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

Device Description

The Southern Implants PEEK abutments are endosseous dental implant abutments. The PEEK abutments are available in a variety of preformed and customized forms. The PEEK abutments are available as temporary abutments.

Temporary abutments are used as an aid in manufacturing a temporary prosthesis for prosthetic rehabilitation. They are used for direct connection to an endosseous implant. Temporary abutments are available in a 2 mm collar direct to implant.

These abutments are made from white PEEK (ASTM F2026).

The PEEK abutments are premanufactured and are available in a variety of connections, engaging and nonengaging, to suit the implant systems manufactured by Southern Implants.

Titanium retaining screws are also available to use with the PEEK abutments.

AI/ML Overview

I am sorry, but the provided text is a 510(k) summary for a medical device (Southern Implants PEEK Abutments) and does not contain information about acceptance criteria and a study proving a device meets those criteria, especially for AI/ML-based devices.

The document explicitly states: "No clinical studies were conducted." and focuses on demonstrating substantial equivalence to a predicate device based on material, manufacturing, intended use, and non-clinical testing (sterilization, packaging, biocompatibility).

Therefore, I cannot extract the information you requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML device evaluation.

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K Number

K172160

Device Name

Southern Implants PEEK Abutments

Manufacturer

Southern Implants (Pty) Ltd

Date Cleared

2018-02-09

(206 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K120954

Intended Use

Device Description

The healing abutments are attached onto the implant during phase 2 surgery to maintain the tissue opening while the prosthesis is being fabricated. Temporary abutments are used as an aid in manufacturing a temporary prosthetic rehabilitation. They can either be used for direct connection to an endosseous implant or they can be used for connecting the prosthesis to a compact conical abutments. Temporary abutments are available in a 2 mm collar direct to implant and 1mm collar on abutment level. The temporary abutments for the compact conical abutments are for multi-unit use only.

These abutments are made from white PEEK (ASTM F2026).

The PEEK abutments are premanufactured and are available in a variety of connections, engaging and non-engaging, to suit the implant systems manufactured by Southern Implants.

Titanium retaining screws are also available to use with the PEEK abutments.

AI/ML Overview

This is a report for a 510(k) premarket notification for Southern Implants PEEK Abutments. There is no mention of a study involving artificial intelligence (AI) or machine learning within the provided document. Therefore, I cannot extract information related to acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details as they pertain to an AI device.

The document discusses the substantial equivalence of the Southern Implants PEEK Abutments to a predicate device based on non-clinical testing and performance verification, but not in the context of an AI/ML algorithm.

Here's what I can provide based on the document regarding the device itself (not an AI component):

Acceptance Criteria and Device Performance (Non-AI related)

Since this submission is for a medical device (dental abutments) and not an AI/ML device, the concept of "acceptance criteria" is based on demonstrating substantial equivalence to a legally marketed predicate device (K120954, NobelProcera PEEK Abutments) through comparisons of intended use, materials, design, and non-clinical performance testing.

Acceptance Criteria Category	Reported Device Performance (Southern Implants PEEK Abutments)
Indications for Use	The Southern Implants PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation. (Equivalent to predicate).
Intended Use	Healing Abutment / Temporary Abutment (Equivalent to predicate).
Material	Polyetheretherketone (PEEK) (Equivalent to predicate).
Color	White (Predicate is Natural and White).
Attachment Method	Screw retained (Equivalent to predicate). Engaging and Non-Engaging for Temporary Abutments.
Duration of Use	180 days, single use (Equivalent to predicate).
Implant/Abutment Connection	Southern Implants MAX (External Hex, Tri-Nex, Internal Hex); For Temporary Abutments: Southern Implants MAX (External Hex, Tri-Nex, Deep Conical, Internal Hex, Internal Taper, Compact Conical). (Different from predicate which is Nobel Biocare Internal Conical/External Hex/Internal Tri-lobe, but new device compliments Southern Implants' range).
Height (mm)	Healing Abutments: 5 – 6 mm (Predicate: 5 mm). Temporary Abutments: 9-14.5 mm (Predicate: 12 mm).
Collar Height (mm)	Temporary Abutments: 1-2 mm. (Predicate: 1-1.5 mm).
Diameter (mm)	Healing Abutments: 6x9, 8x11 (Predicate: 6x7, 7x8). Temporary Abutments: 3.35 - 7.35 mm (Predicate: Not given).
Abutment Profile	Various anatomical shapes intended for different tooth locations (Equivalent to predicate for Healing Abutments). Cylinder with retention feature (Equivalent to predicate for Temporary Abutments).
Sterility	Sterile, delivered sterile, not intended for user sterilization. (Predicate is Sterile for Healing Abutments; Non-Sterile for Temporary Abutments).
Sterilization Validation	Gamma radiation, validated per ISO 11137. Proposed user sterilization (steam) validated per ISO 17665.
Packaging Validation	Validated per ISO 11607. Accelerated aging per ASTM-F-1980 for 5 years shelf life.
Biocompatibility	Subject device is manufactured from the same material using the same manufacturing method as the predicate, has the same intended use, and the same patient contact type and duration. Biocompatible in accordance with ISO 10993-1. No cytotoxicity shown per ISO 10993-5.

Regarding AI/ML specific questions:

A table of acceptance criteria and the reported device performance: Not applicable for an AI device as this is a traditional medical device (dental abutments).
Sample sized used for the test set and the data provenance: Not applicable. Tests were non-clinical for material properties, sterilization, and packaging.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth wasn't established by experts as it would be for an AI diagnostic device.
Adjudication method: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device would be its physical and chemical properties and performance as assessed by standardized tests.
The sample size for the training set: Not applicable (no AI).
How the ground truth for the training set was established: Not applicable (no AI).

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