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The Leone Orthodontic Implant TADs (Temporary Anchorage Devices) are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only.

Leone TADs are miniscrews made of titanium for surgical use (ISO 5832-3/ASTM F136). These orthodontic miniscrews are self-drilling with right-hand thread and they are available in an 8mm length. These devices are supplied sterile and sterilized by gamma irradiation.

The provided FDA 510(k) clearance letter and its associated 510(k) summary pertain to a Leone Orthodontic Implant TAD (Temporary Anchorage Device), which is a physical medical device (an endosseous dental implant). The documentation does not describe an AI/ML-driven device or a study involving a test set, ground truth experts, or MRMC studies.

Therefore, I cannot provide details on acceptance criteria and a study that proves the device meets those criteria for an AI/ML system based on this document. The document describes non-clinical performance testing for a physical implant.

However, I can extract the acceptance criteria and study information that was used to demonstrate substantial equivalence for this physical medical device.

Acceptance Criteria and Study for Leone Orthodontic Implant TAD (Physical Device)

The "acceptance criteria" for this physical device are implicitly defined by the demonstration of substantial equivalence to a predicate device (PSM LOMAS/BENEFIT Screws, K110392) through a series of non-clinical performance tests and material comparisons. The acceptance is based on the results of these tests showing comparability to, and no significant differences from, the legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance (as demonstrated by comparison to Predicate)

• Insertion capacity
• Failure Torque
• Pull-out retention
• Bending strength
• Screw accessory torsion resistance | Non-clinical tests performed (ASTM F543, ISO 19023, ISO 5832-3).
  "The results of the analysis demonstrate that the subject device and the legally marketed predicate device performances are substantially equivalent for the assessed endpoints, because the outcomes of the test are comparable between the proposed and the predicate device." |
  | Surface Analysis: Acceptable residual contamination. | SEM Surface Analysis performed to assess residual contamination. |

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated as a number of devices tested for each non-clinical test. The document refers to "the results of the analysis" and "outcomes of the test" for performance tests without giving specific N values. For biocompatibility, it leverages prior clearance (K070483) and adherence to ISO standards, which would imply a specific number of samples for in vitro and in vivo tests, but these numbers are not detailed here.
• Data Provenance: The tests are described as non-clinical laboratory tests, implying data generated from controlled experimental conditions, not patient data. The origin (e.g., specific country of test lab) is not specified. It is inherently "prospective" in the sense that the tests were performed specifically to support this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This section is not applicable as the device is a physical implant, not an AI/ML system requiring human expert interpretation or ground truth establishment from patient data for performance validation. The "ground truth" for non-clinical testing refers to established engineering specifications and standard test methods.

4. Adjudication Method for the Test Set:

This section is not applicable for a physical device's non-clinical testing. Adjudication methods like 2+1 or 3+1 typically apply to human reader studies for AI/ML performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

This section is not applicable. No clinical studies, and therefore no MRMC studies, were performed or required for this 510(k) submission, as explicitly stated: "No clinical performance data were provided to demonstrate substantial equivalence."

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

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

7. The Type of Ground Truth Used:

For the performance testing of this physical medical device, the "ground truth" is established by:

• Engineering Standards: Established international and national standards (ASTM F543, ISO 19023, ISO 5832-3, ISO 10993-1, ISO 10993-5, ISO 10993-12, ISO 11137 series). These standards define the test methodologies and acceptable performance ranges or comparative metrics.
• Predicate Device Performance: The performance of the legally marketed predicate device (K110392) serves as the benchmark against which the subject device's performance is compared for substantial equivalence.

8. The Sample Size for the Training Set:

This section is not applicable. This is a physical device; there is no "training set" for an AI/ML algorithm.

9. How the Ground Truth for the Training Set was Established:

This section is not applicable. As there is no training set, there is no ground truth to be established for it.

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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 T-FIT is designed to provide a fixed anchorage point for attaching orthodontic appliances, facilitating the orthodontic movement of teeth. It is used temporarily and removed upon completion of the orthodontic treatment for use in patients aged 12 and older. The screws are intended for single use only.

The T-FIT is designed to serve as a fixed anchorage point for attaching orthodontic appliances to facilitate the movement of teeth during orthodontic treatment. The system is intended for temporary use and is removed once treatment is complete. The T-FIT is available in thread diameters Ø1.4 mm, 1.6 mm, and 2.0 mm and thread lengths of 6.0 mm, 8.0 mm, 10.0 mm, 12.0 mm, and 14.0 mm. Thread lengths of 12.0 mm and 14.0 mm are only available with Ø2.0 mm diameter models. All screws are manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F 136-13). The T-FIT is provided non-sterile and is intended for single use only. Additionally, the T-FIT is designed to be used with commonly available dental surgical instruments.

The FDA 510(k) Premarket Notification for the T-FIT device does not contain information typically associated with acceptance criteria and studies for AI/ML-driven devices. The T-FIT is an orthodontic anchorage screw, a physical medical device, and the submission focuses on its material, dimensions, and mechanical performance compared to a predicate device.

Therefore, the requested information regarding acceptance criteria, reported performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not applicable to this specific submission.

The document describes non-clinical performance testing for a physical device, primarily focusing on mechanical and biocompatibility aspects, as well as sterilization:

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

The document describes performance testing conducted according to recognized standards, rather than providing a table of specific acceptance criteria and reported performance values. The objective of these tests is to demonstrate substantial equivalence to the predicate device.

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

The document does not specify sample sizes for the mechanical tests, nor does it provide details on data provenance as these are physical device tests, not clinical data sets. The tests are "nonclinical," meaning they were conducted in a laboratory setting.

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. Ground truth, in the context of expert review, is not relevant for the mechanical and biocompatibility testing of a physical medical device.

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

Not applicable. Adjudication methods are typically used for establishing ground truth in clinical imaging or diagnostic studies, which is not the nature of the tests described here.

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 type of study is relevant for AI-assisted diagnostic devices, not for a physical orthodontic screw.

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

Not applicable. The T-FIT is a physical device, not an algorithm.

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

Not applicable. The "ground truth" for mechanical testing would be the physical properties measured under standardized conditions, and for biocompatibility, it would be the results from specified biological assays and tests against established safety limits for materials.

8. The sample size for the training set:

Not applicable. The T-FIT is a physical device; 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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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 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 Ortholock Anchorage Devices are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only.

The Ortholock anchorage device is an implantable self-drilling orthodontic microimplant intended to provide a temporary fixed anchorage point to facilitate orthodontic treatment. The device interacts with an appliance accessory, which includes two insertion locations for Ortholock and a tube for the attachment of general orthodontic appliances. The devices are made from Ti6Al4V and their surfaces are anodized so the different lengths can easily be visually identified.

The provided text describes the regulatory clearance of a medical device called "Ortholock Anchorage Devices" and details its equivalence to predicate devices, primarily through bench testing. It does not include information about acceptance criteria for typical AI/ML medical devices, nor does it describe a study with performance metrics in the way these are typically presented for AI/ML device evaluations.

Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving the device meets those criteria, as the document does not contain this type of information for an AI/ML device.

The document focuses on the substantial equivalence of the Ortholock Anchorage Devices to existing predicate devices based on:

• Indications for Use: Both the subject device and predicate devices are intended to provide fixed anchorage for orthodontic appliances to facilitate tooth movement in adolescents and adults, for temporary use.
• Material: All devices are made from Titanium Alloy.
• Surface Treatment: All are anodized.
• Principle of Operation: All are orthodontic implants used for anchorage of orthodontic appliances.
• Sterilization: All are provided non-sterilized and user-sterilized, with sterilization validated.
• Bench Testing: Comparative bench testing was performed for torsional properties, driving torque, axial pullout strength, and self-tapping performance, demonstrating similar mechanical performance values to the primary predicate device (The C-Type and Special Type Orthodontic Anchor Screws, K063495) and having similar characteristics to the reference device (PSM Medical BENEFIT Screw, K110392).

The information provided is for a traditional medical device (orthodontic microimplant), not an AI/ML device, and thus does not include data like sample sizes for test sets, data provenance, expert ground truth, MRMC studies, standalone performance for an algorithm, or training set details.

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The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.

The ATOZ Mini-Screw is a temporary screw used as a fixing point for orthodontic treatment. The screw head has a round shape and has a cross groove in the middle so that it can be inserted and removed with a dental screwdriver. The ATOZ Mini-Screw has several models of the same design and diameter, only different lengths. The material of The ATOZ Mini-Screw is Titanium Alloy (ASTM F136). It is single-use only and may not be reused. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use.

The provided text is a 510(k) summary for the ATOZ Mini-Screw, an orthodontic anchor screw. It describes the device, its indications for use, and a comparison to predicate devices, along with non-clinical testing results. However, it explicitly states that clinical data was not required for this submission.

Therefore, many of the requested criteria cannot be extracted from this document, as they pertain to clinical studies and performance evaluation against a defined ground truth, which were not part of this 510(k) submission.

Here's a breakdown of what can be extracted and what cannot:

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

Since no clinical study was performed, there are no "acceptance criteria" related to diagnostic or evaluative performance against a medical condition, nor is there "reported device performance" in that context. The document refers to "bench test" results to demonstrate substantial equivalence to a predicate device, focusing on mechanical strength and biocompatibility.

Table of Bench Test Criteria and Performance (from "Summary of Non-Clinical Data")

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 would have their own sample sizes for material testing, but this is not specified in the summary.

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 with human experts was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical test set 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. The ATOZ Mini-Screw is a physical medical device (orthodontic anchor screw), not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The ATOZ Mini-Screw is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" would be established by adherence to recognized international standards (ISO, ASTM) for mechanical properties, biocompatibility, and sterilization, along with material specifications for the Titanium Alloy (ASTM F136).

8. The sample size for the training set: Not applicable as no machine learning training set was used.

9. How the ground truth for the training set was established: Not applicable as no machine learning training set was used.

In summary, the provided document is a 510(k) premarket notification that relied on non-clinical (bench) testing and comparison to predicate devices to demonstrate substantial equivalence, rather than clinical studies involving patient data or expert evaluations of diagnostic performance.

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The ORTHO MI SYSTEM 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. It is intended for single use only.

The ORTHO MI SYSTEM 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. It is intended for single use only.

The screw diameters and lengths vary as shown below. It is made of a machined piece of Ti-6Al-4V ELI titanium alloy (ASTM F 136-13).

These size combinations are the same across all model types (Double Head, Wing, Slot) with exception case.

The provided document is an FDA 510(k) Premarket Notification for the "ORTHO MI SYSTEM," an endosseous dental implant (orthodontic anchor screw). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies like those required for PMA (Premarket Approval).

Therefore, the document explicitly states: "No clinical data were necessary for the demonstration of substantial equivalence." This means there was no study performed to prove the device meets acceptance criteria in the way a clinical study for an AI/CADe device would.

Instead, acceptance criteria are met through bench testing demonstrating compliance with relevant performance and safety standards, and ensuring the device's technical characteristics and indications for use are substantially equivalent to marketed predicate devices.

Here's a breakdown of the missing and implied information based on the provided text:

Acceptance Criteria and Device Performance

Since no clinical study was conducted, there are no "acceptance criteria" in the sense of clinical performance metrics (like sensitivity, specificity, or reader improvement). The acceptance criteria are tied to bench test performance against established standards and the demonstration of substantial equivalence to predicate devices.

Study Information (as requested, but largely N/A for this 510(k) submission)

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

   • Test Set Sample Size: Not applicable. No clinical test set was used. The "test set" for this submission would refer to the physical devices subjected to bench testing according to the specified standards. The number of devices tested is not detailed, but it would have been sufficient to meet the requirements of the standards cited.
   • Data Provenance: Not applicable. No biological or clinical data was collected from patients or subjects. The data derived from physical testing of the device hardware.

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

   • Number of Experts/Qualifications: Not applicable. There was no ground truth determination by experts in a clinical context. Bench testing relies on objective measurements against engineering and materials standards.

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

   • Adjudication Method: Not applicable. No human interpretation requiring adjudication was involved.

4. 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:

   • MRMC Study: No. This device is an orthodontic anchor screw, a physical implant, not an AI/CADe system. Therefore, no MRMC study was performed.

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

   • Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

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

   • Type of Ground Truth: Not applicable in a clinical sense. The "ground truth" for this device's performance is adherence to established engineering, materials, sterilization, and biocompatibility standards, and demonstrating physical properties consistent with predicates.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable. This is a physical medical device, not a machine learning algorithm requiring a training set.

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

   • Ground Truth for Training Set: Not applicable.

In summary, the provided document details a 510(k) submission for a physical medical device (orthodontic anchor screw). These submissions do not typically involve clinical trials or studies like those conducted for AI/CADe devices, and therefore, most of the questions regarding clinical performance metrics, expert adjudication, or AI model training are not applicable. The "proof" of meeting acceptance criteria lies in comprehensive non-clinical (bench) testing demonstrating compliance with relevant consensus standards and establishing substantial equivalence to previously cleared predicate devices.

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The screws are intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. They are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are intended for single use only.

The Syntec Orthodontic Mini Screw Extended System is a modification of our own device Syntec Orthodontic Mini Screw (K090476). The screws are fabricated from stainless steel (SUS316L) per ISO 5832-1:2007/ASTM F138-13 and Titanium-6 Aluminum-4 Vanadium Eli (Extra Low Interstitial) Alloy per ISO 5832-3:1996/ASTM F136-13 as same as previous devices (K090476). The modifications included in the subject submission are a change to the screw hole type, from the previously cleared circular design, to a rectangular shape.

The provided text does not contain information about an AI/ML-based medical device. Instead, it describes a traditional medical device, the "Syntec Orthodontic Mini Screw Extended System," and its 510(k) premarket notification to the FDA.

Therefore, I cannot provide the requested information about acceptance criteria, study details, ground truth establishment, or human-in-the-loop performance studies, as these concepts are typically applied to AI/ML device evaluations and are not present in this document.

The document primarily focuses on demonstrating substantial equivalence of the new orthodontic mini screw system to a previously cleared predicate device, based on material composition, dimensions, and manufacturing processes, with a minor modification in screw hole shape. The performance data section refers to non-clinical tests (dimensional, material mechanical property standards, biocompatibility, fracture load, rotational fracture torque, and axial pull-out strength), stating these tests were leveraged from the predicate device and not repeated for the new submission.

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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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