(201 days)
The Align Studio is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options based on 3Dmodels of the patient's dentition before the start of an orthodontic treatment.
The use of the Align Studio requres the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
Align Studio is a PC-based software that sets up virtual orthodontics via digital impressions. It automatically segments the crown and the gum in a simple manner and provides basic model analysis to assist digital orthodontic procedures.
The provided document, an FDA 510(k) summary for "Align Studio," does not contain detailed information about specific acceptance criteria, a comprehensive study proving the device meets those criteria, or the methodology (e.g., sample size, expert qualifications, ground truth establishment) typically associated with such studies for AI/ML-based medical devices.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices (Ortho System and CEREC Ortho Software) rather than presenting a detailed performance study against predefined acceptance criteria for an AI-powered system. The Non-Clinical Test Summary section briefly mentions "software validation" and "performance testing" but without quantifiable metrics or specific methodologies. It states that "Align Studio meets all performance test criteria and that all functions work without errors" and "test results support the conclusion that actual device performance satisfies the design intent and is equivalent to its predicate device."
Therefore, I cannot populate the table or answer most of the questions as the required information is not present in the provided text.
Here's what can be extracted based on the limited information provided:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with quantifiable performance metrics specific to an AI/ML system's output. It broadly states the device "meets all performance test criteria" and "functions work without errors." The focus is on functional equivalence to predicate devices rather than specific quantitative performance targets for an AI component.
2. Sample size used for the test set and the data provenance
Not specified. The document does not detail the test set used for performance evaluation, nor its size or origin (country, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified. The document doesn't describe the establishment of a ground truth for a test set, which would typically involve expert review for AI/ML performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not specified, as a detailed ground truth establishment process is not described.
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
No MRMC comparative effectiveness study is mentioned. The submission focuses on substantial equivalence based on device features and intended use, not on human reader performance with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "Non-Clinical Test Summary" section mentions "Performance Testing" which could imply standalone testing, but no specific metrics for an algorithm-only performance (e.g., segmentation accuracy, measurement precision without human interaction) are provided. The device is described as "PC-based software" for "virtual orthodontics" that "automatically segments the crown and the gum," implying an algorithm performing actions. However, the document does not detail the standalone performance metrics for this automated segmentation or other AI features.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not specified. Given the lack of detailed performance study information, the type of ground truth used is not described.
8. The sample size for the training set
Not specified. The document does not provide details on the training set used for any AI/ML components within the "Align Studio" software.
9. How the ground truth for the training set was established
Not specified. Without information on a training set, the method of establishing its ground truth is also not provided.
Summary of available information regarding software validation and performance:
- Software Validation: "Align Studio contains Basic Documentation Level software was designed and developed according to a software development process and was verified and validated."
- Performance Testing: "Through the performance test, it was confirmed that Align Studio meets all performance test criteria and that all functions work without errors. Test results support the conclusion that actual device performance satisfies the design intent and is equivalent to its predicate device."
- Clinical Studies: "No clinical studies were considered necessary and performed."
This filing relies on demonstrating substantial equivalence to already cleared predicate devices based on shared technological characteristics and intended use, rather than presenting a novel performance study for an AI/ML component with specific acceptance criteria and detailed clinical validation results.
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.