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Nucleoss Tpure Implant System are medical devices intended to be surgically placed in the bone of the maxillary and/or mandibular arches to provide support for prosthetic restorations (crowns, bridges or overdenture) in edentulous or partially edentulous patients to restore a patients' chewing function.

Nucleoss Tpure Dental Implants are intended for delayed loading after 12 weeks.

Nucleoss Abutments and Prosthetic parts are intended for use with Nucleoss Tpure Dental Implants in the maxillary and/ or mandibular arches to provide support for crowns, bridges or overdenture for edentulous patients.

The Nucleoss Tpure Implant System consists of the Nucleoss Tpure Dental Implant, Nucleoss Dental Abutments, Covers, Gingiva Formers, Comfort Caps, and accessories.

The Nucleoss Tpure Implant is a bone level, root form implant constructed of unalloyed titanium per ISO 5832-2, with an SLA surface treatment. Nucleoss Tpure Implants have a conical form design, with a double lead thread form and two vertical anti-rotation grooves. The internal structure is designed as a conical internal hex connection with 80 degree bevel.

Nucleoss Tpure Implants are provided in the following sizes: 3.4 mm diameter with lengths of 10, 12 and 14 mm, and 3.8, 4.2, 5.0 mm diameters with lengths of 8, 10, 12, and 14 mm.

Nucleoss Dental Abutments are constructed of titanium alloy per ISO 5832-3and are intended for cement-retained and screw-retained restorations. An internal hexagon allows connection to the Nucleoss Tpure implant. Nucleoss Dental Abutments are available in Straight, Angled, Multi-unit, Ball and Equator designs. The Angled abutment is provided in angles of 10, 20 and 30 degrees. The Multi-unit abutment is available in a straight design, and angled designs of 17 and 30 degrees. Nucleoss Covers, Comfort Cap and Gingiva Formers are available for use during the healing period following surgical placement of the implant. The Nucleoss Tpure Implant System also includes metal housings combined with caps to provide a secure coupling for the denture prosthetic attachment to the Ball and Equator abutments.

All of the Nucleoss Tpure Implant System components are single-use devices. The Nucleoss Tpure Implant and related Cover is provided sterile. The Nucleoss Abutments and accessories are provided nonsterile for end-user sterilization.

This document describes a 510(k) premarket notification for the Nucleoss Tpure Implant System. A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria in a clinical study with a detailed and quantified performance table as might be found for novel AI/ML devices or pharmaceutical trials.

Therefore, the information typically requested in your prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, how ground truth was established for the training set) is generally not applicable to this type of medical device submission (dental implants). These are mechanical and material-based devices, not AI/ML-driven diagnostic or prognostic tools.

Instead, substantial equivalence for the Nucleoss Tpure Implant System is demonstrated through:

• Comparison of Technological Characteristics: Showing that the device has similar indications for use, material composition, surface treatment, and design to predicate devices.
• Non-clinical Performance Data: Testing to confirm the device's physical and biological properties meet safety and performance standards.

Here's the information extracted from the document, presented in a modified format relevant to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this device (Nucleoss Tpure Implant System), "acceptance criteria" and "reported device performance" are primarily demonstrated through comparisons to predicate devices and non-clinical performance testing to established standards, rather than clinical performance metrics like sensitivity/specificity for a diagnostic AI.

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

• Not Applicable: This 510(k) submission relied on non-clinical (bench) testing and comparison to predicate devices, not clinical trials with "test sets" of patient data as understood in AI/ML performance evaluation. The testing involved materials and manufactured components.

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: Ground truth, in the context of expert consensus on patient data, is not relevant to this type of device submission for dental implants. Device performance was assessed via engineering and materials testing against established standards.

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

• Not Applicable: Adjudication methods are typically for clinical study endpoints or expert review of diagnostic findings, which are not part of this 510(k) submission.

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

• Not Applicable: MRMC studies are used for evaluating diagnostic performance, often for AI-assisted image interpretation. This device is a mechanical implant, not an AI diagnostic tool.

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

• Not Applicable: This device does not involve an algorithm.

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

• Not Applicable: The "ground truth" for this device's safety and effectiveness is established by adherence to recognized engineering and biomaterials standards (e.g., ISO for fatigue, ASTM for MRI safety, ISO for sterilization), and comparison of its technological characteristics to legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable: There is no "training set" as this is not an AI/ML device.

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

• Not Applicable: There is no "training set" or associated ground truth for this type of medical device submission.

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