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Bone Screw is used to stabilize and fixate bone grafts, bone filling material, and/or barrier membranes used for regeneration of bone in the oral cavity.

Bone Screw is using as anchor to fix the bone plate, membrane that cover bone material or block bone for bone regeneration or remodeling. Ø1.2 diameter screw is for fixing non-resorbable membrane or non-resorbable titanium membrane (Osstem OssBuilder OB2 and OB3), cleared in K172354.

The specifications of the proposed device are as follow;

• Bone Screw
• Diameter (mm): Ø1.2
• Length (mm): 3.0, 4.0, 5.0

This document is a 510(k) clearance letter for a bone screw, not a study evaluating an AI/software as a medical device (SaMD). Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria and studies proving device performance for an AI/SaMD.

The 510(k) summary focuses on demonstrating "substantial equivalence" of the new Bone Screw device to existing predicate devices based on:

• Indications for Use: The new device has the same intended use as the predicate.
• Technological Characteristics: Similarities in material (Titanium Alloy), manufacturing process (machined), design, and sterilization method (Gamma Irradiation).
• Performance Testing: Non-clinical tests (Driving Torque, Axial Pullout Strength, Torsional Strength) were conducted to show the new device performs comparably to the predicate, especially regarding a new smaller thread diameter.
• Biocompatibility and Shelf-life: Leveraged data from the predicate device due to material and packaging similarities.
• MR Compatibility: Assessed using scientific rationale and published literature, not a study with acceptance criteria.

Therefore, I cannot extract the requested information as it pertains to an AI/SaMD from this document.

If you have a document describing the performance study of an AI/SaMD, I would be happy to help you extract that information.

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Estar-ZE is a ceramic intended to manufacture dental restorations, including inlays, artificial teeth, crowns and bridges.

Estar-ZE is a ceramic intended to manufacture dental restorations, including inlays, artificial teeth, crowns and bridges.

Estar-ZE is prefabricated ceramic block (pre-sintered yttrium-stabilized zirconium oxide) which is to be milled and sintered in the furnace to produce the final dental restorations. After sintering, it forms polycrytstalline oxide ceramic consisted of Tetragonal Zirconium Oxide Polycrystal (TZP). In accordance with ISO 6872:2015, it is classified as Type II Class 5 zirconia.

Estar-ZE is provided in non-sterile and available in various shades and thickness of disk shape and block shape

Here's a breakdown of the acceptance criteria and study information for the Estar-ZE device, based on the provided FDA 510(k) summary:

Device: Estar-ZE (Porcelain Powder for Clinical Use)

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The provided document describes non-clinical performance testing to demonstrate substantial equivalence of the Estar-ZE device.

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

The document does not specify the exact sample sizes for the mechanical properties or biocompatibility testing. It only states that the device was "designed and tested" and that "all tests have passed the evaluation criteria."

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin specified for the test data itself (although the manufacturer is based in Korea).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the device is a ceramic material and the testing described is non-clinical (mechanical properties, biocompatibility), not involving human diagnostic interpretation or ground truth established by experts.

4. Adjudication Method

This information is not applicable for the reasons stated above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed. This type of study is typically relevant for AI/software devices where human readers provide diagnoses or interpretations.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not performed. This is also relevant for AI/software devices. The Estar-ZE is a physical dental material.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on established international standards:

• ISO 6872:2015 Dentistry - Ceramic Materials for mechanical properties (e.g., flexural strength, classification).
• ISO 10993 suite of standards for biocompatibility.

8. Sample Size for the Training Set

This information is not applicable. The Estar-ZE is a physical ceramic material, not an AI/machine learning algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated above.

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T2 PLUS is digital X-Ray imaging equipment for dental professionals that converts X-Ray signals into digital signals to acquire 2D images and reconstruct them into 3D images, using Panoramic (PANO), Cephalometric (CEPH), and Computed Tomography (CT) technology for the diagnosis of the anatomical structure of the oral and maxillofacial area. T2-CS-P provides all three modes, whereas T2-C-P provides the first two modes and excludes the CEPH mode. The devices are operated and used by physicians, dentist and X-Ray technicians.

Use is contraindicated for patients with a head circumference of less than 48 cm or those aged 2 years or younger.

T2 PLUS is a digital X-ray CT, panoramic, and Cephalo imaging system device composed of X-ray generator, X-ray controller, X-ray supporter, image processing unit (sensor), PC, and software. The apparatus attached to the equipment column is a structure that can be rotated 360 by the system control unit. This system control unit actuates the motor control, X-ray generator, and image processing unit (sensor). The height controlling unit controls the column and adjusts the height of the equipment. The X-ray generator and image processing unit (sensor) are attached to the rotating apparatus. When the rotating apparatus starts the rotation, X-ray is irradiated from the Xray generator (generating unit). This X-ray irradiation penetrates the subject and reaches the image processing unit (sensor), and then is converted into electric signals to secure imagery information. Inside the imaging section of the image processing unit (sensor), real time X-ray input is converted into electric signals and consecutively combined, resulting in imagery information. The combined panoramic imagery information is then sent to the PC and saved in patient management software.

The provided document describes the T2 Plus digital X-ray imaging equipment, focusing on its substantial equivalence to a previously cleared predicate device rather than presenting a detailed study with acceptance criteria for a novel AI or diagnostic algorithm. Therefore, many of the requested elements for a study proving a device meets acceptance criteria are not explicitly stated or applicable in this 510(k) summary.

However, I can extract the information pertinent to the device's performance evaluation and a "study" conducted to support substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria & Reported Device Performance:

The document does not explicitly state quantitative "acceptance criteria" for diagnostic performance in terms of metrics like sensitivity, specificity, or AUC, as it's a submission for substantial equivalence of imaging equipment, not a new diagnostic algorithm that interprets images. The study's aim was to show equivalent image quality to the predicate device.

"In conclusion, the imaging evaluator confirmed that both the proposed device and the predicate device produce radiological images of adequate quality for dental and orthodontic diagnosis." |
| Produce "radiological images of equivalent quality" for diagnosis. | "This confirmed that the proposed device and the predicate device produce radiological images of equivalent quality, making them suitable for diagnosis." |

Note: The acceptance criteria are inferred from the study's objective: to demonstrate equivalent image quality for diagnostic purposes. No specific quantitative thresholds (e.g., "score must be X or higher") are provided.

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

• Test Set Sample Size: A total of 31 cases were reviewed.
  • CT: 10 cases
  • Cephalometric (Ceph): 10 cases
  • Panoramic (Pano): 11 cases
  • For each case, both the proposed device (T2-CS-P) and the predicate device (T2-CS) images were reviewed, meaning 31 image sets from T2-CS-P and 31 image sets from T2-CS.
• Data Provenance: Not explicitly stated regarding country of origin. The study states images were from "patients of the same gender and similar age group, under identical conditions." It implies retrospective image collection from existing patients, as it refers to "patients" not trial participants.
  • Given the manufacturer is based in the Republic of Korea, the data may originate from there, but this is not explicitly stated.

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

• Number of Experts: "A radiologist" (singular) was used as the "evaluator."
• Qualifications of Experts: The qualification provided is "a radiologist." No further details on years of experience, sub-specialty, or board certification are given.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable/None explicitly described. Since only one radiologist served as the evaluator, there was no need for adjudication among multiple readers. The radiologist's assessment served as the primary evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and Effect Size:

• MRMC Study: No. This was not an MRMC study. It involved a single evaluator (radiologist) comparing images from the proposed device and predicate device.
• Effect Size: Not applicable, as no MRMC study was performed and no quantitative diagnostic performance metrics (e.g., sensitivity, specificity, AUC) were reported. The evaluation was qualitative ("scores... were identical").

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

• Standalone Study: Not applicable. The device is imaging equipment. The "study" evaluated the image quality of the equipment as interpreted by a human radiologist, not the performance of an independent AI algorithm. There is no AI component described that would operate in a "standalone" mode for diagnostic interpretation.

7. The Type of Ground Truth Used:

• Type of Ground Truth: The "ground truth" for purpose of this image quality comparison was the expert consensus/opinion of a single radiologist regarding the image quality and its adequacy for diagnosis. This is not a "true" clinical ground truth from pathology or long-term outcomes, but rather a subjective assessment of image utility.

8. The Sample Size for the Training Set:

• This information is not provided. The document focuses on performance testing for substantial equivalence, not on the development of an AI model that requires a training set. The device is X-ray imaging equipment, not an AI diagnostic algorithm, so the concept of a "training set" for the device itself is not applicable in the typical sense of machine learning.

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

• Not applicable, as there is no description of a "training set" for an AI model within the context of this device's performance evaluation.

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K5 is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The dental treatment unit is intended for use in the dental clinic environment and is used by trained dentists and/or dental assistants.

A Dental Unit and Chair K5 is designed for dental treatment of children and adults. It is a dental treatment unit in accordance with IEC 80601-2-60. The 3-way syringe is a dental instrument in accordance with EN 1639. It aids the dental application in the mouth of the patient by supplying air, water or spray. This product is designed for use in dentistry only and may only be used by trained medical personnel. K5 is similar to other commercially available products based on the intended use, the technology used, the claims, the electrical power and performance characteristics. It is substantially equivalent in design, function and intended use to the predicate device.

The provided text describes a medical device, the K5, which is a dental operative unit and accessories, including a dental chair. It is a 510(k) submission to the FDA. However, the document does not contain acceptance criteria or a study that proves the device meets those criteria in the context of performance metrics like sensitivity, specificity, accuracy, or reader performance with or without AI assistance.

The document focuses on demonstrating substantial equivalence to a predicate device (K3, K183347) based on indications for use, technological characteristics, and compliance with various safety and performance standards.

Here's a breakdown of the requested information based on the provided text, highlighting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the document. The document discusses compliance with safety standards and functional equivalence to a predicate device, but it does not specify quantitative acceptance criteria for features like diagnostic accuracy, sensitivity, or specificity, nor does it provide a table of reported device performance against such criteria. The device is a dental operative unit, not an AI/diagnostic software, so these types of performance metrics are not applicable in this context.

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

This information is not applicable in the context of AI/diagnostic software. The document describes non-clinical testing for areas like biocompatibility, cleaning validation, electrical safety, electromagnetic compatibility, and software verification/validation. These tests do not involve a "test set" of clinical data for performance evaluation in the way an AI algorithm would.

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

This information is not applicable. The device is a dental operative unit, and its evaluation focuses on safety, functionality, and compliance with engineering standards, not on diagnostic performance or interpretation by experts to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. As there is no "test set" of clinical data for diagnostic performance requiring expert interpretation, no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices, particularly AI-powered ones, to assess how human readers' performance changes with AI assistance. The K5 is a dental operative unit, not a diagnostic AI tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study in the context of an algorithm or AI was not done. The K5 is a physical dental unit with electronics and software for controlling its functions, not an AI algorithm intended for standalone performance evaluation in a diagnostic capacity.

7. The Type of Ground Truth Used

This information is not applicable in the context of diagnostic accuracy. The "ground truth" for the K5 device's evaluation is primarily based on:

• Compliance with recognized standards (e.g., IEC 60601-1 for electrical safety, ISO 10993-1 for biocompatibility).
• Functional performance (e.g., chair movement, fluid delivery, suction) as designed and tested against specifications.

8. The Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" in the context of machine learning or AI algorithms because the K5 is a dental operative unit, not an AI-driven diagnostic or analytical tool.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

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The OSSTEM Abutment system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

TS Abutment System is made of titanium alloy. TS Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. TS Abutment System is similar to other commercially available products based on the intended use, technology used, material composition employed and performance characteristics.

The provided document is a 510(k) summary for the Osstem Implant Co., Ltd. TS Abutment System. It describes the device and claims substantial equivalence to previously cleared predicate devices. The document does not describe a study that uses acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity, nor does it involve expert reviews or clinical trials for such metrics.

Instead, the submission focuses on demonstrating substantial equivalence through comparisons of technical characteristics and performance testing (bench testing, biocompatibility, sterilization validation, etc.) against existing predicate devices and established standards.

Therefore, most of the requested information regarding acceptance criteria for device performance (accuracy, sensitivity), sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment would not be applicable to this type of regulatory submission. This submission does not pertain to an AI/ML powered device, but rather a physical dental implant component.

However, I can extract information related to the technical comparisons that demonstrate substantial equivalence.

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

The document does not present explicit acceptance criteria in terms of numerical performance metrics (e.g., specific thresholds for accuracy, sensitivity). Instead, the acceptance is based on demonstrating that the subject device's characteristics and performance are "substantially equivalent" to predicate devices, often by adhering to established standards or by justifying that any differences do not raise new questions of safety or effectiveness. The reported "performance" for most components is implicitly that they function equivalently to their predicates and meet relevant mechanical and biological standards.

Here's a summary of the non-clinical performance and "acceptance criteria" through comparative analysis:

• Same design, function, connection, and platform as predicate.
• Adherence to ISO 14801 standard (maintaining 11mm distance between embedding plane and hemispherical loading member).
• Differences (e.g., added lengths or diameters) not creating a new worst-case scenario. | Rigid Abutment: No additional fatigue testing conducted, as the proposed device has the same design, function, connection, platform, and moment arm as the reference/predicate, and added lengths are within acceptable ranges or previously cleared for similar components.
  Transfer Abutment: No additional fatigue testing conducted for similar reasons, justifying that changes in connection features were evaluated and not a new worst case, and that the device has the same moment arm.
  Angled Abutment: No additional fatigue testing conducted, as differences in feature (guide for connecting with implant body) do not change the fundamental design or platform and the proposed device's fatigue is considered equal to or greater than the predicate.
  FreeForm ST Abutment: No additional fatigue testing conducted, as added dimensions are within the range of the reference device and it maintains the same moment arm.
  Temporary Abutment: No additional performance test needed as it's for temporary use, and the proposed gingiva height has primary predicate clearance.
  Multi Abutment: No additional fatigue testing conducted, as added dimensions (gingival height) are covered by primary predicates and it maintains the same moment arm.
  Ti Cylinder Screw: No fatigue testing considered necessary as it's a component using with cylinder, and material biocompatibility is established.
  Convertible Abutment: No additional performance tests as difference is sterilization process. Its mechanical performance is expected to be equivalent to predicate. |
  | Biocompatibility | The device materials must have acceptable biocompatibility, typically demonstrated by using materials already cleared in predicate devices or by following ISO 10993-1. | The TS Abutment System uses the same materials (e.g., Ti-6Al-4V (ASTM F136), Titanium Gr.3 (ASTM F67), Titanium Gr.4 (ASTM F67)), manufacturer, manufacturing process, and surface treatment as primary predicate and reference devices. Therefore, no additional biocompatibility testing was conducted. |
  | Sterilization Validation | The sterilization process must be validated to ensure sterility, or justified if changes from predicates do not create a new worst-case scenario. For sterile devices, shelf-life must be validated. | For those components provided sterile, the validation of the gamma irradiation process was previously conducted for the predicate device. Changes in dimensions for the subject device do not create a new worst-case scenario for sterilization, thus no additional validation was required. Shelf-life for sterile components (e.g., Transfer Abutment, Angled Abutment, Multi Abutment, Convertible Abutment, Port Abutment, Stud Abutment, Healing Abutment) is established as 8 years. For non-sterile devices made of titanium, no specific shelf-life is considered for the material itself due to its known stability. |
  | Pyrogen Test | Absence of pyrogens to meet established standards (e.g., ISO 10993-11:2006 and USP). | Bacterial Endotoxin Test Report on implants was referenced from K161604, indicating previous compliance. |
  | MR Compatibility | Evaluation of magnetically induced displacement force and torque based on FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." | Non-clinical worst-case MRI review was performed using scientific rationale and published literature (e.g., Woods et al., 2019), addressing parameters for magnetically induced displacement force and torque for all compatible implant bodies, abutments, and fixation screws and material composition. |

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

• Sample Size for Test Set: Not applicable. This submission relies on comparisons to predicate devices and existing standards, not a new test set for performance evaluation in the clinical sense (e.g., diagnostic accuracy).
• Data Provenance: The document references previously cleared 510(k) submissions (e.g., K182091, K161689, K221684, K163634, K161604, K120847) from Osstem Implant Co., Ltd. and one from Southern Implants (Pty) Ltd. The specific country of origin for the data from these predicate clearances is not detailed in this summary, but the manufacturer of the subject device is based in the Republic of Korea. The data is retrospective, as it refers to performance data and justifications from prior clearances.

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" as typically understood in AI/ML diagnostic performance studies was established or used for this device's submission. The evaluation is based on engineering principles, materials science, and conformity to recognized standards.

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

Not applicable. No adjudication method for a 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. This is not an AI-powered device.

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

Not applicable. This is not an AI-powered device.

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

Not applicable. No "ground truth" of this nature was used. The ground truth, in a regulatory sense for this type of device, is conformity to established material specifications, manufacturing processes, and recognized performance standards (like ISO 14801 for fatigue testing).

8. The sample size for the training set

Not applicable. This is not an AI-powered device.

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

Not applicable. This is not an AI-powered device.

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The OSSTEM Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.

SS Abutment System is made of titanium alloy. SS Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

The medical device described in the document is the SS Abutment System from Osstem Implant Co., Ltd. This device is an endosseous dental implant abutment, classified as Class II under regulation 21 CFR 872.3630 with product code NHA.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission claims substantial equivalence to predicate devices, focusing on design, function, indications for use, material, manufacturing process, and performance characteristics. The acceptance criteria are implicitly aligned with the performance characteristics of the predicate devices, particularly regarding mechanical properties, biocompatibility, sterilization, and MR compatibility.

For ComOcta Milling Abutment: Lengths (L 14, L 14.35) not in predicate range, but diameter range is same. Performance: "fatigue of the proposed device is considered to be equal to or greater than that of the predicate device." No additional fatigue testing. Modifiability is within safe limits (min post height 4mm, gingival height 1-3mm, no angulation).

For Port Abutment: Larger diameter (Ø6.06) compared to predicate (Ø4.8), same length range. Performance: "added diameter is bigger than reference device and the lengths 3.5~6.5mm is same as the range of reference device." "not received single load because this is used for making overdenture that means load is dispersed to the full denture. Therefore, we don't consider additional fatigue testing."

For O-ring Abutment: Larger diameter (Ø4.3) compared to predicate (Ø3.5), same gingiva height range. Performance: "added diameter is bigger than reference device and the gingiva height 0~4mm is same as the range of predicate device." "not received single load because this is used for making overdenture that means load is dispersed to the full denture. Therefore, we don't consider additional fatigue testing."

For Closing Screw: Longer dimensions than predicate. Performance: "does not affect safety and effectiveness because it is used to protect the exposed platform of the implant during healing period." No additional fatigue testing. |
| Biocompatibility | Compliance with FDA Guidance Document Use of International Standard ISO 10993-1. The material composition of the device should be safe for biological contact. | "The SS Abutment System has same materials, manufacturer, manufacturing process etc., as predicate devices. Therefore, we didn't conduct additional biocompatibility test." |
| Sterilization Validation | Demonstrated sterility and maintenance of sterility throughout the claimed shelf-life. The sterilization process should be validated and consistent with predicate devices or established methods. | "Validation of the gamma irradiation process was previously conducted for the predicated device. There has been no change to the manufacturing or sterilization processes since then and the subject devices do not present a new worst case for sterilization validation; therefore, additional validation is not required." |
| Shelf-life | Stability and integrity of the device over its claimed shelf-life. | "SS Abutment System are made with titanium and titanium alloy we don't consider about shelf life of material by itself because this metal is widely known that it generally has no adversely affect by aging. Therefore we certify that product such like metal has no shelf life." The predicate device likely had an 8-year shelf life for some components (e.g., Closing Screw), and this is maintained where applicable. |
| MR Compatibility | Safety in the Magnetic Resonance (MR) Environment, including assessment of magnetically induced displacement force and torque, per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." | "Non-clinical worst-case MRI review was performed to evaluate the Subject device components in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance." |

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

The document does not describe a traditional "test set" in the context of a clinical performance study. Instead, performance is established through non-clinical testing and comparison to predicate devices, often leveraging the fact that the subject device either has:

• Identical characteristics to a predicate.
• Dimensions that are considered to offer equivalent or superior performance (e.g., larger diameter on an implant component).
• A different intended use/loading condition (e.g., overdenture dispersing load) that mitigates concerns about increased stress from dimensional changes.

Therefore, there is no sample size for a "test set" from patients or images. The "samples" would be the configurations of the devices tested in laboratory settings (e.g., for fatigue), or the material samples for biocompatibility, or the specific device designs analyzed for MR compatibility. The document does not specify the number of units tested for any of these non-clinical evaluations, but refers to "worst-case scenarios" for mechanical testing, which implies selection of specific configurations deemed most challenging.

Data Provenance: Not applicable as no human or image data is used for performance testing. The "data" comes from laboratory physical testing, material standards, and scientific literature.

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

Not applicable. As this is a non-clinical submission based on substantial equivalence to predicate devices and established standards (e.g., ISO, ASTM, FDA guidance), there is no "ground truth" derived from expert consensus on patient data. The "truth" is based on adherence to engineering and material science principles, and regulatory guidelines.

4. Adjudication method for the test set

Not applicable for the reasons outlined in point 3.

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 dental implant abutment, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This is a physical medical device, not a software algorithm.

7. The type of ground truth used

The "ground truth" for this submission is based on:

• Standards and Guidance Documents: ISO 14801 for fatigue testing, ISO 10993-1 for biocompatibility, and FDA guidance documents for dental implants and MR compatibility.
• Material Science: Established properties of Titanium Alloy (ASTM F136), Titanium Gr 3 & 4 (ASTM F67), and POM (Polyoxymethylene).
• Existing Validations: Relying on previous biocompatibility, sterilization, and shelf-life validations performed for predicate devices with identical materials, manufacturing processes, or for which the subject device does not represent a new worst-case.
• Scientific Rationale: For MR compatibility, scientific literature and rationale are used.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable for the reasons outlined in point 8.

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N1 is a dental portable X-ray imaging system that captures radiographic images for dental diagnosis using intraoral imaging sensors. Only trained and qualified dental practitioner or radiologist shall use N1 to diagnose and treat diseases related to the teeth, jaws, and/or other oral structures in adults and children.

N1 is a portable dental X-ray imaging device powered by a rechargeable lithium polymer battery pack. It generates X-rays optimized for dental examinations (on teeth, etc.). The N1's X-ray generator equipped with an X-ray tube consists of control unit, user interface, X-ray aperture (collimator), a back-scatter shielding glass, and remote irradiation switch. The x-ray detectors (digital detectors or analog film) are not accessories for use with the N1. N1 is a product designed to diagnose the conditions of teeth through X-irradiation using its intraoral imaging sensors. Software is included for operation and configuration of the N1. It is of Moderate level of concern and it's not based on the predicate software.

The provided FDA 510(k) summary for the N1 device (K232012) does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria beyond general safety and electrical compliance.

The document states:

• "No clinical studies are submitted." (Page 5, Section 8)
• "We performed the applicable non-clinical tests in the FDA guidance document for solid state x-ray detectors. The digital detectors used for testing are not part of the subject device." (Page 5, Section 7)
• "Software validation and verification test, EMC/Electrical Safety tests, and performance tests were conducted and the test results support that the subject device is substantially equivalent to the predicate device." (Page 5, Section 7)
• The conclusion mentions some differences in specifications but states, "there was no significant difference in the safety / performance of the product, and it was confirmed that the Portable dental X-ray imaging device had better performance than the equivalent device in some specifications." (Page 6, Section 9) This implies a comparison to a predicate device, but no specific performance metrics or acceptance criteria are detailed.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving those criteria are met from this document. The submission focuses on demonstrating substantial equivalence to a predicate device primarily through non-clinical testing (electrical safety, EMC, software verification/validation) and comparing technical specifications, rather than reporting on a clinical or performance study with defined acceptance criteria for diagnostic accuracy or effectiveness.

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The Osstem Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-units restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra wide Implant System is intended to be used in the molar region.

Products with diameter of less than 3.25mm should be used exclusively for the lateral incisor in the maxilla and a central or lateral incisor in the mandible.

The Osstem Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. The Ultra-Wide implants are intended to be used only to replace molar teeth and angled abutments are not to be used with the Ultra-Wide implants.

Osstem Implant System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.

Here's an analysis of the provided text to extract information about acceptance criteria and the supporting study:

The document is a 510(k) summary for the Osstem Implant System, seeking substantial equivalence to predicate devices. As such, it focuses on demonstrating that the new device modifications (primarily additional dimensions and a non-hex connection for some implants) are as safe and effective as the previously cleared predicate devices. Therefore, the "acceptance criteria" discussed are primarily about meeting existing performance standards (like ISO 14801 for fatigue testing) and demonstrating consistency with the predicate devices in terms of materials, manufacturing, indications for use, etc.

Since this is a substantial equivalence submission for a dental implant system involving physical product variations rather than a novel AI/software device, many of the typical AI-specific criteria (like MRMC studies, effect size of AI assistance, standalone algorithm performance, number of experts for ground truth, adjudication methods, training set size/ground truth establishment) are generally not applicable or explicitly stated in the context of this traditional medical device submission.

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

For the specific modifications in the proposed device, the primary acceptance criterion for mechanical performance is successful fatigue testing according to ISO 14801:2016 for the worst-case scenario. Other performance criteria are met by leveraging tests performed on predicate devices, demonstrating equivalence in materials, manufacturing, and design principles.

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

• Fatigue Testing (ISO 14801:2016): The document mentions "worst-case implant-abutment combination" was chosen. ISO 14801 typically specifies minimum sample sizes (e.g., 5 or 10 samples per test condition for static or dynamic testing). The exact number of samples tested for the new Non-Hex implants is not explicitly stated in this summary, nor is the provenance of the test data (e.g., conducted in-house, by a certified lab). However, such tests are generally conducted prospectively on newly manufactured devices or representative samples.
• Other tests (Sterilization, Shelf-Life, Biocompatibility, Bacterial Endotoxin): These were leveraged from predicate devices (K121585, K121995, K161604). The sample sizes and provenance for those original predicate device studies are not detailed in this submission.

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 for this type of device submission. This is a mechanical and material performance evaluation, not a diagnostic or interpretative device requiring clinical expert ground truth for a test set. Design requirements and performance standards (like ISO 14801) define the "ground truth" to be met.

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

• Not applicable for this type of device submission. Adjudication methods are typically used in clinical or image-based studies to resolve discrepancies among experts.

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 dental implant system, not a diagnostic or AI-assisted device.

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

• Not applicable. This is a hardware medical device; there is no algorithm or AI component for standalone performance.

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

• For mechanical performance (like fatigue testing), the "ground truth" is defined by international standards (ISO 14801:2016) and applicable FDA guidance documents. These standards specify test methods, failure criteria, and acceptable performance limits for dental implants.
• For material and biological compatibility, the "ground truth" is established by adherence to ISO 10993 standards for biocompatibility, ISO 11137 for sterilization, and ASTM F1980 for shelf-life. These are laboratory-based, objective performance measures.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set. The device design and materials are based on established engineering principles and prior predicate devices.

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

• Not applicable.

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The OSSTEM Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

Osstem Abutment System is compatible with the following implant systems.
Osstem Implant Co., Ltd. TS SA Fixture Internal Hex 3.2, 3.5, 3.75, 3.77, 4.2, 4.25, 4.4, 4.6, 4.63, 4.65, 4.8, 4.9, 5.05, 5.08, 5.1, 5.25, 5.92, 5.95, 6, 6.2, 6.8, 7.1
Osstem Implant Co., Ltd. US SA Fixture External Hex 3.6, 4.2, 5.1, 5.2
Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Osstem Abutment System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.
Osstem Abutment System is substantially equivalent in design, function and intended use to the predicate devices as above.

The provided text is a 510(k) Summary for the Osstem Abutment System, which aims to demonstrate substantial equivalence to previously cleared predicate devices. It does not contain information related to an AI/ML-driven medical device, nor does it conduct a study measuring medical device performance against specific acceptance criteria in the manner one would see for an AI/ML model for diagnostic or prognostic purposes.

The document discusses non-clinical performance testing to support substantial equivalence, primarily focusing on materials, design, and mechanical properties (fatigue testing). It explicitly states:

• "Non-clinical testing data are submitted to demonstrate substantial equivalence." (Page 10)
• "No clinical studies are submitted." (Page 11)

Therefore, I cannot fulfill the request as it asks for information typically found in submissions for AI/ML-driven diagnostic devices, such as:

• A table of acceptance criteria and reported device performance (in terms of clinical metrics like sensitivity, specificity, AUC)
• Sample sizes for test sets, data provenance
• Number of experts and their qualifications for ground truth
• Adjudication methods
• MRMC comparative effectiveness study results
• Standalone performance
• Type of ground truth
• Training set sample size and ground truth establishment

The document presents a comparison to predicate devices, stating that new dimensions or minor design changes are not considered "worst-case" for fatigue given existing predicate device testing, thus negating the need for additional testing in some instances. It relies on the substantial equivalence principle, which means the device is as safe and effective as a legally marketed device.

In summary, the provided text does not contain the specific information required to answer your detailed questions about acceptance criteria, study design, and performance metrics for an AI/ML device.

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T2 is digital X-Ray imaging equipment for dental professionals that convert X-Ray signals into digital signals to acquire 2D images and reconstruct them into 3D images, using Panoramic (Pano), Cephalometric (Ceph), and Computed Tomography (CT) technology for the diagnosis of the anatomical structure of the oral and maxillofacial area.

T2 is a digital X-ray CT, panoramic, and Cephalo imaging system device composed of X-ray generator, X-ray controller, X-ray supporter, image processing unit (sensor), PC, and software. The apparatus attached to the equipment column is a structure that can be rotated 360 by the system control unit. This system control unit actuates the motor control, X-ray generator, and image processing unit (sensor). The height controlling unit controls the column and adjusts the height of the equipment. The X-ray generator and image processing unit (sensor) are attached to the rotating apparatus. When the rotating apparatus starts the rotation, X-ray is irradiated from the X-ray generator (generating unit). This X-ray irradiation penetrates the subject and reaches the image processing unit (sensor), and then is converted into electric signals to secure imagery information. Inside the imaging section of the image processing unit (sensor), real time X-ray input is converted into electric signals and consecutively combined, resulting in imagery information. The combined panoramic imagery information is then sent to the PC and saved in patient management software.

The provided document is a 510(k) summary for the T2 imaging device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with acceptance criteria.

Therefore, many of the requested details regarding acceptance criteria for clinical performance, sample sizes, expert qualifications, and ground truth establishment from a clinical trial perspective are not available in this document. The document explicitly states: "No clinical studies are submitted."

Here's a breakdown of the available information based on the prompt's questions:

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

The document does not provide specific acceptance criteria or reported device performance in terms of clinical accuracy (e.g., sensitivity, specificity) against a clinical ground truth. Instead, the substantial equivalence hinges on non-clinical performance tests demonstrating compliance with relevant standards and technical specifications being similar to the predicate device.

The closest to "acceptance criteria" are the performance specifications listed in the "Substantial Equivalence Matrix" (pages 4-5) which compare the proposed device (T2) to the predicate device (T1-CS, T1-C). These are primarily technical specifications rather than diagnostic performance metrics.

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, as no clinical studies were submitted. Non-clinical performance tests were conducted, but details on the "test set" for those are not provided in terms of origin or type (e.g., phantom data).

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, as no clinical studies were submitted.

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

Not applicable, as no clinical studies were submitted.

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 T2 device is an X-ray imaging system, not an AI-assisted diagnostic tool. No clinical studies, let alone MRMC studies, were reported.

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

Not applicable. The T2 device is an X-ray imaging system, not an AI algorithm. Its performance is related to image acquisition and reconstruction, not autonomous diagnostic interpretation.

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

Not applicable, as no clinical studies were submitted. For the non-clinical performance, the "ground truth" would be established by physical measurements and adherence to technical standards.

8. The sample size for the training set

Not applicable. This device is a hardware imaging system, not a machine learning algorithm that requires a training set in the conventional sense.

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

Not applicable. This device is a hardware imaging system, not a machine learning algorithm.

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