(22 days)
The AFP Imaging Sens-A-Ray Digital Dental X-Ray System with ProImage Software is intended for use with standard digital dental X-ray systems and computer stations for system operation, archive data storage, image capture and enhancement, and patient data and support. It is intended for use with standard digital dental X-ray systems and computer stations for system operation, archive data storage, image capture and enhancement, and patient data and support.
The ProImage Software is essentially identical to the Sens-A-Ray software described in K923067. The AFP Imaging ProImage Software and Sens-A-Ray System are intended to be used in conjunction with standard X-Ray systems. X-Ray images are sent by a digitized processor to a computer screen for image presentation. As with the Sens-A-Ray Software, the ProImage Software provides and controls the following functions: A patient/image database, which logs a patient's statistical and image data, Image exposure, Image storage, Image processing, Image retrieval and post-processing, Image hardcopy. The modifications to the Sens-A-Ray software involve enabling video images and intraoral images to be manipulated within the same software package. The minor modifications involve better database search and structure to allow the user to catalog patient images in an easier and more intuitive format. The other improvements are feature improvements resulting from user input. The feature improvements include: Colorizing image, auto-contrast, re-expose, and "view histogram" functions, Importing multiple images and adjusting the size and resolution of images, Adding an endodontic mode which allows full-screen X-rays. The modifications above were made to accommodate more advanced digital X-ray systems and to provide the user with better imaging capabilities within a single software package. These modifications remain within the scope of the intended use and fundamental technology of the original Sens-A-Ray system. The ProImage Software is intended for use with a sensor unit, image unit, and image grabber that were previously cleared under K923067. The ProImage Software is also compatible with the AFP IntraOral camera, subject of K922942 and other legally marketed intraoral cameras.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Sens-A-Ray System with ProImage Software:
The provided 510(k) summary is for a special 510(k), which typically means the modifications being made are minor and do not significantly alter the fundamental technology or intended use of a previously cleared device. Therefore, the level of detailed performance testing and clinical study data often found in a traditional 510(k) or PMA submission is not present.
Based on the provided document, here's what can be extracted:
Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it focuses on demonstrating substantial equivalence and confirming that the modified software functions as intended without adverse effects.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance (Implicit from 'Testing' section) |
|---|---|---|
| Functional Equivalence | Capture, enhance, and deliver dental images for viewing and storage (similar to predicate). | "Verification and validation testing was successfully performed to confirm that the modified software functions as intended." |
| Intended Use | To be used with digital dental imaging systems for capture, evaluation, and storage of high quality digital dental X-rays using existing X-ray equipment. | "Verification and validation testing was successfully performed to confirm that the modified software functions as intended." (Implicitly, this includes maintaining the intended use). |
| Safety | No new safety concerns introduced by modifications. | Not explicitly stated as a separate criterion, but implied by demonstrating functional equivalence and 'as intended' performance. |
| Performance Characteristics | Essentially identical performance characteristics to the predicate device in terms of image capture, enhancement, and delivery. | "The AFP Imaging ProImage Software and the predicate devices have essentially identical performance characteristics." |
| Software Functionality | All advertised/implemented new features (colorizing, auto-contrast, import multiple images, endodontic mode, database improvements) function correctly. | "Verification and validation testing was successfully performed to confirm that the modified software functions as intended." |
Study Details
-
Sample Size(s) Used for the Test Set and Data Provenance:
- Sample Size(s): The document does not specify any sample sizes for testing.
- Data Provenance: Not mentioned. Given the nature of a Special 510(k) for software modifications, it's highly likely that testing was done internally by the manufacturer using internal data or simulated data, rather than a large clinical test set. It's not specified if it was retrospective or prospective.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- The document does not mention the use of experts to establish ground truth for a test set. This type of extensive ground truth establishment is typically reserved for devices making diagnostic claims where accuracy against a gold standard needs to be proven. This device is an accessory for image capture and enhancement, not making a new diagnostic claim.
-
Adjudication Method for the Test Set:
- Not applicable/Not mentioned, as there's no indication of a test set requiring adjudication in the context of comparative performance or diagnostic accuracy.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The document is for software modifications to an existing device, focusing on functional equivalence and "as intended" performance, not an assessment of human reader improvement with or without AI assistance.
-
Standalone (Algorithm Only) Performance Study:
- Yes, in spirit, a standalone performance assessment was conducted. The "Verification and validation testing" mentioned would assess the software's functional performance on its own, ensuring that the image processing, database management, and other features work as programmed. However, this is not a clinical standalone performance study in the sense of demonstrating diagnostic accuracy or sensitivity/specificity for a specific clinical task. It's more of a software quality assurance and functional verification.
-
Type of Ground Truth Used:
- The document does not explicitly mention "ground truth" in the context of a clinical or diagnostic study. For software modifications like these, the "ground truth" for "verification and validation testing" would typically be derived from:
- Functional Specifications: Ensuring the software's output matches its design requirements (e.g., if a filter is applied, the image should visibly change as expected).
- Predicate Device Behavior: Ensuring the modified software functions similarly to the original cleared device.
- User Expectations: Addressing improvements requested by users.
- The document does not explicitly mention "ground truth" in the context of a clinical or diagnostic study. For software modifications like these, the "ground truth" for "verification and validation testing" would typically be derived from:
-
Sample Size for the Training Set:
- The document does not mention a training set. This is not an AI/machine learning device in the modern sense (it's from 2000 and primarily descriptive in its function). The software is rule-based and functional, not "trained" on data to learn patterns.
-
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no mention of a training set or AI/machine learning component.
Summary of Device and Study Context:
This Special 510(k) is for minor software modifications to an already cleared digital dental X-ray system. The focus is on demonstrating that these modifications do not change the fundamental technology or intended use, and that the modified software continues to function as intended. Therefore, the "study" described is primarily software verification and validation testing rather than a clinical trial or a performance study to establish diagnostic accuracy metrics. The criteria are largely implicit in demonstrating functional equivalence to the predicate device and proper operation of the new/improved features.
§ 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.