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The Oneday Mini Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols:

• The intended use for the 3.0mm, 3.3mm diameter Oneday Mini Implant is limited to the replacement of maxillary lateral incisors and mandibular incisors.

• Immediate placement in extraction situations with a partially or completely healed alveolar ridge.

• It is intended for delayed loading.

The Oneday Mini Implant System is used to replace missing teeth in various situations ranging from a single tooth loss to the complete loss of incisors teeth. This system is restricted to substitute the maxillary lateral incisors and mandibular incisors. It is two stage endosseous screw type implant with internal hexagonal connection. This system consists of the fixture, cover screw, and various abutments. Only the subject abutments can be used with the subject fixtures. The Fixture is made of Pure Titanium of ASTM F67 and the surface of the fixture is treated with the SLA(Sand-blasted, Large grit, Acid-etched surface). Fixture is provided sterile.

This document is a 510(k) summary for the Oneday Mini Implant System, primarily focused on demonstrating substantial equivalence to a predicate device (UF(II) Narrow Implant System by DIO Corporation, K161987) rather than proving performance against specific acceptance criteria for an AI/ML device.

Therefore, many of the requested details related to AI/ML device acceptance criteria, study design (like MRMC, training/test set ground truth, expert adjudication), and performance metrics (e.g., AUC, sensitivity, specificity) are not present in this document because it is for a traditional dental implant device, not an AI/ML powered device.

However, I can extract the information relevant to a traditional medical device's acceptance criteria and performance proof, focusing on the equivalence to a predicate device.

Acceptance Criteria and Study for the Oneday Mini Implant System (A Traditional Medical Device)

1. Table of Acceptance Criteria and Reported Device Performance:

For a traditional medical device like a dental implant, "acceptance criteria" are typically demonstrated through various non-clinical tests (mechanical, material, sterilization, biocompatibility) and comparison to a legally marketed predicate device. The performance is assessed by showing substantial equivalence to this predicate, meaning it is as safe and effective as the predicate.

2. Sample Size for the Test Set and Data Provenance:

• Test Set (for performance evaluation): For a traditional device showing substantial equivalence, there isn't a "test set" in the sense of a distinct dataset used to calculate performance metrics like sensitivity/specificity for an algorithm. Instead, the "testing" involves performing specific engineering and biological tests (e.g., fatigue testing on a sample of implants, sterilization validation on a sample of devices) and comparing the design specifications and materials to a predicate device.
  • Fatigue Testing: "Fatigue Testing under the worst-case scenario according to ISO 14801:2016." The standard dictates sample sizes.
  • End User Sterilization Validation: Performed on the "subject Healing Abutment Mini with the greatest surface area" to be representative. Standards dictate sample sizes.
  • Data Provenance: The document does not specify the country of origin for the testing data. Test results are generally from controlled laboratory environments using product samples. Most data is "leveraged" from previous 510(k) clearances (K192294 and K161987) for similar devices, suggesting a retrospective use of existing data to support the current claim of equivalence.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable in the context of this 510(k) summary for a traditional medical device. Ground truth for device performance is established through adherence to recognized international standards (e.g., ISO, ASTM) for material properties and mechanical testing, and through comparison to a device already cleared by the FDA (the predicate). There is no "expert panel" establishing a clinical ground truth for a diagnostic output as there would be for an AI/ML imaging device.

4. Adjudication Method for the Test Set:

• Not applicable. There is no "adjudication" of results in the sense of reconciling differing expert opinions, as this is not an AI/ML diagnostic device with human readers. Testing results are objective measurements against pre-defined engineering and biological standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC study was not done. This type of study is relevant for diagnostic devices, particularly AI/ML-powered ones, to assess the impact of the AI on human reader performance. This document is for a physical medical implant.

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

• No, a standalone evaluation was not done. This concept applies to AI/ML algorithms that might provide a diagnostic output without human intervention. This document is for a physical medical implant.

7. The type of ground truth used:

• The "ground truth" for the Oneday Mini Implant System is based on:
  • Adherence to recognized international standards: e.g., ISO 14801:2016 for fatigue, ISO 11137 for sterilization, ISO 10993 for biocompatibility, etc.
  • Demonstrated equivalence to a legally marketed predicate device: The predicate device (UF(II) Narrow Implant System, K161987) has already been determined to be safe and effective by the FDA. The substantial equivalence argument posits that since the new device is fundamentally similar and meets performance parameters, it is also safe and effective.

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" as this is not an AI/ML device.

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