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510(k) Data Aggregation
(245 days)
Blue Sky Plan software module for Blue Sky Bio Aligner G is intended for use as a medical frontend device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays or retainers, based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.
Blue Sky Bio Aligner G is a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous gentle force.
The use of the Blue Sky Bio Plan software module for Blue Sky Bio Aligner G requires 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.
The Blue Sky Bio Aligner G consists of a series of clear plastic aligner trays that offer a solution for aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions.
Blue Sky Bio Aligner G starts with the dental clinician prescribing aligners to treat a patient's malocclusion, and the decision to use a methacrylate-based resin for sequential aligners.
A dental clinician (e.g. orthodontist or dentist), using a standard personal computer prescribes the Blue Sky Bio Aligner G based on an assessment of the patient's teeth and determines the course of treatment, using Blue Sky Bio's Blue Sky Plan software (K180107). The clinician takes molds of the patient's teeth and completes a prescription form and sends the molds to the dental lab, which in turn scans the molds and uploads the .STL files of the molds in Blue Sky Plan software. This digital file is a series of CAD files (.STL) for building models that can be used to fabricate aligners. Alternatively, the dental clinician may generate the digital files by scanning the patient's mouth directly, using an intraoral scanner, and then sends the files to the dental lab.
The dental lab or the clinician designs a series of digital models and plastic trays intended to gradually realign the patient's teeth, using Blue Sky Plan software. The prescribing physician reviews and approves the model scheme before the aligners are produced. Once approved by the clinician, the dental lab produces the Blue Sky Bio Aligner G sequential aligners, which are 3D printed with a clear biocompatible resin.
The Blue Sky Bio Aligner G are sent to the dental clinician who then provides them to the patient, confirming fit and design. Over a period of time, additional trays are provided sequentially to the patient by the clinician to gradually move the target teeth to the designed position. The dental health professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.
The provided document does not contain information regarding the acceptance criteria of a device based on a study, nor does it detail a study that proves the device meets specific acceptance criteria related to its performance in terms of diagnostic accuracy or similar metrics.
The document is a 510(k) Premarket Notification from the FDA, and it primarily focuses on establishing "substantial equivalence" of the Blue Sky Bio Aligner G & Blue Sky Plan Software for Blue Sky Bio Aligner G to legally marketed predicate devices. This process relies on demonstrating that the new device has the same intended use and similar technological characteristics to a predicate device, and that any differences do not raise new questions of safety or effectiveness.
Here's what can be extracted from the document concerning performance and testing, and why it doesn't fit the requested format for acceptance criteria and a study proving performance:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the document. The document discusses non-clinical performance testing for the physical aligner G product (Blue Sky Bio Aligner G) for material properties, but it does not specify performance acceptance criteria for the software component (Blue Sky Plan Software) or the combined system related to its orthodontic function (e.g., accuracy of tooth movement prediction, clinical outcome metrics).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No such test set data, sample size, or provenance is described for either the aligner or the software's clinical performance. The document explicitly states: "No human clinical testing was performed to support the substantial equivalence of Blue Sky Bio Aligner G."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable as no clinical performance study involving a test set with expert-established ground truth was conducted or described for regulatory submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as no clinical performance study involving a test set was conducted or 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:
This information is not applicable. The software, "Blue Sky Plan Software for Blue Sky Bio Aligner G," is described as a "medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design." It is a planning and design tool, not an AI assistance tool for human readers in a diagnostic capacity that would typically require MRMC studies. The document does not suggest AI assistance for "human readers," but rather a tool for clinicians to design treatments.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
While the software performs functions, the document does not describe a standalone performance study in a manner that would typically be associated with AI algorithms (e.g., a specific diagnostic accuracy metric without human intervention). Its use is explicitly described as requiring "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," indicating a human-in-the-loop workflow.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable as no clinical performance study requiring ground truth was described. The "ground truth" for the device's function is the clinical outcome achieved by the orthodontist using the tool and aligners, but this is not assessed in a study for this 510(k) submission.
8. The sample size for the training set:
This information is not present. The document does not describe the development or training of an AI algorithm that would typically involve a training set. The software is described as a "medical front-end device providing tools," implying a software tool for design and management rather than a machine learning model that requires training data in the context of typical AI device submissions.
9. How the ground truth for the training set was established:
This information is not present as no training set or AI algorithm training is described.
Summary of Device Performance and Acceptance Criteria from the Document:
The document focuses on substantiating equivalence primarily through:
- Material Composition: "Blue Sky Bio Aligner G is composed of a methacrylate-based resin." This is compared to predicate devices.
- Non-Clinical Performance Testing: "Blue Sky Bio Aligner G was tested and met the applicable requirements of ISO 20795-2:2013 – Dentistry – Base Polymers – Part 2: Orthodontic base polymers." And "Bench test results allowed us to conclude that Blue Sky Bio Aligner G meets its intended use."
- Biocompatibility: "Blue Sky Bio Aligner G meets the biocompatibility requirements of the following standards: ISO 10993-1:2018; ISO 7405:2018." "Biocompatibility testing has shown that Blue Sky Bio Aligner G is safe and biocompatible for the stated intended use."
- Technological Characteristics Comparison: A detailed table (pages 8-9) compares the new device's indications, FDA product code, physical/clinical properties, technical attributes, and software attributes to predicate and reference devices.
Conclusion based on the provided text:
The provided FDA 510(k) document does not contain the type of acceptance criteria and detailed study data (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies) typically associated with the performance evaluation of a device, especially an AI/ML diagnostic or prognostic tool, as requested in your prompt. This document is instead a demonstration of "substantial equivalence" based on similar intended use and technological characteristics, supported by bench testing of material properties and biocompatibility. The regulatory submission path for this device did not require human clinical trials to demonstrate specific performance metrics like those for diagnostic accuracy.
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(24 days)
Blue Sky Bio Aligners are a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous gentle force.
Blue Sky Bio Aligners are a series of clear plastic aligners that offer a solution for aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions.
A dental health professional (e.g. orthodontist or dentist), using a standard personal computer prescribes the Blue Sky Bio Aligners based on an assessment of the patient's teeth, determines the course of treatment with the system, takes molds of the patient's teeth and completes a prescription form using standard dental software used for tooth alignment, Blue Sky Bio then designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription using standard dental software used for tooth alignment. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Blue Sky Bio produces trays, which are formed of clear, then, thermoformed plastic. The trays are sent back to the dental health professional who then provides them to the patient, confirming fit and design. Over a period of time, additional trays are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the designed position. The dental health professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.
The provided text describes the 510(k) premarket notification for Blue Sky Bio Aligners, establishing its substantial equivalence to predicate devices. It focuses on the device's characteristics, indications for use, and comparison to existing aligner systems. However, it explicitly states that no performance testing was conducted for the device itself or its materials (Essix) because the material already has 510(k) clearance as an aligner material, and the aligner production technology is considered "essentially identical" to the predicate.
Therefore, the specific information requested about acceptance criteria, study data, sample sizes, expert involvement, and ground truth for performance evaluation is not available in the provided document. The submission relies on the established safety and effectiveness of the existing predicate devices and materials.
Below is a table summarizing the requested information that can be extracted or derived from the text, with an explicit mention where information is not provided:
Acceptance Criteria and Device Performance Study Information
| Information Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 1. Table of Acceptance Criteria and Reported Performance | No specific quantifiable acceptance criteria for device performance (e.g., accuracy of tooth movement, treatment success rate) are stated in this 510(k) submission. The submission's argument for substantial equivalence is based on: - Indications for Use equivalence: To be substantially equivalent to predicate devices. - Technological Characteristics equivalence: Design, technology, materials, and composition must be substantially equivalent to predicate devices. - Mechanism of Action equivalence: Similar to predicate devices. - Material properties: Essix material (the aligner material) must demonstrate "sufficient tensile strength, elasticity, ductility, chemical resistance, and clarity for use as a clear tray aligner," as per its existing 510(k) clearance (K062828). - Software functionality: Software must facilitate ordering and processing of aligners and maintain safety and effectiveness compared to predicates, without changing the functions of Blue Sky Bio Plan. | No specific quantifiable device performance metrics are reported. The submission asserts substantial equivalence based on the following: - Indications for Use: Blue Sky Bio Aligners have "substantially equivalent Indications for Use" to the 3M Clear Tray Aligner (predicate). - Technological Characteristics: "The results of this comparison demonstrate that the design, technology, materials, and composition of Blue Sky Bio Aligners are substantially equivalent to the predicate devices." The technology is described as "essentially identical to that used by a number of sequential aligner systems including the predicate device, 3M Clear Tray Aligners." - Mechanism of Action: "The mechanism of action is similar to the predicate devices and supports a determination of substantial equivalence." - Material: The aligners use Essix from Dentsply, which "has a 510k clearance as an aligner material (K062828, MQC unclassified)." Therefore, it is assumed to meet the necessary material properties. - Biocompatibility: No separate biocompatibility testing was performed as the material already has 510(k) clearance. - Software Verification and Validation: "Software verification and validation testing of the aligner showed that the addition of the aligner module did not change the functions of Blue Sky Bio Plan." The software was considered a "moderate" level of concern and documentation was provided as per FDA guidance. Crucially, the document states: "Bench testing was not performed due to the difficulty in evaluating this type of dental device in a laboratory setting." And "no performance tests were done on it [Essix material]." |
| 2. Sample size and data provenance for test set | Not applicable, as no performance testing was performed on the device or its materials. | Not applicable, as no performance testing was performed on the device or its materials. |
| 3. Number and qualifications of experts for ground truth | Not applicable, as no performance testing was performed on the device or its materials. | Not applicable, as no performance testing was performed on the device or its materials. ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 4. Adjudication method for test set | Not applicable, as no performance testing was performed on the device or its materials. | Not applicable, as no performance testing was performed on the device or its materials. ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 5. MRMC comparative effectiveness study? | No. The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify any improvement in human reader performance with AI assistance (as this is an aligner, not an AI diagnostic device). | Not applicable. ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 6. Standalone (algorithm only) performance study? | No. The document states that "Bench testing was not performed due to the difficulty in evaluating this type of dental device in a laboratory setting." Performance is assumed through substantial equivalence to existing devices and materials. | Not applicable. |
| 7. Type of ground truth used | Not applicable, as no performance testing was performed on the device or its materials. | Not applicable, as no performance testing was performed on the device or its materials. ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 8. Sample size for the training set | Not applicable, as this is a physical dental aligner product, not an AI algorithm that requires a training set. The software module mentioned facilitates ordering and processing, but its development does not involve a "training set" in the machine learning sense. | Not applicable. |
| 9. How ground truth for the training set was established | Not applicable. | Not applicable. |
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