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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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