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The HIOSSEN Pre-milled Abutments are intended for use with HIOSSEN dental implants to provide support for prosthetic restorations such as crowns, bridges or overdentures. All digitally designed CAD/CAM customizations for the HIOSSSEN Pre-milled Abutments are intended to be sent to a HIOSSEN validated milling facility.

HIOSSEN Pre-milled Abutments are intended to support prosthetic restorations such as crowns, bridges or overdentures and used only with the Hiossen implant fixtures. HIOSSEN Pre-milled Abutments are customized (Milled) as per the patient specific requirements in the Hiossen validated milling laboratory. The HIOSSEN Pre-milled Abutments are designed and manufactured by Hiossen, Inc.

The HIOSSEN Pre-milled Abutments are Ti-6Al-4V titanium alloy (ASTM F136) cylindrical "blanks" with HIOSSEN dental implant-specific interface (abutment to implant connection and screw channel) to be designed and milled at a HIOSSEN validated milling facility using CAD/CAM technology to fabricate a patient-specific abutment.

The blank cylindrical HIOSSEN Pre-milled Abutments are supplied to the Hiossen validated milling centre. Based on the design requirements provided by the dentist, the lab will design abutment using 510k cleared CAD software and blank cylinders will be milled using the CAM machine. This customized patient specific milled abutment will be sent back to the dentist for implantation into the patient after steam sterilization.

Here's a summary of the acceptance criteria and study information for the HIOSSEN Pre-milled Abutment device, based on the provided FDA 510(k) K241003 submission:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) submission for the HIOSSEN Pre-milled Abutment does not list specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) in the way one might see for AI/software devices. Instead, the acceptance criteria are met by demonstrating compliance with established performance standards and regulations for this type of medical device. The "reported device performance" is demonstrated through successful compliance with these standards and the comparison to legally marketed predicate and reference devices.

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

The submission does not describe a traditional "test set" in the context of an algorithm or software requiring a dataset for performance evaluation. This device is a physical dental abutment. The "testing" refers to compliance with performance standards for physical properties, materials, and processes, rather than a data-driven performance study.

Therefore, information on sample size for a test set, data provenance (e.g., country of origin, retrospective/prospective), number of experts, adjudication methods, MRMC studies, or standalone algorithm performance is not applicable or not provided for this type of medical device submission.

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

Not applicable, as this is a physical medical device clearance, not an AI/software performance study involving ground truth establishment by experts on a dataset.

4. Adjudication Method for the Test Set

Not applicable for the same reasons as above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a physical dental abutment, not an AI-assisted diagnostic or therapeutic device for which a MRMC study would be relevant.

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

Not applicable. This is a physical device, and there is no "algorithm only" component in the sense of AI software being evaluated for standalone performance. The CAD/CAM technology is part of the manufacturing process, not an independent diagnostic or interpretive algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

Not applicable. For this device, "ground truth" is established through engineering specifications, material standards, and validated manufacturing processes (e.g., accuracy of milling, material composition conformity), rather than clinical ground truth from human interpretation of data.

8. The Sample Size for the Training Set

Not applicable. The device is a physical product. While CAD/CAM technology is used in its customization, the submission does not refer to "training sets" in the context of machine learning. The "training" here would refer to the development and validation of the CAD/CAM technical specifications and milling processes.

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

Not applicable for the same reasons as above. The "ground truth" for the manufacturing process involves adherence to design specifications, material properties, and validated milling parameters.

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The EK Dental Implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented, screw or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is indicated for delayed loading. Ultra wide versions are indicated for use in the molar region only.

The EK Dental Implants (Ø3.5mm & Ø3.3mm) are made of titanium alloy (Ti 6Al 4V) for Fixtures and Simple Mount and pure titanium for Cover Screw. The EK Dental Implants (Ø3.5mm & Ø3.3mm) are indicated for use in mandibular and maxillary lateral and central incisor, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

The EK D3.3 and Ultra Wide Dental Implants are intended to be surgically placed in the bone of the upper or lower jaw arches, providing support to prosthetic devices to restore normal chewing functions. There are two types: SA and NH, both are bone level implants with the exact same internal hex, tapered body, use the same components and prosthetic parts, are manufactured from the same medical grade titanium materials and sterilized via gamma radiation. They only difference is the surface; SA is sand blasted and acid etched and NH is sand blasted and acid etched plus treated with a layer of low crystalline HA and super hydrophilic coating.

The EK D3.3 and Ultra Wide Dental Implants are available in various lengths and diameters; configurations are listed in the table below.

This document describes the premarket notification (510(k)) for the EK D3.3 and Ultra Wide Dental Implants. It focuses on establishing substantial equivalence to previously cleared predicate devices rather than providing a study demonstrating performance against specific acceptance criteria for a new device's efficacy or safety.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria for a new device's performance. Instead, it relies on demonstrating that the new device (EK D3.3 and Ultra Wide Dental Implants) is substantially equivalent to existing, legally marketed predicate devices, thereby leveraging their established safety and effectiveness.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

• No new acceptance criteria: The document is a 510(k) summary, which aims to show substantial equivalence. It does not define new, quantitative acceptance criteria for this specific device's novel performance.
• No new performance study: The document explicitly states "No clinical performance report(s) is being submitted." The non-clinical data section describes various tests (Biocompatibility, Sterilization Validation, Shelf Life, Surface Treatment Characterization, Fatigue Testing, MR conditional) where the new device is either identical to the predicate, uses the same processes/materials, or is referenced from existing data. These are comparative tests to support equivalence, not studies proving performance against a set of newly established acceptance criteria for a novel AI device or a device requiring new clinical evidence of effectiveness.
• No AI component: The device described is a dental implant, a physical medical device, not an AI/ML-driven device. Thus, questions regarding AI-specific criteria (MRMC studies, standalone performance, ground truth establishment) are not applicable.

In summary, the provided text details a regulatory submission leveraging substantial equivalence, not a study demonstrating a device's performance against specific acceptance criteria.

To answer your prompt, I would need a document describing a new device that underwent a performance study to prove its efficacy or safety against pre-defined acceptance criteria, ideally including an AI/ML component if you intend to ask about those specific details.

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EK DIGITAL ABUTMENTS are intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

EK DIGITAL ABUTMENTS are digitally designed patient specific abutments manufactured from titanium Alloy (Ti-6AI-4V ELI) and titanium alloy + zirconia. The EK Hybrid abutments are a two-piece abutment consisting of a pre-manufactured titanium base (ASTM F136) and a CAD/CAM patient-matched mesostructure component (ISO 6872) and PANAVIA F 2.0 (K032455) cement is used to attach the two structures. They are intended only for use with HIOSSEN EK dental implants to provide support for customized prosthetic restorations. EK DIGITAL ABUTMENTS are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. Each EK DIGITAL ABUTMENT is individually prescribed by the clinician.

The provided text is a 510(k) Summary for the EK Digital Abutments and does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria, especially in the context of an AI/ML powered device. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, manufacturing processes, and mechanical testing.

However, I can extract the information that is present concerning performance and testing:

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

The document does not explicitly state acceptance criteria in a quantitative manner for specific performance metrics. It indicates that the device's mechanical properties were evaluated against the ISO 14801 standard.

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 mentions "The worst case implant and titanium abutments" were chosen for the mechanical fatigue tests. It does not specify the exact number of samples or details on data provenance (country of origin, retrospective/prospective).

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

This section is not applicable as the study described is a mechanical fatigue test of a physical device, not an AI/ML powered device relying on expert-established ground truth.

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

This section is not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The device is a physical dental abutment, not an AI/ML diagnostic tool.

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

This section is not applicable.

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

For the mechanical fatigue testing, the "ground truth" is defined by the physical failure of the samples under controlled load and cycling conditions, as specified by the ISO 14801 standard. This is a physical, objective measurement rather than an expert interpretation or pathology.

8. The sample size for the training set

This section is not applicable as there is no mention of a training set, indicating this is not an AI/ML device.

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

This section is not applicable as there is no mention of a training set.

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The ET Abutment System are indicated for use with ET Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients.

The ET Abutment System are indicated for use with ET dental implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients. Manufactured from medical grade titanium alloy and delivered non-sterilized. The ET Abutments are available in various lengths and diameters; configurations are listed in the table below.

This document describes a 510(k) premarket notification for a medical device called the "ET Abutment System," which is an endosseous dental implant abutment. The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through de novo clinical trials.

Therefore, the submission does not contain information about specific "acceptance criteria" for an AI algorithm's performance, nor does it detail a study proving such a device meets these criteria in the typical sense of AI/ML performance evaluation. The "studies" referenced are non-clinical bench tests demonstrating the physical and material properties of the dental abutments are comparable to existing, legally marketed devices.

Based on the provided text, here's an analysis of the "acceptance criteria" and "proof" in the context of this 510(k) submission:

The acceptance criteria and proof fundamentally revolve around demonstrating substantial equivalence to predicate devices, not performance against a specific clinical metric for an AI algorithm.

Missing Information:

The document concerns a physical dental device (abutment system), not an AI/ML powered device. As such, the concept of "acceptance criteria" for AI performance, clinical study design for AI (sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, etc.) are not applicable to this submission. The FDA letter confirms the device type: "Endosseous Dental Implant Abutment."

However, to address the prompt's implied need for "acceptance criteria" and "studies" as they relate to this specific device (dental abutment), I will interpret the request within the context of a 510(k) submission for a non-AI medical device.

1. Table of Acceptance Criteria and Reported Device Performance (as interpreted for a Dental Abutment System)

In a 510(k) submission for a dental abutment, "acceptance criteria" are typically defined by demonstrating that the proposed device has the same technological characteristics and similar performance to legally marketed predicate devices, or that differences do not raise new questions of safety and effectiveness. The "reported device performance" comes from non-clinical bench testing.

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

Since this is a physical medical device submission and not an AI/ML algorithm:

• Sample Size for Test Set: Not applicable in the context of an AI test set. For physical device testing, the sample sizes would be determined by the relevant ISO standards (e.g., ISO 14801 for fatigue testing). These specific numbers are not detailed in the summary but are typically part of detailed test reports that support the conclusion of substantial equivalence.
• Data Provenance: The data comes from non-clinical testing (bench tests) performed to standard specifications (e.g., ISO 14801). The "ET Abutment System are contract manufactured by the predicate device manufacturer," implying the manufacturing process and potentially some historical performance data are shared or directly comparable.
  • Country of Origin: Not specified for the non-clinical test data itself, but the applicant (Hiossen Inc.) is in Fairless Hills, Pennsylvania, USA. The predicate manufacturer (Osstem Implant Co., Ltd.) is generally based in South Korea, suggesting potential international collaboration or shared manufacturing data.
  • Retrospective or Prospective: Not applicable in the context of patient data. The non-clinical tests would be conducted prospectively on newly manufactured devices.

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

• This concept is not applicable as this is not an AI/ML diagnostic or image analysis device that requires expert labeling or interpretation for "ground truth." The "ground truth" here is the adherence to material specifications, dimensional tolerances, and performance under specific mechanical and biological test conditions as defined by international standards.

4. Adjudication Method for the Test Set

• This concept is not applicable as there is no "test set" in the sense of clinical cases requiring interpretation or adjudication by multiple readers/experts. Performance is based on mechanical, material, and sterilization testing against predefined standards.

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

• Not applicable. This type of study is for evaluating human performance with or without AI assistance, typically in image interpretation or diagnosis. This submission is for a physical dental implant component. The document explicitly states: "No clinical performance report(s) is being submitted."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not applicable. This pertains to AI algorithm performance.

7. Type of Ground Truth Used

• The "ground truth" for this device's acceptance is based on engineering standards, material specifications, and performance data from validated non-clinical bench tests. This includes:
  • ASTM (American Society for Testing and Materials) standards for materials (e.g., ASTM F136 for titanium alloy).
  • ISO (International Organization for Standardization) standards for testing medical devices (e.g., ISO 14801 for fatigue testing of dental implants, ISO 17665-1 for moist heat sterilization).
  • FDA guidance documents (e.g., "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments," "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment").
  • Direct comparison to the established characteristics and performance of the legally marketed predicate devices.

8. Sample Size for the Training Set

• Not applicable. This concept relates to AI/ML model development. There is no "training set" for a physical dental abutment. The device's design and manufacturing rely on established engineering principles and prior knowledge from the predicate device.

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

• Not applicable. Again, this refers to AI/ML model training. The "ground truth" for developing a physical device is derived from engineering design principles, material science, and the performance history of similar devices.

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The EK Dental Implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented, screw or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is indicated for delayed loading. Ultra wide versions are indicated for use in the molar region only.

The EK Dental Implants (Ø3.5mm) are made of titanium alloy (Ti 6Al 4V) for Fixtures and Simple Mount and pure titanium for Cover Screw. The EK Dental Implants (Ø3.5mm) are indicated for use in mandibular and maxillary lateral and central incisor, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

The EK Dental Abutments are indicated for use with EK Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients.

The EK Dental Implants are intended to be surgically placed in the bone of the upper or lower jaw arches, providing support to prosthetic devices to restore normal chewing functions. There are two types: SA and NH, both are bone level implants with the exact same internal hex, tapered body, use the same EK Dental Abutments, are manufactured from the same medical grade titanium materials and sterilized via gamma radiation. They only difference is the surface; SA is sand blasted and acid etched and NH which is SA + Dglucose + NaCI.

The EK Dental Abutments are indicated for use with EK Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients. Manufactured from medical grade titanium alloy and delivered non-sterilized.

The EK Dental Implants and Abutments are available in various lengths and diameters; configurations are listed in the table below.

The provided document is a 510(k) premarket notification for dental implants and abutments. It focuses on demonstrating substantial equivalence to previously cleared devices, rather than proving the device meets specific acceptance criteria through a clinical or performance study with a test set, ground truth, or expert readers as typically seen for novel AI/ML medical devices.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not directly applicable to this type of submission.

Instead, the document demonstrates substantial equivalence by comparing the proposed EK Dental Implants and Abutments to predicate and reference devices across several key characteristics:

• Intended Use: The proposed devices have the same intended use as the predicate devices (supporting single or multiple-unit restorations in edentulous mandibles and maxillae, for delayed loading).
• Design/Structure: The proposed implants have an internal hex connection, are submerged fixtures, and have a tapered body shape, similar to the predicate devices. The abutments are also comparable in design to their reference devices.
• Material: The implants use Pure Titanium Grade 4 (ASTM F67) and Titanium alloy Ti-6Al-4V (ASTM F136), which are standard materials also used in the predicate devices. Abutments use similar materials (Ti-6Al-4V, Co-Cr-Mo Alloy, Gold alloy as per the reference devices).
• Surface Treatment: The implants employ SA (Sandblasted and Acid etched) and NH (SA + D-glucose + NaCl) surfaces, which are consistent with the predicate and reference devices.
• Sterilization: Implants are gamma irradiated, and abutments are provided non-sterile for steam sterilization by the user, matching the predicate/reference devices.
• Packaging: Similar packaging methods are used as the predicate devices.
• Performance Characteristics (Non-Clinical):
  • Biocompatibility: Not re-tested, as the materials and manufacturing processes are the same as predicate/reference devices.
  • Sterilization Validation: Not re-tested for implants (same process as predicate) or for abutments (provided non-sterile like reference devices, with user steam sterilization).
  • Shelf Life: Not re-validated for implants (same as predicate's 8-year validated shelf life and packaging) or for abutments (non-sterile, non-mechanical, no stated shelf life, similar to reference devices).
  • Surface Treatment Characterization: Not re-tested, as surfaces are manufactured using the same process and materials as predicate/reference devices.
  • Fatigue Testing: Conducted in accordance with ISO 14801. The worst-case implant and abutment configurations withstood 5,000,000 cycles without failure at a substantially equivalent load to the primary predicate.
• Clinical Performance Testing: No clinical performance report(s) were submitted, indicating that substantial equivalence was demonstrated through non-clinical data and comparison to predicates.

In a 510(k) substantial equivalence submission for a traditional medical device like a dental implant, the "acceptance criteria" are effectively the demonstration of sufficient similarity in technological characteristics and performance (often non-clinical) to a legally marketed predicate device. The "study" proving this device meets the "acceptance criteria" is the comprehensive comparison outlined above, coupled with relevant non-clinical testing (like fatigue testing).

Therefore, I cannot populate the table or answer the specific questions in the format requested, as they pertain to a different type of validation study (e.g., for an AI/ML diagnostic algorithm, which would involve a test set, ground truth established by experts, and statistical performance metrics).

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The EM Provisional is intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of a permanent endosseous dental implant(s).

The EM Provisional is a dental implant made of titanium alloy (Ti-6Al-4V) and is supplied sterile. The surface is machined finished and is intended to be surgically placed in the bone of the upper or lower jaw arches.

This document is a 510(k) Premarket Notification from Hiossen, Inc. for their dental implant device, EM Provisional. According to the provided text, this submission argues for "substantial equivalence" of the EM Provisional to existing predicate devices, rather than presenting a study proving a device meets specific performance criteria through a clinical or non-clinical study that would generate the kind of data typically found in an AI/software as a medical device (SaMD) submission.

Therefore, the requested information, specifically regarding acceptance criteria, device performance from a test set, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details, is not available in this document. This document primarily focuses on demonstrating that the new device (EM Provisional) is structurally and functionally equivalent to already cleared devices, meaning it does not pose new or increased risks and performs similarly.

Instead of performance metrics from a new study, the document makes the following arguments for substantial equivalence:

1. Acceptance Criteria and Device Performance (as presented in this substantial equivalence argument, not a performance study):

The "acceptance criteria" here relate to the device being substantially equivalent to its predicate. The "performance" is demonstrated by asserting similarity in design, materials, and manufacturing, rather than through measured accuracy, sensitivity, or specificity.

• Screw form
• One-piece fixture and abutment
• Available in diameters: Ø1.8, Ø2.5 mm
• Available in lengths: 10.0, 13.0, 15.0 mm |
  | Material Equivalence | Both EM Provisional and the predicate MS System (Provisional) are made of Titanium alloy Ti-6Al-4V (ASTM F 136). |
  | Surface Finish Equivalence | Both EM Provisional and the predicate MS System (Provisional) have a machined finished surface. |
  | Sterilization Equivalence | Both EM Provisional and the predicate MS System (Provisional) are Radiation Sterile, and the EM Provisional uses the same manufacturing process, material, and sterilize barrier system as the predicate. |
  | Packaging Equivalence | EM Provisional packaging is consistent with the predicate: Secured in plastic ampule, housed in Tyvek-lidded blister tray, placed in a tamper-evident outer package (predicate uses "outer box" but intent is the same). The reference device (Hiossen Implant System K140934) also uses similar packaging. |
  | Risk Equivalence | The proposed device does not pose any new or increased risks as compared to the legally marketed predicate and reference devices. Asserted due to identical manufacturing processes, materials, and design to the predicate, making re-testing for biocompatibility, sterilization validation, surface treatment characterization, fatigue, compressive strength, and pull-out unnecessary per the "least burdensome principle." No clinical performance reports were submitted, reinforcing reliance on equivalence to existing devices. |

2. Sample size used for the test set and the data provenance:
Not applicable. There was no "test set" in the context of an AI/SaMD performance study. The submission relies on pre-existing data and knowledge of the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No new ground truth was established for a performance study. Equivalence is asserted based on engineering and material comparisons.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication process for a test set was performed.

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, not an AI/SaMD.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical dental implant, not an AI/SaMD.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable. Ground truth as typically understood for SaMD performance studies is not relevant here. The ground for "equivalence" is based on established performance and safety profiles of the predicate device.

8. The sample size for the training set:
Not applicable. This device is a physical dental implant, not an AI/SaMD.

9. How the ground truth for the training set was established:
Not applicable. This device is a physical dental implant, not an AI/SaMD.

In summary, this document demonstrates substantial equivalence of a physical dental implant to a legally marketed predicate device based on similarities in design, materials, and intended use, rather than through a novel performance study proving it meets specific acceptance criteria typically associated with SaMD or other complex medical devices requiring such studies.

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The EM SA Implant System (DENTURE) is intended to be place in the bone of the upper or lower jaw arches providing support to dental prosthetic devices, specifically for denture stabilization to restore a patient's chewing function. It is intended for single use only.

The EM SA Implant (NARROW RIDGE) is intended to be use in the treatment of missing mandibular central and lateral incisors to support dental prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. It is intended for single use only. It is intended for delayed loading.

The EM SA Implant System is a dental implant made of titanium alloy (Ti-6AI-4V) and is supplied sterile. The surface treatment of EM SA Implant System is SA (Sandblasted and Acid etched) and is intended to be surgically placed in the bone of the upper or lower jaw arches.

The EM SA Implant System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. It is substantially equivalent in design, function and intended use to the OSSTEM Implant Co., Ltd.'s MS SA Implant System (K122171).

The provided text is a 510(k) Pre-market Notification for the Hiossen EM SA Implant System. This document asserts substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with performance metrics. Therefore, it does not contain the detailed information requested in the prompt regarding acceptance criteria, study design, sample sizes for test and training sets, data provenance, expert ground truth, adjudication methods, or MRMC comparative effectiveness studies.

Here's an explanation of why the requested information is not available in the provided text:

• 510(k) Pre-market Notification: This regulatory pathway demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, indications for use, and performance characteristics to existing devices, rather than conducting new, comprehensive clinical performance studies to prove superiority or meet novel performance criteria as might be seen for PMA submissions or novel AI devices.
• Medical Device Type: The EM SA Implant System is an endosseous dental implant, which is a physical device made of titanium alloy. The "device" in this context is a physical implant, not an AI/ML algorithm or software. Therefore, the questions related to AI/ML specific aspects like "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the loop performance)," or "sample size for the training set" are not applicable.
• Focus on Equivalence: The document's primary goal is to establish equivalence. It emphasizes that the new device uses the same materials, manufacturing processes, surface treatments, sterilization methods, and has similar designs to predicate devices. This implies that if the predicate devices meet safety and effectiveness standards, the new device, being substantially equivalent, should also.

Based on the provided text, here is what can be extracted or deduced regarding the evaluation process for this specific medical device submission, recognizing that it's not an AI/ML device and thus many questions are not directly applicable:

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

The document does not explicitly state quantitative acceptance criteria or precise performance metrics in the format typically seen for novel device performance studies. Instead, it aims to demonstrate substantial equivalence to predicate devices, implying that its performance is comparable and therefore acceptable.

A summary of the comparison to predicate devices, which serves as the basis for "acceptance" (of equivalence):

The document concludes that the proposed device is "substantially equivalent with respect to the intended use, structure, material, surface, sterilization and design with the legally marketed primary predicate device" and that "The slight difference in thread diameter and length is a simple size addition. The proposed device does not pose any new or increased risks as compared to the legally marketed primary predicate and reference devices."

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

• Test Set Sample Size: Not applicable. No clinical performance testing with a "test set" was submitted for this 510(k) pathway as per the document: "No clinical performance report(s) is being submitted."
• Data Provenance: Not applicable. The submission relies on non-clinical data (biocompatibility, sterilization, shelf life, surface treatment, fatigue testing) which were either reasoned not necessary to re-test due to equivalence to predicates using identical processes and materials, or demonstrated compliance with international standards (e.g., ISO 11137 for sterilization, ISO 11607-1 for shelf life). These are laboratory/engineering tests, not patient 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. There was no clinical "test set" or requirement for expert-established ground truth mentioned in this 510(k) submission.

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

• Not applicable. No "test set" was used for clinical performance evaluation.

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, not an AI/ML software or system that would involve human "readers" or AI assistance.

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

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

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

• Not applicable in the clinical trial sense. The "ground truth" for this submission revolves around established engineering and material science standards. For example:
  • Biocompatibility: Established by demonstrating the use of identical manufacturing processes and materials (titanium alloy Ti-6Al-4V, ASTM F 136) as the predicate device, which is a "well known and well established material." Compliance with ISO 10993 (Biological Evaluation of Medical Devices) is implied through equivalence.
  • Sterilization Validation: Established by demonstrating identity to the predicate device in manufacturing process, material, sterile barrier system, and use of gamma radiation under the same conditions, validated following ISO 11137.
  • Shelf Life: Established by demonstrating identical packaging materials & methods as a reference device (Hiossen Implant System, K140934) which had an 8-year shelf life validated per ISO 11607-1, and stating the device is medical grade titanium, non-mechanical, non-active.
  • Surface Treatment Characterization: Established by demonstrating identical manufacturing process, material, and SA (Sandblasted, Acid etched) surface treatment as the predicate device.
  • Fatigue Testing: Established by demonstrating identical manufacturing process, material, and "very similar design" to a predicate device (MS SA) that was fatigue tested in accordance with ISO 14801:2003.

8. The sample size for the training set

• Not applicable. This device is a physical implant; there is no "training set" in the context of an AI/ML algorithm.

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

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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The ET IV SA Dental Implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented, screw or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra wide version is intended to be used in the molar region.

The ET IV SA Dental Implants are dental implants made from medical grade pure titanium metal (ASTM F67) and is supplied sterile. It is intended to be surgically placed in the bone of the upper or lower jaw arches. The ET IV SA Dental Implant is available in various lengths from 7.0 to 15mm and diameters from 4.4 to 7.1mm. The surface is SA: Sand blasted and Acid etched.

The provided text describes the ET IV SA Dental Implants, a dental implant system. The document is a 510(k) premarket notification summary from the FDA.

Here's an analysis of the provided text in relation to your request about acceptance criteria and studies:

Key Takeaway: This document does not contain specific acceptance criteria or an independently conducted study to prove the device directly meets acceptance criteria in the typical sense of a clinical trial or algorithm performance study. Instead, it argues for substantial equivalence to previously cleared predicate devices based on non-clinical testing and comparison of characteristics. Therefore, many of your requested points are not applicable or cannot be extracted directly from this type of FDA submission.

However, I will extract relevant information where available and note when information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, specific performance acceptance criteria and direct performance metrics in comparison to those criteria are not provided in this 510(k) submission. The document focuses on showing the new device is substantially equivalent to predicate devices. The "reported device performance" is essentially that it performs equivalently to the predicate devices in the tested categories.

The subsequent points (2-9) are largely for studies involving AI/ML algorithms or clinical trials with ground truth establishment, which are not present in this document. However, I will address them to indicate their absence or provide the most relevant information given the context.

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

• Not applicable / Not provided: This document describes a medical device (dental implant) that underwent non-clinical performance testing (biocompatibility, sterilization validation, fatigue testing) based on existing data from predicate devices, rather than a new "test set" of patient data in the context of an algorithm or diagnostic study.

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

• Not applicable / Not provided: Ground truth establishment by experts is typically relevant for diagnostic or AI/ML device studies. The assessments here are based on engineering comparisons and material properties, referencing established standards (e.g., ISO 14801:2007 for fatigue testing) rather than adjudicated expert interpretations of a dataset.

4. Adjudication method for the test set

• Not applicable / Not provided: No multi-reader adjudication process is mentioned, as this is not a study involving interpretations by multiple readers.

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: No MRMC study was conducted or is relevant for this type of dental implant submission. This device does not involve AI assistance for human readers.

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

• No: This device is a physical dental implant, not an algorithm. Standalone algorithm performance is not applicable.

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

• Not applicable / Indirectly: For the non-clinical tests referenced:
  • Biocompatibility: Ground truth is established by compliance with biocompatibility standards (e.g., ISO 10993 series), and relying on the predicate device's compliance.
  • Sterilization Validation: Ground truth is compliance with sterilization standards (e.g., ISO 11137 for radiation sterilization), relying on the predicate device's compliance.
  • Fatigue Testing: Ground truth is established by meeting the requirements of ISO 14801:2007 for dental implants, relying on the predicate device's test data.

8. The sample size for the training set

• Not applicable / Not provided: This device did not involve a "training set" in the context of AI/ML or statistical modeling. The "data" relied upon consists of design specifications, material properties, manufacturing processes, and non-clinical test reports from the predicate devices.

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

• Not applicable / Not provided: As there is no training set mentioned in the context of an algorithm, there's no ground truth established for it. The ground truth for the non-clinical tests is based on established scientific and engineering principles and international standards.

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IS3 is indicated for use in measuring the stability of dental implants in the oral cavity and the maxillofacial region.

IS3 measurement system consists of: IS3 Instrument Hand-held instrument, Multi Peg Driver Driver to attach the ISQ peg to the implant, IS3 Charger 100-240 VAC to 5VDC charger for the instrument batteries, Multi Peg Measurement pin to attach to the implant. Different pins are available to fit different implant types.

The IS3 instrument is a hand-held, battery-driven device for measuring the relative stability of a dental implant. A small pin "Multi peg" is attached to the dental implant by a screw-connection, with the Multi Peg Driver. The pin has a small magnet incorporated into its top. The instrument is held towards the Multi Peg, and sends short magnetic pulses that bring the pin into vibration. After a pulse has been sent, the instrument measures the vibration by sampling the signal from the alternating magnetic field that follows from the vibrating pin. The frequency of the signal is determined by the instrument and is presented as an "ISQvalue", 1 to 100, where a higher number means higher stability. The measurement takes about 1 second.

The instrument consists of a microcontroller and circuits to send the magnetic pulses, to receive the measurement signal, and to present the measurement value. A circuit for battery-charging is also included. Two 2-digit LED displays, one on each side of the instrument, show the measurement value and also communicate possible error codes and software id number at start-up. One operating key is used to turn the instrument on and off. The electronics are contained in a plastic body, which is sealed except for the back of the instrument which has a charging connector. The plastic body is made from PC/ABS plastic except for the tip, which is made from PEEK. No part of the instrument is intended to contact the patient; however, there can be unintentional contact with the tip of the instrument. The instrument is battery-driven and contains re-chargeable NiMh-batteries. The batteries can be charged during use, but it should not be attached while measuring due to the risk of power line interference making it impossible to measure. For safety, a charger complying with IEC 60601-1 is used.The charger connector is of a type that does not allow other chargers to be connected, thereby eliminating the risk of the wrong charger being used.

The provided document for the HIOSSEN IS3 device (K180527) does not contain detailed acceptance criteria and a study that proves the device meets these criteria in the typical format of a clinical or performance study for AI/ML-enabled devices.

This FDA 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device (Tellos ISQ Buddy, K143445), not on providing performance metrics against specific, quantitative acceptance criteria for diagnostically or prognostically critical AI/ML-driven tasks. The IS3 device is described as measuring the resonance frequency of an implant pin to determine an "ISQ-value" for implant stability, which is a direct measurement based on a physical principle. It does not appear to involve AI/ML for image analysis, diagnosis, or prediction, which typically require detailed performance studies.

Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this document, as they are not applicable to the type of device and submission presented.

However, I can provide information based on the document's content regarding the device's technical performance and comparison to predicate devices, which serves as its "proof" of meeting requirements for substantial equivalence.

Here's a breakdown of the available information:

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

The document does not explicitly state quantitative "acceptance criteria" in the format of specific thresholds for metrics like sensitivity, specificity, AUC, or accuracy, as would be common for AI/ML-powered diagnostic devices. Instead, the "performance" is demonstrated by its functional equivalence and compliance with relevant standards, and it measures an ISQ value from 1-100.

2. Sample sized used for the test set and the data provenance
The document does not describe a "test set" in the context of a dataset for validating AI/ML performance. The "testing" mentioned refers to compliance with engineering standards (EMC, software validation, sterilization, biocompatibility, electrical safety) for the device itself, rather than testing its diagnostic accuracy on a clinical dataset. Thus, there is no sample size for a test set of clinical data from this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set requiring expert-established ground truth for AI/ML performance is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The IS3 is a direct measurement device, not an AI assistance tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device functions as a standalone instrument for measuring ISQ value. Its performance is inherent in its design and compliance with technical standards, as outlined above. It's not an "algorithm only" in the sense of AI/ML, but a physical measurement system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the fundamental measurement principle, the "ground truth" is the physical resonance frequency of the attached pin, which the instrument is designed to accurately measure and convert to an ISQ value. Beyond this, the device's "performance" is assessed by its ability to meet engineering and safety standards, rather than by comparison to clinical ground truth for a diagnostic task.

8. The sample size for the training set
Not applicable, as this is not an AI/ML device requiring a training set.

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

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ET Hybrid Abutment is a customized abutment intended for use with HIOSSEN ET dental implant in the edentulous or partially edentulous maxilla or mandible to provide support for prosthetic restorations such as crowns and bridges. All digitally designed copings for use with the ET Hybrid Abutment for CAD/CAM are intended to be sent to a HIOSSEN Inc. manufacturing facility for manufacture.

ET Hybrid Abutment is intended to be placed onto Hiossen dental implants to provide support for customized prosthetic restorations such as crowns and bridges. The proposed devices are composed of ET Link Abutment and Coping. The ET Link Abutment is premanufactured abutment by Hiossen Inc. only and the coping would be manufactured and bonded into the ET Link Abutment by Hiossen only with design input using CAD software from both by dental laboratories and by Hiossen Inc. The final device of ET Hybrid Abutment is under controlled by Hiossen's Quality System and provided to the customer. ET Hybrid Abutment is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. Titanium alloy is the raw material for the Link Abutment and Zirconia material is for the Coping. The ET Hybrid Abutment gives the flexibility to design customized prosthetics.

This document is a 510(k) summary for the ET Hybrid Abutment by HIOSSEN Inc., intended for use with HIOSSEN ET dental implants to support prosthetic restorations. The submission relies on the substantial equivalence to a primary predicate device, ET Hybrid Abutment (K162390), and two reference predicates: Straumann Variobase Abutments (K132219) and ET SmartFit Abutment (K123627). No clinical studies were submitted. Therefore, the information provided below will be based on the non-clinical testing and comparison to predicate devices, rather than a clinical study establishing the device's meeting of acceptance criteria from human data.

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

The document does not explicitly state "acceptance criteria" in a quantitative format for the entire device. Instead, it relies on demonstrating substantial equivalence to predicate devices through material similarity, manufacturing processes, intended use, and non-clinical testing (biocompatibility and fatigue). The performance is demonstrated by conformance to relevant ISO standards for dental implants.

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: Specific sample sizes for the fatigue tests (ISO 14801) are not explicitly stated in this 510(k) summary. ISO standards typically specify minimum sample sizes for such tests.
• Data Provenance: The origin of the testing data is not explicitly stated in terms of country, but it would have been conducted by or for HIOSSEN Inc., which is based in Fairless Hills, Pennsylvania, USA. The testing is prospective as it was conducted to support the
  510(k) 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. This is a medical device (dental abutment) undergoing non-clinical mechanical and biological testing for substantial equivalence, not an AI or diagnostic device requiring expert consensus for a ground truth in image interpretation or patient diagnosis.

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

Not applicable. As this is not a diagnostic device or a study involving human interpretation of data, there is no adjudication method used. The testing relies on objective, standardized physical and material property measurements.

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-assisted diagnostic device, and therefore, no MRMC study or AI-related effectiveness study was conducted.

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

Not applicable. This is a physical medical device (dental abutment), not an algorithm or software.

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

The "ground truth" in this context refers to the established standards and specifications for material properties, mechanical performance, and biocompatibility of dental implant abutments. These are based on:

• International Standards: Primarily ISO 14801 for fatigue testing, and ISO 17665-1, ISO/TS 17665-2 for sterilization validation.
• Predicate Device Data: The performance and safety profile of the legally marketed predicate devices (K162390, K132219, K123627) serve as the benchmark for demonstrating substantial equivalence.
• Material Specifications: Established specifications for Titanium Alloy Ti-6AL 4V and Zirconia Oxide.

8. The sample size for the training set

Not applicable. There is no training set as this is not a machine learning or AI device.

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

Not applicable. No training set was used.

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