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UNIQA® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. UNIQA® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

UNIQA Conical Connection Implants: #UCI & #UC7 are to be used only with straight abutments.

Conical Mini implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

UNIQA® Dental Implant System is consist of endosseous form dental implants, internal hex implants, tapered design; cover screws, healing caps and abutment systems; The Dental Implants provided in two types of design:(a) Conical Hex; (b) Internal Hex; Each implant design is available in two options of surface treatment (1) Pure & Porous, P&P which consists of Hydroxyapatite and Calcium Phosphates; or (2) SBA - which consists of sand blast large particles with acid etched;

The provided text describes UNIQA® Dental Implants System and its comparison to predicate devices, but it does not contain information about acceptance criteria for a study or the study details to prove the device meets acceptance criteria related to a diagnostic or AI-assisted product.

The document is a 510(k) premarket notification for a medical device (dental implants and abutments). It focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through comparison of:

• Intended Use and Indications for Use: The UNIQA® system has the same general indications as its primary predicate, with some specific details for certain implant types (e.g., mini implants for specific jaw regions, use with straight abutments) matching reference devices.
• Technological Characteristics: This includes thread design, measurements (diameter/length), connection type, material (Titanium Alloy Ti6Al4V ELI), surface treatment (Pure & Porous, P&P or SBA), self-tapping feature, sterilization method (Gamma Ray), and packaging (Double packaging).
• Performance Testing: Bench tests like fatigue testing (ISO 14801), sterilization validation (ISO 11137, ISO 17665), shelf life (ASTM F-1980), biocompatibility (ISO 10993-5), and surface cleanliness are mentioned. These tests are performed to ensure the device's safety and effectiveness in relation to its physical and material properties, rather than its diagnostic performance.

Therefore, I cannot provide the requested information about acceptance criteria and study details for a diagnostic or AI-assisted device, as this information is not present in the provided text.

The document explicitly states: "Clinical Testing - No clinical data is included in this submission." This confirms that no studies involving human subjects were conducted or reported for this submission to establish a clinical performance metric.

To reiterate, the provided text does not contain:

• A table of acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, accuracy).
• Reported device performance values for diagnostic tasks.
• Sample size used for a test set in a diagnostic study.
• Data provenance for a diagnostic study.
• Number of experts or their qualifications for establishing ground truth in a diagnostic study.
• Adjudication methods for ground truth in a diagnostic study.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Standalone performance (algorithm only without human-in-the-loop performance) for a diagnostic algorithm.
• Type of ground truth used for a diagnostic study (expert consensus, pathology, etc.).
• Sample size for a training set of a diagnostic algorithm.
• How ground truth for a training set of a diagnostic algorithm was established.

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