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ICX-Implant System is indicated for use in partially or fully edentulous patients to support maxillary and mandibular single-unit, multiple-unit, and overdenture dental restorations. ICX- Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants with lengths less than 7.0 mm are indicated for delayed loading only.

ICX-Implant System CAD CAM abutments are intended for use with dental implants as a support for single unit or multiple unit prostheses in the maxilla of a partially or fully edentulous patient. All digitally designed abutments for use with ICX-Implant System CAD CAM abutments are intended to be manufactured at a medentis medical GmbH validated milling center.

The purpose of this submission is to obtain marketing clearance for an endosseous dental implant and abutment system. ICX-Implant System, from medentis medical GmbH. The ICX-Implant System includes a range of endosseous dental implants and prosthetic components. All implants have a selftapping apical thread with a tapered body and root-form designs with an internal hex implant/abutment connection. The implant body surface is blasted and acid-etched.

Abutments are available in multiple designs, including straight and angled abutments intended for single tooth and multi-unit restorations.

The provided text is a 510(k) summary for the "ICX-Implant System." This document is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to previously cleared devices rather than proving the device meets specific acceptance criteria through a standalone performance study.

Therefore, the document does not contain the detailed information required to fully answer all aspects of your request, especially regarding specific acceptance criteria for AI/algorithm performance, multi-reader multi-case studies, or detailed ground truth establishment for a test/training set in the context of an AI device.

The document does describe non-clinical performance data for the dental implant system itself (e.g., sterilization, biocompatibility, mechanical testing) to show its safety and effectiveness, but not for an AI component.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

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

• Missing: The document does not define "acceptance criteria" in the context of an AI/algorithm's performance (e.g., sensitivity, specificity, AUC). Instead, it discusses the substantial equivalence of the ICX-Implant System and its components to predicate devices based on technological characteristics, materials, and indications for use.
• The "Performance Data" section (Page 7) lists non-clinical tests performed, such as:
  • Validation of gamma irradiation sterilization to a sterility assurance level (SAL) of 10⁻⁶.
  • Bacterial endotoxin testing:

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Implacil Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit and/or multi-unit restorations. When a one-stage surgical is applied, the Implacil Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Implacil Implant System is composed of three implant lines that are divided according to the implant-toabutment interface: External Hex (HE), Internal Hex (HI) and Morse Taper AR Due Cone (CM AR). HE and HI lines are composed of tissue-level implants while CM AR line of bone-level implants. Each implant line is composed of implants and related prosthetic components available in multiple designs (temporary, screwed, cementable, angled, straight, UCLA, ball).

HE implant line implants are available in two root-forms designs: conical (tapered) and cylindrical. Conical implants are available in three diameters and platforms (3.5, 4.0 and 5.0 mm) and five lengths (7.0, 9.0, 11.0, 13.0 and 15.0 mm). Cylindrical implants are provided in four diameters (3.3, 3.75, 4.0 and 4.75 mm), three platforms (3.5, 4.0 and 5.0 mm) and five lengths (8.0, 10.0, 11.5, 13.0 and 15.0 mm). HE cylindrical implants of diameters 3.75 and 4.0 share the same platform of 4.0 mm.

HI implant line implants are available in two root-forms designs: conical (tapered) and cylindrical. Conical implants are available in three diameters and platforms (3.5, 4.0 and 5.0 mm). For diameters 3.5 and 4.0 are available in the lengths 8.0, 9.0, 11.0, 13.0 and 15.0 mm, and for diameters 5.0 are available in the lengths 7.0, 9.0, 11.0, 13.0 and 15.0 mm. Cylindrical implants are provided in four diameters (3.3, 3.75, 4.3 and 4.75 mm) and three platforms (3.5, 4.0 and 5.0 mm). For diameter 3.3 are available in the lengths 8.0, 9.0, 11.0, 13.0 and 15.0 mm, and for diameters 3.75 and 4.3 are available in the lengths 7.0, 9.0, 11.0, 13.0 and 15.0 mm. HI cylindrical implants of diameters 3.75 and 4.3 share the same platform of 4.0 mm.

CM AR implant line implants are available in conical root-form design only, in four diameters (3.5, 4.0, 4.5 and 5.0 mm) and five lengths (7.0, 9.0, 11.0, 13.0 and 15.0 mm).

lmplacil implants are made of commercially pure titanium (ASTM F67). Implacil prosthetic components are made of commercially pure titanium (ASTM F67) or titanium alloy (ASTM F136). Implant System screws (abutment screw, UCLA screws and coping screws) are made of titanium alloy (ASTM F136).

The subject device abutments components mate exclusively with the subject implants of the same line (HJ, HE, CM AR).

The provided document is a 510(k) Summary for a dental implant system. It outlines the device description, intended use, and a comparison to predicate and reference devices to demonstrate substantial equivalence. Crucially, this document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of AI/ML-based medical devices.

The "Performance Data" section explicitly states: "No clinical data were included in this submission." Instead, it lists non-clinical data for physical and material properties of the dental implants, such as sterilization validation, shelf life testing, biocompatibility, and mechanical performance (fatigue and torsional loading).

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth establishment, or MRMC comparative effectiveness studies, as these types of studies are not described in this 510(k) submission for a traditional medical device (dental implants), which are not a software device or AI/ML-based device.

If you are looking for information on acceptance criteria and study data for AI/ML-based medical devices, you would need to consult a different type of FDA submission, specifically for software as a medical device (SaMD) or AI-enabled medical devices, where such performance data would be critical for demonstrating safety and effectiveness.

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The Pro PEEK Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability.

CM Pro PEEK abutments are temporary intermediary prosthetic components to be installed onto CM Implants to support the provisional prosthesis up to 6 months. They are composed of a customizable cylindrical body with an internal channel for the screw access and of a base for anti-rotational implant connection. The customizable portion is manufactured in PEEK (high performance polymer – specific for dental use) and the implant-to-abutment interface is made of titanium alloy. They have a coupled screw for fixing them to the Implant. They present a hexagonal indexing at the apical end of the Morse taper connection to provide anti-rotational feature to the implant-to-abutment connection, and facilitates proper alignment of the prosthesis to the implant. They are available in diameters of 4.5 and 6.0 mm and in lengths of 0.8, 1.5, 2.5, 3.5, 4.5 and 5.5 mm. The customization of the PEEK chimney must be done into the mouth of patient or chairside. Chairside customization means that the device preparation must be done in a controlled environment in the operating room, in the context of the prosthetic placement, in a surgical site's aseptic environment using sterilized tools. The dentist can wear the PEEK chimney with the aid of suitable techniques, high speed handpiece and cooling, according to the patient interocclusal space, respecting the minimum of 5mm of height. No customization is allowed for the diameter/ wall thickness of the abutment, as well as no angulation. No CAD/CAM design and fabrication is allowed for the CM Pro PEEK Abutments. Only hand-milling may be used for abutment modification. The CM Pro PEEK abutments can be used before the installation of the final prosthesis to maintain, stabilize and shape the soft tissue (gum) during the healing phase.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the "test set" in terms of number of devices for biocompatibility, mechanical, or sterilization testing. It mentions "samples" were submitted for testing.

The data provenance is from laboratory testing performed by or for JJGC Indústria e Comércio de Materiais Dentários SA, a company based in Curitiba, Parana, BRAZIL. The clinical data was not submitted or relied upon, so the testing is likely retrospective in the sense that it's laboratory data, not data gathered from human trials.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable as the studies conducted are laboratory-based performance tests (biocompatibility, mechanical, sterilization validation) and do not involve human interpretation or subjective assessment that would require expert ground truth establishment in the way it's typically understood for AI/diagnostic devices. The acceptance criteria are based on established international standards (ISO, ASTM) and FDA guidance documents.

4. Adjudication Method for the Test Set

This is not applicable for the type of laboratory performance studies described. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of medical images or clinical outcomes, which did not occur here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study involved laboratory performance testing of the device itself, not a comparison of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

No, a standalone algorithm performance study was not done. This submission is for a physical medical device (dental abutment), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests consists of:

• Compliance with international standards: ISO 10993 series for biocompatibility, ISO 14801 and FDA Guidance for Mechanical Strength, ISO 11135 and ISO 10993-7 for Sterilization, and ASTM F1980, ISO 11737, US Pharmacopeia, ASTM E499/E499M, ASTM F1929, and ASTM F88/F88M for Shelf Life.
• Predicate device characteristics: The subject device's performance is compared against the established performance and characteristics of legally marketed predicate devices to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical dental abutment, not an AI model that requires a training set.

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

This information is not applicable as there is no training set for a physical device.

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Zygomatic Implants are indicated for surgical installation in the zygoma region, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Zygomatic Implants are recommended for the posterior (pre-molar/ molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration. Zygomatic Implants may be loaded immediately when stability is achieved and with appropriate occlusal loading.

This submission includes threaded root-form dental implants designed for placement into the zygomatic bone with either an external hexagon abutment interface, or a Morse taper abutment interface. Both implant designs are provided with a thread major diameter of 4.4 mm at the coronal end of the implant (over a length of 10 mm), which tapers to a thread major diameter of 3.9 mm for the remaining implant length. Both implant designs are provided in multiple threaded lengths ranging from 30 mm to 52.5 mm. All implants are made of commercially pure titanium, Grade 4, conforming to ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700).

This submission includes transepithelial abutments with external hexagon or Morse taper interfaces for connection to the zygomatic implants. The external hexagon abutments have a platform diameter of 4.1 mm and are provided in gingival heights of 3, 4, or 5 mm. The Morse taper transepithelial abutments also have a platform diameter of 4.1 mm and are provided in gingival heights of 1.5, 2, 3, 4, or 5 mm.

This submission also includes a Protection Cylinder that is used to protect the abutment during healing of the gingival tissue. The Protection Cylinder may be installed on either abutment design (external hexagon or Morse taper) with the corresponding Protection Cylinder Screw.

All transepithelial abutments, external hexagon transepithelial abutment screws, protection cylinders, and protection cylinder screws are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

All zygomatic implants are packaged assembled with the corresponding implant mount and provided sterilized by gamma irradiation. All transepithelial abutments, external hexagon transepithelial abutment screws, protection cylinders, and protection cylinder screws are provided sterilized by exposure to ethylene oxide.

The provided text describes a submission for a Neodent Implant System to the FDA for 510(k) clearance, asserting its substantial equivalence to previously marketed predicate devices. This type of submission focuses on comparing a new device to existing ones rather than proving the device meets specific acceptance criteria through a clinical trial with a defined ground truth and expert adjudication.

Therefore, the document does not contain the information requested regarding acceptance criteria met by a study, sample sizes for test and training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for the training set.

Instead, the document details:

• Non-clinical data: Biocompatibility, engineering analysis, dimensional analysis, and dynamic compression-bending testing according to ISO 14801. These are physical and material property tests to ensure the device meets certain strength and safety standards, but are not "acceptance criteria" in the sense of accuracy, sensitivity, or specificity for an AI/algorithm-based device.
• Clinical literature data: This is a review of existing data rather than a prospective study designed to meet specific performance criteria for the subject device.

Here's what can be extracted, acknowledging the limitations regarding "acceptance criteria" in the AI/algorithm sense:

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

The document does not specify "acceptance criteria" for performance in the typical sense of metrics like sensitivity, specificity, accuracy, etc., for a diagnostic or AI device. Instead, the "performance" demonstrated is a comparison to predicate devices, where the primary outcome considered is implant survival rates.

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

• Subject device (test set, as per clinical literature):
  • Sample Size: 16 subjects with a total of 37 zygomatic implants.
  • Data Provenance: Clinical literature data (retrospective review of published studies). Country of origin is not specified.
• Predicate device (comparison in clinical literature):
  • Sample Size: 45 subjects with a total of 90 zygomatic implants and 165 conventional dental implants.
  • Data Provenance: Clinical literature data (retrospective review of published studies). Country of origin is not specified.

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

Not applicable. This was a review of clinical literature data focusing on implant survival, not an expert-adjudicated test of an AI/algorithm's performance. The "ground truth" would implicitly be the observed clinical outcome (implant survival/failure) as reported in the literature, which is based on clinical assessment by treating physicians.

4. Adjudication method for the test set

Not applicable, as it's a review of clinical literature data, not an expert adjudication process for algorithmic output.

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 submission is for a physical medical device (dental implants), not an AI/algorithm where human reader performance would be a relevant metric.

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

Not applicable. This is not an AI/algorithm device.

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

The "ground truth" implicitly used for the clinical literature data was outcomes data (implant survival/failure) as observed and reported in the clinical studies.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm and therefore does not have a "training set."

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

Not applicable. There is no training set for this device.

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