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The EM Provisional is intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of a permanent endosseous dental implant(s).

The EM Provisional is a dental implant made of titanium alloy (Ti-6Al-4V) and is supplied sterile. The surface is machined finished and is intended to be surgically placed in the bone of the upper or lower jaw arches.

This document is a 510(k) Premarket Notification from Hiossen, Inc. for their dental implant device, EM Provisional. According to the provided text, this submission argues for "substantial equivalence" of the EM Provisional to existing predicate devices, rather than presenting a study proving a device meets specific performance criteria through a clinical or non-clinical study that would generate the kind of data typically found in an AI/software as a medical device (SaMD) submission.

Therefore, the requested information, specifically regarding acceptance criteria, device performance from a test set, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details, is not available in this document. This document primarily focuses on demonstrating that the new device (EM Provisional) is structurally and functionally equivalent to already cleared devices, meaning it does not pose new or increased risks and performs similarly.

Instead of performance metrics from a new study, the document makes the following arguments for substantial equivalence:

1. Acceptance Criteria and Device Performance (as presented in this substantial equivalence argument, not a performance study):

The "acceptance criteria" here relate to the device being substantially equivalent to its predicate. The "performance" is demonstrated by asserting similarity in design, materials, and manufacturing, rather than through measured accuracy, sensitivity, or specificity.

• Screw form
• One-piece fixture and abutment
• Available in diameters: Ø1.8, Ø2.5 mm
• Available in lengths: 10.0, 13.0, 15.0 mm |
  | Material Equivalence | Both EM Provisional and the predicate MS System (Provisional) are made of Titanium alloy Ti-6Al-4V (ASTM F 136). |
  | Surface Finish Equivalence | Both EM Provisional and the predicate MS System (Provisional) have a machined finished surface. |
  | Sterilization Equivalence | Both EM Provisional and the predicate MS System (Provisional) are Radiation Sterile, and the EM Provisional uses the same manufacturing process, material, and sterilize barrier system as the predicate. |
  | Packaging Equivalence | EM Provisional packaging is consistent with the predicate: Secured in plastic ampule, housed in Tyvek-lidded blister tray, placed in a tamper-evident outer package (predicate uses "outer box" but intent is the same). The reference device (Hiossen Implant System K140934) also uses similar packaging. |
  | Risk Equivalence | The proposed device does not pose any new or increased risks as compared to the legally marketed predicate and reference devices. Asserted due to identical manufacturing processes, materials, and design to the predicate, making re-testing for biocompatibility, sterilization validation, surface treatment characterization, fatigue, compressive strength, and pull-out unnecessary per the "least burdensome principle." No clinical performance reports were submitted, reinforcing reliance on equivalence to existing devices. |

2. Sample size used for the test set and the data provenance:
Not applicable. There was no "test set" in the context of an AI/SaMD performance study. The submission relies on pre-existing data and knowledge of the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No new ground truth was established for a performance study. Equivalence is asserted based on engineering and material comparisons.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication process for a test set was performed.

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. This device is a physical dental implant, not an AI/SaMD.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical dental implant, not an AI/SaMD.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable. Ground truth as typically understood for SaMD performance studies is not relevant here. The ground for "equivalence" is based on established performance and safety profiles of the predicate device.

8. The sample size for the training set:
Not applicable. This device is a physical dental implant, not an AI/SaMD.

9. How the ground truth for the training set was established:
Not applicable. This device is a physical dental implant, not an AI/SaMD.

In summary, this document demonstrates substantial equivalence of a physical dental implant to a legally marketed predicate device based on similarities in design, materials, and intended use, rather than through a novel performance study proving it meets specific acceptance criteria typically associated with SaMD or other complex medical devices requiring such studies.

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