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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.

The OBS/Biokey Anchorage Screw, consisting of stainless steel (SUS-316LVM) and titanium alloy (Ti-6Al-4V ELI), is a 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 pre-prosthetic appliances, in order to facilitate the orthodontic movement of teeth. The OBS/Biokey Anchorage Screw and associated accessories are supplied non-sterile and should be sterilized before use. The devices are used temporarily with the intention to be removed after orthodontic treatment. The average temporary implantation period for the anchorage screw is six months. Screws are intended for single-use only.

The purpose of this submission is to implement six additional specification models: BM, AT, AY, CH, FH, and HH. The BD model was previously cleared under K152297.

The intended use, materials, manufacturing process, and sterilization method of the OBS/Biokey Anchorage Screw for BD, BM, AT, AY,CH, FH, and HH are the same. The differences are the type and dimensions (diameter and length). Different kinds of OBS/Biokey Anchorage Screw are manufactured to meet market needs. The BD model is available in diameters of 1.5. 2mm and lengths of 6. 8. 10. 12. 14mm. The BM and AT models are available in diameters of 1.6, 2mm and lengths of 6, 8, 10, 12, 14mm. The AY model is available in diameter of 1.4mm and lengths of 6, 8, 10mm. The CH, FH, and HH models are available in diameters of 1.4, 1.6, 2mm and lengths of 6, 8, 10, 12, 14mm.

The provided text describes a 510(k) premarket notification for a medical device, the OBS Anchorage Screw/Biokey Anchorage Screw. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new medical device is safe and effective through extensive clinical trials for unique claims.

Therefore, many of the requested elements for a study proving a device meets acceptance criteria for an AI/clinical diagnostic (e.g., ground truth establishment with experts, MRMC studies, training set details) are not applicable to this 510(k) submission for an orthodontic anchorage screw.

The "acceptance criteria" and "study" in this context refer to the engineering and material performance tests demonstrating that the modified device maintains the same safety and effectiveness as its predicate, despite minor dimensional and design variations.

Here's a breakdown of the requested information based on the provided text, indicating what is present and what is not applicable:

1. A table of acceptance criteria and the reported device performance

The document does not provide a direct table of specific numerical acceptance criteria and reported performance values for each test. Instead, it states that the tests were performed "in accordance to" specific ISO and ASTM standards, and that the results "indicate that the OBS/Biokey Anchorage Screw met acceptance criteria and is substantially equivalent to the predicate device."

• Acceptance Criteria (Implicitly based on standards):
  • Biocompatibility: Compliance with ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization and Irritation), ISO 10993-11 (Systemic Toxicity).
  • Sterilization Validation: Compliance with ISO 11737-1, ISO 11737-2, ISO 17665-1, ISO 17665-2, and AAMI/ANSI ST79 for steam sterilization.
  • Mechanical Performance: Compliance with ASTM F543 (Standard Specification and Test Methods for Metallic Medical Bone Screws).
• Reported Device Performance: The document states that the test results "met acceptance criteria" and demonstrated "substantial equivalence" to the predicate device. Specific numerical results are not detailed in this summary.

2. Sample sizes used for the test set and the data provenance

• Sample Size: Not explicitly stated for each test in the provided summary. Performance testing is generally conducted on a sufficient number of samples to demonstrate statistical significance or compliance with the specified standards.
• Data Provenance: The tests are non-clinical (laboratory/bench testing) and were performed to support this specific regulatory submission for the device manufactured by BOMEI CO., LTD. (Taiwan). The data is retrospective in the sense that the tests were completed prior to submitting the 510(k).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This is a mechanical/material performance and sterility validation study, not a clinical study involving human interpretation of medical data. The "ground truth" for these tests is defined by the established parameters and methodologies within the cited international standards (ISO, ASTM, AAMI/ANSI). Experts in fields such as materials science, biomechanical engineering, and microbiology are involved in defining and conducting such tests, but their role is not to "establish ground truth" in the way human readers would for an imaging AI.

4. Adjudication method for the test set

• Not Applicable. As this is non-clinical bench testing, there is no need for adjudication in the context of human reader disagreement, as would be the case in an AI/clinical diagnostic study. The "adjudication" is inherent in the standardized test procedures and interpretation of results against the specified criteria.

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

• No. This is a medical device for providing anchorage in orthodontics, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• No. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• Reference Standards/Physical Measurements: The "ground truth" for this device's performance is established by adherence to and measurements against the specified properties and performance requirements outlined in the cited international standards (ISO 10993 series for biocompatibility, ISO 11737 series, ISO 17665 series, and AAMI/ANSI ST79 for sterilization, and ASTM F543 for mechanical performance). These involve laboratory measurements, assays, and biological testing, not expert consensus on medical images or pathology.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

• Not Applicable. As per point 8.

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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

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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