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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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The Fin-S Orthodontic/Dental Microimplant is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. This device is intended for single use only.

The Fin-S Orthodontic/Dental Microimplant is composed of Titanium-6 Aluminum-4 Vanadium Alloy Grade 5 (ATSM F1472-08, ISO 5832-2:1999) material. It has been designed specifically for orthodontic or dental use and has a head which includes two round holes for insertion of various ligatures, coil springs, and elastomers. It also includes two rectangular slots which accept various forms of orthodontic archwires. The smaller diameter of implant, allows its insertion into many areas of the upper and lower jaws and between the roots of teeth. It is divided into four groups of various lengths. Round Head (6,8,10,12mm), Palatal (4,6,8,10mm), Reverse Thread (6,8,10,12mm), and Long Head (6,8,10,12mm). The round head design is the primary device which includes all of the design elements. The Palatal design is essentially the same as the Round Head Design, but has a shortened soft tissue collar. The Reverse Thread design is the same as the basic Round Head Design but has threads that are reversed and allow for counter-clockwise insertion. Finally, The Long Head design is the same as the basic Round Head Design, but has a lengthened soft tissue collar.

The provided text describes a 510(k) submission for the Fin-S Orthodontic/Dental Microimplant. This submission focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing and product comparison, rather than an AI-driven device requiring extensive performance studies against acceptance criteria in the manner of diagnostic algorithms.

Therefore, many of the requested points, particularly those related to AI algorithm performance (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone performance), are not applicable to this type of device submission.

However, I can extract information related to the non-clinical testing performed and the comparison to predicate devices, which serve as the "acceptance criteria" for substantial equivalence in this context.

Here's the breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Fin-S Orthodontic/Dental Microimplant are primarily based on demonstrating substantial equivalence to predicate devices, and non-clinical testing to ensure biocompatibility and sterility.

Study Information (as applicable to a 510(k) for a physical device)

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Cytotoxicity Test: "An established cell line was obtained from a recognized cell repository." The specific number of cell cultures or replicates is not stated. Data provenance is not specified beyond "recognized cell repository."
   • Sterilization Test: "Bacillus atrophaeus and Geobacillus Stearothermophilus spore strips and inoculated microimplants." The specific number of strips or microimplants tested is not stated. Data provenance is not specified.
   • Note: For a physical device like a microimplant, "test set" and "data provenance" typically refer to samples used in laboratory testing (biocompatibility, sterility, material characterization), not clinical data or imaging data.

2. 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):

   • Not Applicable. The ground truth for biocompatibility (cytotoxicity) is determined by observing cell cultures under a microscope against predefined criteria, not by human expert consensus on images. The ground truth for sterility is determined by microbiological assay results (killing of specified spore organisms). For material composition and dimensions, it's objective measurement/testing.

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

   • Not Applicable. As described above, the assessments are objective laboratory tests, not subjective interpretations requiring adjudication.

4. 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 is not an AI-driven device or an imaging diagnostic device.

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

   • Not Applicable. This is a physical medical device, not an algorithm.

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

   • Biocompatibility: Microscopic examination of cell cultures for visual clues of cytotoxicity against a control culture.
   • Sterilization: Microbiological testing (e.g., absence of growth from spore strips or inoculated microimplants post-sterilization).
   • Material Composition & Dimensions: Laboratory analytical techniques and metrology.
   • Substantial Equivalence: Comparison of device characteristics (materials, dimensions, intended use) against legally marketed predicate devices.

7. The sample size for the training set:

   • Not Applicable. This is a physical device, not an AI algorithm. There is no concept of a "training set" in this context.

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

   • Not Applicable. As there is no training set.

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The proposed OrthoFix Screw is intended to provide a fixed anchorage point for attachment of orthodontic 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 OrthoFix Screw is fabricated from titanium Alloy, which meets the material requirements specified in the ASTM 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 OrthoFix Screw in the orthodontic treatment. Distal to the recess is a square indentation that is used as a screw head for screwing the OrthoFix Screw with an instrument, insertion handle tip that is connected to a commercially available insertion handle. The insertion handle tip is manufactured with a medical grade stainless steel 316L. 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 OrthoFix Screw is threaded for quick insertion and provides stability and bio mechanic retention once the screw is fully inserted. The distal tip of the screw is machined with high precision manufacturing to aid the orthodontist in self screwing or self drilling.

The application describes the OrthoFix Screw as an endosseous dental implant intended to provide a fixed anchorage point for orthodontic appliances. The study evaluates the device's mechanical properties through non-clinical testing and compares it to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size for the mechanical tests. It refers to "Torque testing performed on the OrthoFix Screw" and "Shear Cut and Tensile Strength (Axial) tests." It can be inferred that a sufficient number of devices were tested to draw the reported conclusions, but no specific count is provided.

The data provenance is not specified (e.g., country of origin). The testing described is non-clinical laboratory testing, not human study data.

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

This information is not applicable to the provided study. The study focuses on non-clinical mechanical testing, not a clinical assessment requiring human expert ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable as the study involves non-clinical mechanical testing, not clinical diagnosis or interpretation that would require adjudication.

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

No, an MRMC comparative effectiveness study was not done. The study presented is a non-clinical mechanical performance comparison.

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

No, this is a medical device (screw) and not an AI algorithm. Therefore, "standalone" performance in the context of AI is not applicable. The device's performance is inherently "standalone" in that it performs its mechanical function independently. However, its clinical effectiveness is always in conjunction with a human orthodontist.

7. The Type of Ground Truth Used:

For the mechanical tests, the "ground truth" used was the mechanical properties and performance of the predicate device (Jeil Medical Corp.'s Dual Top Anchor System Screw, K033767) as a benchmark for substantial equivalence, along with established engineering standards and expected forces in orthodontic applications (e.g., 300grs maximum load).

8. The Sample Size for the Training Set:

This information is not applicable. This is not a machine learning or AI-based device that requires a training set.

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

This information is not applicable as there is no training set for this type of medical device.

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The Orthodontic Bone Anchor (OBA) System screw anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adolescents greater than age 12 and adults.

The Orthodontic Bone Anchor (OBA) System plate anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adults.

The Synthes (USA) Orthodontic Bone Anchor System is intended to be implanted intraorally and used as an anchor for orthodontic procedures. The System includes screw anchors, plate anchors, instruments, and a module case for storage and sterilization.

Screw Anchors
The screw anchor portion of the system consists of 1.55 mm self-drilling and self-tapping screw anchors which incorporate a non-threaded gingival collar beneath the screw head to protect the soft tissue. Once implanted, orthodontic appliances such as archwires, elastics, and springs can be attached to the head of the anchor.

The screw anchors are manufactured from titanium alloy (Ti-6Al-7Nb).

Plate Anchors
The plate anchor portion of the system consists of T-shaped plate anchors which are attached to the bone via 1.55 mm cortex screws and 1.85 mm emergency screws. The plate anchors are offered in three designs (mesh, bracket, and domed) to allow attachment of orthodontic devices such as brackets, archwires, elastics, and springs

The plate anchors are manufactured from commercially pure titanium. The screws used to fix the plate anchors to the bone are manufactured from titanium alloy (Ti-6Al-7Nb)

The provided text describes a 510(k) premarket notification for the Synthes Orthodontic Bone Anchor System. This submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a detailed study with specific performance metrics against those criteria.

Therefore, many of the requested sections (e.g., acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth information) cannot be extracted from this document as this type of information is generally not required or provided in a 510(k) summary for mechanical devices like bone anchors.

The document primarily states:

• Non-Clinical Testing Data: "The Synthes Orthodontic Bone Anchor System was tested for resistance to pullout under clinical loads by means of axial, shear, and cantilever loading. Screws were also tested for insertion torque, removal torque, and yield and failure torque."
• Substantial Equivalence: "The proposed devices are similar to the predicate devices identified above in terms of indications, principles of operation (provide fixed anchorage for orthodontic movement of teeth), device design/geometry, and materials. Information presented supports substantial equivalence."

This indicates that mechanical testing was performed, but specific acceptance criteria and the quantitative results validating against them are not detailed in the provided summary. The focus is on demonstrating that the new device performs similarly to existing, legally marketed devices.

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