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The Provata 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 Provata Implant System is intended for immediate function when good primary stability with appropriate occlusal loading is achieved. The intended use for the Ø3.30 Provata implants is limited to replacement of maxillary and mandibular lateral and central incisors. The 12° angled Co-Axis Provata Implants are intended to only be used with straight abutments.

The TIB Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The TIB 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.

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

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.

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 hexagon interface and mating abutments. The implants are provided in two diameters: Ø3.30 and Ø4.07 mm. The Ø3.30 implants are provided in two designs: Straight and Co-Axis (prosthetic platform inclined 12° from orthogonal to the long axis of the implant). Both the Straight and Co-Axis versions are available in fully roughened and 3 mm machined coronal section configurations. The Ø3.30 Straight and Co-Axis implants are each provided in in one prosthetic diameter (2.90 mm), and in overall lengths of 8.5, 10, 11.5, 13, 15, 18 mm. The Co-Axis implants are to be used with straight abutments only.

The Ø4.07 implants subject to this submission are provided in length 6.4mm and as Straight (0°) implants only. The Ø4.07 implants are provided with a 3.575 mm prosthetic diameter and are available in fully roughened and 2 mm machined coronal section configurations.

This submission also includes: a Cover Screw (one design/size); Healing Abutments in two diameters (3.5 and 4.5 mm) each in three gingival heights (3, 4, and 6 mm); Titanium Cylinder Abutments for temporary restorations in one size and two designs (engaging and non-engaging); Passive Abutments with a plastic burn-out component, in one size and two designs (engaging and non-engaging); PEEK Abutments for temporary restorations in one size and two designs (engaging and non-engaging); Compact Conical Abutments in straight (0°) and 20°, angled design for multi-unit restorations: Narrow TIB Abutment Bases (engaging): and abutment screws.

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, limited to a straight (0°) restoration.

The Narrow and Compact Conical TIB Abutment bases are two-piece abutment designs, consisting standard premanufactured titanium alloy abutments for supporting 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 base then serves as the interface between the endosseous implant and the Zirconia restoration. The TIB Abutment Base is 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 Provata implants are manufactured from unalloyed titanium conforming to ASTM F67, with a smooth machined collar (0.6mm or extended machined surface of 2 or 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 K163634 and K180465. 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 PEEK Abutments are manufactured from medical grade white Polyetheretherketone. 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 K163634, K180465, K193084 and K191250.

The provided text is a 510(k) summary for the Provata Implant System, which describes various dental implants and abutments. It focuses on demonstrating substantial equivalence to predicate devices and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria beyond the general statement of "demonstrated fatigue performance of the subject device that exceeds its indication" based on ISO 14801 testing.

Therefore, most of the requested information cannot be extracted from the given text.

However, I can extract information related to performance testing and mention the lack of specific acceptance criteria and performance reports.

1. A table of acceptance criteria and the reported device performance
   This information is not explicitly provided in the document. The document states that "Dynamic testing was performed on worst-case subject device constructs. The results from the testing demonstrated fatigue performance of the subject device that exceeds its indication." However, no specific acceptance criteria or quantitative performance results are reported.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size for Test Set: Not specified. The document only mentions "worst-case subject device constructs" were used for dynamic compression-bending testing.
   • Data Provenance: Not specified.

3. 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. The reported testing is non-clinical (mechanical fatigue testing), not related to clinical ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   Not applicable. This is not a clinical study involving adjudication.

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
   No, a multi-reader multi-case comparative effectiveness study was not done. This submission is for dental implants and abutments, and the non-clinical performance data focuses on mechanical and biological characteristics, not AI-assisted human reading.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   Not applicable. The performance data is based on non-clinical mechanical testing and material equivalence.

8. The sample size for the training set
   Not applicable. This is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established
   Not applicable. This is not an AI/machine learning device.

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The Osteon Precision Milled Suprastructure is indicated for attachments in the treatment of partially orfully edentulous for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.

The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:

• · Nobel Biocare Multi Unit Abutment Plus, 4.8mm, max 30°
• · Nobel Biocare Xeal Abutments, 4.8mm, max 30°
• · Nobel Biocare Multi Unit Abutment, 4.8mm, max 30°
• MIS Multi-unit Abutments, 4.8mm
  • · C1 Conical Connection Implant System, max 30°
  • · V3 Conical Connection Implant System, max 30°
  • · Internal Hex Implant System, max 30°
  • · Conical Connection, max 30°
• Southern Compact Conical Abutments, 4.8mm
  • · MAX Implant System, 0°
  • · Provata Implant System, max 30°
  • · Deep Conical (DC) Implants, 0°
  • · Piccolo Implants, 0°
  • · External Hex Implants, max 30°
• · Astra Tech Implant System® Multi Base Abutment EV, 4.8mm, max 30°
• Keystone Multi Unit Abutment, 4.8mm, 0°
• · Neodent GM Mini Conical Abutment, 4.8mm, max 30°
• · Implant Direct GPS® Angled Abutment, 5.0mm, max 30°
• · Dentium SuperLine® Abutments, 4.5-5.5mm, max 30°
• · Zimmer Angled Tapered Abutments, 4.5mm, max 30°
• · Paltop Multi Unit Abutment, 5.0mm, max 17°

The Osteon Precision Milled Suprastructures (also referred as superstructures) are metallic dental restorative device that is intended for attaching by screw retention to dental abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring their chewing function. These suprastructures attach to previously-cleared original equipment manufacturers (OEM) dental abutments using the (OEM) prosthetic screws. The abutmentborne subject devices are indicated for placement only on OEM implant/abutment constructs placed according to the labeling of the previously-cleared systems, and not to exceed the maximum angulation allowed for each OEM implant/abutment construct as identified in the Indications for Use Statement of the subject system.

The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's impression. The suprastructure is manufactured in biocompatible Titanium alloy with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical, within our premises.

Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence categorized as type A and type B.

This document is a 510(k) summary for a dental device, the Osteon Precision Milled Suprastructure. It outlines the regulatory process and demonstrates substantial equivalence to predicate devices, rather than presenting a study that proves the device meets specific performance acceptance criteria. Therefore, most of the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available in this document.

Here's why and what information can be extracted:

• This is a 510(k) submission: The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its performance against a set of novel acceptance criteria through a clinical trial.
• Focus on Substantial Equivalence: The document compares features like indications for use, materials, design, and manufacturing processes to existing devices.
• Non-Clinical Testing Mentioned: The document refers to non-clinical tests performed, but these are primarily for demonstrating compatibility, material safety, and sterility, not performance against specific clinical efficacy or accuracy metrics.

Information that can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance:

This document does not present explicit "acceptance criteria" in the traditional sense of performance metrics for an AI/algorithm-driven device. Instead, it demonstrates similarity to predicate devices based on design specifications and material properties. The "performance" is implicitly deemed acceptable if it's shown to be substantially equivalent to the established predicate devices.

(Note: "Similar" indicates that the values or characteristics fall within or are comparable to those of the predicate/reference devices, with stated differences not impacting safety/efficacy from the manufacturer's perspective.)

2. Sample sizes used for the test set and the data provenance:

• Test Set Sample Size: Not applicable. This submission relies on "non-clinical tests" (dimensional analysis, biocompatibility, sterilization validation) and comparison to existing predicate marketing clearances. It does not describe a "test set" in the context of an AI/ML algorithm evaluation with human interpretation or image analysis. The "test" consists of demonstrating manufacturing conformance and material properties for the physical device.
• Data Provenance: The device is manufactured by Implant Solutions PTY LTD (trading as Osteon Medical) in Mulgrave, Victoria, 3170 Australia. The non-clinical tests (e.g., biocompatibility and sterilization validation) would have been performed there or at certified labs. These are bench tests, not clinical data sets.

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

• Not applicable. There's no "ground truth" to establish in the context of an AI/ML algorithm or diagnostic accuracy study. The assessment is based on physical device characteristics and established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. This is not a study requiring adjudication of expert interpretations.

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 is a physical dental device (suprastructure), not an AI algorithm.

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

• Not applicable. This is a physical dental device (suprastructure), not an AI algorithm.

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

• Not applicable. The "ground truth" for this medical device submission is compliance with engineering specifications, material standards (e.g., ASTM F136), and validated manufacturing processes, all demonstrated through non-clinical bench testing.

8. The sample size for the training set:

• Not applicable. This is a physical dental device. While it is manufactured using CAD/CAM technology, it does not involve an AI/ML model that requires a training set of data.

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

• Not applicable. See point 8.

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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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