(94 days)
Carestream's Dental Imaging Software is intended to be used with Carestream's dental digital imaging devices by healthcare professionals to display, adjust, measure, print and store 2D digital images of the dento-maxillofacial region of the human anatomy to support image diagnosis.
Dental Imaging Software
The provided documents (K141607) contain an FDA 510(k) clearance letter for "Dental Imaging Software" and its "Indications for Use." However, these documents do not describe acceptance criteria, a study that proves the device meets acceptance criteria, or any of the detailed information requested regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.
The 510(k) clearance process primarily demonstrates substantial equivalence to a legally marketed predicate device, not necessarily detailed performance metrics against specific acceptance criteria.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be said based on the provided text, and what cannot:
Information that CANNOT be found in the provided document:
- A table of acceptance criteria and the reported device performance: This document does not detail specific performance metrics, such as sensitivity, specificity, accuracy, or any quantitative acceptance criteria.
- Sample sized used for the test set and the data provenance: No test set information is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment details are provided.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: No adjudication method is described.
- 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 MRMC study or AI assistance is mentioned. The device is described as "Dental Imaging Software" for display, adjustment, measurement, print, and storage of images, implying a viewing and processing tool rather than an AI diagnostic aid.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone performance is discussed, as the device is for use "by healthcare professionals to display, adjust, measure, print and store."
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): No ground truth type is specified.
- The sample size for the training set: No training set information is provided.
- How the ground truth for the training set was established: No training set ground truth establishment details are provided.
Information that CAN be inferred or directly stated from the provided document:
The primary "acceptance criterion" for this 510(k) clearance, as stated in the letter, is substantial equivalence to a legally marketed predicate device. The letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."
The study that "proves" this equivalence is the 510(k) submission itself, which typically includes comparisons to predicate devices regarding technological characteristics, safety, and effectiveness. However, no details of this submission are present in the provided text.
Summary based on available information:
| Criterion | Details from Document (K141607) |
|---|---|
| 1. Acceptance Criteria & Reported Device Performance | Acceptance Criteria: Substantial equivalence to a legally marketed predicate device. This is the explicit basis for 510(k) clearance. |
| Reported Device Performance: Not detailed in these documents. The focus is on the device's intended use to "display, adjust, measure, print and store 2D digital images of the dento-maxillofacial region of the human anatomy to support image diagnosis." No quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are provided or referenced as acceptance criteria for this specific clearance. | |
| 2. Sample size and Data Provenance (Test Set) | Not specified in the provided documents. |
| 3. Number of Experts and Qualifications (Test Set Ground Truth) | Not specified in the provided documents. |
| 4. Adjudication Method (Test Set) | Not specified in the provided documents. |
| 5. MRMC Comparative Effectiveness Study & Effect Size (AI vs. No AI) | No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned. The device is described as "Dental Imaging Software" for image handling by healthcare professionals, not explicitly as an AI-powered diagnostic aid that would typically be evaluated for improved human reader performance. |
| 6. Standalone (Algorithm Only) Performance Study | Not specified. The device is intended for use "by healthcare professionals," implying human-in-the-loop operation. |
| 7. Type of Ground Truth Used | Not specified in the provided documents. |
| 8. Sample Size for Training Set | Not specified in the provided documents. |
| 9. How Ground Truth for Training Set was Established | Not specified in the provided documents. |
§ 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).