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For the implants:

The Single Platform SP1 Implant System is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. The Single Platform SP1 Implant System is intended for immediate function when good primary stability with appropriate occlusal loading is achieved.

The Single Platform SP1 implants in lengths 20, 22 and 24 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

For the conventional abutment and screws:

The Conventional Abutments and Prosthetic Screws are premanufactured prosthetic components directly connected to endosseous dental implants and intended for use in fully edentulous maxilla and/or maxilla and/or mandible to provide support for crowns, bridges or overdentures.

For the Titanium Abutment Bases and Passive Abutments:

The TIB and Passive Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The TIB and Passive abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

For the Temporary Titanium Cylinders:

The Southern Implants Temporary Titanium Abutments are prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

This submission includes fully threaded root-form dental implants with an internal cone and hexagon interface and mating abutments. The implants are provided in three diameters: Ø3.5, Ø4.0 and Ø5.0 mm. The implants are provided in a straight (0° angled) configuration only, with a 3.0 mm extended machined coronal section. The implants are provided in one prosthetic diameter (2.95 mm implants are provided in overall leneths of 8, 10, 11.5, 13, 16, 18 and 20 mm. The Ø4.0 mm implants are provided in overall lengths of 8, 10, 11.5, 13, 16, 18, 20, 22 and 24 mm. The Ø5.0 mm implants are provided in overall lengths of 8, 10, 11.5, 13, 16, and 18 mm.

This submission also includes: a Cover Screw, Healing Abutments in four diameters and multiple gingival heights, Titanium Cylinder Abutments for temporary restorations, Passive Abutments with a plastic burn-out component, Equator Overdenture Abutments in multiple gingival heights, Compact Conical Abutments in straight (0) and angled (17° and 30°) designs, TIB Abutment Bases, and abutment screws.

The Passive Abutments may be restored using either traditional cast-on workflows or digital CAD/CAM workflows using milled zirconia restorations (similar use to the TIB Abutment Bases).

Using the traditional cast-on workflow, the Passive Abutments function as UCLA castable abutments which interface with a plastic, burn-out sleeve used to fabricate a prosthesis that is bonded directly to the top of the abutment, limited to a straight (0°) restoration when utilizing precious metal cast-on restorations.

Using digital CAD/CAM workflows, the TIB Abutment Bases and Passive Abutments function as two-piece abutment designs, consisting of standard premanufactured titanium alloy abutments for supporting the second half (or top-half) of the abutment, a hybrid/crown dental restoration and mesostructure (SageMaxx Zirconia) bonded with cement (Ivoclar Vivadent Multilink Hybrid cement). The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The TIB Abutment Bases and Passive Abutments then serves as the interface between the endosseous implant and the Zirconia restoration. The TIB Abutment Bases and Passive Abutments are designed to support the restoration on an endosseous implant in order to restore chewing function for the patient.

The mesostructured restoration is a CAD/CAM designed prosthesis milled out of Zirconia (SageMaxx Zirconia), which is designed to fit the abutment base in order to restore chewing function for the patient. Each restoration is custom designed using 3Shape Abutment Designer Software in order to meet the requirements of each patient on a case-by-case basis. Limitations have been put in place in 3Shape Abutment Designer in order to prevent malfunctioning of the restoration and a maximum allowable angulation of 20° for the mesostructured component.

All Single Platform SP1 implants are manufactured from unalloyed titanium conforming to ASTM F67, with a smooth machined collar (extended machined surface of 3 mm). The remainder of the entire endosseous threaded surface) is grit-blasted. The subject device implant material and surface is identical to the implants cleared in K222457 and K163060. The Cover Screw and Healing Abutments are manufactured from unalloyed titanium conforming to ASTM F67. The remaining Abutments are manufactured from titanium alloy conforming to ASTM F136. The abutment screws are manufactured from titanium alloy conforming to ASTM F136. All subject device components are manufactured in the same facilities using the same materials and manufacturing processes as used for the Southern Implants devices previously cleared in K222457 and K163060.

The provided text describes a 510(k) premarket notification for the "Single Platform SP1 Implant System." This document focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than proving that the device meets specific acceptance criteria through a clinical study or a standalone algorithm performance test.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in terms of clinical performance with statistical measures, expert reading, and ground truth establishment is not present in the provided document. The 510(k) pathway for medical devices typically relies on demonstrating that a new device is as safe and effective as a predicate device, rather than requiring new clinical efficacy studies unless there are significant technological differences or new intended uses that raise new safety or effectiveness questions.

The "Performance Data" section explicitly states: "No clinical data were included in this submission."

However, I can extract information related to the non-clinical performance data provided to support substantial equivalence and the device's characteristics compared to predicates.

Here's a breakdown of what is available:

1. Table of Acceptance Criteria and Reported Device Performance:
The document does not define specific "acceptance criteria" for clinical performance (e.g., sensitivity, specificity, accuracy) or report device performance against such metrics. Instead, it demonstrates through non-clinical testing that the device's mechanical, material, and functional properties are substantially equivalent to marketed predicate devices.

Here's a table summarizing the non-clinical performance data and findings:

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not applicable in the context of clinical efficacy; the "test set" here refers to the non-clinical testing of the physical device. For example, "dynamic compression-bending testing was performed on worst-case subject device constructs." The exact number of constructs tested is not specified but would be dictated by the ISO standard.
• Data Provenance: The document does not specify the country of origin for the non-clinical testing data directly, but the manufacturer is Southern Implants (Pty) Ltd from Irene, Gauteng, SOUTH AFRICA. The data is retrospective in the sense that it supports a submission for a new device, often using internal lab data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• This information is not applicable as no clinical study with human readers or ground truth established by experts for diagnostic performance was conducted or reported.

4. Adjudication Method for the Test Set:

• Not applicable, as there was no human reader interpretation or clinical assessment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No MRMC comparative effectiveness study was done. The submission explicitly states: "No clinical data were included in this submission." Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.

6. Standalone (Algorithm-Only) Performance:

• Not applicable. This is a physical dental implant system, not an AI algorithm. The only "software" mentioned is for design (CAD/CAM workflow), and its validation is to ensure it prevents designs outside of allowable limitations.

7. Type of Ground Truth Used:

• For the non-clinical performance data, the "ground truth" is established by adherence to recognized international standards (ISO, ASTM, USP) and internal engineering specifications. For instance, the "ground truth" for fatigue performance is the passing criteria defined by ISO 14801.

8. Sample Size for the Training Set:

• Not applicable. This product does not involve machine learning or AI models that require a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable as there is no training set for an AI/ML model.

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