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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 screws are manufactured from commercially SUS316L (stainless steel) and Ti6AL-4V (Titanium alloy). The screws are available with thread diameter are 1.5mm and 2.0 mm, and total thread lengths is 7.0mm. The minor technological modification for Mico One Orthodontic Screw is designed for easy insertion and removal. The design of smooth curve surface of screw head is comfortable to patient and the screws with or without a 0.7mm/0.8mm diameter hole can supply different orthodontic methods for orthodontists.

This document is a 510(k) summary for a medical device called "Mico One Orthodontic Screw". It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

Here's an analysis based on your requested information:

This document does NOT describe the acceptance criteria and a study proving a digital device meets acceptance criteria. Instead, it describes acceptance criteria and testing for a physical medical device (an orthodontic screw).

Therefore, many of your requested points, especially those related to AI/algorithm performance, ground truth establishment, expert adjudication, and training/test set sizes for digital devices, are not applicable to this submission.

However, I can extract the relevant information for the physical device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific numerical targets and corresponding reported performance values for each criterion. Instead, it refers to industry standards and general performance categories.

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

The document does not specify the sample size for the mechanical performance or biocompatibility testing. It also does not explicitly state the provenance of the data (e.g., country of origin). Since these are bench tests, "retrospective" or "prospective" as typically applied to clinical data don't fully apply, but they would be controlled laboratory studies.

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

This section is not applicable as this is testing for a physical device, not a digital device requiring human expert ground truth for interpretation. Mechanical and biocompatibility tests rely on standardized measurement methods and laboratory analysis.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in interpreting medical images or clinical data, which is not relevant to the physical device testing described.

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 section is not applicable as this document pertains to a physical orthodontic screw, not an AI or digital device designed to assist human readers.

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

This section is not applicable as this document pertains to a physical orthodontic screw, not an algorithm.

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

For the mechanical performance, the "ground truth" is established by the specifications defined in the ASTM F543 standard. For biocompatibility, the "ground truth" is determined by the Pass/Fail criteria outlined in the ISO 10993 series of standards.

8. The sample size for the training set

This section is not applicable as this document describes testing for a physical device, not an AI or machine learning model that requires a training set.

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

This section is not applicable for the same reason as point 8.

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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

This product is orthodontic screw used for straightening of irregular teeth. It is designed for indications such as malocclusion treatment, straightening of irregular teeth, improvement of intermaxillary space and occlusion, and maintenance after orthodontic treatment.
It is surgically placed in the bone of the upper or lower jaw arches to provide support for orthodontic devices and it is used temporarily and is removed after orthodontic treatment has been completed.
Orthodontic screw is designed to facilitate placement of orthodontic appliances such as wires, springs, and elastic ligatures.
The Orthodontic Screw is a dental device made of titanium alloy metal intended to be used as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.
It is 1.2, 1.4, 1.6 and 1.8mm in screw diameter and 6, 8, 10mm in length.
It is made of Titanium alloy (Ti-6Al-4V ELI).
There are two types of surface treatment one is non-treated (Machineed) another one is Acid etching

The provided text describes the regulatory submission for an Orthodontic Screw, which is a medical device, and includes a summary of nonclinical testing. It does not contain information about acceptance criteria for AI/ML performance, nor does it describe a study involving an AI device or human readers. Therefore, I cannot fulfill the request as it pertains to AI/ML device performance.

However, I can extract information regarding the nonclinical testing performed for this Orthodontic Screw:

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

The document mentions three types of performance tests conducted. It states "We conducted performance test due to addition of smaller diameter Ø1.2mm Fracture load Test, Rotational fracture torque test, Axial pull-out strength test." However, the specific acceptance criteria (e.g., minimum fracture load, torque, or pull-out strength) and the reported device performance values are not provided in the document. The document only lists the types of tests performed.

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

The document does not provide details on the sample size used for these performance tests, nor the data provenance (country of origin, retrospective/prospective).

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 applicable as the tests described are mechanical performance tests of a physical device, not an AI/ML system requiring expert ground truth for imaging or diagnostic tasks.

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

Not applicable for mechanical performance tests.

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 a physical medical device, not an AI system that assists human readers.

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

Not applicable. This is a physical medical device.

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

For the three performance tests (Fracture load Test, Rotational fracture torque test, Axial pull-out strength test), the "ground truth" would be the experimentally measured physical properties of the Orthodontic Screw under specific load conditions. These measurements are typically derived from standardized testing procedures, not from expert consensus, pathology, or outcomes data in the context of device performance claims.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI/ML system.

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

Not applicable. This is a physical device.

Additional Information from the Document:

• Biocompatibility: Demonstrated by reference to K122171.
• Sterilization Validation: Demonstrated by reference to K072896 (gamma irradiation process).
• Surface Treatment Characterization: Demonstrated by reference to K122171.
• Clinical Studies: "No clinical studies are submitted."
• Substantial Equivalence: The claim of substantial equivalence is based on the device having the same principles of operation, material (Titanium alloy Ti-6Al-4V ELI, ASTM F 136), indication for use, and similar design to predicate devices. The performance tests were conducted due to the addition of a smaller diameter (Ø1.2mm) and new head types (Small Head, Bracket Head) and a change in surface treatment (Acid etching).

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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 a dental implant system made of titanium metal intended to be used as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is 1.4, 1.6 and 1.8mm in screw diameter and 6, 8, 10mm in length. It is made of Titanium alloy (Ti-6AI-4V ELI, ASTM F 136- 02A). The surface of the screw is non-treated.

The provided text describes the 510(k) summary for the OSSTEM Implant Co., Ltd.'s Orthodontic Screw. However, it does not contain information about a study proving the device meets acceptance criteria in the context of an AI/algorithm-based device.

The "device" in this context is a physical Orthodontic Screw, and the review focuses on its substantial equivalence to a predicate device, primarily through material, design, and non-clinical mechanical testing, not through performance metrics of an AI.

Therefore, many of the requested fields related to AI performance are not applicable. I will fill in the relevant available information based on the document provided.

Acceptance Criteria and Study for OSSTEM Implant Orthodontic Screw

This submission is for a physical medical device (Orthodontic Screw), not an AI/algorithm-based device. Therefore, the acceptance criteria and study detailed here focus on non-clinical performance and substantial equivalence to a predicate device, rather than AI performance metrics, ground truth establishment, or human-in-the-loop studies.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test set sample size: Not explicitly stated for the non-clinical tests (fracture load, rotational fracture torque). These tests would typically involve a statistically relevant number of physical samples, but the specific quantity is not provided in this summary.
• Data provenance: The tests were conducted internally by OSSTEM Implant Co., Ltd. ("Osstem standard"). The country of origin for the data is implicitly Republic of Korea (where OSSTEM is based). The data is from non-clinical (laboratory) testing.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
Not applicable for this type of device and testing. Ground truth for mechanical tests is established by physical measurement against engineering standards, not expert consensus.

4. Adjudication method for the test set:
Not applicable. Mechanical test results are quantitative and do not require expert adjudication in the same way clinical or image-based assessments do.

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 non-clinical tests (fracture load, rotational fracture torque), the "ground truth" or reference was Osstem internal standards (OS-C-0013 and OS-C-0012). For substantial equivalence, the ground truth was the characteristics of the predicate device (Super Orthodontic Screw, K062156).

8. The sample size for the training set:
Not applicable. This is not an AI device, so there is no training set in the context of machine learning.

9. How the ground truth for the training set was established:
Not applicable.

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Super 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 Super Orthodontic Screw is a dental implant system made of titanium metal intended to be used as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is 1.6 and 1.8 mm in screw diameter and 6, 8, 10, 12mm in length. It is made of Titanium 6AI-4V alloy(ASTM F 136-98). The surface of the screw is non-treated and that of head is TiN coated. There is a hole in the screw head through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. It is supplied non-sterile and must be sterilized prior to use by Steam heat sterilization.

The provided document for K062156, Osstem Implant Co., Ltd.'s "Super Orthodontic Screw," does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria.

This 510(k) submission is a "premarket notification" that focuses on demonstrating "substantial equivalence" to predicate devices. It relies on a comparison of characteristics (material, design, use concept) and general safety, performance, and product validations, rather than specific performance metrics and dedicated studies with acceptance criteria as typically found in more recent device submissions or clinical trial reports.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert qualifications, or ground truth for a performance study from this document.

However, I can extract the general claims made about the device's validation:

General Claims Regarding Validation:

"Super Orthodontic Screw has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US regulations. An extensive review of literature pertaining to the safety and biocompatibility of Super Orthodontic Screw has been conducted. Appropriate safeguards have been incorporated in the design of Super Orthodontic Screw."

Without further documentation beyond this 510(k) summary, it's impossible to fulfill the request for detailed acceptance criteria and study information. This submission primarily serves to establish substantial equivalence based on general design, materials, and intended use, rather than presenting a detailed performance study against specific acceptance criteria.

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The Speedy Orthodontic Screw is intended for use as temporary anchor for orthodontic treatment.

Speedy Orthodontic Screw is intended to provide a fixed anchorage for orthodontic movement of teeth. It is composed of screw and head; screw is implanted in the maxilla and/or mandible, and head is used for the connection of wire. It is from 5.35-10.5mm in total length and is made of Titanium 6Al-4V alloy. It is used temporarily and is removed after orthodontic treatment has been completed. It is supplied sterile and intended for single use only.

This submission is a 510(k) summary for a medical device called the "Speedy Orthodontic Screw." It's a premarket notification to the FDA, demonstrating that the new device is "substantially equivalent" to an existing, legally marketed device (the predicate device). This type of submission relies on showing similarities in design, materials, and intended use, rather than conducting new clinical trials for acceptance criteria specific to AI performance. Therefore, many of the requested fields are not applicable to this type of device submission.

Here's the breakdown based on the provided text:

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

This information is not explicitly stated in the provided text as separate acceptance criteria with corresponding performance metrics for an AI device. The submission is not for an AI device, but a physical medical device. The "review" section mentions "safety, performance, and product validations" and a "review of literature pertaining to the safety and biocompatibility." These are general statements of evaluation rather than specific, quantifiable acceptance criteria or performance numbers.

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

Not applicable. This is a physical, non-AI medical device submission. No "test set" of data in the context of AI performance analysis is mentioned. The submission relies on demonstrating substantial equivalence to a predicate device.

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. No "ground truth" establishment in the context of image interpretation or diagnostic accuracy for an AI device is described.

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

Not applicable. No "adjudication method" for interpreting data is mentioned for this physical device submission.

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, and therefore, no MRMC study involving human readers and AI assistance would have been conducted or reported here.

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

Not applicable. This is a physical device, not an algorithm.

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

Not applicable. There is no mention of "ground truth" in the context of an AI device's performance. The safety and effectiveness of the device are assessed by demonstrating similarity to the predicate device and inherent material/design properties.

8. The sample size for the training set

Not applicable. 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. No training set or associated ground truth establishment is relevant to this device submission.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the document):

The document describes a submission based on substantial equivalence to a predicate device, not on specific clinical studies demonstrating new performance metrics against predefined acceptance criteria for an AI or novel physical device.

The "study" or justification for safety and effectiveness is presented as:

• Comparison to a Predicate Device: The Speedy Orthodontic Screw is compared to the "Dual Top Anchor System Screws, Jeil Medical Corporation, K033767." The submission states that the new device has "the same device characteristics as the predicate device. Material, design and use concept is similar."
• Safety and Performance Validations: The document claims the device "has been subjected to extensive safety, performance, and product validations prior to release." While "extensive" is stated, no specific details, methodologies, or results of these validations are provided in this summary.
• Literature Review: "An extensive review of literature pertaining to the safety and biocompatibility of Speedy Orthodontic Screw has been conducted." Again, no specific literature or findings are detailed.
• Incorporated Safeguards: The submission states that "Appropriate safeguards have been incorporated in the design of Speedy Orthodontic Screw."

In essence, the "proof" is the argument of substantial equivalence to an already legally marketed, safe, and effective device, reinforced by general statements about safety testing and literature review, rather than a detailed report of novel performance data against specific, quantifiable acceptance criteria.

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Indicated to provide 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 OsteoMed Orthodontic Screw System is comprised of screws in diameters of 1.2mm to 2.0mm in thread lengths of 4.0mm to 8.0mm. The screws are made from titanium alloy. Pilot Drills and screwdrivers will also be a part of the system.

This document is a 510(k) premarket notification for the OsteoMed Orthodontic Screw System. It is a regulatory submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study evaluating the performance of AI. Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert involvement, or adjudication methods for an AI device.

The document discusses:

• Device Proprietary Name: OsteoMed Orthodontic Screw System
• Device Common Name: Bone Screw
• Intended Use: To provide 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.
• Materials: Titanium alloy
• Predicate Devices: Straumann Ortho Implant (K982509) and Nobel Biocare Inplant Orthodontic Anchor System (K000643).
• Basis for Equivalence: Similarities in intended use, material, design, and operational principle to the predicate devices.
• Conclusion: OsteoMed believes the device does not raise new safety or effectiveness issues due to these similarities.

In summary, there is no information in the provided text to answer your questions about acceptance criteria and an AI study. This document is a regulatory submission for a physical medical device, not an AI software.

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