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The ACR Screw System is indicated for use as a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth for use in patients 12 years of age and older. It is used temporarily and is removed after orthodontic treatment is complete. The screws are intended for single use only.

The ACR Screw System is indicated for use as a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment is complete. The average temporary implantation period for the anchorage screw is six months. Screws are intended for single use only.

Screws are essentially C-type screw head design and size. Screw diameters and lengths are offered in the following range: thread diameter (1.75 mm) and overall length (11.10 – 15.10 mm). The screw tip has a self-drilling feature for insertion and removal. It is manufactured from a machined piece of Ti-6Al-4V ELI titanium alloy (ASTM F 136-13). These devices are supplied sterilized by gamma irradiation. This device is individually packaged in a polyethylene bag.

The provided document is a 510(k) premarket notification for the ACR Screw System, an orthodontic anchorage screw. It describes the device, its indications for use, and its substantial equivalence to predicate devices, primarily through non-clinical testing. However, it does not contain a study that quantitatively proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or similar measures typically associated with diagnostic or AI-driven devices.

The document focuses on demonstrating physical and material equivalence, as well as safety and basic functionality. Therefore, I cannot fully answer your request for acceptance criteria and a study proving device performance in the way you've outlined for AI/diagnostic devices.

Here's an attempt to extract relevant information given the limitations of the provided text:

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

The document details performance testing related to mechanical properties, biocompatibility, sterilization, bacterial endotoxin, and shelf-life. However, explicit quantitative acceptance criteria and detailed reported performance values for each are not presented in a comparative table within the document. Instead, it states that tests "met predetermined acceptance criteria" or "all test requirements were met."

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

The document does not specify sample sizes for mechanical, sterilization, bacterial endotoxin, or shelf-life testing. The data provenance is implied to be from internal testing by BioMaterials Korea, Inc. or their contracted labs, primarily from South Korea, as indicated by the manufacturer's and consultant's addresses. All tests are non-clinical (laboratory/bench).

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

This is not applicable to the non-clinical testing described. Ground truth for these types of tests is established by standardized testing protocols and measurement instruments, not human expert consensus.

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

Not applicable, as this is for non-clinical 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

Not applicable. This device is a physical orthodontic screw, not an AI or diagnostic imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

Not applicable. This device is a physical product.

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

The ground truth for the non-clinical tests (mechanical properties, biocompatibility, sterilization, etc.) is established by adherence to international standards and validated laboratory test methods (e.g., ISO and ASTM standards for material properties, sterility, and packaging integrity).

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI algorithm requiring a training set.

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

Not applicable.

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The subject devices are intended to be place in the mouth for use as an anchor in orthodontic procedures.

The anchor plates for attachment to the orthodontic device offer four types (T-Type, Y-Type and W-Type). This plate has three portions; head, arm and body, and there are two types of head portion. Anchor plate is developed to provide intraoral absolute anchorage for the intrusion or molars. Anchor Plate does not disturb any kind of tooth movement because they are placed outside the dentition. The anchor plate consists of pure titanium alloy, which is suitable for osseointegration and also tissue integration.

The provided document is a 510(k) premarket notification for a medical device called "Anchor plate." This type of document is generally used by manufacturers to demonstrate that their device is substantially equivalent to a predicate device already legally marketed in the U.S. It primarily focuses on comparing the new device against existing predicates based on technological characteristics, intended use, and performance data to establish safety and effectiveness.

This document does not describe the acceptance criteria and study that proves the device meets the acceptance criteria in the format requested in the prompt.

Specifically, it lacks:

• A table of acceptance criteria with reported device performance against those criteria.
• Details on sample size used for a "test set" (as this is not a diagnostic device, there isn't a traditional test set of clinical cases).
• Information on data provenance for a clinical test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance study.
• Type of ground truth used (pathology, outcomes data, etc.) for clinical evaluation.
• Training set size or how ground truth for a training set was established (again, not a diagnostic AI device).

Instead, the document focuses on non-clinical performance data and a comparison to predicate devices, which is typical for a 510(k) submission for a mechanical implantable device.

Here's an extraction of the relevant performance data and comparisons that are available in the document:

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

The document mentions comparative performance testing but does not present a formal table of acceptance criteria. Instead, it compares the proposed device's mechanical properties to those of the primary predicate device. The "acceptance criteria" are implicitly that the proposed device performs comparably or better than the predicate device.

Note: The document states "the results showed that the properties considered were similar when used for intended use" despite the numerical differences in bending strength and tensile force, suggesting that the observed differences were deemed clinically acceptable.

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

• Test Set Sample Size: Not explicitly stated for performance testing. Mechanical tests typically involve a certain number of units, but the specific quantity is not reported. This is a non-clinical device; there isn't a "test set" of clinical data.
• Data Provenance: The tests were conducted by the manufacturer, BioMaterials Korea, Inc., (South Korea). It is preclinical (bench and biocompatibility) data, not clinical patient data. The tests are non-clinical (bench testing and biocompatibility).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. This is a pre-clinical (bench) study for a mechanical device, not a diagnostic or clinical study requiring expert ground truth for imaging or clinical outcomes.

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

• Not applicable. This is a pre-clinical (bench) study.

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-enabled device requiring MRMC studies.

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

• Not applicable. This is not an algorithm or AI device.

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

• For mechanical properties: The "ground truth" is measured physical properties against established standards (e.g., ISO 9585 for bending strength) or internal validated test methods.
• For biocompatibility: The "ground truth" is established by adherence to recognized standards like ISO 10993.

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not a machine learning model requiring a training set.

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

• Not applicable.

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a) The Bone Plates are indicated for orofacial (maxilla or mandible) fracture or damage.
b) The Bone Screws are indicated for the fixation of the Bone Plate.

Bone Plate; Bone Screw

This document is a 510(k) clearance letter from the FDA for a bone plate and bone screw. It primarily focuses on regulatory approval rather than a detailed study description of how the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and study details is not present in the provided text.

Based on the provided text, here's what can be extracted:

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

The document does not specify quantitative acceptance criteria or report specific performance metrics for the bone plate and bone screw. The letter is a clearance for market entry based on substantial equivalence to predicate devices, not a detailed performance study report.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document.

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

This information is not provided in the document.

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

This information is not provided in the document. The device in question (bone plate and screw) is a physical medical device, not an AI-assisted diagnostic tool, so an MRMC study related to AI assistance would not be applicable.

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

This information is not provided in the document. As noted, this is a physical medical device, not an algorithm.

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

This information is not provided in the document. The clearance is based on substantial equivalence, implying that the device's design and materials are comparable to existing, legally marketed predicate devices, rather than being validated against specific clinical ground truth data presented in this letter.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

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The SL Type and SPL Type Orthodontic Anchor Screws are intended for use as a temporary anchor for orthodontic treatment.

Not Found

The provided text describes an FDA 510(k) clearance letter for SL Type and SPL Type Orthodontic Screws. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document only confirms that the FDA has reviewed the premarket notification and determined the device to be substantially equivalent to legally marketed predicate devices for its stated indications for use.

Therefore, I cannot provide the requested information.

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The C Type, CT Type and Special Type Orthodontic Anchor Screws are intended for use as a temporary anchor for orthodontic treatment.

Not Found

The provided text is a letter from the FDA regarding a 510(k) premarket notification for dental implants. It does not contain any information about acceptance criteria, study details, or device performance metrics.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided document.

The document only states that the device is "substantially equivalent" to legally marketed predicate devices, which allows it to be marketed. It does not include any performance data or a study description.

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