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The NB Mini Implant System is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The NB Mini Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The NB Mini Implant System consist of below: Fixture - NB Fixture Mini Abutment - Cover Screw - . Healing Abutment - Scan Healing Abutment - Scan Healing Abutment Screw - Cemented Abutment Mini - . Angled Abutment Mini - Abutment Screw The NB Fixture Mini is made of Ti-6AI-4V Eli (Conforming to ASTM F136) which will be placed in the alveolar bone to replace the function of the missing tooth. The NB Mini Implant System consists of dental implants, abutments for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and morse taper bevel. The surface of the fixture 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).

This document is a 510(k) summary for the NB Mini Implant System by Arum Dentistry Co., Ltd. It declares that the device is substantially equivalent to existing predicate devices. Consequently, it does not contain a typical acceptance criteria table with reported device performance as would be found in a study demonstrating novel device performance. Instead, it provides a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, here’s an analysis of the "acceptance criteria" and "study" information:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, this document is a 510(k) summary for substantial equivalence, not a standalone performance study with explicit acceptance criteria. The "acceptance criteria" in this context are implicitly that the subject device's performance is substantially equivalent to legally marketed predicate devices. The "reported device performance" is presented through direct comparison of features and results of non-clinical benchtop tests against these predicate devices.

The table below summarizes the comparative information provided for the NB Fixture Mini (one component of the NB Mini Implant System) against its primary predicate and a reference device. Similar comparative summaries are provided for other components (Cover Screw, Healing Abutment, Scan Healing Abutment, Cemented Abutment Mini, Angled Abutment Mini, and Abutment Screw), all concluding substantial equivalence.

2. Sample size used for the test set and the data provenance

The document refers to a variety of non-clinical testing data for various components of the NB Mini Implant System:

• Mechanical performance testing (Fatigue test): "For each compatible implant line, worst-case constructs were subjected to static compression and compression fatigue testing." No specific numerical sample size is provided.
• Bone to Implant Contact (BIC) analysis: Conducted with NB Fixture Mini implants of diameters less than 3.25mm. No specific numerical sample size is provided.
• Surface area analysis: Conducted with NB Fixture Mini implants of diameters less than 3.25mm. No specific numerical sample size is provided.
• Pullout test: Conducted with NB Fixture Mini implants of diameters less than 3.25mm. No specific numerical sample size is provided.
• Biocompatibility: Demonstrated by reference to ARUM DENTISTRY submission K213506.
• Sterilization validation: Performed according to ISO 11137-1 and ISO 11137-2 (method VDmax25 for 25 kGy dose, referenced from K213506), End User Moist Heat Sterilization Test (ANSI/AAMI ST79, ISO 17665-1, -2, ISO 11737-1, -2 and ISO 11138-1, referenced from K213506), and LAL endotoxin testing (AAMI / ANSI ST72:2011/(R)2016).
• Shelf-Life: Accelerated aging method in accordance with ASTM F1980.

The data provenance is not explicitly stated as country of origin, retrospective or prospective, but all tests are non-clinical, meaning they were performed in a lab setting, likely by the manufacturer or a contract lab. The referenced 510(k) submissions (K213506, K190849, K220079, etc.) indicate these are devices marketed in the US, but the company (Arum Dentistry Co., Ltd.) is from the Republic of Korea.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the studies described are non-clinical benchtop tests, not clinical studies involving expert interpretation of patient data to establish ground truth.

4. Adjudication method for the test set

This section is not applicable as the studies described are non-clinical benchtop tests, not clinical studies requiring adjudication of human reader interpretations.

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

This section is not applicable. The device is an endosseous dental implant system, not an AI or software-based diagnostic tool that would typically be evaluated with MRMC studies or AI assistance.

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

This section is not applicable as the device is a physical medical implant, not an algorithm or AI system.

7. The type of ground truth used

For the non-clinical performance tests:

• Mechanical fatigue: The "ground truth" or reference for evaluating performance is the established mechanical properties and fatigue resistance standards (e.g., ISO 14801), and the performance of the predicate devices.
• Biocompatibility: Demonstrated via material testing and reference to previous submissions, ensuring the material meets established safety standards for biological interaction.
• Sterilization: Ground truth is defined by sterility assurance levels (e.g., SAL of 10^-6) and adherence to recognized standards (ISO 11137, ANSI/AAMI ST79).
• Shelf-Life: Ground truth is established by test methods (ASTM F1980) that predict long-term stability and integrity.
• BIC, Surface Area, Pullout: These are physical measurements compared against predicate device performance, implying the predicate's performance serves as the reference for "substantially equivalent" ground truth.

8. The sample size for the training set

This section is not applicable as the device is a physical medical implant, not an AI or software system that requires a training set.

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

This section is not applicable as the device is a physical medical implant, not an AI or software system that requires a training set and corresponding ground truth.

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The ZENEX Implant System Narrow (3.0, 3.2mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

The implants may be restored immediately

1. with a temporary prosthesis that is not in functional occlusion,
2. when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
3. for denture stabilization using multiple implants in the anterior mandible and maxilla.
   The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

The ZENEX Implant System Narrow consists of dental implants, and screws for use in one or two-stage dental implant placement and restorations. The fixtures and abutments in this system are: ZENEX MULTI Fixture, ZENEX PLUS Fixture, Cover Screw, Healing Abutment, Cemented Abutment (Hex, Non-Hex), Angled Abutment (Hex, Non-Hex), Temporary Abutment (Hex, Non-Hex), FreeMilling Abutment (Hex, Non-Hex), CCM Cast Abutment (Hex, Non-Hex), and Abutment Screw. An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The implant-Abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the ZENEX MULTI and PLUS Fixtures are treated with SLA(sand-blasted, large-grit, acid-etched). The subject fixture, cover screw and healing abutment are provided sterile. Other abutments are provided non-sterile and packaged separately.

The provided text is a 510(k) summary for the ZENEX Implant System Narrow, a dental implant device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for performance of an AI/ML device. Therefore, the requested information regarding acceptance criteria and performance studies for an AI/ML device cannot be extracted from this document.

The document details:

• Device Description: Components (fixtures, abutments), materials (Ti-6Al-4V ELI, Co-Cr-Mo Alloy), and surface treatments (SLA, TiN coated).
• Indications for Use: Single tooth replacement, multiple tooth replacement, denture stabilization.
• Predicate Devices: A list of previously cleared dental implants and accessories used for comparison.
• Substantial Equivalence Discussion: A comparative table outlining various characteristics of the subject device against its primary predicate and reference devices, focusing on design, connection, material, surface, sterilization, shelf life, and indications for use.
• Non-Clinical Data: Lists mechanical and material tests conducted (Bacterial Endotoxin, Fatigue Testing on fixture) and leveraged from predicate devices (Sterilization Validation, Shelf-Life, End User Sterilization Validation, Biocompatibility). It also mentions an MR environment review.

There is no information in this document about:

1. Acceptance criteria for an AI/ML device.
2. Reported device performance metrics (e.g., sensitivity, specificity, accuracy) of an AI/ML device.
3. Sample sizes for test sets in an AI/ML study.
4. Data provenance for an AI/ML study.
5. Number or qualifications of experts for AI/ML ground truth.
6. Adjudication methods for AI/ML ground truth.
7. MRMC comparative effectiveness study results for AI/ML.
8. Standalone performance of an AI/ML algorithm.
9. Type of ground truth used for an AI/ML study.
10. Sample size for the training set of an AI/ML model.
11. How ground truth for the training set was established for an AI/ML model.

This 510(k) summary is for a physical dental implant system, not a software or AI/ML-driven device.

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