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Southern Implants MAX implant is intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications. This MAX implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses or full arch prostheses. It further adds the option for immediate loading on single unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

This submission includes threaded root-form dental implants with an external hex and internal tri-lobe interface and mating abutments. The implants are provided in diameters of 6, 7, 8 and 9mm and lengths of 6, 7, 9 and 11mm. Specifically:

• MAX Implants with External Hex Connection
  • Ø6 mm at lengths of 6, 7, 9, 11 mm
  • Ø7 mm at lengths of 7, 9, 11 mm
  • Ø8 mm at lengths of 7, 9, 11 mm
  • Ø9 mm at lengths of 7, 9, 11 mm
• TRIMAX Implants with Tri-lobe Connection
  • Ø7 mm at lengths of 7, 9, 11 mm
  • Ø8 mm at lengths of 7, 9, 11 mm
  • Ø9 mm at lengths of 7, 9, 11 mm
• PROMAX Implants with Internal Hex Connection
  • Ø6 mm at lengths of 7, 9, 11 mm
  • Ø7 mm at lengths of 7, 9, 11 mm
  • Ø8 mm at lengths of 7, 9, 11 mm
  • Ø9 mm at lengths of 7, 9, 11 mm

This submission also includes: Coverscrews in two diameters and implant connection interfaces: Healing Abutments in two implant connection interfaces (tri-lobe and internal hex) with lengths between 3 and 6mm and diameters between 6 and 7.8mm; Titanium Cylinder abutments for temporary restorations in two implant connection interfaces (tri-lobe and internal hex) in engaging and non-engaging configurations; Cosmetic Abutments for permanent restorations in two engaging implant connection interfaces (tri-lobe and internal hex); Gold Cylinder Abutments for permanent restorations in three implant connection interfaces (external hex, tri-lobe and internal hex) in engaging and non-engaging configurations; Passive Abutments for permanent restorations in two implant connection interfaces (trilobe and internal hex) in engaging and non-engaging configurations; Compact Conical abutments in an internal hex connection for multi-unit restorations; and abutment screws. The Gold Cylinder Abutments and Passive Abutments are 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.

All MAX implants are manufactured from unalloyed titanium conforming to ASTM F67. The implant surface is grit blasted with varying lengths of unroughened coronal portions. The Cover Screw, Healing Abutment, Titanium Cylinder Abutment, Cosmetic Abutment and Passive Abutment are manufactured from unalloyed titanium conforming to ASTM F67. The Gold Cylinder Abutment is manufactured from a gold alloy. The Compact Conical Abutments manufactured from titanium alloy conforming to ASTM F136. The abutment screws are manufactured from titanium alloy conforming to ASTM F136, or goldplatinum alloy. 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 K071161, K163634, K070905 and K180465.

This document is a 510(k) summary for the Southern Implants MAX Implant System. It primarily asserts substantial equivalence to existing predicate devices, rather than presenting a standalone study with defined acceptance criteria and performance results directly from that study. Therefore, the requested information, particularly around acceptance criteria and performance specifically measured against those criteria in a dedicated study, is not explicitly detailed in the provided text for the subject device itself.

However, based on the information provided, we can infer the basis for equivalence and the performance data that was referenced or relied upon.

Here's an attempt to answer your questions based on the provided text, highlighting where the information is inferred or not explicitly stated for the "subject device" as a new, independently tested device:

1. Table of Acceptance Criteria and Reported Device Performance

The submission for the Southern Implants MAX Implant System focuses on demonstrating substantial equivalence to existing predicate devices rather than meeting specific performance acceptance criteria for a novel device. Therefore, a table of new acceptance criteria and new device performance specifically for the Southern Implants MAX Implant System is not explicitly provided in the document as it would be for a de novo device.

Instead, the performance data presented is comparative, aiming to show that the subject device performs similarly to or better than predicate devices across various attributes. The acceptance criterion is implicitly "demonstrate substantial equivalence" based on similar materials, design principles, and mechanical performance.

The document states:

• "Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility (referenced from K071161 and K180465); engineering analysis; dimensional analysis; sterilization validation according to ISO 11137-1, ISO 11137-2, ISO 17665-1, ISO TS 17665-2; bacterial endotoxin according to USP 39-NF34; sterile barrier shelf life (referenced from K071161)."
• "Pull out tests and surface area analysis comparing the worst-case subject device to the predicate device were performed."
• "In support of substantial equivalence in terms of mechanical performance, engineering analysis and dimensional analysis was performed and demonstrated fatigue performance of the subject device to be substantially equivalent to that of the predicate device K071161and reference devices K163634 and K180465."
• "Pullout tests and surface area analysis demonstrated that the subject device is substantially equivalent to the reference device K163634."

Implicit Acceptance Criteria and Reported Performance (based on substantial equivalence):

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified in the document for any of the non-clinical tests (engineering analysis, dimensional analysis, pull-out tests, surface area analysis). These tests typically involve a relevant number of devices or materials to be statistically significant or representative of the design space.
• Data Provenance: The document explicitly states "No clinical data were included in this submission." All data are non-clinical (biocompatibility, engineering analysis, dimensional analysis, sterilization, bacterial endotoxin, shelf life, pull-out, surface area analysis), likely performed in-house by the manufacturer or by contracted testing laboratories. The country of origin for the data generation is not specified, but the manufacturer is Southern Implants (Pty) Ltd, located in Irene, Gauteng, South Africa. The data would be considered prospective for the specific tests performed for this submission, even if some reference older data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This question is not applicable to the provided document. The submission is for a medical device (dental implant system) where substantial equivalence is demonstrated through non-clinical (bench) testing, not through diagnostic image interpretation requiring expert ground truth establishment.

4. Adjudication method for the test set

• This question is not applicable. There is no human interpretation or adjudication involved in the type of non-clinical tests described for this device submission.

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

• This question is not applicable. This is not an AI/software device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This question is not applicable. This is not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• This question is not applicable in the typical sense for a diagnostic device. For the non-clinical performance data, the "ground truth" would be established by validated test methods and engineering principles (e.g., standard physical/mechanical property measurements, biological assay results, comparison to known material properties, adherence to ISO standards for sterilization).

8. The sample size for the training set

• This question is not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

• This question is not applicable. This is not a machine learning or AI device that requires a training set.

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