Search Results

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

• 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. |

Ask a specific question about this device