(156 days)
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."
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| For Devices Delivered Sterile (Fixture & Cover Screw) | ||
| Gamma Sterilization Validation Test | Sterility Assurance Level (SAL) of 10^-6 (according to ISO 11137-1:2006) | Met the criteria of ISO 11137-1:2006; SAL of 10^-6 validated. |
| Shelf-Life Test | Equivalence to predicate devices (according to ASTM F1980) | Met the criteria of ASTM F1980; worst-case construct tested, results demonstrated equivalence to predicate. Shelf life for devices provided sterile is 5 years. |
| Biocompatibility Testing | Compliance with ISO 10993-1:2009, -3:2014, -5:2009, -6:2007, -10:2010, -11:2006 (for fixtures) | Met the criteria of the standards and demonstrated substantial equivalence with the predicate device. Performed according to ISO 10993-1:2009 and FDA guidance. |
| LAL Endotoxin Testing | Compliance with AAMI / ANSI ST72:2011/(R)2016 | Met the criteria of the standards and demonstrated substantial equivalence with the predicate device. |
| Non-Pyrogenic Claim (NB 1 SA Fixture) | Not applicable | Devices will not be marketed as non-pyrogenic. |
| For TiN Coating Abutments | ||
| Biocompatibility Testing | Compliance with ISO 10993-1:2009, -5:2009, -10:2010 | Met the criteria of the standards and demonstrated substantial equivalence with the predicate device. Performed according to ISO 10993-1:2009 and FDA guidance. |
| For Devices Delivered Non-Sterilized (Abutments) | ||
| End User Sterilization Validation Test | Compliance with ANSI/AAMI ST79, ISO 17665-1,-2, ISO 11737-1,-2, ISO 11138-1 and FDA guidance | Recommended sterilization validated according to ISO 17665-1 and ISO 17665-2 and applicable FDA guidance. Worst-case construct tested, results demonstrated equivalence to predicate device. |
| Biocompatibility Testing (Ti-6Al-4V ELI) | Compliance with ISO 10993-1:2009, -3:2014, -5:2009, -6:2007, -10:2010, -11:2006 | Met the criteria of the standards and demonstrated substantial equivalence with the predicate device. Performed according to ISO 10993-1:2009 and FDA guidance. |
| Surface Modification Information (Fixtures) | Provided (roughness, composition, SEM with SLA) | Surface modification information such as surface roughness, surface composition analysis, and SEM imaging with SLA (Sandblasted with Large-grit and Acid-etching) for fixtures was provided. (Results not explicitly detailed as acceptance criteria). |
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.