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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 Multi One Implant System is intended for surgical placement in the bone of the upper or lower jaw to provide support for prosthetic devices to restore chewing function. Implants may be used with single-stage or two-stage procedures. They can be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Blue Sky Bio Multi One Implants are indicated for multiunit restorations in splinted applications. Blue Sky Bio Multi One Implant System with a 45° angulation are indicated for surgical installation in the pterygoid region only, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function.

Blue Sky Bio Long Implant System is intended for surgical placement in the bone of the upper jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. Implants may be used with single-stage or two-stage procedures, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Blue Sky Bio Long implants can be placed bicortically in cases of reduced bone density. Blue Sky Bio Long implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. Blue Sky Bio Long Implant System with a 45° angulation are indicated for surgical installation in the pterygoid region only, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function.

Blue Sky Bio PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

Blue Sky Bio BIO|MAX MULTI ONE Implants include a one-piece implant/abutment construct provided with body diameters of 3.0 mm to 4.3 mm. in multiple lengths from 10 mm to 20 mm. They are provided with a head angulation of 17°, 30°, or 45°. Multi One Implants with body diameters of 3.5 mm and 4.3 mm, in lengths ranging from 10 mm to 20 mm with a 45° angulation are indicated for the pterygoid region only. Implant body diameters of 3.0 mm and 3.25 mm are only intended for the alveolar ridge and not intended for placement in the pterygoid region.

Blue Sky Bio BIO|LONG implants and BIO|MAX MULTI ONE LONG implants include implant lengths designed for placement into the posterior maxillary region. including the pterygoid plate. The implants have one of three connections, an internal hexagon interface (3.5 mm platform), a tapered internal hexagon interface (NP platform) or a Multi One one-piece design. The implants are provided with a body diameter of 3.7 mm to 5.0 mm in implantable lengths ranging from 20 mm to 25 mm. BIO|MAX MULTI ONE LONG implants are provided with a head angulation of 17°, 30°, or 45°. Blue Sky Bio BIO/LONG implants and BIQIMAX MULTI ONE LONG implants are intended to be used with the TILT procedure in the maxilla as shown in the clinical literature. Implants with 45° angulation are indicated for the pterygoid region only. BIOJINTERNAL HEX LONG implants (3.5 mm Platform) are for use with abutments of up to 30° only.

Details of specific implant diameters and lengths are outlined in the table below. Abutment screws compatible with the BIOJLONG Implants were cleared in K060957. K102034 and K190491.

Blue Sky Bio PEEK abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation. Subject device PEEK abutments are provided with two implant/abutment connections, BIO|INTERNAL HEX (3.5 mm Platform) and BIO|MAX (NP).

The subject device implants are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium- 6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). Previously cleared abutments and abutment screws are made of material conforming to ASTM F136. Temporary PEEK abutments are made from TECAPEEK conforming to ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications.

The Blue Sky Bio Implant System (K212785) is a dental implant system. The document does not explicitly state acceptance criteria or a formal study that proves the device meets specific acceptance criteria in the typical sense of a clinical trial with predefined endpoints and statistical analysis. Instead, the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices through non-clinical performance testing and a review of existing clinical literature.

Here's a breakdown of the information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit acceptance criteria with corresponding reported device performance in terms of clinical outcomes (e.g., success rates, marginal bone loss) derived from a dedicated study of the subject device. Instead, it relies on:

• Non-clinical performance test data demonstrating compliance with ISO standards and FDA guidance for dental implants.
• Clinical literature review to support the safety and effectiveness of similar implant dimensions and placement techniques, concluding that the subject device's dimensions and indications do not raise new questions of safety and effectiveness.

Here's a summary of the non-clinical performance and the basis of equivalence:

2. Sample Size Used for the Test Set and the Data Provenance

• Non-clinical tests: The document does not specify sample sizes for the non-clinical tests. For leveraged data (packaging, sterilization, material biocompatibility), the sample sizes would refer to those used for the predicate devices, which are not detailed here. For fatigue, the ISO standard typically specifies a minimum number of samples (e.g., 11 per group for staircase method).
• Clinical Literature Review (not a "test set" in the traditional sense): This is a review of retrospective and prospective studies already published in scientific literature. The data provenance is global, as scientific literature authors are not limited by country. The "test set" here refers to the patient cohorts described in the reviewed articles, which would vary significantly. For example, one article mentions "1053 pterygoid implants in 676 patients" (Article 7).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This is not applicable as there was no dedicated clinical "test set" with a pre-established ground truth. The submission relies on scientific literature published by various researchers and clinicians, implicitly accepted by the regulatory body as supporting evidence.

4. Adjudication Method for the Test Set

Not applicable, as there was no dedicated clinical "test set" requiring adjudication.

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

Not applicable. This device is a dental implant system, not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this is a physical medical device (dental implant).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the safety and effectiveness claims related to clinical use (e.g., implant success rates, complications, bone loss), the "ground truth" is derived from the clinical outcomes data reported in the published scientific literature that was reviewed. This literature typically involves various forms of clinical follow-up, radiographic assessment, and professional judgment by the treating clinicians/researchers in those studies.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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Blue Sky Bio CAD-CAM Abutments are intended to be used in conjunction with Blue Sky Bio endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. All digitally designed abutments for use with Blue Sky Bio CAD-CAM Abutments are intended to be sent to a Blue Sky Bio validated milling center for manufacture.

The purpose of this submission is to obtain marketing clearance for Blue Sky Bio CAD-CAM Abutments, to be used with compatible components from the Blue Sky Bio Dental Implant System cleared in K051507. K060957, and K102034. The subject device includes Titanium Base Abutments, Cobalt Base Abutments, and Titanium Blank Abutments. For the Titanium Base Abutments and the Cobalt Base Abutments, the final finished device is intended to be used as a two-piece abutment composed of the base bottom-half (titanium base or cobalt base) bonded to a CAD-CAM zirconia top-half. Each abutment type provided in six (6) internal implant connections to the previously-cleared compatible Blue Sky Bio implants (BIO | MAX; BIO | Internal Hex; BIO | Conus 12; BIO | One Stage; and BIO | Trilobe). Titanium Base Abutments are designed for retention of a CAD-CAM fabricated zirconia superstructure and are provided in both straight and 15° angled base designs, and with engaging, non-engaging, and nonengaging conical implant connections. Cobalt Base Abutments are provided in both straight and 15° angled base designs, and with engaging and non-engaging implant connections. Cobalt Base Abutments (Straight) are designed to be a base for a final abutment fabricated by either of two methods. The first method is the same as for the Titanium Base Abutments: a CAD-CAM fabricated zirconia superstructure is bonded to the Cobalt Base Abutment (Straight) and the final two-piece abutment is used for the prosthetic restoration. For the second method, the Cobalt Base Abutments (Straight) can be cast to a straight abutment only, no angulation. The design of the final abutment can be by CAD-CAM, fabricated in wax, and fixed to the Cobalt Base Abutment, or the final design be done using traditional wax-up technique. The final one-piece abutment is fabricated using standard lost wax casting techniques. Cobalt Base Abutments (Angled 15°) are designed to be a base for a CAD-CAM fabricated zirconia superstructure bonded to the Cobalt Base Abutment (Angled 15°) and the final two-piece abutment is used for the prosthetic restoration. Cobalt Base Abutments (Angled 15°) are not to be cast to a final abutment. Titanium Blank Abutments are designed for fabrication of a customized all titanium alloy abutment by CAD-CAM processes. Titanium Blank Abutments have an engaging implant connection. The subject device abutments are made of titanium alloy conforming to ASTM F136 , or cobaltchromium alloy conforming to ASTM F1537. The titanium alloy subject device components are manufactured from identical materials, in the identical facilities using the identical manufacturing processes as used for Blue Sky Bio products cleared previously in K051507, K060957, and K102034. All zirconia superstructures (copings) for use with the subject devices Titanium Base Abutments and Cobalt Base Abutments will be made at a Blue Sky Bio validated milling center under FDA quality system regulations, and the material will conform to ISO 13356. All wax designs for casting to the subject device Cobalt Base Abutments also will be made at a Blue Sky Bio validated milling center. For the lost wax technique, final one piece abutment may be cast in cobalt-chromium alloy or nickel-chromium alloy.

The provided text is a 510(k) Summary for Blue Sky Bio CAD-CAM Abutments, which is a dental device. It focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing detailed acceptance criteria and study results for a novel AI/ML device.

Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving a device meets these criteria for an AI/ML product.

The text describes:

• Device: Blue Sky Bio CAD-CAM Abutments (dental implant components).
• Indications for Use: To be used with Blue Sky Bio endosseous dental implants to support single-unit or multi-unit prosthetic restorations. Digitally designed abutments are sent to a Blue Sky Bio validated milling center for manufacture.
• Performance Data (Non-clinical): Mentions sterilization validation (ISO 17665-1, ISO 17665-2), biocompatibility testing (ISO 10993-5, ISO 10993-12), and static and dynamic compression-bending testing (ISO 14801).
• Clinical Data: Explicitly states "No clinical data were included in this submission."
• Substantial Equivalence: Compares the subject device to various predicate and reference devices in terms of indications for use, design principles, materials, physical dimensions, packaging, and sterilization methods. The mechanical testing (ISO 14801) is mentioned as mitigating minor design differences.

Without information specific to an AI/ML device, I cannot fulfill the request to describe acceptance criteria and a study proving an AI/ML device meets them, nor can I populate the table or provide details on sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, or training set details.

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The proposed Blue Sky Bio TAD is intended to provide a fixed anchorage point for attachment of orthodonic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for a single use only. For use in adolescents greater than age 12 and adults.

The Blue Sky Bio TAD is fabricated from titanium Alloy without surface treatment, which meets the material requirements specified in the standard ASTM F-136-08. The head on the proximal portion of the screw incorporates a recess, which provides an option for the orthodontist to pass through a wire and tie it in the neck of the Blue Sky Bio TAD in the orthodontic treatment. Distal to the recess is a square indentation that is used as a screw head.

The smooth neck distal to the proximal head employs a hole through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. Distal to the neck is the collar, which has a tapered design to protect the soft tissue. The distal portion of the proposed Blue Sky Bio TAD is threaded for quick insertion and provides stability and biomechanic retention once the screw is fully inserted. The distal tip of the screw is machined with high precision manufacturing.

The Blue Sky Bio TAD is an endosseous dental implant intended to provide a fixed anchorage point for orthodontic appliances. The provided text describes the non-clinical testing performed to demonstrate its substantial equivalence to predicate devices, rather than a clinical study with acceptance criteria for device performance.

Therefore, the requested information specifically on acceptance criteria and a study proving the device meets those criteria, as well as details like sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, and standalone performance, cannot be extracted from this document as these types of studies were not conducted or reported for this submission. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the Blue Sky Bio TAD to its predicate device."

However, I can provide a summary of the non-clinical tests performed, the general purpose of these tests, and the ground truth used for materials, which is documented in the provided text.

Summary of Non-Clinical Testing for Blue Sky Bio TAD

The Blue Sky Bio TAD was deemed substantially equivalent to predicate devices based on non-clinical performance tests, material equivalence, and manufacturing process equivalence. Clinical testing was not required for this submission.

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria and reported performance values are not detailed in the provided text for most tests, a table format for "acceptance criteria" and "reported device performance" as typically seen in clinical studies or detailed engineering reports cannot be fully constructed. However, the document outlines the types of tests performed and the standards they followed, which imply that the results met the requirements of those standards.

2. Sample Sizes Used for the Test Set and Data Provenance

• Test Set Sample Size: Not specified for any of the non-clinical tests (Axial Pull-out, Peak Torque, Insertion Torque, Sterilization, Shelf Life). These tests are typically conducted on a small number of samples representative of the manufactured device.
• Data Provenance: Not specified. These are non-clinical lab tests, likely performed internally or by a contracted lab. There's no mention of country of origin or whether data is retrospective or prospective as these terms are more relevant to clinical studies involving patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. Ground truth for these non-clinical tests is established by adherence to recognized international standards (e.g., ASTM, ISO) or published scientific methodologies. There is no mention of expert consensus for these specific tests.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies where expert consensus is needed to establish ground truth for diagnostic or prognostic outcomes. These are not relevant for the engineering and material performance tests described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not reported. The document explicitly states that clinical testing was not required. These studies are relevant for evaluating the performance of AI-assisted diagnostic devices with human readers.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

• Standalone Performance: No, a standalone performance study was not reported. This is a physical medical device (dental implant), not a software algorithm that would have standalone performance metrics.

7. Type of Ground Truth Used

• Ground Truth for Non-Clinical: The ground truth for the non-clinical tests is based on established international standards (e.g., ASTM, ISO) and published scientific literature/methodologies (e.g., "Article by Drs. Jolley and Chung Published in the Journal of Clinical Orthopedics" for peak torque). For biocompatibility, the ground truth is based on the material's conformance to ASTM F136 and its long history of safe use in similar implant applications.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no training set for a physical device.

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Blue Sky Bio Zygomatic Implant System is indicated for surgical installation in the zygoma region, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Blue Sky Bio zygomatic implants are recommended for the posterior (pre-molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration. Blue Sky Bio zygomatic implants may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

The purpose of this submission is to expand the Blue Sky Bio Zygomatic Implant System cleared in K153064. This submission includes abutments with two interface connection designs for attachment to the previously cleared zygomatic implants: an internal hexagon connection (with a 45° bevel) and a tapered internal hexagon connection (with a 12° taper). The internal hexagon connection abutments are provided in platforms of 3.5 mm and 4.5 mm. The tapered internal hexagon connection abutments are provided in platforms of 3.5 mm (NP) and 4.3 mm (RP). All subject abutments have an angulation of 45° and are for support of screw-retained overdenture prosthetic restorations. Except for the angulation, the subject device abutments have the same designs as corresponding abutments cleared in K153064. The abutment screws compatible with the subject device abutments were cleared in K060957 and K102034. The subject device abutments are made of titanium alloy conforming to ASTM F136. The previously cleared abutment screws also are made of material conforming to ASTM F136.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

The document is a 510(k) Premarket Notification from the FDA for the Blue Sky Bio Zygomatic Implant System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than proving safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study" described are primarily related to non-clinical performance testing to support this equivalence, particularly for an expanded indication (new abutment angulation).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the performance testing performed to demonstrate equivalence to the predicate device. For devices like this, the "acceptance criteria" generally align with established standards for dental implants and their components.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a precise sample size in terms of number of abutments or implants tested for the mechanical performance data. It mentions "constructs" for dynamic compression-bending testing. For ISO 14801, a typical number of samples for fatigue testing is outlined in the standard, usually involving multiple samples at different load levels to determine a fatigue limit. However, the exact number is not explicitly stated in this summary.
• Data Provenance: The data is non-clinical performance testing performed by the manufacturer (Blue Sky Bio, LLC) or a contracted lab. It is inherently prospective in the sense that the tests were conducted specifically for this submission. There is no mention of country of origin for the data, but it can be assumed to be from a lab adhering to the relevant ISO standards typically accepted in the US for regulatory submissions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the described studies are non-clinical (mechanical and material testing), not clinical studies involving patient data or expert interpretation of medical images/outcomes. Ground truth in this context is established by adherence to specified engineering standards (e.g., ISO 14801, ASTM F136).

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or outcome assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This submission explicitly states: "No clinical data were included in this submission." MRMC studies typically assess the diagnostic performance of a device or algorithm in a clinical context, often with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study in the context of an algorithm or AI is not applicable here. This device is a physical dental implant system, not a software algorithm. The "standalone" performance relates to the mechanical integrity of the physical components.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance data primarily consists of established engineering standards and material specifications.

• For mechanical testing, the ground truth is the pass/fail criteria defined by ISO 14801 (e.g., meeting a certain fatigue limit without failure).
• For material composition, the ground truth is conformity to ASTM F136 specifications for titanium alloy.
• For sterilization, the ground truth is validation against ISO 17665-1 and ISO 17665-2.

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reasons as point 8.

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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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Blue Sky Bio Zygomatic Implant System is indicated for surgical installation in the zygoma region, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Blue Sky Bio zygomatic implants are recommended for the posterior (pre-molar/molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration. Blue Sky Bio zygomatic implants may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Blue Sky Bio Zygomatic Implant System submission includes threaded root-form dental implants and mating abutments designed for placement into the zygomatic bone. The zygomatic implants are provided with an internal hexagon connection and a tapered internal hexagon interface for connection to the subject abutments. The internal hexagon connection implants are provided with a body diameter of 4.7 mm and platform diameters of 3.5 mm and 4.5 mm. The tapered internal hexagon connection implants are provided with a body diameter of 4.3 mm and a narrow platform (NP) connection, and with a body diameter of 5.0 mm with a regular platform (RP) connection. All implants are provided in multiple overall threaded lengths ranging from 35 mm to 55 mm. This submission includes mating abutments with platform diameters of 3.5, 4.3, and 4.5 mm. and each abutment diameter is provided with 17° and 30° of angulation. All subject device abutments are for support of screw-retained overdenture prosthetic restorations. The abutment screws compatible with the subject device abutments were cleared in K060957 and K102034. The subject device zygomatic implants are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The previously cleared abutment screws also are made of material conforming to ASTM F136.

This is a 510(k) premarket notification for a dental implant system, which primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices rather than proving a device meets specific performance acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in this context.

The document mainly focuses on comparing the new device's characteristics to those of predicate devices and showing that any differences do not raise new questions of safety or effectiveness.

Here's a breakdown of the information that is available or applicable from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence submission, formal "acceptance criteria" in the sense of predefined thresholds for clinical performance against a disease are not provided. Instead, the device demonstrates performance through engineering analysis, dimensional analysis, and dynamic compression-bending testing to show it is comparable to predicate devices.

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

• Sample Size for Test Set: Not explicitly stated in terms of a "number of cases" or "number of patients" as this was a non-clinical submission. For the dynamic compression-bending testing per ISO 14801, the standard typically specifies the number of samples required for fatigue testing, but the exact number used in this specific test is not provided in the summary.
• Data Provenance: Non-clinical (lab-based engineering and material testing). Not applicable in terms of country of origin or retrospective/prospective for clinical data.

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

Not applicable. Ground truth in a clinical sense (e.g., disease presence/absence determined by expert radiologists) is not relevant for this type of non-clinical device submission.

4. Adjudication method for the test set:

Not applicable. No expert adjudication process as this was a non-clinical submission.

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:

Not applicable. This device is a physical dental implant system, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

• For Biocompatibility: Material specifications (ASTM F136) and prior clearance of similar materials in predicate devices (K102034 and K060957).
• For Dimensional Analysis: Engineering drawings and measurements, compared against predicate device specifications.
• For Dynamic Compression-Bending Testing: The performance requirements of the ISO 14801 standard and the comparative performance of the primary predicate device (K141777).

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. No training set was used.

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