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510(k) Data Aggregation
(360 days)
The screws are intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. They are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are intended for single use only.
The Syntec Orthodontic Mini Screw Extended System is a modification of our own device Syntec Orthodontic Mini Screw (K090476). The screws are fabricated from stainless steel (SUS316L) per ISO 5832-1:2007/ASTM F138-13 and Titanium-6 Aluminum-4 Vanadium Eli (Extra Low Interstitial) Alloy per ISO 5832-3:1996/ASTM F136-13 as same as previous devices (K090476). The modifications included in the subject submission are a change to the screw hole type, from the previously cleared circular design, to a rectangular shape.
The provided text does not contain information about an AI/ML-based medical device. Instead, it describes a traditional medical device, the "Syntec Orthodontic Mini Screw Extended System," and its 510(k) premarket notification to the FDA.
Therefore, I cannot provide the requested information about acceptance criteria, study details, ground truth establishment, or human-in-the-loop performance studies, as these concepts are typically applied to AI/ML device evaluations and are not present in this document.
The document primarily focuses on demonstrating substantial equivalence of the new orthodontic mini screw system to a previously cleared predicate device, based on material composition, dimensions, and manufacturing processes, with a minor modification in screw hole shape. The performance data section refers to non-clinical tests (dimensional, material mechanical property standards, biocompatibility, fracture load, rotational fracture torque, and axial pull-out strength), stating these tests were leveraged from the predicate device and not repeated for the new submission.
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(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.
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