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NobelParallel™ Conical Connection implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function.

NobelParallel™ Conical Connection implants are indicated for single or multiple restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

Implants with <7mm length are for delayed loading only when appropriate stability has been achieved.

NobelParallel™ Conical Connection (herein referred to as NobelParallel™ CC) implants are threaded, root-form, endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore a patient's chewing function.

The sterile, single-use only implants, made of commercially pure titanium (ASTM F67-13), range in length from 6.5 – 17.5 mm (physical implant length) and are provided in four (4) diameters (Ø 3.75 mm, 4.3 mm, 5.0 mm, and 5.5 mm). The implants feature a conical connection which is compatible with Nobel Biocare's narrow platform (NP), regular platform (RP), and wide platform (WP) abutments. The conical connections are color coded to identify the compatible abutment platform(s).

Each implant is individually packaged and provided with its corresponding titanium alloy cover screw (Ti-6Al-4V, per ASTM F136-13 and ISO 5832-3).

The provided text is a 510(k) Summary for a medical device called NobelParallel™ Conical Connection implants. It describes the device, its intended use, comparison to predicate devices, and performance data provided for substantial equivalence determination.

Here's a breakdown of the requested information based on the provided text. Please note that the document is a summary and therefore may not contain all the granular details of a full study report.

Acceptance Criteria and Device Performance

This document does not explicitly state acceptance criteria in a quantitative table format with corresponding device performance values. Instead, it describes differences and similarities to predicate devices and lists the types of studies performed to support substantial equivalence. The implication is that the device's performance, as demonstrated by these studies, met the FDA's criteria for substantial equivalence to existing legally marketed devices.

However, based on the performance data listed, we can infer the types of performance evaluated:

Detailed Study Information (Based on available text):

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

   • Clinical Study: "retrospective multi-center single cohort clinical study on NobelParallel Conical Connection short implant (<7mm)."
     • Sample Size: Not specified in the summary.
     • Provenance: "multi-center" implies multiple locations, but specific countries are not mentioned. "retrospective" indicates data was collected on events that occurred in the past.
   • Non-clinical tests: For fatigue, surface area, sterilization, packaging, shelf-life, and endotoxin, sample sizes are not specified.

2. 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)

   • The document describes a clinical study and non-clinical tests for a dental implant. Establishing "ground truth" in the typical sense (like for AI image analysis) doesn't directly apply here. The clinical study would involve patient outcomes assessed by clinicians. For non-clinical tests, "ground truth" is typically established by recognized standards (e.g., ISO, ASTM, USP) and laboratory protocols, not by expert consensus in the same way an AI model's output would be adjudicated. No specific number or qualifications of experts for establishing "ground truth" are mentioned.

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

   • Not applicable in the context of this 510(k) summary for a dental implant's performance assessment. Adjudication methods like 2+1 are typically for establishing ground truth for diagnostic AI algorithms, not for evaluating physical device performance or clinical outcomes in general.

4. 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. This is a 510(k) summary for a physical medical device (dental implant), not a diagnostic AI device requiring MRMC studies.

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

   • Not applicable, as this is not an algorithm or AI device.

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

   • Clinical Study: The clinical study would rely on "outcomes data" related to the performance of the short implants. This could include implant survival rates, bone integration, complications, etc., as assessed by treating clinicians.
   • Non-clinical tests: The "ground truth" for non-clinical tests is based on established regulatory standards (ISO, ASTM, USP) and laboratory measurements of physical and material properties.

7. The sample size for the training set

   • Not applicable. This is a 510(k) summary for a physical medical device, not an AI/ML algorithm that requires a training set.

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

   • Not applicable, as there is no training set for a physical medical device.

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