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Simpact Dental Implant System is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained terminal or intermediate abutment support for fixed bridgework.

The Simpact implant is a threaded/tapered internal connection implant. The Simpact implant is intended for immediate placement, where immediate implant placement is defined by the International Congress of Oral Implantologists (ICOI) as the placement of an implant at the time of tooth extraction, into the extraction socket.

The Simpact implant is intended for immediate provisional loading when primary stability and proper occlusion are present. Immediate Provisionalization is defined by the International Congress of Oral Implantologists (ICOI) as a clinical protocol for the placement of an interim prosthesis with occlusal contact with the opposing dentition, at the same clinical visit of implant placement. The Simpact implant can be restored with a temporary prosthesis in single tooth and multiple tooth applications.

The SIMPACT Endosseous Dental Implant System.

The Simpact implant is a threaded/tapered internal connection implant.

The medical device in question, the SIMPACT Endosseous Dental Implant System, is a dental implant. The provided text from the 510(k) summary (K081226) does not contain a detailed study report with specific acceptance criteria and performance data for the device in the way one would expect for an AI/ML medical device or a device requiring extensive clinical trials for efficacy.

Instead, this 510(k) submission primarily focuses on establishing substantial equivalence to predicate devices. This means that formal acceptance criteria and a study demonstrating the device meets those criteria in terms of numerical performance metrics (like sensitivity, specificity, accuracy, or effect size) are not present in the provided document, because the regulatory pathway for this type of device at the time did not typically require such studies for substantial equivalence.

The document states: "The SIMPACT implant system and its predicate devices have the same indications for use have a similar design and are made of the similar materials." and "The SIMPACT implant system is substantially equivalent to its predicate devices. This conclusion is based upon the fact that this device is substantially equivalent in terms of indications for use, materials, design and principles of operation." This indicates that the "performance" of the SIMPACT implant is deemed acceptable because it is similar to already legally marketed devices.

Therefore, for the specific questions related to acceptance criteria and study details, the answer will reflect the nature of a 510(k) submission for a non-software device establishing substantial equivalence.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Strictly speaking, the document does not define specific acceptance criteria (e.g., numerical thresholds for success) or report quantitative performance data for the SIMPACT Endosseous Dental Implant System in the way one would for a clinical trial or performance study of an AI/ML device. The "acceptance criteria" here are implicitly met by demonstrating substantial equivalence to predicate devices in terms of materials, design, indications for use, and principles of operation.

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

Not Applicable (N/A). The provided 510(k) summary does not describe a "test set" of data or a clinical study in the typical sense (e.g., for performance metrics) for the SIMPACT device itself. Substantial equivalence was primarily established through comparison of specifications, materials, design, and indications for use against predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not Applicable (N/A). As no test set from a clinical study is described, no experts were used to establish ground truth for such a set based on this document.

4. Adjudication Method for the Test Set

Not Applicable (N/A). No test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done for the SIMPACT Endosseous Dental Implant System, as it's a physical medical device (implant) and not a diagnostic imaging system or AI software that would typically utilize such a study design.

6. If a Standalone Performance Study Was Done

No, a standalone performance study (algorithm only performance without human-in-the-loop) was not primarily relied upon or described. The regulatory strategy was substantial equivalence to predicate devices, focusing on materials, design, and intended use as the basis for performance assumptions. The performance is assumed to be similar to legally marketed predicate devices, not demonstrated through an independent, standalone study with specific performance metrics in this document.

7. The Type of Ground Truth Used

Not Applicable (N/A) in the software/AI sense. For a physical device like an implant, "ground truth" concerning its direct "performance" (e.g., osseointegration, stability, longevity) would typically come from long-term clinical outcomes, histological analysis, or mechanical testing. However, the provided document only focuses on demonstrating substantial equivalence based on design, materials, and intended use compared to existing devices rather than new clinical ground truth establishment for this specific device.

8. The Sample Size for the Training Set

Not Applicable (N/A). This device is a physical dental implant, not an AI/ML algorithm requiring a "training set."

9. How the Ground Truth for the Training Set Was Established

Not Applicable (N/A). This device is a physical dental implant, not an AI/ML algorithm with a training set and corresponding ground truth.

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