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The Noris LONGY and LONGY-N implants are indicated for splinted restorations in the maxilla, utilizing a minimum of two implants to support fixed or removable prosthetic devices with partially or fully edentulous upper jaws, and may be suitable for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The procedure can be accomplished in a one-stage or two-stage surgical operation.

The subject dental implant devices are single use devices, provided sterile by Gamma Radiation, made of Titanium alloy Ti-6Al-4V ELI (ASTM F136). The LONGY Implants and LONGY-N Implants bare internal hex connection, diameters of 3.75 and 4.0mm and lengths of 18, 20, 22 and 25 mm. The Noris LONGY and LONGY-N implants are indicated for splinted restorations in the maxilla, utilizing a minimum of two implants to support fixed or removable prosthetic devices in patients with partially or fully edentulous upper jaws, and may be suitable for immediate loading when good primary stability is achieved. The procedure can be accomplished in a one-stage surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

LONGY and LONGY-N dental implants are compatible with FDA cleared Noris Medical Ltd. Internal Hex platform abutments and superstructures only intended for multiple-unit loading, provided that they do not exceed an angulation of 30° (≤30).

The provided text is a 510(k) Premarket Notification from Noris Medical Ltd. for their LONGY Implant and LONGY-N Implant. It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving a device meets specific acceptance criteria through a study involving AI or human reader performance.

Therefore, the document does not contain the information required to answer the prompt's request for acceptance criteria and a study proving device performance against those criteria, especially in the context of AI assistance or human reader improvement.

The document details the following:

• Device Name: LONGY Implant and LONGY-N Implant
• Regulation Number/Name: 21 CFR 872.3640 (Endosseous Dental Implant)
• Regulatory Class: Class II
• Product Code: DZE
• Indications for Use: Splinted restorations in the maxilla, utilizing a minimum of two implants to support fixed or removable prosthetic devices in patients with partially or fully edentulous upper jaws, suitable for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Can be accomplished in a one-stage or two-stage surgical operation.
• Predicate Devices: Neodent Implant System - GM Helix LG ® (K190958 - Primary), Noris Medical Ltd. - TUFF (K140440 - Reference), Neodent Implant System - Zygoma GM (K190718 - Reference), Noris Medical Ltd. - Zygomatic Implants (K151909 - Reference), Noris Medical Ltd. - MBI Dental Implant System (K153043 - Reference).
• Device Description: Single-use, sterile (Gamma Radiation), made of Titanium alloy Ti-6Al-4V ELI (ASTM F136), internal hex connection, diameters of 3.75 and 4.0mm, lengths of 18, 20, 22, and 25 mm.
• Performance Data: Fatigue tests per ISO 14801, biocompatibility, sterilization validation, shelf-life testing, mechanical testing, and MRI review. These tests are to demonstrate substantial equivalence, not to establish performance against specific clinical acceptance criteria in a user-performance or AI-assisted context.

Missing Information (as per the prompt's requirements):

1. A table of acceptance criteria and the reported device performance: Not provided in the context of clinical endpoints or user performance. The performance data discussed (fatigue, biocompatibility, etc.) are for device safety and mechanical integrity, not for clinical diagnostic or treatment performance against specific numerical acceptance criteria.
2. Sample size used for the test set and the data provenance: No test set is described for evaluating AI or human reader performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no AI/human reader study is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. This document is about a physical dental implant, not AI software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to the presented data (which is about implant mechanical and material properties).
8. The sample size for the training set: Not applicable (no AI/machine learning model discussed).
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a dental implant, focusing on its physical and material properties to demonstrate substantial equivalence for market clearance. It does not contain information related to AI or human-in-the-loop studies, nor does it define acceptance criteria in the manner requested by the prompt for such studies.

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S.I.N. Dental Implant System Zygomatic implants are intended for placement in the maxillary arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System Zygomatic implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The purpose of this submission is to add components to the S.I.N. Dental Implant System. This submission includes zygomatic dental implants and mating abutments for screw-retained, multi-unit prostheses.

The subject device Zygomatic Plus Morse Taper implants have a body diameter of 4.0 mm that tapers to approximately 2.3 mm at the apex. The implants have a Morse taper ("CM") abutment interface connection, with an internal 16° cone taper. The abutment platform is 4.0 mm. All implants are threaded starting at the apex and extending approximately 17 mm in the coronal direction, with a major thread diameter of 4 mm; the thread tapers over the final 6 mm of the implant to the apex. The implants are provided with overall lengths of 30, 32.5. 35. 37.5. 40. 42.5.45. 47.5. 50. 52.5.57.5. and 60 mm. The surface of all subject device implants is acid-etched from the implant platform to the apex, followed by application of a hydroxyapatite coating (HA nano).

The subject device abutments are multi-unit, indexed abutments for use only with the subject device Zygomatic Plus Morse Taper implants for maxillary full-arch restorations. The subject device abutments have a prosthetic platform diameter of 4.8 mm, and gingival heights of 1.5, 2.0, and 2.5 mm. The prosthetic post is angled 52° or 60° to the long axis of the implant. These components are used with previously cleared abutment screws.

All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. All implants have an acid-etched HA100 surface treatment, identical to that cleared in K231127. All subject device abutments are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F136. All subject device implants and abutments are provided sterile to the end user.

The provided text is a 510(k) Summary for a dental implant system. It explicitly states that no clinical data were included in this submission to support substantial equivalence (see "No clinical data were included in this submission." on page 6 of 9).

Therefore, it is not possible to provide specific details about acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, or MRMC studies, as这些 types of studies were not conducted or reported in this 510(k) submission.

The "Performance Data" section (pages 6-7 of 9) refers to non-clinical data only:

• mechanical testing
• gamma irradiation sterilization
• bacterial endotoxin testing
• MR environment evaluation
• sterile barrier shelf life data
• biocompatibility data

These tests are typically conducted to assess the physical and biological characteristics of the device, not its clinical performance in patients as would be measured in an AI/MRMC study.

In summary, based on the provided document, no study was conducted to prove the device meets acceptance criteria related to AI/MRMC performance as outlined in your request. The submission relies on substantial equivalence to predicate devices, supported by non-clinical performance data.

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S.I.N. Dental Implant System Zygomatic implants are intended for placement in the maxillary arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System Zygomatic implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The purpose of this submission is to add components to the S.I.N. Dental Implant System. This submission includes zygomatic dental implants, mating abutments for screw-retained, multi-unit prostheses, and the corresponding abutment screws.

The subject device Zygomatic Plus Morse Taper implants have a body diameter of 4.0 mm that tapers to 1.65 mm at the apex. The implants have a Morse taper ("CM") abutment interface connection, with an internal 16° cone taper. The abutment platform is 4.0 mm. All implants are threaded starting at the apex and extending approximately 17 mm in the coronal direction, with a major thread diameter of 4 mm; the thread tapers over the final 6 mm of the implant to the apex. The implants are provided with overall lengths of 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 57.5, and 60 mm. The surface of all subject device implants is acid-etched from the implant platform to the apex, followed by application of a hydroxyapatite coating (HA nano).

The subject device abutments are multi-unit, indexed abutments for use only with the subject device Zygomatic Plus Morse Taper implants for maxillary full-arch restorations. The subject device abutments have a prosthetic platform diameter of 4.8 mm, and gingival heights of 2 mm and 3 mm. The prosthetic post is angled 45° to the long axis of the implant. These components are used with subject device abutment and prosthetic screws, or previously cleared screws.

All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. All implants have an acid-etched HA1200 surface treatment, identical to that cleared in K200992. All subject device abutments are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F136. All subject device implants, abutments, and abutment screws are provided sterile to the end user.

I am sorry, but based on the provided text, I cannot provide a comprehensive description of the acceptance criteria and the study that proves the device meets them, as requested. The document is an FDA 510(k) summary for a dental implant system. While it mentions performance data, it primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a full study report of the subject device's performance against those criteria.

Here's why I cannot fulfill each requested point:

1. A table of acceptance criteria and the reported device performance: The document does not explicitly state acceptance criteria for the new device in a quantifiable way beyond citing compliance with standards like ISO 11137-1, ISO 11137-2, ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119, ASTM F67, and ASTM F136. It mentions mechanical testing was done "to demonstrate that the subject device abutments... have sufficient strength for the intended use," but it doesn't provide specific numerical acceptance limits or the reported performance values against them.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The text states "Non-clinical data provided in this submission...mechanical testing conducted using a method modified from ISO 14801 and engineering analysis," but it does not specify the sample size used for this mechanical testing. There is no information about data provenance (country of origin, retrospective/prospective). No clinical data was included 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): This information is not relevant to the type of non-clinical, mechanical, and sterilization testing described in the document. No expert review of a "test set" in the context of clinical interpretation or diagnosis is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no expert "test set" for clinical evaluation is mentioned.

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 device is a dental implant system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a dental implant system, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here would be the physical properties and performance characteristics determined by established engineering and sterilization standards (e.g., sterility assurance level, mechanical strength, biocompatibility, MR compatibility). These are not expert consensus in a clinical sense, pathology, or outcomes data.

8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established: Not applicable, for the same reason as point 8.

The document focuses on demonstrating that the S.I.N. Dental Implant System (specifically the new zygomatic implants and abutments) is substantially equivalent to legally marketed predicate devices through non-clinical data, including:

• Gamma irradiation sterilization validation.
• Mechanical testing (modified from ISO 14801).
• MR compatibility testing (referenced from K222231 and standards ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119).
• Sterile barrier shelf life data (referenced from K203725).
• Biocompatibility data (referenced from K200992 and standards ASTM F67, ASTM F136).

The substantial equivalence argument highlights similarities in indications for use, design principles, materials, manufacturing, sterilization, and shelf life to various predicate and reference devices. However, it does not provide detailed acceptance criteria and specific performance results for the subject device beyond qualitative statements like "sufficient strength."

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Indications for Use for NUVO IF Implants and conventional abutments:

The NUVO IF Implant System is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage or twostage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

The Titanium Temporary Abutment is indicated to provide temporary support for prosthesis structure for up to 6 months.

The Attachment Equator and Attachment Removable Prosthesis are indicated for the attachment of full or partial dentures to NUVO implants.

Indications for Use for Rotational and Anti-rotational Titanium Bases abutments:

Titanium Base Abutment is a titanium base placed onto dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement or screw-retained single or multi-unit restorations or screw-retained single restorations.

All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

The Rotational Titanium Base is indicated for cement or screw-retained multi-unit restorations.

Indications for Use for CARES® Abutment IF:

The CARES® Abutment is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations (copings or crowns). It is indicated for cementretained single restorations. All digitally designed abutments for use with the CARES® Abutment are intended to be sent to Straumann for manufacturing at a validated milling center.

The NUVO IF Implant System consists of implants, cover screws, and abutments.

Implants: Intended for single use, provided sterile via gamma irradiation, manufactured of commercially pure titanium (Grade 4), bone level design, apically tapered thread-form with apical cutting flutes in various diameters and lengths, and provided with an internal hexagonal implant-to-abutment interface.

Cover Screws: Intended for single use, used to protect the internal geometry of the implants during healing, placed out of occlusion, provided sterile via gamma irradiation or ethylene oxide gas, manufactured of titanium alloy (Ti6Al4V-ELI), and provided with an implant-to-abutment interface compatible with the internal hexagonal geometry of the implants.

Abutments: Intended for single use, provided sterile via ethylene oxide gas or non-sterile, manufactured of titanium alloy (Ti6Al4V-ELI) or a combination of POM polymer and cobalt-chromium alloy, conical format available in different diameters, height of cementable area and gingival height, screw-retained to the implant, provided with an implant-to-abutment interface compatible with the internal hexagonal geometry of the implants, provided with coronal geometries in rotational (non-indexed) and anti-rotational (indexed) versions, and Titanium Base abutments are two-piece abutments composed of a titanium base and a patient-specific CAD/CAM top-half.

This looks like a 510(k) summary for a dental implant system (NUVO IF Implant System), not a study describing acceptance criteria and performance data for an AI/ML medical device. Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies for an AI device.

The document discusses:

• Trade/Device Name: NUVO IF Implant System
• Regulation Number/Name: 21 CFR 872.3640, Endosseous Dental Implant
• Regulatory Class: Class II
• Product Code: DZE, NHA
• Indications for Use: Surgical placement in maxilla or mandible for prosthetic device support, including immediate loading, temporary support, and attachment of dentures.
• Device Description: Details on implants (material, design, size, sterilization), cover screws (material, use, sterilization), and various abutment types (materials, design, sterilization, use).
• Predicate Devices: Several predicate devices are listed and compared for substantial equivalence.
• Performance Data: This section details non-AI/ML performance testing, including:
  • Dynamic fatigue testing per ISO 14801.
  • Sterilization validation (gamma irradiation per ISO 11137-1/2, ethylene oxide per ISO 11135, moist heat per ISO 17665-2).
  • Ethylene oxide residuals testing per ISO 10993-7.
  • Biological Safety Assessment per ISO 10993-1 (cytotoxicity per ISO 10993-5, chemical characterization per ISO 10993-18).
  • Package transport integrity per ISTA 2A.
  • Product and package stability per ASTM F1980.
  • Product endotoxin testing (LAL) per ANSI/AAMI ST72.

There is no mention of an AI/human-in-the-loop study, ground truth establishment, sample sizes for training/test sets for AI, or expert adjudication.

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The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The Neodent GM Helix LG implants can be placed bicortically in cases of reduced bone density. The Neodent GM Helix LG implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

The subject dental implant devices are single use devices, provided sterile by Gamma Radiation, made of commercially pure Titanium grade 4 (ASTM F67 – ISO 5832-2). The GM Helix LG Implant is a long conical implant with external diameters of 3.75 and 4.0 mm and lengths of 20, 22.5 and 25 mm. It has trapezoidal threads, conical apex with spherical tip and helical chambers, cylindrical body and Grand Morse prosthetic interface. The GM Helix LG implants share the same design characteristics as the existing GM Helix but are longer than the previously cleared range of implants. Indicated to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function.

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

The provided text, a 510(k) summary for the Neodent Implant System, does not describe the acceptance criteria and study that proves the device meets clinical performance criteria in the way a traditional clinical study report would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through various performance tests.

Therefore, many of the requested elements for a clinical study analysis (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not explicitly stated in this type of regulatory submission. The goal of a 510(k) is to show that the new device is as safe and effective as a legally marketed predicate device, primarily through non-clinical performance and a comparison of technological characteristics.

However, I can extract the relevant information regarding the performance data and how it supports the claim of substantial equivalence.

Acceptance Criteria and Device Performance (as inferred from the 510(k) summary)

The "acceptance criteria" in this context are not explicitly listed with numerical targets as they would be for a direct clinical performance claim. Instead, the acceptance criteria are implicitly met by demonstrating that the subject device performs equivalently to or satisfactorily when compared to the predicate device or established standards, based on the performed in vitro tests.

Here's a table summarizing the performance evaluations described:

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated for any of the performance tests. These are typically in vitro (laboratory) tests, not human subject studies.
• Data Provenance: The tests are in vitro engineering/materials tests performed in a laboratory setting, not derived from patient data (retrospective or prospective). The location of the test performance is not specified beyond being part of the submission from "JJGC Indústria e Comércio de Materiais Dentários SA" (dba Neodent) in Brazil.

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

• Not Applicable. For in vitro performance testing of a dental implant, "ground truth" as it pertains to clinical outcomes or expert interpretation of patient data is not established. Performance is measured against engineering standards and internal specifications.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where subjective assessments (e.g., image interpretation) require consensus among experts. This is not relevant for the in vitro mechanical and material tests described.

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

• No. An MRMC study is a type of clinical study involving multiple human readers assessing cases, often with and without AI assistance, to measure diagnostic performance. This submission does not describe such a study. The device is a physical dental implant, not a diagnostic AI system.

6. Standalone (Algorithm Only) Performance Study:

• No. A "standalone performance study" typically refers to the algorithmic performance of an AI diagnostic device without human interaction. This is not applicable to a dental implant device.

7. Type of Ground Truth Used:

• Engineering Standards and Specifications. The "ground truth" for the in vitro tests is based on established engineering standards (e.g., ISO 14801, ISO 11137-2, ISO 10993 series) and the internal specifications of the device, often benchmarked against the predicate device's performance characteristics. Pathology or outcomes data are not used for these in vitro tests.

8. Sample Size for the Training Set:

• Not Applicable. The device is a physical dental implant, not an AI or machine learning algorithm that requires a training set.

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

• Not Applicable. As there is no training set, this question is not relevant.

In summary: The provided document is a 510(k) summary, which aims to demonstrate substantial equivalence of a new medical device to a legally marketed predicate. The "studies" described are primarily in vitro engineering and materials performance tests designed to show that the new device shares similar technological characteristics and performs equivalently to the predicate, ensuring it is as safe and effective. It is not a clinical study report with human subjects, associated ground truth establishment by experts, or AI performance metrics.

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