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The Immediate Stabilizing Implant (ISI) is a one-piece threaded dental implant with the abutment incorporated into the design for a single stage surgical procedure. The implant is intended to be surgically placed in the bone of the upper or lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function. Immediate loading can be obtained if implants are rigidly splinted.

Self-tapping one-piece CP Titanium threaded dental implant, with a roughened surface treatment. Available in 3.25mm, 4.0mm, and 5.0mm diameter, and in lengths of 8mm 10mm, 12mm, 14mm & 16mm.

The provided document is a 510(k) Pre-Market Notification for a dental implant (Immediate Stabilizing Implant - ISI). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and performance metrics.

Therefore, the document does not contain the requested information regarding acceptance criteria and a study proving the device meets those criteria, as it's not a clinical study report. The information about sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, and training sets is typically found in documentation for devices that require extensive performance validation, often through clinical or non-clinical testing that directly measures performance against pre-defined criteria.

Instead, the document focuses on comparing the ISI device's design, function, labeling, material composition, and intended use to existing predicate devices to assert substantial equivalence.

Here's a breakdown of why the requested information is absent:

1. Acceptance Criteria and Reported Device Performance: These are usually established for new devices undergoing rigorous testing for safety and efficacy. For a 510(k), the "performance" is primarily assessed against the predicate device's characteristics and historical safety/effectiveness.
2. Sample Sizes and Data Provenance: This relates to clinical or analytical studies. The 510(k) summary provided does not describe such a study.
3. Number of Experts, Qualifications, Adjudication Method: These are elements of studies involving expert review, common for diagnostic or imaging devices. This is a physical implant, not a diagnostic tool.
4. MRMC Comparative Effectiveness Study: This is specific to diagnostic aids that influence human reader performance.
5. Standalone Performance: While aspects of a device's physical/mechanical performance might be tested, a "standalone" performance in the context of an algorithm's output (as typically asked) is not relevant here.
6. Type of Ground Truth: Ground truth (e.g., pathology, outcomes data) is used to validate the accuracy or effectiveness of a diagnostic or predictive device. For a dental implant, the "effectiveness" is determined by successful integration and function, which is typically demonstrated over time in clinical use, not usually by a single ground truth in a 510(k) submission.
7. Training Set Sample Size and Ground Truth for Training Set: These are concepts related to machine learning and AI, which are not applicable to the ISI dental implant.

In summary, the provided document demonstrates substantial equivalence based on a comparison to predicate devices, not through a study with defined acceptance criteria and performance metrics in the way a diagnostic or AI-powered device would.

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