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The UF(II) Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The UF(II) Implant System(Ø3.8 ~ Ø5.5) can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability is achieved with appropriate occlusal loading.

UF(II) Fixture is made of pure titanium grade 4 (ASTM F67) and the surface treatment is done with SLA (Sand-blasted, Large grit, Acid-etched). The diameters of fixture are 3.8, 4.0, 4.5, 5.0, 5.5mmand the lengths of fixture are 7.0, 8.5, 10.0, 11.5, 13.0, 15.0,16.0mm in this system. All fixture lengths are available in all diameters, except for the 7.0mm length, which is not available in 3.8 or 4.0mm diameters. The abutments and superstructures consist of Healing Abutment, Cemented Abutment Screw, Cover Screw, Solid Abutment, Cemented Cylinder, Cylinder Screw and Conical Abutment.

The provided text describes a 510(k) summary for the UF(II) Implant System, which relies on demonstrating substantial equivalence to predicate devices rather than proving a specific performance metric against acceptance criteria in the way a clinical study for a novel device would. Therefore, much of the requested information regarding clinical study design, sample size, expert adjudication, MRMC studies, effect sizes, training sets, and ground truth establishment is not directly applicable or available in this document.

The document focuses on non-clinical testing to demonstrate that the device meets criteria of established standards and is substantially equivalent to predicate devices.

Here's an attempt to extract the closest available information based on your request, highlighting what is implicitly or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are meeting the criteria of the referenced standards and demonstrating substantial equivalence to predicate devices. The "reported device performance" is the outcome of non-clinical tests that conclude these criteria are met.

Non-Clinical Test Acceptance Criteria and Reported Performance for UF(II) Implant System

• Accelerated aging shelf life testing was conducted according to ASTM F1980 for devices provided sterile (real-time testing ongoing to support results). |
  | Fatigue Test | Compliance with ISO 14801:2007 (Dentistry-Implants-Dynamic fatigue test for Endosseous Dental Implants) and ISO 14801:2016. Testing performed on worst-case scenario as per FDA guidance. | - The subject device was tested and met the criteria of ISO 14801:2007 and ISO 14801:2016.
• The worst-case scenario was chosen for testing. |
  | Biocompatibility | Compliance with ISO 10993-1:2009 ("Biological evaluation of medical devices-Part 1: Evaluation and testing within risk management process") and FDA Guidance document "Use of International Standard ISO 10993-1..." for relevant tests (Sensitization, Acute systemic toxicity, Cytotoxicity, Intracutaneous Reactivity Test, Pyrogen Test, Implantation Test). Abutment and superstructure must raise no new biocompatibility issues compared to predicates. | Fixture:
• Sensitization: Conducted according to ISO10993-10.
• Acute systemic toxicity: Conducted according to ISO 10993-11.
• Cytotoxicity: Conducted according to ISO10993-5.
• Intracutaneous Reactivity Test: Conducted according to ISO 10993-10.
• Pyrogen Test: Conducted according to USP.
• Implantation Test: Conducted according to ISO 10993-6.
  Abutment and Superstructure:
• No new biocompatibility issues raised due to identical nature of body contact, contact duration, material formulation, manufacturing processes, and sterilization methods compared to predicate devices. No additional testing required. |
  | Mechanical Testing | Confirm external appearance (smooth, no cracks/damage), dimensional analysis, measurement of fixture-to-abutment gap, rotational angle (no significant rotation), maximum/removal torque for screws, static shear strength (equivalent to ISO 14801), and adequate packaging. | - Appearance Test: Confirmed smooth external appearance without cracks or damage.
• Dimension Test: Confirmed same fundamental technology through dimensional analysis.
• Measurement of the gap between Fixture and abutment: Confirmed same fundamental technology through dimensions.
• Rotational Angle Test: Confirmed no significant rotation for the subject device.
• Maximum Torque for dental implant screw Test: Confirmed equivalent rotational torque.
• Removal Torque for dental implant screw Test: Confirmed equivalent removal torque.
• Static Shear Strength Test: Conducted according to ISO 14801, confirming equivalent static shear strength.
• Packaging Test: Confirmed adequate and equivalent packaging. |
  | Substantial Equivalence | The device is similar in design, dimensions, material, intended use, surface treatment, and technological characteristics to identified predicate devices (K122519, K161987, K060501, K070569), raising no new questions of substantial equivalence. | Documentation provided shows comparison tables demonstrating similarity to predicates. Differences (e.g., fixture diameter range, surface treatment for abutments) are addressed and stated not to raise new questions of substantial equivalence. |

Specific Information on Study Design (Not Applicable to this 510(k) submission)

As this is a 510(k) premarket notification primarily relying on substantial equivalence through non-clinical testing, there are no clinical studies of the type you describe (e.g., involving human readers, ground truth consensus for image interpretation, effect sizes of AI assistance). The document focuses on demonstrating that the device meets established engineering and biological safety standards, and is equivalent to previously cleared devices.

Therefore, the following points are not applicable to the provided document:

2. Sample size used for the test set and the data provenance: Not applicable, as this refers to clinical test data. Non-clinical tests would use physical samples of the device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical assessment is not established in this type of submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. 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. This device is a dental implant system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as it pertains to clinical performance assessment. Ground truth for non-clinical tests would be established through reference standards, metrology, and validated test methods.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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