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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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The BIO-RAY A-1 Anchor Screw System is intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It's used temporarily and intended after orthodontic treatment has been completed. The screw is intended for single use only.

The BIO-RAY A-1 Anchor Screw System is made of stainless steel 316L (ASTM F138) and titanium alloy Ti-6Al-4V (ASTM F136). Electrolytic polishing is for surface treatment of stainless steel screws and anodizing is for surface treatment of Ti-6Al-4V screws. There is a self-drilling and self-tapping feature in the screw tip for insertion and removal . The screw head designs include a mushroom, hook, or none head feature for attachment to orthodontic appliances. The screws are available in various configurations, shapes and sizes.

The provided document describes the BIO-RAY A-1 Anchor Screw System, an orthodontic mini-screw, and its substantial equivalence to predicate devices. The document explicitly states that clinical studies were determined to be not required to support substantial equivalence. Therefore, the information regarding acceptance criteria and study design elements related to clinical performance (such as sample size for test set, data provenance, expert ground truth, adjudication methods, MRMC studies, effect size, and standalone algorithm performance) is not available or applicable in this context.

The acceptance criteria and the study that proves the device meets them are based on non-clinical performance (bench testing, biocompatibility, and sterilization validation).

Here's the breakdown of the available information:

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

2. Sample size used for the test set and the data provenance:
Not applicable as no clinical test set was used. The non-clinical tests were conducted on device samples. The provenance of these samples is the manufacturer, Microware Precision Co., Ltd. in Taiwan. The tests are prospective in nature, as they are conducted for regulatory clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no clinical test set requiring expert ground truth was used. Ground truth for non-clinical tests is established by adhering to the standards (e.g., ASTM, ISO, USP) and the results obtained from standardized testing methods.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable as no clinical test set requiring adjudication was used.

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 device is a medical implant, not an AI-assisted diagnostic or imaging system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable as this is a medical implant, not an AI algorithm.

7. The type of ground truth used:
For non-clinical performance, the "ground truth" is defined by the established industry standards (e.g., ASTM F543 for mechanical properties, ISO 10993 series for biocompatibility, ISO 17665-1 for sterilization) and the expected performance thresholds specified within those standards or internal specifications derived from predicate device performance.

8. The sample size for the training set:
Not applicable as this is a physical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established:
Not applicable as this is a physical device, not an AI algorithm that requires a training set.

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The MC Bio Supertack tacks are used for the stabilization of absorbable membranes during the bone tissue regeneration and bone repair in the maxillofacial or mandibular area.

The MC Bio Supertack system is designed to stabilize barrier membranes onto cortical plate bone, this may be used in maxillofacial or mandibular bone.

General patient health, bone type and quality, and functional loads exerted should be considered and carefully evaluated prior to use.

The MC Bio Supertack tacks are used for the stabilization of absorbable and non-absorbable membranes during the bone tissue regeneration and bone repair in the maxillofacial or mandibular area. The MC Bio SUPERTACK system is designed to stabilize barrier membranes onto cortical plate bone, this may be used in maxillofacial or mandibular bone.

Gnereral patient health, bone type and quality, and functional loads exerted should be considered and carefully evaluated prior to use.

The MC Bio SUPERTACK System consists of 3mm, 4mm and 5mm bone tacks and associated instrumentation.

The tacks material consist of Titanium alloy, as specified in ASTM F136 STANDARD for Wrought Titanium- 6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy, anodized blue color.

The devices are provided non-sterile.

This document is a 510(k) premarket notification for a medical device called the "MC BIO SuperTack" tack, which is used for stabilizing absorbable membranes during bone tissue regeneration and repair in the maxillofacial or mandibular area. The document establishes substantial equivalence to a predicate device (SALVIN Bone Tack) rather than presenting a study for acceptance criteria and reported device performance in the typical sense of a diagnostic or AI device.

Therefore, the requested information (acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, training set information) is not applicable to this submission, as it is a device clearance based on substantial equivalence, not a performance study as would be seen for a new diagnostic algorithm or a clinical trial.

However, I can extract the information on non-clinical testing performed to establish equivalence:

Non-Clinical Testing and Equivalence Conclusion:

Instead of acceptance criteria and device performance in a clinical or diagnostic context, the submission focuses on demonstrating substantial equivalence to a predicate device (SALVIN Bone Tack 3mm and 5mm) through technological comparisons and non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable for this type of submission. The mechanical and biocompatibility tests are conducted on test samples of the device, not a "test set" of patient data. The document does not specify the number of samples used for these non-clinical tests. Data provenance for such tests would be from laboratory testing.

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

• Not applicable. The ground truth here is based on engineering standards (ASTM F136), laboratory test results for biocompatibility, and manufacturing specifications, not expert clinical consensus on a patient dataset.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 or diagnostic device that involves human readers.

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

• Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For biocompatibility: Established laboratory test standards (MTT cytotoxicity using cell cultures).
• For sterilization: Validated sterilization cycle aligned with established medical device sterilization standards.
• For mechanical properties: Engineering flexional tests compared against the properties of the predicate device.
• For design/material: Comparison to technical drawings and material specifications (ASTM F136) of the predicate device and the new device.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device.

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

• Not applicable.

Conclusion from The Document:

The submission concludes that the MC Bio Supertack tacks are "substantially equivalent" to the legally marketed predicate device based on:

• Engineering inspections
• Dimensional and technological comparisons
• MTT cytotoxicity test results
• Sterilization validation
• Flexional test results
• Material (Titanium alloy as specified in ASTM F136 standard)
• Intended Use
• Manufacturing process (anodization for blue color does not modify biocompatibility).

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