(444 days)
OrthoCAD iQ is a computer-guided system intended for use as an aid in orthodontic treatment planning for use by dental professionals trained in orthodontic treatment including radiographic analyses and treatment planning. OrthoCAD iQ is intended for use with commercially-available brackets and wires that apply continuous gentle force to reposition the teeth. It also uses indirect bonding trays to affix the brackets in position.
The device consists of the following components and accessories: proprietary software that calculates the position of dental brackets based on the dental impressions and treatment plan supplied by the patient's orthodontist, commercially-available metal, plastic, or ceramic brackets supplied by the orthodontist for that patient, a camera wand with a light curing feature, and customized indirect bonding trays containing the brackets, which are in a hard plastic case. The device does not include the adhesive that affixes the brackets to the teeth or the wires that are used with the brackets to form braces.
Here's an analysis of the provided text, focusing on the acceptance criteria and study data for Cadent's OrthoCAD iQ device:
Acceptance Criteria and Device Performance for Cadent's OrthoCAD iQ
Based on the provided 510(k) summary, the information regarding specific, quantifiable acceptance criteria and detailed study results is very limited. This document is a summary for regulatory approval, which often focuses on establishing substantial equivalence rather than presenting extensive clinical trial data with specific metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Electrical Safety | "Testing has demonstrated the electrical safety of the OrthoCAD iQ." |
| Software Functionality/Performance | "Software verification and validation confirmed the performance of the device." |
| Intended Use Performance (Aid in orthodontic treatment planning, proper bracket placement, repositioning teeth) | "Clinical cases demonstrate that it functions as intended." |
| Substantial Equivalence to Predicate Devices | "OrthoCAD iQ has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. ... The minor technological differences between this device and its predicate devices raise no new issues of safety or effectiveness. Thus, the OrthoCAD iQ is substantially equivalent." |
Critique: The acceptance criteria are broadly stated and the reported performance is qualitative rather than quantitative. There are no specific thresholds (e.g., "accuracy of bracket placement must be within X mm," or "software reliability must be Y%"). This is typical for a 510(k) summary that relies heavily on substantial equivalence to predicate devices, where the predicates' established safety and effectiveness implicitly serve as benchmarks.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified.
- Data Provenance: The document states "Clinical cases demonstrate that it functions as intended." This implies the use of real patient data, but the country of origin, whether it was retrospective or prospective, or the number of cases are not detailed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: The intended users are "dental professionals trained in orthodontic treatment." It can be inferred that these professionals, likely orthodontists, would have been involved in the "clinical cases." Specific qualifications (e.g., years of experience, board certification) are not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. With no specified number of experts or details on how ground truth was established, an adjudication method cannot be inferred.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No, an MRMC comparative effectiveness study is not mentioned or described in the provided text. The document focuses on the device's functionality and substantial equivalence, not on comparing human reader performance with and without AI assistance.
- Effect Size of Human Readers with/without AI: Not applicable, as no MRMC study was performed.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- Standalone Performance Study Done: Yes, implicitly. The "Software verification and validation confirmed the performance of the device" and "Clinical cases demonstrate that it functions as intended" suggest the software's performance was evaluated independently in its role of calculating bracket positions and aiding treatment planning. However, specific metrics for this standalone performance (e.g., accuracy of bracket placement prediction) are not provided. The device itself is described as a "computer-guided system" where the software calculates bracket positions.
7. Type of Ground Truth Used
- Type of Ground Truth: Inferred to be expert consensus/clinical outcomes. The statement "Clinical cases demonstrate that it functions as intended" suggests that the success of the treatment planned and executed with the device (i.e., whether the teeth were repositioned as intended and the brackets were placed correctly to achieve this) served as the ground truth. This would typically be assessed by the treating orthodontist or a panel of experts.
8. Sample Size for the Training Set
- Training Set Sample Size: Not specified. The document describes the system's function but does not detail its development or any machine learning aspects that would explicitly involve a training set. If there's an underlying AI/machine learning component, the size of a training set would be relevant, but this information is absent. If the software is purely deterministic based on predefined rules, a "training set" in the machine learning sense might not apply.
9. How Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not specified. Given the lack of information on a training set or explicit machine learning components, how its ground truth would be established is not addressed.
§ 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.