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Oneday Implant Abutment is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Implants with diameters larger than 5 mm are intended to be used in the molar region.

The Oneday Implant Abutment is a material for dental surgery and is an abutment used to support and maintain prosthetic restored teeth in case of partial or total loss of teeth. It is used in combination with a fixture implanted in the jawbone.

This document describes a 510(k) premarket notification for the "Oneday Implant Abutment," a dental device. The primary purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics, or if there are differences, those differences do not raise new questions of safety and effectiveness.

The provided text details the device description, indications for use, comparison to predicate devices, and non-clinical test data. It is crucial to understand that this document does NOT describe the acceptance criteria and a study proving a device meets those criteria in the context of clinical performance or AI/software validation. Instead, it describes mechanical, material, and biocompatibility testing for a physical dental implant component to demonstrate its substantial equivalence to an existing device.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth establishment for AI systems, training set sample size) are not applicable to this type of device submission. This is a traditional medical device submission, not a submission for a software-as-a-medical-device (SaMD) or an AI/ML-driven device that would involve performance metrics related to diagnostic accuracy or clinical outcomes.

Here's an analysis of the provided information relative to your request:

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

The acceptance criteria here are standards for mechanical performance, biocompatibility, and sterilization, rather than performance metrics for an AI algorithm.

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

• Sample Size: The document does not specify exact sample sizes for the non-clinical tests (e.g., number of abutments tested for fatigue, sterilization, or biocompatibility). This information is typically detailed in the full test reports referenced in the submission, not summarized in the 510(k) summary letter.
• Data Provenance: The tests are non-clinical (laboratory-based) performed on "subject device" or "worst-case test article" samples. There is no patient data involved for these tests. The country of origin for the data generation (the testing laboratories) is not specified in this summary. These are prospective tests performed specifically for this submission.

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

• This is not applicable. The "ground truth" for mechanical testing, sterilization, and biocompatibility is based on established ISO and ANSI standards. There are no "experts" establishing a "ground truth" in the clinical imaging or diagnostic sense. The evaluations are objective measurements against predefined thresholds.

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

• This is not applicable. Adjudication methods are typically used in clinical studies, particularly for subjective assessments (e.g., image interpretation). These are objective non-clinical tests.

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 is not applicable. The device is a physical dental implant abutment, not an AI-powered diagnostic or assistive tool. No MRMC study would be performed for this type of device.

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

• This is not applicable. There is no algorithm or software for which standalone performance would be relevant for this physical device.

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 objective pass/fail criteria specified by the referenced ISO/ANSI standards for mechanical properties, sterility assurance levels, and biocompatibility endpoints. There is no clinical "ground truth" in the sense of pathology or outcomes data for this specific submission, as it relies on non-clinical testing for substantial equivalence.

8. The sample size for the training set:

• This is not applicable. This is a physical medical device, not a software/AI product requiring a training set for model development.

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

• This is not applicable. See point 8.

In summary: The provided document is a 510(k) summary for a physical medical device, the Oneday Implant Abutment. It demonstrates substantial equivalence primarily through comparisons of design, materials, intended use, and adherence to established performance standards through non-clinical (laboratory) testing. It does not involve AI/ML technology or associated validation studies typically seen in software medical device submissions, and therefore, many of the detailed questions regarding AI performance criteria and study design are not relevant to this specific document.

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