Search Results

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.

Ask a specific question about this device

Noris Medical Ltd. Conical Platform Dental Implants System is intended to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function.

Noris Medical Ltd. Conical platform Dental Implants diameter 3.25 are intended to replace lateral incisor in Maxilla and/or a central or lateral incisor in the mandible for supporting prosthetic devices that may aid in restoring the patient's chewing function.

The procedure can be accomplished in a one-stage surgical operation. All impants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

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 UniCon and Tuff Unicon Implants are designed with conical connection comprises of cone and internal hex connection, diameters of 3.25, 3.5, 3.75 and 4.2 mm and lengths of 8, 10, 11.5, 13, 16 and 18 mm. Both Implants are designed with three thread zones, the Tuff UniCon with lower V-shape thread zone and UniCon with sharp buttress threads enables self-tapping. The middle zone square type thread of Tuff UniCon and wide edge buttress of UniCon is used for compressing cancellous bone. The micro threads on the upper zone enables less pressure on the crestal bone. The subject devices undergo RBM (Resorbable Blasting Media) surface treatment and color anodization within its connection for the purpose of color coding. It is indicated to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function. The Implants Diameter Ø3.25 are intended to replace lateral incisor in maxilla and/or a central or lateral incisor in the mandible for supporting prosthetic devices that may aid in restoring the patient's chewing function.

Healing Caps are Titanium devices mounted onto the dental implant before the soft tissue is sutured around the implant and are intended to protect the implant bore. The Subject Healing Cap with the conical connection fits the UniCon and Tuff Unicon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The Healing Cap provided with 4.3mm, 4.8mm and 5.2mm Diameter and 4.5mm, 5.5mm, 6.5m, 7.5mm, 8.5mm External Body Height. The subject device undergoes color anodization.

The Subject Abutments (temporary, straight, angular and screw retained) with the conical connection fits the UniCon and Tuff UniCon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The subject device undergoes color anodization. The abutments are provided in different types and dimensions.

Multi-Unit Straight/Angular Screw Retained abutment are intended to function in the mandible or maxilla to support multiple-unit temporary or permanent restorations on Noris dental implants. The Subject Abutments with the conical connection fits the UniCon and Tuff UniCon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The subject device undergoes color anodization.

The abutment screw is intended to fasten the abutment to a dental implant. The Subject Abutments screw with the conical connection fits the UniCon and Tuff Unicon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The Abutments screw provided with 2mm Diameter and 7.3 mm Length. The subject device undergoes color anodization.

Cover screw- Healing Caps and Cover Screws are Titanium devices mounted onto the dental implant before the soft tissue is sutured in place around the implant and which are intended to protect the implant bore. The Subject Cover screw with the conical connection fits the UniCon and Tuff Unicon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The cover screws are provided with 3.2mm, 3.5mm Diameters and 4.9 mm Length. The subject device undergoes color anodization.

Based on the provided FDA 510(k) summary for the "Conical Platform Dental Implants System," here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Important Note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. This is different from a PMA (Premarket Approval) application, which requires clinical efficacy and safety studies. Therefore, the "study that proves the device meets the acceptance criteria" in this context refers to non-clinical performance testing and comparisons to predicate devices, rather than a full-scale clinical trial with human subjects. The document primarily focuses on physical and material characteristics and demonstrates equivalence through engineering analyses rather than clinical outcomes with an AI component.

The request asks for information that is more typical of a software as a medical device (SaMD) or AI/ML device approval, such as "number of experts," "adjudication method," "MRMC study," and "training set ground truth." However, this document describes a dental implant system, which is a physical device, and does not mention any AI/ML components. Therefore, many of the requested points related to AI/ML device evaluation are not applicable or cannot be found in this submission. I will address the points that are applicable to this type of device and note where information is not present in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this physical device are primarily based on demonstrating substantial equivalence to predicate devices in terms of design, materials, indications for use, and performance testing (specifically fatigue).

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

Since this is a physical device and the primary evidence provided is non-clinical performance data (fatigue testing, material characterization, etc.) rather than a clinical study with a "test set" of patients, the concept of a sample size for a test set and data provenance (country, retrospective/prospective) as it applies to AI/ML or clinical trial data isn't directly applicable here in the same way.

• Sample Size for Testing: The document states that "Fatigue tests per ISO 14801 were performed to determine the fatigue strength for UniCon implants." ISO 14801 specifies the number of samples for fatigue testing (typically 6-12 samples per group, depending on the desired confidence and methodology), but the exact number used is not explicitly stated in this summary. Other tests (biocompatibility, reprocessing, pyrogen, MRI review) were leveraged or based on scientific rationale, meaning new physical samples were likely not tested for these aspects as equivalence to previously cleared devices was the basis.
• Data Provenance: Not applicable in the context of a clinical test set for a physical device where the primary evaluation is non-clinical. The company is Noris Medical Ltd., located in Nesher, Israel.

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

This question is highly relevant for AI/ML devices where "ground truth" often involves expert annotation or consensus. For this physical dental implant device, ground truth is established through:

• International Standards: e.g., ISO 14801 for fatigue testing, ASTM F136 for material specifications. These standards define the "ground truth" for material properties and mechanical performance.
• Regulatory Guidance: e.g., FDA Guidance for MRI safety, USP for pyrogen limits. These guidances define the acceptable methodology and results.
• Predicate Device Characteristics: The comparison of technological characteristics to predicate devices (K140440, K142260, K130462) establishes the "ground truth" for substantial equivalence.

There is no mention of human experts defining "ground truth" in the way it's done for diagnostic image interpretation by multiple radiologists. The expertise lies within the material science, mechanical engineering, and regulatory compliance teams that designed the device and conducted/evaluated the non-clinical tests.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or subjective assessment of a test set that would require an adjudication method like 2+1 or 3+1. Performance is measured against objective engineering standards and direct comparison of physical/material characteristics.

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

No. An MRMC study is specific to diagnostic imaging devices, particularly those involving human interpretation of medical images, often assisted by AI. This document pertains to a physical dental implant system and therefore, this type of study was not conducted or required. No AI assistance or human reader improvement is mentioned.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Not applicable. This device is a physical dental implant system and does not involve an algorithm or AI component.

7. The Type of Ground Truth Used

The "ground truth" for this device application is primarily based on:

• Engineering Standards: Specific material properties, mechanical performance (e.g., fatigue strength as per ISO 14801), and dimensional tolerances.
• Predicate Device Characteristics: The established safety and effectiveness of the chosen predicate devices serve as the benchmark for demonstrating substantial equivalence for the new device's indications for use, materials, and design.
• Leveraged Data: For biocompatibility, reprocessing sterilization, and pyrogen limits, the "ground truth" is that the material, manufacturing, and surface treatments are identical to previously cleared devices (K151909 and K140440), therefore their established safety and performance data (ground truth) is directly applicable.

No pathology reports or patient outcomes data as "ground truth" are mentioned in this 510(k) summary, as it relies on non-clinical data for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML component described, so there isn't a "training set" in the context of machine learning.

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

Not applicable, as there is no AI/ML component or training set described.

Ask a specific question about this device

Noris Medical Dental Implants System is intended to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function. The procedure can be accomplished in a one-stage or two-stage surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Noris Medical Dental Implants are tapered internal hex 2.1. implants, designed to enable easy insertion while supporting excellent initial stability. The variable thread design enables self-tapping, thus providing solutions for a variety of bone conditions. Noris Medical multi-design features offer a solution for immediate placement and immediate loading. The implantation procedure can be accomplished in a one-stage or two-stage surgical operation. Packaging has been designed for quick identification and easy opening. The scope of this submission is Noris Medical Cortical Implant as part of the Noris Medical dental Implants system identical platform. Cortical implants are able to undergo immediate loading when good primary stability is achieved and with appropriate occlusal loading. The Cortical system can be used in extraction sites for immediate implantation. Cortical implant is available in different sizes to suit relevant implantation site. Made of titanium alloy Ti 6Al 4V ELI.

Here's an analysis of the acceptance criteria and the study that proves the Noris Medical Dental Implants System - Cortical meets those criteria, based on the provided FDA 510(k) summary:

Overview

The provided document is a 510(k) Summary for the Noris Medical Dental Implants System - Cortical. The core purpose of a 510(k) submission is to demonstrate that a new medical device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective. In this case, the clinical test section details a study that supports the safety and effectiveness of the implant with respect to a specific performance criterion: marginal bone loss. The non-clinical tests (biocompatibility, sterilization, performance testing) also contribute to demonstrating substantial equivalence but are not the focus of a comparative clinical performance criterion for this device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 40 Noris cortical implants were placed in 19 patients. The document states "The sample population was statistically derived as n=38" which is a bit ambiguous; it likely refers to the minimum required sample size for the study to achieve statistical significance, with 40 implants actually being tested.
• Data Provenance:
  • Country of Origin: Israel ("Israeli private clinic").
  • Retrospective or Prospective: Retrospective clinical study.

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

The document does not specify the number of experts or their qualifications for establishing ground truth (specifically, measuring crestal bone height/loss). Measurements were taken from panoramic radiographs and CT scans. It's common in such retrospective studies that image analysis is performed by the researchers or a trained technician, often validated by a clinician. However, this detail is not provided.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. Since it's a retrospective study, it's possible that data was collected and analyzed by a single party or an unadjudicated team.

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

• Was it done?: No. This study is an observational clinical study assessing the performance of the Noris Medical Dental Implants System - Cortical in a real-world setting, focusing on marginal bone loss and survival rate. It does not involve human readers comparing AI-assisted vs. non-AI-assisted diagnosis or treatment.
• Effect size of improvement with AI vs. without AI assistance: Not applicable, as this was not an AI-assisted MCMC study.

6. Standalone (Algorithm-Only) Performance Study

• Was it done?: No. This device is an endosseous dental implant, a physical medical device, not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance (e.g., marginal bone loss) is an inherent characteristic of the physical implant itself when used in patients.

7. Type of Ground Truth Used

• Clinical Outcomes/Measurements: The ground truth for the clinical study was established through quantitative measurements of crestal bone height and subsequent calculation of marginal bone loss from panoramic radiographs taken at baseline and follow-up intervals (e.g., 6, 12, 24, and up to 33 months). Implant survival (100%) was also a key outcome.
• Note: The document mentions "Adjudication method (e.g. 2+1, 3+1, none) for the test set" in the prompt template, which implies a study where human readers interpret data. In this clinical study, measurements are taken directly from images or clinical observation, not through a diagnostic interpretation process that requires expert consensus adjudication in the same way an AI diagnostic algorithm might.

8. Sample Size for the Training Set

• Not applicable. This report describes a physical medical device (dental implant), not a machine learning or AI algorithm that requires a training set. The clinical study described served as a test/validation set for the device's performance in humans.

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

• Not applicable. See point 8.

Ask a specific question about this device

Noris Medical Dental Implants System is intended to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function. The procedure can be accomplished in a one-stage or two-stage surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Noris Medical Zygomatic Dental Implant System is intended to be implanted in the upper jaw arch to provide support for fixed or removable prosthetic devices in patients with partially or fully edentulous maxillae.

The Noris Medical Dental Implants System includes Multi Unit and Vari Connect abutments with various gingival heights and angles (17°, 30°, 45°, 52°, 60°), and Vari Connect Extenders. The system also includes abutment fixation screws. The abutments are intended to be used with specific Noris Medical Dental implants (K151909 and K140440). The Multi-Unit system provides a solution for screw-retained prostheses, while the Vari-Connect system is for removable prostheses. The components are manufactured from Titanium alloy.

The provided text describes a 510(k) submission for the Noris Medical Dental Implants System. While it discusses the device's equivalence to predicate devices and presents clinical data, it does not explicitly state acceptance criteria or a specific study proving the device meets those criteria in the format requested.

Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices through comparisons of:

• Intended Use: Similar to predicate devices.
• Technological Characteristics: Similar to predicate devices (e.g., material, design, connection type).
• Performance Testing: Biocompatibility, sterilization, and mechanical fatigue tests were performed, but specific acceptance criteria for these tests within the context of a "device performance" summary are not detailed.
• Clinical Data (Real-World Evidence): Retrospective studies on both a predicate device and the subject device are presented to support clinical performance, but these are comparative rather than against pre-defined acceptance criteria for a new device.

Therefore, many of the requested fields cannot be directly extracted from the provided text because the study presented is a comparative effectiveness study (comparing the Noris Medical device to predicate devices and real-world evidence, which serves as a benchmark rather than a fixed acceptance criterion).

However, I can extract information related to the clinical data presented, which serves as the closest equivalent to a "study" proving performance in this context of a 510(k) submission.

Here's an attempt to answer the questions based on the available information, noting where information is not present:

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

The document does not provide a formal table of explicit acceptance criteria with numerical targets. Instead, it relies on demonstrating "substantial equivalence" and reporting success rates from retrospective clinical studies, comparing them to predicate device performance.

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

• Subject Device (Noris Medical Multi Unit):
  • Sample Size: 33 patients, encompassing 88 Multi Unit abutments.
  • Data Provenance: Retrospective study. Country of origin not explicitly stated but the company is "Noris Medical Ltd. 8 Hataasia street, Nesher 3688808, Israel," suggesting the data could be from Israel or a region where Noris Medical devices are used. The implants were placed between 2013 and 2020.
• Predicate Device (Nobel Biocare Multi Unit):
  • Sample Size: 44 completely edentulous maxillary rehabilitations (77 Multi unit abutments).
  • Data Provenance: Retrospective study, "Real-world evidence... from the literature" (Ref. 1: J. Clin. Med. 2021, 10, 3600). The specific country of origin for this study is not detailed beyond the journal citation, but the reference indicates "Armando L, Miguel de Araújo Nobre, Ana Ferro, Carlos Moura Guede, Ricardo Almeida and Mariana Nunes," suggesting a potential origin in Portugal or similar European context.

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)

• The document does not specify the number or qualifications of experts used to establish the ground truth for either the Noris Medical or Nobel Biocare retrospective studies. Clinical outcomes (success/failure) were reported, likely by the treating clinicians or study investigators, but expert adjudication details are not provided.

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

• The document does not specify any adjudication method for the clinical outcomes reported in either retrospective study.

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, an MRMC comparative effectiveness study was not done. The studies presented are clinical outcome studies on dental implants and abutments, not diagnostic imaging studies involving human readers and AI. This question is not applicable to the type of device and studies described.

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

• No, a standalone (algorithm-only) performance study was not done. This product is a physical dental implant system, not a software algorithm. This question is not applicable.

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

• For both the Noris Medical and Nobel Biocare clinical studies, the "ground truth" was based on clinical outcomes data (prosthetic success, abutment success, complications, absence of micro movements, bleeding, soft tissue downgrowth, pain) observed over a follow-up period by clinicians.

8. The sample size for the training set

• The document describes studies for substantial equivalence and clinical performance evaluation, not machine learning model training. Therefore, a "training set" in that context is not applicable or described. The clinical studies mentioned are test sets for device performance.

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

• As a "training set" is not applicable in this context, the method for establishing its ground truth is also not applicable.

Ask a specific question about this device

Noris Medical Dental Implants System is intended to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function. The procedure can be accomplished in a one-stage or two-stage surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Noris Medical MBI Dental Implant System is One-Piece, self-tapping Implant, with integrated ball attachment, for singlestage implantation to stabilize a tissue-supported denture. MBI is designed for placement in a very narrow ridge.

Noris Medical MBI Dental Implant System is One-Piece, self-tapping Implant, with integrated ball attachment, for singlestage implantation to stabilize a tissue-supported denture. MBI is designed for placement in a very narrow ridge.

I apologize, but the provided text only contains an FDA 510(k) clearance letter for a dental implant system. It outlines regulatory information and indications for use, but it does not contain any information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets said criteria.

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. This document is a regulatory approval notice, not a study report.

Ask a specific question about this device

Noris Medical Dental Implants System is intended to replace missing tooth teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function. The procedure can be accomplished in a one-stage or two-stage surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Noris Medical MBI Dental Implant System is One-Piece, self-tapping Implant, with integrated ball attachment, for singlestage implantation to stabilize a tissue-supported denture. MBI is designed for placement in a very narrow ridge.

Noris Medical MBI Dental Implant System is One-Piece, self-tapping Implant, with integrated ball attachment, for singlestage implantation to stabilize a tissue-supported denture. MBI is designed for placement in a very narrow ridge.

This document is an FDA 510(k) clearance letter for the Noris Medical MBI Dental Implant System. It discusses the regulatory approval, but it does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and substantial equivalence to a predicate device, not on specific performance metrics or studies proving those metrics.

Ask a specific question about this device

Noris Medical Dental Implants System is intended to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function. The procedure can be accomplished in a one-stage or two-stage surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Noris Medical Zygomatic Dental Implant System is intended to be implanted in the upper jaw arch to provide support for fixed or removable prosthetic devices in patients with partially or fully edentulous maxillae.

Noris Medical Dental Implants are tapered internal hex implants, designed to enable easy insertion while supporting excellent initial stability. The variable thread design enables self-tapping, thus providing solutions for a variety of bone conditions. Noris Medical multi-design features offer a solution for immediate placement and immediate loading. The implantation procedure can be accomplished in a one-stage or twostage surgical operation for all implants type beside the Mono(Noris Medical cleared K140440) which is for one stage only. Packaging has been designed for quick identification and easy opening.

The Noris Medical Zygomatic Dental Implant is designed to provide a solution for cases of atrophic maxilla. The shape of the Noris Medical Zygomatic Dental Implant consists of sharp threads at the apical part. The platform of the Noris Medical Zygomatic Dental Implant is 3.75mm platform, with internal Hex connection. The Noris Medical Zygomatic Dental Implant is available in a large variety of lengths, from 30 mm to 57.5 mm.

Prosthetic Components for Noris Medical Zygomatic Implant: Multi unit and Vari connect 45° prosthetic system are subject of this current submission as a part of the Zyqomatic Dental Implant System.

Materials and Production: The implants and prosthetic components are manufactured from Titanium alloy complying with standard ASTM F 136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for surgical implant applications. Noris Medical employs the RBM (Resorbable Blast Media) surface treatment technology. The product is packed using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10 ° validated in compliance with ANSI/AAMI/ISO 11137-1.

The provided document is a 510(k) summary for the Noris Medical Zygomatic Dental Implant System (K151909). It describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical and clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" as clear numerical thresholds for performance metrics. Instead, it demonstrates substantial equivalence to predicate devices through various tests and a retrospective clinical study. The "reported device performance" is primarily presented as a success rate from the clinical study.

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

• Sample size for the test set (Clinical Study): 18 patients, involving a total of 29 Zygomatic implants.
• Data provenance: Retrospective clinical case studies. The study was conducted in one clinical site in Israel.

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

The document does not specify the number of experts or their qualifications used to establish the ground truth for the clinical study. It mentions that patients were evaluated at a minimum of 6 months post-surgery for the success endpoint of osseointegration. Imaging (CT and panoramic radiographs) was used for evaluation.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1). It only states that "Patients were evaluated at a minimum of 6 months post-surgery, with the success endpoint identified as osseointegration following implant placement."

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

No, an MRMC comparative effectiveness study was not done. The study described is a retrospective clinical case study of the device itself, not a comparison of human readers with and without AI assistance.

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

This question is not applicable. The device is a physical dental implant system, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the clinical study, the ground truth for device success was defined as osseointegration following implant placement. This was assessed through patient evaluations at follow-up and imaging (CT and panoramic radiographs).

8. The Sample Size for the Training Set

This question is not applicable. The document describes a medical device (dental implant system), not an AI/ML algorithm that requires a training set. The clinical study described served as a validation/test set for the device's performance.

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

This question is not applicable, as there is no training set for an AI/ML algorithm described.

Ask a specific question about this device

Noris Medical Ltd Dental Implants System is intended to replace missing tooth/ teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function. 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.

Mono implants are specifically indicated for replacing maxillary lateral incisors and mandibular central and lateral incisors. They are used for immediate, non-occlusal provisionalization in single-tooth restorations. Multiple-unit restorations should be splinted together and may be used immediately when clinically appropriate.

The Noris Medical Dental Implants System consists of one or two stage endosseous form dental implants, internal hexagonal and one piece implants system Abutments and Superstructures are used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation. The implantation procedure can be accomplished in a one-stage or two-stage surgical operation for all implants type beside the Mono which is for one stage only. The system includes Tuff Implants, Tuff TT Implants, Onyx Implants, and Mono Implants, all made of titanium alloy Ti 6Al 4V ELI. The system also includes prosthetic components such as healing caps, cemented restorations (straight and angular abutments), screw retained restorations (Multi unit, Esthetic screw abutments), removable restorations (Vari connect abutments, Ball attachments, Flat attachments), and accessories. The implants and prosthetic components are manufactured from Titanium alloy (Ti 6Al 4V ELI) and employ the SLA (Sandblasted, Large grit, Acid etched) surface treatment technology.

The Noris Medical Dental Implants System is a device intended to replace missing teeth, and the information provided is a 510(k) Summary submitted to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical setting.

Therefore, many of the requested categories related to clinical study design, acceptance criteria tables with performance, sample sizes for test/training sets, expert involvement, and ground truth establishment cannot be fully addressed from the provided document as it focuses on demonstrating equivalence through non-clinical testing and comparison with predicates.

Here's what can be extracted and inferred from the document regarding the device's assessment:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of acceptance criteria with reported device performance in the way a clinical study would. Instead, it relies on demonstrating substantial equivalence to predicate devices by comparing technical characteristics (like material, dimensions, design) and performing non-clinical tests (sterilization, aging, fatigue). The "acceptance criteria" are implicitly met if the device's technical characteristics and non-clinical test results are comparable to or meet the standards expected of the predicate devices.

The "performance" is reported as:

• Sterilization: Achieved an SAL of $10^{-6}$ in compliance with ANSI/AAMI/ISO 11137-1:06 and EN ISO 11137-2:12.
• Shelf Life: Substantiated a 5-year shelf life through accelerated aging per ASTM-F-1980:07, followed by peel, dye, and burst tests on packaging.
• Mechanical Performance: Static and dynamic compression performance testing was conducted per ISO 14801:07 ("Dentistry-Implants-Dynamic fatigue test for Endosseous Dental implants") using a worst-case scenario. The results are stated to "indicate that the Noris Medical Dental Implants System is substantial equivalent to the predicate devices."

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

• Test Set Sample Size: Not applicable in the context of a clinical test set. The non-clinical tests (SEM, surface analysis, sterilization validation, accelerated aging, static/dynamic compression) would have involved specific numbers of device units or components, but these numbers are not disclosed in the summary.
• Data Provenance: The tests were conducted by Noris Medical, Ltd. (Israel). The document does not specify the country of origin for the test data directly, but given the submitter's location in Israel, it's highly probable the testing occurred there or through contracted labs. The studies were non-clinical (laboratory/in-vitro), not retrospective or prospective patient studies.

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

Not applicable. This device underwent non-clinical performance testing and comparative analysis against predicate devices, not evaluation involving expert-established ground truth for a clinical test set.

4. Adjudication Method for the Test Set:

Not applicable. There was no clinical test set requiring adjudication in the context of this 510(k) submission.

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

No. A MRMC study was not done. The submission explicitly states: "No clinical studies were performed."

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

Not applicable. This is a medical device (dental implant system), not an algorithm or AI-driven system.

7. Type of Ground Truth Used:

The "ground truth" for the assessment of this medical device is based on engineering standards, material specifications, and performance characteristics of legally marketed predicate devices.

• Engineering Standards: ASTM F136 (for titanium alloy), ANSI/AAMI/ISO 11137-1:06 and EN ISO 11137-2:12 (for sterilization), ASTM-F-1980:07 (for accelerated aging), and ISO 14801:07 (for dynamic fatigue).
• Predicate Device Characteristics: Comparison of materials, dimensions, design, intended use, and indications for use with the identified predicate devices (MIS K040807, MIS K080162, A.B. dental K112440, A.B. dental K132125, Nobel Biocare K061477).

8. Sample Size for the Training Set:

Not applicable. This is a medical device, not a machine learning model, so there is no "training set."

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

Not applicable.

Ask a specific question about this device