(160 days)
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.
| Test Performed | Implied Acceptance Criteria (Based on Standard/Purpose) | Reported Device Performance |
|---|---|---|
| Axial Pull-out Strength | Compliance with ASTM F543 requirements for the effectiveness of the mechanical design and elimination of orthodontic mini-implant. | Not explicitly stated, but implied to meet standard. |
| Peak Torque Value | Compliance with findings/methodology from the "Article by Drs. Jolley and Chung Published in the Journal of Clinical Orthopedics." | Not explicitly stated, but implied to meet article's criteria. |
| Insertion Torque Test | Torque required for insertion must validate the surgical procedure provided in the instructions for use, in a worst-case scenario. | Not explicitly stated, but implied to validate procedure. |
| Sterilization | Validation according to ISO 11137-1 & ISO 11137-2 (for sterile product), and ISO 17665-1 & ISO 17665-2 (for non-sterile product). | Not explicitly stated how values met, but validated. |
| Shelf Life (Packaging) | Maintain sterile barrier integrity after accelerated and real-time aging, confirmed by ASTM D4169, ASTM F88, and dye penetration testing. | Packaging integrity confirmed for proposed shelf life. |
| Biocompatibility | Conformance to ASTM F136; history of safe use as dental implant material; identical to predicate device materials and processing. | Device made of ASTM F136 titanium alloy, considered biocompatible due to equivalence. |
| Pyrogenicity | Meet pyrogen limit specifications for every batch. | Pyrogenicity test conducted on every batch. |
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.