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Blue Sky Plan Software orthodontic module 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 design of a series of dental casts which may be used for sequential aligners, based on 3D models of the patient's dentition before the start of an orthodonic treatment. It can also be applied during the treatment to inspect and analyze the progress of treatment, and at the end of treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.

Blue Sky Bio Aligner Z and Blue Sky Bio Aligner Z FLX are 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 force.

The use of the Blue Sky Plan Software module requires 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.

A dental clinician, using a standard personal computer prescribes the orthodontic appliance based on an assessment of the patient's teeth and determines the course of treatment using the Blue Sky Plan Software. 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 the aligners. Alternatively, the dental clinician may generate the digital files by scanning the patient's mouth directly, using an intraoral scanner, and then send the files to the dental lab.

The Blue Sky Bio Aligners (Z and Z FLX) consist of a series of clear plastic aligner trays which are fabricated with the selected thermoplastic material (either a thin polyurethane sheet or a composite of copolyester and polyurethane). Both materials are commercially used for thermoforming customized removable aligners for the intended use.

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 Z or Z FLX.

The finished aligners are sent to the dental clinician who then provides them to the patient, confirming fit and form. Over a period of time, additional aligner trays are provided sequentially to the patient by the clinician to gradually move the target teeth to the designed position. The dental clinician monitors treatment from delivery of the first aligner to the final aligner.

The trays are held in place by pressure and can be removed by the patient at any time.

The provided text is an FDA 510(k) clearance letter and a 510(k) Summary for the Blue Sky Plan Software and Blue Sky Bio Aligner Z/Z FLX. While it describes the device, its intended use, and its substantial equivalence to predicate devices, it does not contain the specific details about acceptance criteria, the full study design, or performance metrics that would typically be found in a clinical study report or a more detailed section of the 510(k) submission itself.

The document does mention:

• "Device Testing Laboratory Testing" which states: "Test data were submitted to validate the processes used for the design and manufacture of the clear customized aligners. Testing was conducted to characterize device performance characteristics according to ASTM D638. Testing to verify and validate the software has been included in this 510(k) documentation."
• "Biocompatibility" testing according to ISO 10993.
• "No animal or human testing are required for this product." This is a key statement, indicating that no human clinical study was performed or required for this 510(k) clearance. The clearance is based on substantial equivalence to existing devices, supported by bench testing and software verification/validation.

Therefore, I cannot extract the detailed information requested in your prompt (acceptance criteria with reported performance, sample sizes for test sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set details) because this information is not present in the provided FDA 510(k) summary.

The closest I can come to fulfilling your request, based only on the provided text, is to state what was tested at a high level and what was not tested (human clinical performance).

Based on the provided document, the following information can be extracted regarding device testing and acceptance:

The FDA 510(k) summary for the Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX indicates that the clearance was based on demonstrating substantial equivalence to predicate devices, supported by laboratory testing and software verification/validation, rather than a human clinical study with specific performance acceptance criteria against ground truth.

Therefore, many of the specific details requested regarding human studies, expert consensus, and detailed performance metrics are not available in this document, as such studies were explicitly stated as "not required for this product."

Here's what can be gathered directly from the text:

• 1. A table of acceptance criteria and the reported device performance:

  • Acceptance Criteria (Implied): The primary acceptance criterion for this 510(k) clearance is demonstrating substantial equivalence to legally marketed predicate devices, supported by bench testing and software verification/validation.
  • Reported Device Performance:
    • Mechanical Properties: Testing was conducted to characterize device performance characteristics according to ASTM D638 (Standard Test Method for Tensile Properties of Plastics) for the clear customized aligners. Specific numerical results are not provided in this summary, only that "Test data were submitted to validate the processes."
    • Biocompatibility: ISO 10993 testing (Parts 3, 5, 10) was performed according to Good Laboratory Practices to ensure the two thermoplastic materials are biocompatible and non-toxic for oral contact use. Results are summarized as "materials shown to be biocompatible and non-toxic." Specific numerical results are not provided.
    • Software Verification/Validation: "Testing to verify and validate the software has been included in this 510(k) documentation." No specific acceptance criteria or performance metrics for the software are detailed in this summary beyond this general statement.

• 2. Sample size used for the test set and the data provenance:

  • Not explicitly stated in the document for the material and software testing.
  • Data Provenance: The testing mentioned (ASTM D638, ISO 10993) is laboratory-based (bench testing). No human data or data provenance (country, retrospective/prospective) is applicable, as "No animal or human testing are required for this product."

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • Not applicable. No human experts were involved in establishing ground truth for a clinical test set, as no human clinical testing was performed or required for this submission.

• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

  • Not applicable. No human clinical test set requiring adjudication was used.

• 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 study was done. The document explicitly states: "No animal or human testing are required for this product." The software 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 not presented as an AI-assisted diagnostic tool that would typically undergo MRMC studies.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

  • Not explicitly detailed in the summary. While "Testing to verify and validate the software has been included," the specifics of standalone performance metrics (e.g., accuracy of segmentation, treatment simulation) are not provided in this public summary.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

  • Not applicable for clinical ground truth. Ground truth for the software's functionality would be defined by engineering specifications and benchmarks against expected computational outputs, not clinical outcomes or expert consensus on patient data.

• 8. The sample size for the training set:

  • Not applicable/Not provided. This document does not suggest the use of machine learning models requiring large training sets in the sense of AI. Even if there were internal training sets for any sort of computational model, the size is not disclosed in this summary.

• 9. How the ground truth for the training set was established:

  • Not applicable/Not provided. Same as above. If the software utilizes any internal models, their "ground truth" would be established through engineering principles rather than clinical data.

In summary, the provided document explicitly states that "No animal or human testing are required for this product" for its FDA clearance. Therefore, detailed information about clinical study designs, expert involvement, and performance metrics typically associated with such studies (like MRMC or standalone AI performance) is absent and not relevant to this specific 510(k) submission. The clearance is based on demonstrating substantial equivalence, supported by bench testing of materials and general software verification/validation.

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