(104 days)
The Digora for Windows 2.0 is a software device intended to using and managing dental x-ray images sent by Digora imaging plate scanner, storing the images and allowing the user to process and examine the images in order to achieve improved diagnoses. The software can also innager other imaging devices such as larger size imaging plate scanners and intraoral video cameras.
Digora for Windows 2.0 is a dental imaging, image processing and archiving software, mainly to be used with Soredex Digora scanner (K934949). With this software is is possible to scan intra oral images using the Digora scanner, perform functions like edge enhancement, 3D emboss, density and contrast manipulation, length and angulation measurement with the image. The software also archives the images in the database, from where images can be stored in image media like CD-rom's.
The provided text describes a 510(k) submission for "Digora for Windows 2.0" dental imaging software. However, it does not contain detailed information regarding specific acceptance criteria, a comprehensive study design with sample sizes, expert qualifications, or ground truth establishment for performance evaluation.
The document focuses on establishing substantial equivalence to a predicate device ("RadWorks Medical Imaging Software") rather than presenting a detailed de novo performance study.
Based on the information provided, here's what can be extracted and what is missing:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance metrics (e.g., accuracy, sensitivity, specificity, F1-score) in a tabular format related to diagnostic image quality or clinical outcomes.
Instead, the acceptance criteria are implicitly tied to demonstrating safety and effectiveness and substantial equivalence to the predicate device. The performance is described in terms of its features and capabilities being "substantially equivalent" to the predicate, with the implication that these features contribute to improved diagnoses.
| Acceptance Criteria (Implicit from Submission) | Reported Device Performance (Summary) |
|---|---|
| I. Safety and Effectiveness | Demonstrated through: |
| 1. Software Verification & Validation | Procedures completed. |
| 2. Clinical Tests | Conducted. |
| 3. Laboratory Tests | Conducted. |
| 4. Risk Management (IEC 601-1-4) | File and summary established. |
| Conclusion: Device is safe and effective when used as labeled. | |
| II. Substantial Equivalence | |
| 1. Similar Design, Operational, and Functional Features to Predicate (RadWorks Medical Imaging Software) | "Digora for Windows 2.0" offers similar imaging procedures, but "much less and their complexity is much limited" compared to the general medical "RadWorks." Specifically, it handles scanning, manipulation (3D emboss, edge enhancement, density/contrast, length/angle measurement, zoom, color, rotate, positive/negative), image storage, video capture, external media support, and printing for dental images. |
Detailed Study Information (Missing or Not Applicable)
The document alludes to "laboratory and clinical tests" but provides no details on the methodology, sample sizes, or specific results of these tests. This 510(k) summary is primarily focused on demonstrating substantial equivalence, which often relies on a comparison of features and intended use rather than a full-scale, de novo clinical performance study with detailed metrics.
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Sample size used for the test set and the data provenance:
- N/A (Not provided). The document mentions "clinical tests" and "laboratory tests" but does not specify the sample size of images or patients used for performance evaluation, nor does it state the country of origin or whether the data was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A (Not provided). Ground truth establishment details are absent.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A (Not provided). Adjudication methods are not mentioned.
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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:
- N/A (Not provided). There is no mention of an MRMC study or any assessment of human reader improvement with or without AI assistance. This device is described as imaging software with processing capabilities, not explicitly as an AI diagnostic aid in the modern sense.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A (Not provided). No standalone performance metrics are discussed. The software is intended to allow a user to "process and examine the images in order to achieve improved diagnoses," implying human interpretation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A (Not provided). The method for establishing ground truth is not specified.
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The sample size for the training set:
- N/A (Not provided). Training set information is not included, as the document doesn't detail the development or validation of machine learning algorithms requiring a distinct training phase.
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How the ground truth for the training set was established:
- N/A (Not provided). As no training set is discussed, its ground truth establishment is also not detailed.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.