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Zygomatic Implants are indicated for surgical installation in the zygoma region, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Zygomatic Implants are recommended for the posterior (pre-molar/ molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration. Zygomatic Implants may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

The subject implant devices are single use devices, provided sterile by Gamma Radiation, made of commercially pure Titanium grade 4 (ASTM F67 – ISO 5832-2). The Zygomatic Implant with an external diameter of 4.0 mm, conical apex, helical flutes, trapezoidal thread and GM prosthetic interface. Indicated for rehabilitation surgical procedures in atrophic maxilla cases, for installation in the zygomatic bone.

The subject abutment devices are single use devices, provided sterile by Ethylene Oxide, made of Titanium allov (TI6AI4V-ELI). They are 45 degrees prosthetic abutments with anti-rotational feature, anatomic gingiva region and GM prosthetic interface to be installed on the implant, offering a structure to support the prosthesis. Indicated for rehabilitation of screw-retained bridges.

The provided text describes the acceptance criteria and the studies performed for the K190718 Zygomatic Implants. However, it does not detail any studies involving AI, human readers, ground truth establishment methods in the AI context, or sample sizes related to AI model training or testing. The document focuses on the substantial equivalence of the Zygomatic Implants and abutments to legally marketed predicate devices based on physical and performance characteristics, and biocompatibility.

Here's the information extracted from the document regarding the acceptance criteria and related studies:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria with reported device performance in a quantitative format for all characteristics. Instead, it compares the subject device's characteristics to predicate devices. The "Equivalence Discussion" column in the "TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE" implicitly serves as the acceptance criteria for substantial equivalence, where "Same" or "Equivalent" signifies meeting the criteria.

Study Details (No AI/ML Component in the Provided Text)

The document is a 510(k) summary for a dental implant system. It focuses on demonstrating "substantial equivalence" to predicate devices through design comparisons and mechanical/biological testing, not on the performance of a medical artificial intelligence/machine learning (AI/ML) device. Therefore, information related to AI-specific parameters (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone AI performance, type of ground truth for AI, training set size, and ground truth for training set) is not applicable to this document.

The studies mentioned are primarily bench testing and biological assessments:

1. Dynamic fatigue test per ISO 14801: To determine the fatigue strength for the implant construct.
2. Torsion Test: To evaluate the implant and abutment screw under static torsional loading.
3. Insertion Test: To evaluate the insertion torque of the implant in jawbone material (types II, III, and IV).
4. Sterilization Validation (Implants): Via gamma irradiation (25 kGy minimum dose) according to ISO 11137-2, achieving a minimum SAL of 1 x 10^-6. Relevant data was leveraged from K141777.
5. Sterilization Validation (Abutments): Via ethylene oxide gas (overkill method) according to ISO 11135, achieving a minimum SAL of 1 x 10^-6. Relevant data was leveraged from K163194.
6. Ethylene Oxide Residuals Assessment: Per ISO 10993-7.
7. Biological Safety Assessment: Guided by ISO 10993-1. Biocompatibility information for implants leveraged from K141777 and for abutments from K163194.
8. Cytotoxicity testing: Per ISO 10993-5.
9. Chemical characterization: Per ISO 10993-18.
10. Biocompatibility sample preparation: Per ISO 10993-12.
11. MRI Compatibility: Leveraged from K182620.

Regarding your specific points (since it's a non-AI device context):

1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified for the bench tests. These are typically controlled laboratory tests, not clinical data. The sponsor is JJGC Indústria e Comércio de Materiais Dentários SA in Curitiba, Parana, Brazil.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as these are technical performance tests, not diagnostic or clinical evaluations requiring expert ground truth in that sense.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for these engineering and biological tests.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable; no AI component.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; no AI component.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For mechanical tests, the "ground truth" is defined by the physical properties and failure points according to engineering standards (e.g., ISO 14801). For biological tests, it's defined by established biocompatibility assays.
7. The sample size for the training set: Not applicable; no AI component involved in a training set.
8. How the ground truth for the training set was established: Not applicable; no AI component.

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