance evaluation of that output's accuracy.
7. Type of Ground Truth Used
- Type of Ground Truth: The statement "implant placement positively match the planning" suggests that the ground truth for evaluating the planning accuracy would likely be actual post-operative implant placement (e.g., confirmed via post-operative imaging or physical measurements) compared against the pre-operative plan generated by the ImplantMaster system.
8. Sample Size for the Training Set
- Sample Size: Not specified. The document does not provide details on the development or training of any AI/ML components (if present), nor does it mention a "training set" in the context of device validation.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not specified. As no training set details are provided, how its ground truth might have been established is also not mentioned.
§ 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).