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Inversa Implants are 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. Inversa Implants are intended for immediate function when good primary stability with appropriate occlusal loading is achieved.

Inversa implants are fully threaded, tapered, root-form dental implants with a design feature known as body shift, where the body design of the implant has a narrow, straight coronal portion with an increased maximum diameter midway down the length of the implant tapering toward the apex. The body of the implant includes two thread types (square and V-shaped) that transition in the middle of the implant body. Inversa implants have a platform that is inclined 12° to the long axis of the implants are made of unalloyed titanium and provided in two connection types (External Hex and Deep Conical).

External Hex Inversa implants are provided in three sizes: coronal diameter 3.5 mm with maximum apical diameter 4.5 mm; coronal diameter 3.5 mm with maximum apical diameter 5.0 mm; and coronal diameter 4.2 mm with maximum apical diameter 5.0 mm. Each size of the External Hex Inversa implant is provided in four lengths (11.5, 13, 15, and 18 mm).

Deep Conical Inversa implants are provided in three sizes: coronal diameter 3.6 mm with maximum apical diameter 4.5 mm; coronal diameter 3.6 mm with maximum apical diameter 5.0 mm; and coronal diameter 4.0 mm with maximum apical diameter 5.0 mm. Each size of the Deep Conical Inversa implant is provided in four lengths (11.5, 13, 15, and 18 mm).

Inversa implants are made from unalloyed titanium conforming to ASTM F67.

This document is a 510(k) summary for the "Inversa Implants" dental implant system, submitted to the FDA. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study proving a device meets specific performance acceptance criteria for a new AI/software device.

Therefore, many of the requested elements (e.g., acceptance criteria for device performance, sample sizes for test sets, expert involvement, MRMC study results, training set details) are not applicable or not found in this type of regulatory submission for a physical medical device like a dental implant.

The "Performance Data" section of this document refers to non-clinical tests for physical characteristics and safety, not for performance of a software/AI device.

Here's an attempt to extract relevant information and explain why other information is absent:

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

This document does not present a table of acceptance criteria and reported device performance in the way one would for a software or AI device. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and intended use.

The "Performance Data" section mentions the following non-clinical tests performed or referenced:

No clinical data were included in this submission. This means no human study was performed to "prove the device meets acceptance criteria" in a clinical setting.

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

• Sample Size for Test Set: Not applicable for this type of submission. The "test set" for a physical device like this refers to the samples of the device used for non-clinical bench testing (e.g., for mechanical strength, sterilization). The specific number of units tested for each non-clinical test (e.g., how many implants were tested for dynamic compression-bending) is not provided in this summary.
• Data Provenance: Not applicable. The data is primarily derived from bench testing (non-clinical) of prototype/production units and references to previously cleared predicate devices (K163634, K163060, K030463, K053478, K070841, K093562). The manufacturer is Southern Implants (Pty) Ltd., based in Irene, Gauteng, South Africa.

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

Not applicable. This is not a submission for a diagnostic AI/software device that requires ground truth established by medical experts. The "ground truth" for a dental implant's performance would be engineering specifications and physical test results, not expert consensus on images.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert readings/assessments.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No. This type of study is typically done for diagnostic imaging devices/software to evaluate human reader performance with and without AI assistance. This submission is for a physical dental implant.

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

Not applicable. This is not an algorithm or software device.

7. The type of ground truth used

For the non-clinical performance data, the "ground truth" would be the physical and chemical properties of the materials and the mechanical performance consistent with engineering standards (e.g., ISO 14801 for dynamic compression-bending). For the regulatory submission, the primary "ground truth" is the demonstration of substantial equivalence to existing, legally marketed predicate devices based on design, materials, and intended use.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an AI/machine learning model for this physical medical device submission.

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

Not applicable, as there is no training set for an AI/machine learning model.

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The Zuga™ Dental Implant System is indicated for immediate or delayed implant placement for surgical and restorative applications in maxillary and/or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges, and overdentures. The Zuga™ Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The Zuga™ Dental Implant System includes endosseous dental implants, sealing caps, healing caps, dental implant abutments, and fixation screws in a variety of sizes to accommodate differing patient anatomy. Implantation is suitable for one-or two-stage procedures. Endosseous implants are bone level, self-tapping, root-form, threaded. The threaded surface is blasted, then passivated. Sizematched anterior and posterior abutments are offered. Thes are fastened to the implant using a fixation screw. Sealing caps and healing caps provide protection to the abutment connection threads during endosseous and gingival healing. The implants are provided sterile, the remaining components must be sterilized prior to use.

The provided text describes a 510(k) premarket notification for the Zuga™ Dental Implant System. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving that the device meets a set of specific acceptance criteria through clinical performance metrics like sensitivity, specificity, or accuracy, as would be common for AI-driven diagnostic devices.

Therefore, the document does not contain the information requested regarding acceptance criteria in terms of performance metrics for an AI/ML device, nor does it detail a study proving the device meets such criteria with respect to AI performance.

Instead, the "Performance Data" section ([15]) focuses on biological and mechanical compatibility/safety testing, which is standard for medical devices like dental implants. These tests are designed to show that the physical device itself is safe and performs as intended, not to evaluate an AI algorithm's diagnostic or predictive capabilities.

Here's an breakdown of the information present and what's missing, based on the prompt's requirements:

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

• Present: The document lists various tests performed and their outcomes which act as "acceptance criteria" for a physical medical device. These are:
  • Static fatigue tests and dynamic fatigue tests (per ISO 14801 and FDA Guidance): "The results show that the Zuga™ Dental Implant System has sufficient mechanical strength for the intended clinical application."
  • Cytotoxicity testing (per ISO 10993-5 and USP ): "The results showed that the Zuga™ Dental Implant System received a passing score and is thus acceptable for clinical application."
  • Sterility tests (per ISO 10993, ISO 11137-1, 11137-2, ISO 17665-1, 17665-2): "yielded no difference in performance between the Zuga™ Dental Implant System and the predicate device."
  • LAL (Limulus Amebocyte Lysate) bacterial endotoxin tests (per ISO 10993 and USP , ): "yielded a EU/Device value that was less than the established acceptance criteria of 20 EU/Device".
  • Shelf life tests (per ISO 11607): "established the shelf life to be five years provided the sterile seal is not breached."
• Missing (for an AI/ML device context): Specific performance metrics like sensitivity, specificity, accuracy, AUC, FROC, etc., and their corresponding acceptance thresholds.

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

• Present: For LAL tests, it states: "The sampling plan consists of selecting 3% of the batch up to a maximum of 10 samples to be pooled for testing."
• Missing (for an AI/ML device context): Sample size for a "test set" of patient data (e.g., medical images, clinical records) for an AI algorithm. Data provenance (country of origin, retrospective/prospective) is not applicable or mentioned for these physical/biological tests.

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

• Missing: This information is not relevant to the mechanical/biological testing of a physical implant. It would be crucial for an AI/ML device based on clinical data.

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

• Missing: Not applicable to the presented data.

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:

• Missing: Not applicable. This device is a physical dental implant, not an AI-assisted diagnostic tool.

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

• Missing: Not applicable.

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

• Present (for physical device tests): The "ground truth" here is adherence to international standards (ISO, ASTM) and USP guidelines for mechanical strength, biocompatibility, sterilization, and endotoxin levels.
• Missing (for an AI/ML device context): Clinical ground truth established by experts or pathology for diagnostic purposes.

8. The sample size for the training set:

• Missing: Not applicable, as this is not an AI/ML device.

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

• Missing: Not applicable.

In summary: The provided document is an FDA 510(k) clearance letter for a physical dental implant system. Its "acceptance criteria" and "performance data" relate to the mechanical, chemical, and biological safety and efficacy of the implant itself, demonstrated through adherence to various international and US standards. It contains no information relevant to the development, testing, or performance of an AI/ML device.

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Southern Implants Zygomatic System Standard implants, Zygan (narrow apex) implants, and Oncology implants are intended to be implanted in the upper jaw arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

This submission includes fully threaded and partially threaded root-form dental implants and mating abutments designed for placement into the zygomatic bone. All implants are provided with an external hexagon abutment interface angled 55° at the head of the implants are provided in three designs: Standard implant, fully threaded, diameter 4.3 mm (coronal) tapering to 3.8 mm (apical), in lengths of 30 mm and 57.5 mm; Zygan implant, partially threaded, diameter 4.3 mm (coronal) tapering to 3.4 mm (apical), in lengths from 30 mm to 57.5 mm; and Oncology implant, partially threaded diameter 4.3 mm (coronal) tapering to 3.8 mm (apical), in lengths from 30 mm to 47. 5 mm.

This submission includes additional designs of Compact Conical Abutments (gingival heights 2, 3, 4, and 5.5 mm) for use with any of the implants. This submission also includes a Titanium Cylinder Abutment, for use with the Compact Conical Abutments, with a collar (gingival) height of 5 mm, and a prosthetic platform diameter of 3.4 mm. All subject device abutments are for support of screw-retained overdenture prosthetic restorations.

All subject device implants are manufactured from unalloyed titanium conforming to ASTM F67. The threaded portions of the implants have the identical aluminum oxide grit-blasted surface as the implants cleared in K093562. The subject device Compact Conical Abutments are manufactured from titanium alloy conforming to ASTM F136. The subject device Titanium Cylinder Abutment is manufactured from unalloyed titanium conforming to ASTM F67. All of the subject device components are manufactured in the same facilities using the same manufacturing processes as used for the previously cleared predicate devices in K093562 and K070841.

Based on the provided text, the document is a 510(k) Premarket Notification for the Southern Implants Zygomatic Implant System. This document does not describe a study involving an AI/Machine Learning device. Instead, it proves the substantial equivalence of a dental implant system to previously cleared predicate devices through non-clinical performance data and comparison of technological characteristics.

Therefore, many of the requested criteria related to AI/ML device studies (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment) are not applicable to this document.

However, I can extract information related to the acceptance criteria and the study (referred to as performance data) that proves the dental implant device meets those criteria.

Here's a breakdown of the relevant information from the document:

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

The document doesn't present a formal table of acceptance criteria with corresponding performance numbers in the way an AI/ML study would. Instead, substantial equivalence is demonstrated through:

• Identical intended use: The Zygomatic Implant System is intended to support fixed or removable dental prostheses in patients with partially or fully edentulous maxillae, identical to the predicate device.
• Similar technological characteristics: Comparisons are made regarding design, dimensions (platform diameter, implant diameter, implant lengths, threaded lengths, connection angle), abutment design, interface, gingival height, abutment angle, prosthesis attachment, and materials.
• Equivalent non-clinical performance: Biocompatibility, engineering analysis, dimensional analysis, sterilization validation, and dynamic compression-bending testing are the "performance data" used to demonstrate equivalence.

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

• Non-clinical testing: No specific "test set" sample sizes are given for the engineering, dimensional, biocompatibility tests (these often rely on established standards and in-vitro methods).
• Clinical Data (referenced for Oncology implant):
  • Sample Size: 40 implants in 20 subjects.
  • Data Provenance: Retrospective (from a published study: Boyes-Varley JG, et al., 2007). The country of origin is not explicitly stated in this document but the journal International Journal of Prosthodontics is international, and one of the authors for the referenced paper (Boyes-Varley) appears to be associated with South Africa (which is also the manufacturer's location).

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

This is not applicable as this is a dental implant device approval based on substantial equivalence to existing devices, primarily through non-clinical testing and referencing a retrospective clinical study. "Ground truth" in the AI/ML sense (e.g., expert labels on images) is not relevant here. The "ground truth" for the retrospective clinical study would be observed patient outcomes.

4. Adjudication method for the test set

Not applicable. There's no expert adjudication process mentioned for this type of device.

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 for a physical medical device (dental implant), not an AI/ML diagnostic or assistive tool.

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

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used

For the retrospective clinical data referenced for the Oncology implant:

• Type of Ground Truth: Clinical outcomes data (implant success, soft tissue complications).

For the non-clinical performance data (biocompatibility, mechanical testing, etc.):

• Type of Ground Truth: Compliance with established international standards (e.g., ISO 14801, ISO 17665-1, ISO TS 17665-2, USP 39-NF 34 ) and comparison to the performance of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

Not applicable. See point 8.

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Southern Implants Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:

• replacing single and multiple missing teeth in the mandible and maxilla,
• immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge,
• . immediate loading in all indications, except in single tooth situations on implants shorter than 8mm or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.

The intended use for 3.0 Deep Conical implants is limited to replacement of maxillary lateral incisors and mandibular incisors

The Deep Conical (DC Implant) has a deep conical connection system. The implants are available in Cylindrical, Tapered, Deep Conical 12º Co-Axis Cylindrical, and Deep Conical 12º Co-Axis Tapered configurations with various lengths and diameters. The implants have a moderately roughened surface, are non-roughened around the coronal region, and have an external thread and microthreads at the coronal end. The Co-Axis Implants are compatible only with straight abutments. The submission also includes various abutments (Cover Screw, Healing Abutments, Overdenture Abutments, Temporary Cylinders, Cosmetic Abutments, Gold Cylinders, Compact Conical Abutments, Passive Abutments, Titanium Abutments, Angled abutments) designed for use with the Deep Conical Implants.

The provided text is a 510(k) Summary for a medical device (Deep Conical (DC) Implants and Accessories) and does not describe an AI/ML powered device. Therefore, it does not include acceptance criteria, performance studies, or details regarding AI model development such as training/test set sizes, ground truth establishment, or expert involvement.

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and non-clinical testing.

Here's an overview of the non-clinical testing performed, but please note that this is not a performance study for an AI/ML device:

Non-clinical Testing and Performance Testing (for a dental implant device, not AI/ML):

• Fatigue testing: In accordance with ISO 14801, to prove sufficient strength. Reported as substantially equivalent to predicate devices.
• Comparative surface area, pullout strength and bone to implant contact analyses: For implants less than 7mm in length. Reported as substantially equivalent to predicate devices.
• Placement torque testing: To show sufficient strength to withstand placement torque. Reported as substantially equivalent to predicate devices.
• Sterilization method validation: Gamma radiation (for sterile devices) validated per ISO 11137; moist heat (for end-user sterilized devices) validated per ISO 17665-1 and ISO 17665-2.
• Packaging validation: In accordance with ISO 11607, with accelerated aging per ASTM-F-1980 to substantiate 5 years shelf life.
• Biocompatibility: The device is manufactured from the same material using the same method as the applicant's predicates, has the same intended use, and patient contact type and duration. It is reported as biocompatible in accordance with ISO 10993-1.

Absence of AI/ML Specific Information:

The document explicitly states: "No clinical studies were conducted." This further confirms the lack of any study that would typically be associated with evaluating the performance of an AI/ML device.

Therefore, the requested information regarding acceptance criteria and performance studies for an AI/ML device cannot be extracted from this document as it pertains to a different type of medical device (dental implants) and its regulatory pathway (510(k) for substantial equivalence).

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