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Mytis Arrow XXXX systems are intended for immediate placement in extraction or surgically prepared sites in partially or fully edentulous mandibles and maxillae (type 1 or II bone), in support of single or multiple-unit restorations including; cement retained, screw retained, or over-denture restorations, and terminal or intermediate abutment support for fixed bridgework.

The Mytis Arrow Implant system comprises various sets of root form endosseous dental implants and compatible implant abutment systems. Mytis Arrow Systems are designed for use in dental implant surgery and are intended to be used in a manor in which the implant integrates with the bone. The Mytis Arrow abutments include various abutments designed to enable the implant process from healing through final restoration. Mytis implants are for single and two-stage surgical procedures.

I am sorry, but the provided text describes a 510(k) premarket notification for a dental implant system (Mytis Arrow Implant Systems). This document focuses on demonstrating substantial equivalence to predicate devices and outlines the intended use and classification of the device.

There is no information within the provided text about:

1. Acceptance criteria for device performance.
2. Study data proving the device meets performance criteria.
3. Sample size for test sets.
4. Data provenance.
5. Number of experts or their qualifications.
6. Adjudication method.
7. MRMC comparative effectiveness studies.
8. Standalone (algorithm only) performance.
9. Type of ground truth used.
10. Sample size for training set.
11. How ground truth for the training set was established.

Therefore, I cannot provide the information requested in your prompt based on the provided document. The document is a regulatory submission for premarket clearance, not a clinical study report.

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