(380 days)
The BIO-RAY A-1 Anchor Screw System is intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It's used temporarily and intended after orthodontic treatment has been completed. The screw is intended for single use only.
The BIO-RAY A-1 Anchor Screw System is made of stainless steel 316L (ASTM F138) and titanium alloy Ti-6Al-4V (ASTM F136). Electrolytic polishing is for surface treatment of stainless steel screws and anodizing is for surface treatment of Ti-6Al-4V screws. There is a self-drilling and self-tapping feature in the screw tip for insertion and removal . The screw head designs include a mushroom, hook, or none head feature for attachment to orthodontic appliances. The screws are available in various configurations, shapes and sizes.
The provided document describes the BIO-RAY A-1 Anchor Screw System, an orthodontic mini-screw, and its substantial equivalence to predicate devices. The document explicitly states that clinical studies were determined to be not required to support substantial equivalence. Therefore, the information regarding acceptance criteria and study design elements related to clinical performance (such as sample size for test set, data provenance, expert ground truth, adjudication methods, MRMC studies, effect size, and standalone algorithm performance) is not available or applicable in this context.
The acceptance criteria and the study that proves the device meets them are based on non-clinical performance (bench testing, biocompatibility, and sterilization validation).
Here's the breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance and Acceptance |
|---|---|---|
| Bench Performance | Self-tapping per ASTM F543 | Met (Substantially equivalent to predicate) |
| Torsional per ASTM F543 | Met (Substantially equivalent to predicate) | |
| Axial pullout per ASTM F543 | Met (Substantially equivalent to predicate) | |
| Driving torque per ASTM F543 | Met (Substantially equivalent to predicate) | |
| Shear loading per ASTM F543 | Met (Substantially equivalent to predicate) | |
| Biocompatibility | Cytotoxicity per ISO 10933-5 | Met (Mitigated risks) |
| Sensitization per ISO 10933-10 | Met (Mitigated risks) | |
| Intracutaneous Reactivity per ISO 10933-10 | Met (Mitigated risks) | |
| Acute Systemic Toxicity per ISO 10933-11 | Met (Mitigated risks) | |
| Material-Mediated Pyrogenicity per USP39/NF34(151) | Met (Mitigated risks) | |
| Implantation per ISO 10993-6 | Met (Mitigated risks) | |
| Sterilization Validation | Sterilization validation per ISO 17665-1 | Met |
2. Sample size used for the test set and the data provenance:
Not applicable as no clinical test set was used. The non-clinical tests were conducted on device samples. The provenance of these samples is the manufacturer, Microware Precision Co., Ltd. in Taiwan. The tests are prospective in nature, as they are conducted for regulatory clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no clinical test set requiring expert ground truth was used. Ground truth for non-clinical tests is established by adhering to the standards (e.g., ASTM, ISO, USP) and the results obtained from standardized testing methods.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable as no 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:
Not applicable. This device is a medical implant, not an AI-assisted diagnostic or imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable as this is a medical implant, not an AI algorithm.
7. The type of ground truth used:
For non-clinical performance, the "ground truth" is defined by the established industry standards (e.g., ASTM F543 for mechanical properties, ISO 10993 series for biocompatibility, ISO 17665-1 for sterilization) and the expected performance thresholds specified within those standards or internal specifications derived from predicate device performance.
8. The sample size for the training set:
Not applicable as this is a physical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable as this is a physical device, not an AI algorithm that requires a training set.
§ 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.