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The NobelPerfect Abutments are pre-manufactured prosthetic components directly connected to the endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation.

The NobelPerfect Abutments are direct replacement abutments for the Replace Scalloped Margin Implant System which was marketed under the trade name NobelPerfect. The NobelPerfect Abutments consist of both healing and definitive abutments. Both abutment types are co-packed with the necessary clinical screw. The NobelPerfect Abutments are available for the narrow platform (NP), regular platform (RP), and wide platform (WP). The definitive abutments are 12.0 mm height from the base of the abutment and have no angulation. Both the healing and definitive abutments are made of titanium vanadium alloy.

This FDA 510(k) summary describes Nobel Biocare AB's NobelPerfect Abutments and asserts their substantial equivalence to a predicate device, the Replace Scalloped Margin Implant System (K021584). The document does not contain acceptance criteria or study results that prove the device meets acceptance criteria for performance metrics often associated with AI/ML-driven medical devices (e.g., accuracy, sensitivity, specificity).

Instead, the document focuses on demonstrating substantial equivalence primarily through comparison of technological characteristics and leveraging existing data from predicate devices for aspects like sterilization, packaging, shelf life, and biocompatibility.

The only "performance data" mentioned is the fatigue limit determination for the NobelPerfect Abutment using ISO 14801. However, the document does not provide the acceptance criteria for this test nor the reported results.

Therefore, I cannot provide the requested information regarding acceptance criteria and study results for device performance in the context of typical AI/ML medical device evaluation. The information provided in the document is for a traditional medical device (dental abutments) seeking 510(k) clearance based on substantial equivalence to a predicate, not for an AI-driven device with performance metrics like accuracy or sensitivity.

If the request assumes this is an AI/ML device, that assumption is incorrect based on the provided document.

However, assuming the intent of the request is to extract any available "performance data" or evidence of meeting standards, even if not explicitly stated as "acceptance criteria" for an AI model, I can highlight what is present:

Missing Information/Not Applicable in this Document:

• Acceptance Criteria for AI Performance Metrics: Not applicable as this is not an AI/ML device description.
• Reported Device Performance (for AI metrics): Not applicable.
• Sample size for test set, data provenance: Not applicable.
• Number of experts, qualifications: Not applicable.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone algorithm performance: Not applicable.
• Type of ground truth: Not applicable.
• Sample size for training set, ground truth for training set: Not applicable.

Information that could be broadly interpreted as "performance" or "meeting criteria" in this specific document:

The document focuses on demonstrating that the NobelPerfect Abutments are substantially equivalent to the predicate device, K021584, based on technological characteristics and non-clinical testing.

1. A table of (implied) acceptance criteria and the reported device performance:

The document doesn't present acceptance criteria in a table format with specific quantitative thresholds. Instead, it relies on demonstrating consistency with or improvement upon the predicate device's characteristics and meeting established standards for certain tests.

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

• Fatigue Limit (ISO 14801): The sample size for this test is not specified in the summary document. Data provenance is not specified.
• Other tests (Sterilization, Packaging, Shelf Life, Biocompatibility): No new testing was performed for the subject device. Existing data from the predicate device (K170135, K021584), validated to relevant international standards (e.g., ANSI/AAMI/ISO 11137), was leveraged. The provenance of this leveraged data is not detailed in this summary.

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)

• This information is not applicable to
  • the type of medical device (physical implant components)
  • the type of evaluation performed (substantial equivalence to a predicate based on material, design, and non-clinical engineering tests like fatigue).
    There is no concept of "ground truth" established by human experts in the context of this 510(k) submission for dental abutments.

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

• Not applicable for the reasons stated in point 3.

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 as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

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

• Not applicable. The "truth" in this context is the adherence to material specifications, validated manufacturing processes, and performance against engineering standards (like ISO 14801), rather than a diagnostic or interpretive ground truth.

8. The sample size for the training set

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

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