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The Neoss Tapered Implant is for single-stage or two-stage surgical procedure and cement or screw retained restorations. The Neoss Tapered Implant is intended for immediate placement and function on single tooth and /or multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.

The Neoss Tapered Implant is a threaded, internal abutment connection, root-form titanium dental implant. The Neoss Tapered Implant consists of a number of implants with a diameter of Ø3.5 to Ø5.5 mm and lengths between 7.0 – 17.0 mm; all sizes have the same internal abutment connection dimension independent of implant diameter. The internal connection is equipped with interlocking elements for an insertion tool and the non-rotational locking of the abutment. The Neoss ProActive Tapered Implant System is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices, which can restore chewing function and aesthetic appearance. Supplied sterile. The Neoss Implant System has specific design characteristics for mating Neoss components such as implants, abutments and prosthetic components. Combining components that are not configured or dimensioned for correct mating can lead to mechanical failure of components, damage to tissue, or unsatisfactory esthetic results. Abutment screws made in gold alloy, titanium or Ti with TiN/Au are available. Screw driver connection is compatible with screwdrivers supplied by Neoss. The abutment screws are supplied non-sterile.

Here's an analysis of the provided text regarding the Neoss Tapered Implant (K113376) and its acceptance criteria and supporting studies.

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, it does not contain the detailed, standalone study results and acceptance criteria typically found in a full scientific publication or comprehensive device validation report.

Based on the information given, here's what can be extracted and what is not available:

Acceptance Criteria and Reported Device Performance

Critique on "Acceptance Criteria": The document doesn't explicitly state numerical acceptance criteria (e.g., "minimum fatigue limit of X N"). Instead, it references the predicate device's performance and general "requirements" as the benchmark. The "reported device performance" for the Neoss Tapered Implant is often a statement of equivalence or enhanced performance compared to previous designs or the predicate, rather than a raw data point against a predefined threshold. The core of this 510(k) is the argument of substantial equivalence, not necessarily meeting new, specific acceptance thresholds for this novel device.

Study Details

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

   • Fatigue Tests: Not specified how many implants were tested. The reference is to "Performed fatigue tests of ProActive implants (K083561)". For the new Tapered Implant, the conclusion of equivalence is based on design similarity, implying reliance on the predicate's testing rather than extensive new fatigue testing for the Tapered Implant itself.
   • Clinical Feedback: Refers to "only one fracture related complaint" for the ProActive Implant (K083561), not specifically for the new Tapered Implant. This is retrospective data from post-market surveillance.
   • Primary Stability: No specific sample size is mentioned for the in vitro tests (insertion, displacement, theoretical implant-bone contact analysis).
   • Osseointegration (Animal Testing): "In animal testing..." No specific sample size or animal model details are provided. This would be prospective animal data.
   • Data Provenance: Not explicitly stated for all tests. Clinical feedback is retrospective. Animal testing and in vitro primary stability tests would likely be prospective, but no country of origin is mentioned.

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

   • This information is not provided in the 510(k) summary. The document focuses on physical and biological testing, not on subjective expert evaluation for "ground truth" in the way an AI/CAD study would.

3. Adjudication method for the test set:

   • Not applicable / Not provided. Since this is focused on physical device performance and animal studies, "adjudication" in the context of expert consensus for ground truth determination is not relevant here.

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:

   • No, this was not done. This is a dental implant, not an imaging device with AI assistance for human readers. This type of study is completely irrelevant to the device being described.

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

   • Not applicable / No. The device is a physical dental implant. There is no algorithm involved in its direct function.

6. The type of ground truth used:

   • Fatigue Testing: Mechanical failure (fracture) or meeting engineering specifications.
   • Primary Stability: Measured mechanical parameters (insertion torque, displacement, theoretical contact area).
   • Osseointegration: Histomorphometric analysis (e.g., bone-to-implant contact percentages, push-out/pull-out strength) from animal studies.
   • Clinical Feedback: Real-world adverse event reporting (fractures).

7. The sample size for the training set:

   • Not applicable / Not provided. There is no "training set" in the context of a machine learning or AI algorithm for this physical device.

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

   • Not applicable / Not provided. As there's no AI/ML component, there's no training set or ground truth establishment relevant to that. The "ground truth" for the physical device's performance is established by direct measurement during testing.

Summary of Device and Study:

The K113376 submission for the Neoss Tapered Implant relies heavily on demonstrating substantial equivalence to its predicate, the Neoss ProActive Implant (K083561). The study evidence presented is:

• Reliance on Predicate Fatigue Data: The Tapered Implant's structural integrity is primarily justified by the predicate's "well in line with requirements" fatigue tests and clinical feedback (one fracture complaint for the predicate), combined with an assertion of "design in critical areas shows enough similarity" between the two implant types.
• In Vitro Primary Stability Testing: The Tapered Implant showed "enhanced primary stability" in in vitro tests compared to a "straight Neoss implant" (presumably an earlier or different Neoss design, but not explicitly stated if it's the predicate ProActive). No specific numerical results are provided.
• Animal Testing for Surface Characteristics: General statements about grit-blasted and acid-etched surfaces (which are properties of the implant, not necessarily new research specific to the Tapered Implant) demonstrating increased osseointegration and bone-to-implant contact compared to other surface treatments.

The documentation is a regulatory summary; it is not a detailed scientific report of new studies specific to the Neoss Tapered Implant with comprehensive data, but rather a justification of its equivalence and safety based on existing knowledge and some comparative in vitro testing.

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