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Indications for Use for Zygoma-S GM Implant:

Zygomatic implants are indicated for intraoral surgical procedures in the zygoma region in cases of severe maxilla bone resorption, to restore the patient's chewing function and aesthetics. Zygomatic Implants may be used in one or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load.

Indications for Use for GM Mini Conical Abutment 52° and 45°:

Product indicated for surgical procedures in zygomatic bones, making possible the rehabilitation with screw-retained abutments over the implant, thus restoring the chewing function. It may be used in one- or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load. Multiple rehabilitations may be splinted rigidly.

Indications for Use for Coping for Removable Prosthesis:

The product, when used with non-zygomatic implants, is intended to be surgically placed in the bone of the upper or lower jaw, to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single stage or two-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with approprate occlusal loading. Multiple tooth applications may be rigidly splinted. When used with zygomatic implants, the product is indicated for surgical procedure only in upper jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used in two-stage procedures (delayed loading protocol) and for multiple unit restorations. Multiple rehabilitations may be splinted rigidly.

The subject devices implants are single use devices, provided sterile by Gamma Radiation, made of commercially pure Titanium grade 4 (ASTM F67). The Zygomatic Implant is a long implant with a nominal diameter of 3.50 and 3.75mm, conical apex with rounded tip, 3 helical chambers, trapezoidal thread and GM prosthetic interface. The cervical portion in both models has Ø 4.3 mm. The length varies from 30 to 55 mm. Zygomatic Implants are intended to provide support for a fixed prosthesis in patients with severe atrophy in the maxillary region. They are extra-long to allow bone anchorage in the zygomatic bone. The subject implants consider the Zygoma Anatomy-Guided approach (ZAGA) for planning the surgical steps, being indicated for extrasinus and extra maxillary installation technique (ZAGA-4).

The subject abutments are single use devices, provided sterile by Ethylene Oxide, made of Titanium alloy (Tl6Al4V-ELI). They are intermediate prosthetic components angled at 52 and 45 degrees with gingiva heights 1.5 and 2.5 mm, to be installed on the implant, offering a structure to support the screw-retained multiple prosthesis. The abutments present GM prosthetic interface and are available in the anti-rotational form in the implant to abutment interface, and rotational form in the abutment to prosthesis interface, presenting different transmucosal heights.

The subject coping is single use device, provided sterile by Ethylene Oxide, made of titanium alloy (Ti6Al4V-ELI). It presents a NEO torque interface for torque application. The subject device has diameter 4.80 mm and total height 4.60 mm. They are indicated for removable prostheses with fitting over Mini Conical Abutment installed in the maxilla or mandible and can be used in partial removable prostheses or over dentures. They are compatible with all previously cleared GM Mini Conical abutments.

The provided document is a 510(k) premarket notification for a medical device (Neodent Implant System - GM Zygomatic Implant System). It focuses on demonstrating substantial equivalence to predicate devices through comparisons of indications for use, technological characteristics, and performance data, primarily bench testing, sterilization validation, shelf life validation, and biocompatibility.

Crucially, this document does not contain information about an AI/ML algorithm or a study validating its performance, nor does it detail acceptance criteria for software or AI/ML components. The product being cleared is a set of dental implants and abutments. Therefore, I cannot extract the acceptance criteria and study details for an AI-powered device as requested.

The document discusses performance data in the context of the physical dental implants and abutments, which includes:

• Performance Testing – Bench: Dynamic fatigue testing (ISO 14801), insertion tests, torsion tests, and microscopic analysis of the implant body.
• Surface treatment: Discussion of the NeoPoros surface.
• MR Compatibility testing: Assessment of safety in MRI environments.
• Sterilization validation: Conformance to ISO standards for Gamma Irradiation (implants) and Ethylene Oxide (abutments).
• Shelf Life validation: Based on packaging integrity and physical stability.
• Biocompatibility: Testing per ISO 10993 standards.
• Clinical data: A review of published literature on zygomatic implants, including survival rates and observed complications (not a specific clinical study conducted for this device clearance).

If you are looking for information regarding acceptance criteria and study data for an AI/ML medical device, this document does not provide it, as it pertains to a different type of medical device.

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

The purpose of this submission is to expand the Blue Sky Bio Zygomatic Implant System cleared in K153064. This submission includes abutments with two interface connection designs for attachment to the previously cleared zygomatic implants: an internal hexagon connection (with a 45° bevel) and a tapered internal hexagon connection (with a 12° taper). The internal hexagon connection abutments are provided in platforms of 3.5 mm and 4.5 mm. The tapered internal hexagon connection abutments are provided in platforms of 3.5 mm (NP) and 4.3 mm (RP). All subject abutments have an angulation of 45° and are for support of screw-retained overdenture prosthetic restorations. Except for the angulation, the subject device abutments have the same designs as corresponding abutments cleared in K153064. The abutment screws compatible with the subject device abutments were cleared in K060957 and K102034. The subject device abutments are made of titanium alloy conforming to ASTM F136. The previously cleared abutment screws also are made of material conforming to ASTM F136.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

The document is a 510(k) Premarket Notification from the FDA for the Blue Sky Bio Zygomatic Implant System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than proving safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study" described are primarily related to non-clinical performance testing to support this equivalence, particularly for an expanded indication (new abutment angulation).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the performance testing performed to demonstrate equivalence to the predicate device. For devices like this, the "acceptance criteria" generally align with established standards for dental implants and their components.

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

• Sample Size for Test Set: The document does not specify a precise sample size in terms of number of abutments or implants tested for the mechanical performance data. It mentions "constructs" for dynamic compression-bending testing. For ISO 14801, a typical number of samples for fatigue testing is outlined in the standard, usually involving multiple samples at different load levels to determine a fatigue limit. However, the exact number is not explicitly stated in this summary.
• Data Provenance: The data is non-clinical performance testing performed by the manufacturer (Blue Sky Bio, LLC) or a contracted lab. It is inherently prospective in the sense that the tests were conducted specifically for this submission. There is no mention of country of origin for the data, but it can be assumed to be from a lab adhering to the relevant ISO standards typically accepted in the US for regulatory submissions.

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

This section is not applicable as the described studies are non-clinical (mechanical and material testing), not clinical studies involving patient data or expert interpretation of medical images/outcomes. Ground truth in this context is established by adherence to specified engineering standards (e.g., ISO 14801, ASTM F136).

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or outcome assessment.

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

No, an MRMC comparative effectiveness study was not done. This submission explicitly states: "No clinical data were included in this submission." MRMC studies typically assess the diagnostic performance of a device or algorithm in a clinical context, often with human readers.

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

No, a standalone performance study in the context of an algorithm or AI is not applicable here. This device is a physical dental implant system, not a software algorithm. The "standalone" performance relates to the mechanical integrity of the physical components.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance data primarily consists of established engineering standards and material specifications.

• For mechanical testing, the ground truth is the pass/fail criteria defined by ISO 14801 (e.g., meeting a certain fatigue limit without failure).
• For material composition, the ground truth is conformity to ASTM F136 specifications for titanium alloy.
• For sterilization, the ground truth is validation against ISO 17665-1 and ISO 17665-2.

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

This section is not applicable for the same reasons as point 8.

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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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Blue Sky Bio Zygomatic Implant System is indicated for surgical installation in the zygoma region, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Blue Sky Bio 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. Blue Sky Bio zygomatic implants may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Blue Sky Bio Zygomatic Implant System submission includes threaded root-form dental implants and mating abutments designed for placement into the zygomatic bone. The zygomatic implants are provided with an internal hexagon connection and a tapered internal hexagon interface for connection to the subject abutments. The internal hexagon connection implants are provided with a body diameter of 4.7 mm and platform diameters of 3.5 mm and 4.5 mm. The tapered internal hexagon connection implants are provided with a body diameter of 4.3 mm and a narrow platform (NP) connection, and with a body diameter of 5.0 mm with a regular platform (RP) connection. All implants are provided in multiple overall threaded lengths ranging from 35 mm to 55 mm. This submission includes mating abutments with platform diameters of 3.5, 4.3, and 4.5 mm. and each abutment diameter is provided with 17° and 30° of angulation. All subject device abutments are for support of screw-retained overdenture prosthetic restorations. The abutment screws compatible with the subject device abutments were cleared in K060957 and K102034. The subject device zygomatic implants 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). The previously cleared abutment screws also are made of material conforming to ASTM F136.

This is a 510(k) premarket notification for a dental implant system, which primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices rather than proving a device meets specific performance acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in this context.

The document mainly focuses on comparing the new device's characteristics to those of predicate devices and showing that any differences do not raise new questions of safety or effectiveness.

Here's a breakdown of the information that is available or applicable from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence submission, formal "acceptance criteria" in the sense of predefined thresholds for clinical performance against a disease are not provided. Instead, the device demonstrates performance through engineering analysis, dimensional analysis, and dynamic compression-bending testing to show it is comparable to predicate devices.

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

• Sample Size for Test Set: Not explicitly stated in terms of a "number of cases" or "number of patients" as this was a non-clinical submission. For the dynamic compression-bending testing per ISO 14801, the standard typically specifies the number of samples required for fatigue testing, but the exact number used in this specific test is not provided in the summary.
• Data Provenance: Non-clinical (lab-based engineering and material testing). Not applicable in terms of country of origin or retrospective/prospective for clinical data.

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

Not applicable. Ground truth in a clinical sense (e.g., disease presence/absence determined by expert radiologists) is not relevant for this type of non-clinical device submission.

4. Adjudication method for the test set:

Not applicable. No expert adjudication process as this was a non-clinical 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:

Not applicable. This device is a physical dental implant system, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.

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

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

7. The type of ground truth used:

• For Biocompatibility: Material specifications (ASTM F136) and prior clearance of similar materials in predicate devices (K102034 and K060957).
• For Dimensional Analysis: Engineering drawings and measurements, compared against predicate device specifications.
• For Dynamic Compression-Bending Testing: The performance requirements of the ISO 14801 standard and the comparative performance of the primary predicate device (K141777).

8. The sample size for the training set:

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:

Not applicable. No training set was used.

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