(289 days)
The Bio-TackS Orthodontic Mini Implant is indicated for use as 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 single use only.
Fixed on jawbone the Bio-TackS Orthodontic Mini Implant is a screw-shaped product used as a fixed point for orthodontic treatment and it is applied in order to secure sufficient physical and mechanical fixing source for treatment.
The provided text describes the Bio-TackS Orthodontic Mini Implant and its substantial equivalence to a predicate device, focusing on non-clinical performance and biocompatibility. It explicitly states that clinical testing was not required (Section 9, page 8). Therefore, the information requested about acceptance criteria and studies proving device performance with human data (e.g., sample size for test set, experts for ground truth, MRMC study, standalone performance, ground truth type for test/training sets) is not available within this document.
The document primarily focuses on demonstrating substantial equivalence through bench testing (non-clinical performance tests) and biocompatibility testing.
Here's the available information relevant to the acceptance criteria and the study that proves the device meets them, based on non-clinical data:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state quantitative acceptance criteria for the "performance tests" in a table format. Instead, it describes performing tests according to a standard (ASTM F543) and comparing the subject device's results to the predicate device, concluding "similar performance."
Reported Device Performance (from Section 8, page 6-7):
| Test | Acceptance Criteria (Implicit: Similar to Predicate) | Reported Device Performance |
|---|---|---|
| Sterilization and Shelf Life | Sterilization validation per ISO 11137-1, 11137-2, 11137-3 (VDmax25 method). Shelf life demonstrated by accelerated aging with evaluations for seal peeling (ASTM F88), dye penetration (ASTM F1929), and sterility testing. | Sterilization validation performed (ISO 11137-1, -2, -3, VDmax25 method). Shelf-life demonstrated by accelerated aging with seal peeling, dye penetration, and sterility testing. |
| Insertion-Removal Torque Test | Mechanical stability similar to predicate device (evaluated at 1440 degrees at 1 rpm). | Both samples (BioTackS BSH1810S and Osstem OSSH1810) demonstrated "almost equivalent torque values" when inserted and removed. |
| Rotational Fracture Torque Strength Test | Material yield strength similar to predicate device. | "The tapered implant fracture occurred in the same tread section." Both implants made from the same raw material (titanium alloy-ELI grade 23), indicating "material yield strengths of both products are the same." All screw-head types tested, results similar. |
| Axial Pull-Out Strength Testing | Effectiveness of mechanical design and elimination similar to predicate device. | "The test data demonstrated similar results due to the similar pitch tread thickness of the samples" (BioTackS BSH1406S and Osstem OSSH1406). |
| Biocompatibility - Cytotoxicity | Non-cytotoxic (per ISO 10993-5) | Non-cytotoxic |
| Biocompatibility - Acute Systemic Toxicity | Non-acute systemic toxicity (per ISO 10993-11) | Non-acute systemic toxicity |
| Biocompatibility - Intracutaneous (Intradermal) Reactivity | No irritation (per ISO 10993-10) | None Irritation |
| Biocompatibility - Local Lymph Node Assay (LLNA) | No hypersensitivity (per ISO 10993-10) | Do not show any hypersensitivity |
2. Sample size used for the test set and the data provenance:
- Bench Tests (Performance Tests): For each specific test (Insertion-Removal torque, Rotational fracture torque, Axial pull-out), the document mentions testing specific models of the Bio-TackS and Osstem implants (e.g., BSH1810S, OSSH1810 for insertion-removal torque). It does not specify the exact number of samples tested for each condition but implies at least one sample of the "worst-case" or specific diameter/length combinations.
- Biocompatibility Tests: Sample sizes are not explicitly stated for these tests (e.g., number of cells for cytotoxicity, number of animals for toxicity/reactivity tests).
- Data Provenance: The tests are explicitly non-clinical bench and laboratory tests. No country of origin for the data is specified, but the applicant (BIO CETEC CO., LTD.) is from the Republic of Korea.
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 no clinical test set requiring human expert ground truth was conducted. The "ground truth" for the non-clinical tests is based on objective measurements against established standards (e.g., ASTM F543, ISO 11137, ISO 10993 series).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set requiring adjudication was conducted.
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, as no clinical study (MRMC or otherwise) involving human readers or AI assistance was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable, as this device (an orthodontic mini implant) is a physical medical device, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical performance tests, the "ground truth" is measured physical and mechanical properties against established engineering and material science standards (ASTM F543), and for biocompatibility, it is biological response as assessed by ISO 10993 standards and laboratory assays.
8. The sample size for the training set:
Not applicable. This is a physical device, and the evaluation did not involve machine learning or AI models with training sets.
9. How the ground truth for the training set was established:
Not applicable (as above).
§ 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.