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ALFA GATE® Dental Implants System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. ALFA GATE® Dental Implants System may be immediate loading when good primary stability is achieved and with appropriate occlusal loading. ALFA GATE® 3.00mm S-LINE & SLIM implants are intended for placement at the mandibular central and lateral incisors and maxillary lateral incisors. Indicated also for denture stabilization using multiple implants. Two Stage Implants: M+, S-LINE, SCI, SCIP, MAX. One Stage Implants: SLIM Implants.

ALFA GATE Dental Implants longer than 13mm are to be used with straight abutments only.

ALFA GATE® Dental Implant System is consist of endosseous form Dental Implants, Internal hex Implants, Internal Conical Connection Implants, One piece Implants, tapered design; cover screws, healing caps and abutment systems; Dental Implants are provided in two options of surface treatment (1) Bioactive Surface-CaP which is a calcium phosphate coating; or (2) Sand blast large particles with acid etched;

Dental Implants:

M+ IMPLANTS - Internal Hex, Conical Connection Implant

Measurements: Diameter mm 3.5, 4.3, 5.0, 6.0; with Length mm 8, 10, 11.5, 13, 16(not for 60 mm);

S-LINE Implants - Internal Hex implant, Narrow Implants

BIOACTIVE S-LINE Implant - Measurements: Diameter mm 3.0 with Length mm 10, 11.5, 13;

POROUS S-LINE Implant - Measurements: Diameter mm 3.0 with Length mm 10, 11.5, 13:

SCI Implants - Internal Hex implant, Spiral conical design

BIOACTIVE SCI Implant - Measurements: Diameter mm 3.3, 3.75, 4.2, 4.7, 5.2, 6.0 with Length mm 8, 10, 11.5, 13, 16 (not for 5.20,60 mm);

POROUS SCIP Implant - Measurements: Diameter mm 3.3, 3.75, 4.2, 4.7, 5.2, 6.0 with Length mm 8, 10, 11.5, 13, 16 (not for 5.2Ø,6Ø mm):

MAX Implant - Internal hex implant, cylindrical and conical body design

Measurements: Diameter mm 3.3, 3.75, 4.2, 4.7, 5.2 with Length mm 8, 10, 11.5, 13, 16;

SLIM Implant - One Piece implants

Measurements: Diameter mm 3.0, 3.3, 3.75 with Length mm 10, 11.5, 13, 15;

Dental Abutments:

Straight abutments (Regular, Thin, Wide, Narrow), Angled Abutments 15° (Regular, Short), Multi Unit, Shoulder abutments, Esthetic Abutments, Concave Esthetic Abutments, Esthetic Abutments 15°, Concave Angulated Abutments 15°, Esthetic Abutments , Alfa lock abutment (locator), Ball attachment Abutment, Ball attachment concave, Healing Caps (Narrow, Regular, Wide, Slim), Concave healing caps, Anatomic Abutment. Angled abutments are only to be used with S-Line, SCI, and MAX implants. M+ and SLIM implants are not to be used with angled abutments. Dental Abutments Conical Connection:

Anatomic straight Abutment (RP, NP), Standard straight abutment (RP, NP), Ball attachment (RP, NP), Healing Caps (RP, NP).

The provided text describes the 510(k) premarket notification for the ALFA GATE® Dental Implants System. The entire document focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on proving device performance against specific acceptance criteria for an AI/ML-based device.

Therefore, I cannot provide the requested information as the provided text does not contain:

1. Acceptance criteria for an AI/ML device: The document pertains to traditional dental implants and abutments.
2. Reported device performance for an AI/ML device: The performance tests conducted are for mechanical, biocompatibility, and sterilization properties of the physical implants, not for an AI/ML algorithm's diagnostic or predictive capabilities.
3. Sample size or data provenance for AI/ML test sets: There are no mentions of test sets, training sets, or data used for AI/ML model evaluation.
4. Information about experts or ground truth for AI/ML evaluation: The document does not discuss expert adjudication or establishing ground truth for evaluating AI/ML performance.
5. MRMC studies or standalone AI performance: These are concepts specific to AI/ML device studies, which are not relevant to the content of this document.

The document primarily relies on bench testing (fatigue, sterilization, shelf-life, biocompatibility, surface tests) and comparison to predicates to demonstrate substantial equivalence for the physical dental implant system. There is no mention of any AI or machine learning component in the ALFA GATE® Dental Implants System.

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