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The NB 1 SA Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate Abutment support for fixed bridgework. NB 1 SA Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.

An endosseous dental implant is a device made of a material such as Pure titanium (Conforming to ASTM F67) which will be placed in the alveolar bone to replace the function of the missing tooth. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The system includes NB I Fixture, Cover Screw, Healing Abutment, Cemented Abutment, and Abutment Screw.

This document describes the NB 1 SA Implant System, an endosseous dental implant. However, the provided text does not contain any information regarding clinical studies, acceptance criteria, or performance data related to an AI/algorithm-based device.

The document is a 510(k) premarket notification for a medical device (dental implants). It focuses on demonstrating substantial equivalence to a previously cleared predicate device, largely by highlighting that the subject device has the same fundamental scientific technology, principle of operation, general shape, functions, diameter, and material as the predicate. The "differences" noted are primarily changes in product name or minor design aspects (like a screw hole in the healing abutment) that the manufacturer argues do not impact substantial equivalence.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided text pertains to a dental implant system and not an AI/algorithm-based medical device. There is no mention of AI, algorithms, performance metrics like sensitivity/specificity, or clinical study designs involving human readers or standalone algorithm performance.

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The NB 1 SA Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate Abutment support for fixed bridgework. NB 1 SA Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.

The NB 1 SA Implant System is composed of ARUM NB 1 SA Fixture, ARUM NB Cover Screw, ARUM NB Healing Abutment, ARUM Cemented Abutment (Hex, Non-Hex), and Abutment screw. ARUM NB 1 SA Fixture is a thread type implant body made of TI CP4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. The surface of the fixture is treated with SLA (Sandblasted with Large grit and Acid-etching). The fixture is placed in the anterior or posterior site of maxillary or mandibular jawbone considering bone quality and bone quantity and it is connected with dental prostheses.

The document provided is a 510(k) Premarket Notification for the NB 1 SA Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical test data, rather than reporting on a specific study that evaluates device performance against acceptance criteria in a clinical setting.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, and MRMC studies are not present in this document. The information provided heavily relies on non-clinical tests to support the substantial equivalence claim.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:

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

Based on the provided text, the acceptance criteria are largely linked to meeting the requirements of specific ISO and ASTM standards for non-clinical testing. The "reported device performance" is that the results of these tests "met the criteria of the standards and demonstrated the substantial equivalence with the predicate device."

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

• Sample Size for Test Set: Not specified in the document. The testing described is primarily non-clinical (sterilization, shelf-life, biocompatibility, LAL endotoxin, material characteristics).
• Data Provenance: Not explicitly stated as "country of origin for data." The submitter is Arumdentistry Co., Ltd. from Daejeon, Republic of Korea. The testing itself is non-clinical and conducted in vitro or ex vivo (e.g., material testing, microbial inactivation). The document does not describe human subject data.
• Retrospective or Prospective: Not applicable as the described tests are non-clinical hardware tests.

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)

Not applicable. The ground truth for the non-clinical tests is established by the specified international standards and guidelines (e.g., ISO, ASTM, AAMI/ANSI). No human expert "ground truth" derived from clinical data is described.

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

Not applicable. The described tests are non-clinical and do not involve adjudication by experts in the context of diagnostic interpretation.

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 MRMC comparative effectiveness study is mentioned. The device is an endosseous dental implant system, not an AI-powered diagnostic tool for human readers.

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

This section is not applicable to the device described. The NB 1 SA Implant System is a physical dental implant.

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

For the non-clinical tests, the "ground truth" is defined by the technical specifications and performance requirements established in the referenced international standards (e.g., SAL of 10^-6 for sterility, specific material properties, successful validation of sterilization cycles, biocompatibility under ISO guidelines, etc.). No clinical ground truth (like pathology or outcomes data) is discussed for this 510(k).

8. The sample size for the training set

Not applicable. This document describes non-clinical testing of a physical medical device, not a machine learning algorithm that requires training data.

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

Not applicable, as no training set is mentioned or relevant to the device described.

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