(180 days)
Temporary anchorage screws are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth.
It is used temporarily and is removed after orthodontic treatment has been completed.
OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium alloy (ISO 5832-3:1996/ASTM F136-13) self-tapping screw with various sizes for applications in the orthodontic field. It is intended to serve as a fixed anchorage point for the attachment of orthodontic and preprosthetics appliances, in order to facilitate the orthodontic movement of teeth. OBS Anchorage Screw is available in the following diameter and length.
- Diameter ( Ø1.5 mm ) x Length ( 8 / 10 / 12 mm ) .
- Diameter ( Ø2.0 mm ) x Length ( 8 / 10 / 12 / 14 mm ) .
There are three types of OBS Anchorage Screw.
- . Square collar mushroom head none hole
- . Square collar mushroom head round hole
- Square collar mushroom head slot hole .
OBS Anchorage Screw and associated accessories are supplied non-sterile and should be sterilized before use.
The sterilization recommendations documented in the instructions for use (IFU) are according to "AAMI / ANSI ST79 Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities" have been validated.
Use a pre-vacuum sterilization method minimum 4 minutes at a temperature of 132°C (270°F). Drying time is 30 minutes.
The devices are used temporarily with the intention to be removed after orthodontic treatment. Screws are intended for single use only.
The provided text describes a 510(k) premarket notification for the "OBS Anchorage Screw," a temporary orthodontic anchorage device. The submission focuses on demonstrating substantial equivalence to predicate devices through performance data, not on the performance of a standalone AI-powered device or comparative effectiveness with human readers.
Therefore, many of the requested elements, such as those related to AI performance, sample sizes for test sets in the context of AI, ground truth establishment for AI, expert involvement for AI adjudication, and MRMC studies, are not applicable to this document. The document describes a medical device, not an AI device.
However, I can extract information related to the acceptance criteria and supporting studies for the physical medical device itself.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Area | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-5, ISO 10993-10, ISO 10993-11 standards. | Testing performed in accordance with ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization and Irritation), and ISO 10993-11 (Systemic Toxicity). Results indicate compliance (implied by conclusion of substantial equivalence). |
| Sterilization Validation | Compliance with ISO 11737-1, ISO 11737-2, ISO 17665-1, ISO 17665-2, and AAMI/ANSI ST79 for steam sterilization. | Testing performed in accordance with these standards for sterility validation and steam sterilization. |
| Mechanical Performance | Performance comparable to predicate devices Syntec Orthodontic Mini Screws and Absoanchor Microimplant, as per ASTM F543. | Mechanical Performance Testing performed with predicate devices in accordance with ASTM F543. Results indicate that OBS Anchorage Screw met acceptance criteria and is substantially equivalent. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of data for an AI algorithm. The performance data refers to physical testing of the device for biocompatibility, sterilization, and mechanical properties. The sample sizes for these tests are not explicitly stated in the provided text.
Data provenance: N/A, as this refers to physical device testing, not data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI device where experts would establish ground truth for a test set.
4. Adjudication method for the test set
Not applicable.
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 is not an AI device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used
For the physical device:
- Biocompatibility: In vitro and in vivo biological responses to the device material, evaluated against established ISO standards.
- Sterilization Validation: Microbiological testing and adherence to established sterilization efficacy standards (ISO and AAMI/ANSI).
- Mechanical Performance: Physical and mechanical properties of the screw (e.g., strength, torque) compared against the performance of legally marketed predicate devices and ASTM F543 standards.
8. The sample size for the training set
Not applicable. This is not an AI device with a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI 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.