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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.

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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.

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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.

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