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The Orthodontic Screw 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. The orthodontic screw is intended in patients aged 12 years and older.

The Mini Screws system has been designed to provide a firm anchorage point in the oral cavity for orthodontic treatment. Mini screws are manufactured with CP Ti Gr 4 and are SLA treated. The Mini Screw system is designed to be applied with different orthodontic solutions and is versatile enough to satisfy different clinical cases. Titanium orthodontic mini screws are intended to provide fixed anchorage for orthodontic treatment used by implanting in the maxillary and mandibular bone. These mini screws used for anchoring purposes can be divided into 3 parts as head, neck and body.

The provided text is an FDA 510(k) clearance letter and summary for a medical device called "Proimtech Mini Screw". This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets strict performance acceptance criteria through the kind of study typically associated with AI/ML software.

Therefore, the information required to answer the prompt regarding acceptance criteria and a study proving a device meets these criteria (especially sections related to AI/ML software performance like sample size, experts, MRMC, standalone performance, and ground truth establishment) is not present in the provided document.

The document discusses the physical characteristics, materials, and intended use of a dental mini-screw, and compares it to similar existing devices to show it is substantially equivalent, thus not requiring a new PMA (Premarket Approval Application). It does not involve an AI/ML component or a study with performance metrics in the way the prompt implies.

Here's how to interpret the available information in the context of the prompt:

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

• Acceptance Criteria (Implicit for Substantial Equivalence): The implicit acceptance criterion for a 510(k) clearance is that the new device is substantially equivalent to a legally marketed predicate device. This means it has the same intended use, and the same technological characteristics, or if it has different technological characteristics, these differences do not raise new questions of safety and effectiveness.
• Reported Device Performance: The document states: "However, testing data such as mechanical testing provided in the submission show that these differences do not raise issues in performance." This very generally indicates that the device met certain mechanical performance benchmarks, but no specific quantitative acceptance criteria or results are provided in the public summary.
  • The document also mentions: "The biocompatibility of our finished products has been carried out in accordance with EN 10993-1 Standard." and "Tests for the mechanical strength of our products have been carried out in accordance with TS EN ISO 19023 and ASTM F543 Standard." This indicates the types of tests performed for this physical device, but not the specific criteria or results.

2. Sample size used for the test set and the data provenance:

• Not applicable (N/A) / Not provided. The summary mentions "testing data" but does not detail sample sizes, data provenance (e.g., country of origin, retrospective/prospective), as it's a physical device, not an AI/ML software tested on a dataset of images/cases.

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

• N/A / Not provided. This is relevant for AI/ML software that requires expert annotation for ground truth. For a physical medical device like a mini-screw, ground truth is established through material standards, mechanical testing protocols, and biocompatibility assessments, not human expert interpretation of data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• N/A / Not provided. This concept applies to human reader studies or data annotation for AI/ML, not a physical device's mechanical or material testing.

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:

• N/A / Not provided. This is specific to AI/ML software. The device is a surgical implant.

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

• N/A / Not provided. This is specific to AI/ML software.

7. The type of ground truth used:

• For a physical device, "ground truth" would be established through engineering standards, material specifications (e.g., ISO 5832-2, ASTM F67-13 for material composition), mechanical testing protocols (e.g., TS EN ISO 19023, ASTM F543 for mechanical strength), and biocompatibility assessments (e.g., EN 10993-1). The document indicates these standards were followed.

8. The sample size for the training set:

• N/A / Not provided. There is no "training set" in the context of a physical device. This refers to AI/ML model development.

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

• N/A / Not provided. As above, no training set for a physical device.

In summary, the provided document details the regulatory clearance of a physical medical device (dental mini-screw) based on substantial equivalence, and therefore does not contain the information typically associated with acceptance criteria and studies for AI/ML software performance.

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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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