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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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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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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. |

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