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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.

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