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MegaGen Dental Implant Abutment is intended to be surgically placed in the maxillary or mandibular areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function.

All digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen validated milling center for manufacture

The MegaGen Dental Implant Abutment includes several components: Healing Abutment, Temporary Cylinder, EZ Post Abutment, EZ Post Cylinder, CCM Abutment, Gold Abutment, Octa Abutment, ZrGEN Abutment, TiGEN Abutment, AXA Abutment (Straight and Angled Types), and Abutment Screw. These components are made of materials such as Ti-6Al-4V-ELI, POM, Co-Cr-Mo alloy, and gold alloy, and are offered with machined or anodized surfaces. Some components are supplied sterile, while others are non-sterile and require sterilization by the user. They are intended for single use. The device provides prosthetic support for dental restorations on endosseous dental implants.

The provided text is a 510(k) summary for the MegaGen Dental Implant Abutment, seeking clearance based on substantial equivalence to predicate devices. It does not contain information about a study that proves the device meets specific acceptance criteria in terms of clinical performance, diagnostic accuracy, or effectiveness with human readers.

Instead, the document details a comparison of the subject device (MegaGen Dental Implant Abutment) with various predicate and reference devices, focusing on technical characteristics, materials, and design. The "acceptance criteria" referred to in the document are primarily related to meeting the characteristics of the predicate devices and demonstrating that any differences do not affect the fundamental function or safety of the device. The "study" that "proves" the device meets these criteria is a non-clinical testing summary, including biocompatibility, sterilization validation, accelerated shelf-life, pyrogen/endotoxin testing, performance testing (ISO 14801), and MR compatibility.

Therefore, many of the requested fields cannot be answered directly from the provided text as they pertain to clinical or diagnostic performance studies involving human subjects or AI algorithms, which are not described here.

Here's a breakdown of the information that can be extracted, and where the requested information is not available:

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance for each component in a consolidated manner. Instead, it discusses "similarities" and "differences" compared to predicate/reference devices, and states that "test results met the pre-set criteria" for performance testing (ISO 14801) and that biocompatibility and sterilization have been validated.

Below is a summarized representation of the comparison for one component (Healing Abutment) as an example, to illustrate the type of comparison presented in the document. The "acceptance criteria" are implied by the characteristics of the predicate/reference devices, and "reported device performance" refers to the subject device's characteristics or the outcome of non-clinical tests.

Example for Healing Abutment:

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

• Test Set Sample Size: Not specified for any clinical or diagnostic evaluation. The evaluations are primarily non-clinical. For performance testing (ISO 14801), the sample size for individual tests like fatigue is not mentioned within this summary, only that tests were performed.
• Data Provenance: Not applicable in the context of clinical/diagnostic data. For non-clinical tests like biocompatibility and sterilization, previous 510(k) submissions (e.g., K110955, K123988, K210161, K220562, E220672, K230618) from MegaGen Implant Co., Ltd. are leveraged. The tests were performed according to international standards (ISO, ASTM, USP).

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

Not applicable. The ground truth for this type of medical device (dental implant abutment) is established by engineering specifications, material properties, and performance under rigorous bench testing conditions, compared to predicate devices. There is no mention of expert consensus for diagnostic ground truth.

4. Adjudication method for the test set

Not applicable. No expert adjudication process for diagnostic imaging or clinical outcomes is described.

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 dental implant abutment, not an AI-assisted diagnostic tool.

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

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

7. The type of ground truth used

The "ground truth" for demonstrating substantial equivalence is based on:

• Comparison to legally marketed predicate devices (their established safety and effectiveness).
• Compliance with recognized international standards (e.g., ISO 10993-1 for biocompatibility, ISO 11137 for sterilization, ASTM F1980 for shelf-life, ISO 14801 for performance/fatigue testing, and FDA guidance documents for MR compatibility).
• Confirmation through non-clinical bench testing that the device's physical and mechanical properties meet predefined criteria, demonstrating that any differences from predicate devices do not raise new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable. This pertains to AI algorithms.

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The BLUEDIAMOND IMPLANT is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:

• Delaved loading
• Immediate loading when good primary stability is achieved and with appropriate occlusal loading.
  For the BLUEDIAMOND IMPLANTS with a Thread Length of 5mm,
  It is indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone and with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks.
  It is specifically recommended for:
• Fixed partial dentures/splinted units (one implant per unit)
• Pontic cases in combination with at least one longer implant
• Fully edentulous cases with at least one 5 mm Short Implant in combination with 2 longer implants in the anterior region and at least four total implants

The BLUEDIAMOND IMPLANT is a dental implant body system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be placed in the maxillary or mandibular areas to restore masticatory function.
It has different thread lengths depending on the diameter and length. The Implanted length of the device is the length that is implanted into the bone, including the length from the thread to the shoulder, which is the non-threaded part.
The Gingival (Cuff) area of the device has grooves; the bottom of the grooves indicate the implantable length.
The BLUEDIAMOND IMPLANT is consisted of the following components.
BLUEDIAMOND IMPLANT Cuff Type: The BLUEDIAMOND IMPLANT is a dental implant body system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be placed in the maxillary or mandibular areas to restore masticatory function.
Material: CP Ti Grade 4 of ASTM F67
Dimension (mm):

• Normal Thread Ø 4.0 x 9.0, 11.0, 13.0, 15.0 (7.0, 9.0); Ø 4.4 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0); Ø 4.7 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0)
• Deep Thread Ø 4.4 x 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0); Ø 4.8 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0); Ø 5.1 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0)
  Diameter X Total Length (Thread Length):
• Normal Thread Ø 4.0: 8.0, 9.0, 10.0, 11.0 (1.0, 2.0); Ø 4.4: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0); Ø 4.7: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0)
• Deep Thread Ø 4.4: 8.0, 9.0, 10.0, 11.0 (1.0, 2.0); Ø 4.8: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0); Ø 5.1: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0)
  Implanted Length (Thread to Shoulder Height): 2.0, 3.0, 4.0
  Gingival (Cuff) Height: Not Found

The BLUEDIAMOND IMPLANTs are compatible to abutments of The BLUEDIAMOND IMPLANT System from K182448, K192614, K210161, K203808, K233450.

The provided text is an FDA 510(k) summary for a dental implant device (BLUEDIAMOND IMPLANT). It focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML medical device. Therefore, it does NOT contain the specific information required to answer your prompt, such as:

• Acceptance Criteria for AI/ML Performance: The document does not describe performance metrics like sensitivity, specificity, AUC, or other measures typically used for AI/ML models. Instead, it focuses on physical and material properties, and mechanical performance (fatigue, pull-out).
• Study Proving Device Meets Acceptance Criteria for AI/ML: No AI model training, validation, or testing is described. The "performance test" section refers to fatigue tests and pull-out tests, which are engineering tests for the physical implant, not for an AI algorithm.
• Sample Sizes for Test Set (AI/ML): Not applicable, as there's no AI/ML test set.
• Data Provenance (AI/ML): Not applicable.
• Number of Experts/Qualifications (AI/ML Ground Truth): Not applicable.
• Adjudication Method (AI/ML Ground Truth): Not applicable.
• MRMC Study (AI/ML): Not applicable.
• Standalone Performance (AI/ML): Not applicable.
• Type of Ground Truth (AI/ML): Not applicable.
• Sample Size for Training Set (AI/ML): Not applicable.
• How Ground Truth for Training Set was Established (AI/ML): Not applicable.

The document primarily discusses:

• Device Description: Material (CP Ti Grade 4), surface treatment (S.L.A), dimensions, components.
• Indications for Use: Placement in maxillary/mandibular molar areas for prosthetic support, delayed and immediate loading protocols, specific recommendations for 5mm thread length implants.
• Substantial Equivalence: Comparison of the BLUEDIAMOND IMPLANT to a primary predicate device (ARi ExCon Implant System) and several reference devices based on design, dimensions, material, surface treatment, sterilization, shelf life, and features.
• Non-Clinical Testing: Biocompatibility, pyrogen/endotoxin testing, sterilization validation, shelf life, modified surface treatment evaluation, and performance test (fatigue test in accordance with ISO 14801, and pull-out testing), and MR compatibility.

In summary, the provided text describes a physical dental implant device and its regulatory submission to the FDA, not an AI/ML-driven medical device. Therefore, it does not contain the information requested about AI acceptance criteria, performance studies, or ground truth establishment.

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The TiGEN Abutment, PMMA Abutment and Scan Healing Abutment are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.

The PMMA Abutment is indicated to be used pror to the final components to maintain, stabilize and shape the soft tissue during the healing plase. They must be placed out of occlusion and are for temporary use (3 months).

For TiGEN Abutment and PMMA Abutment, all digitally designed abutments for use with PMMA Abutment and TiGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture.

The TiGEN Abutment is machined with the final prosthetic in accordance with the intraoral structure. It is machined by using dental CAD/CAM technology in accordance with customized patient's information in MegaGen-validated milling center. The TiGEN Abutment is made of Ti-6Al-4V ELI alloy. And It is provided with abutment screw. All TiGEN Abutment is provided non-sterile. The milled TiGEN Abutment must be sterilized by users prior to use.

The PMMA Abutment is a temporary prosthesis used until the final prosthesis is placed for up to three months. The PMMA Post is machined with the temporary prosthetic in accordance with the intraoral structure by using dental CAD/CAM technology. The PMMA Cuff is made of Ti-6Al-4V ELI alloy and available in various gingival heights. The PMMA Post is made of Polymethyl methacrylate and available in various diameters and lengths so that it can be used according to individual patient conditions. All PMMA Abutment is provided non-sterile with abutment screw. The milled PMMA Abutment must be sterilized by users prior to use.

The Scan Healing Abutment designed to aid in soft tissue contouring during the healing period after implant placement, creating an emergence profile for the final prosthesis. And they have the added design feature to be scannable an intraoral impression by digital scanner. The Scan Healing Abutment is provided with abutment screw and is provided gamma-sterile.

This document pertains to a 510(k) premarket notification for dental implant abutments and does not contain information about an AI/ML medical device. Therefore, a table of acceptance criteria and a study proving the device meets the criteria, as requested by the prompt, cannot be extracted from the provided text for an AI/ML context.

The document discusses the substantial equivalence of the "TiGEN Abutment, PMMA Abutment and Scan Healing Abutment" to already marketed predicate devices. The studies mentioned are primarily bench tests, biocompatibility evaluations, and sterilization/shelf-life validations, which are standard for physical medical devices. There is no mention of an AI/ML component, AI/ML device performance metrics, or related study methodologies like multi-reader multi-case (MRMC) studies.

Without information on an AI/ML component, the requested details such as sample size for test sets (for AI), data provenance, expert ground truth establishment, MRMC studies, standalone AI performance, and training set details are not applicable and cannot be provided.

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The ARi ExCon Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:

• Delayed loading

• Immediate loading when good primary stability is achieved and with appropriate occlusal loading.

For TiGEN Abutment and ZrGEN Abutment, all digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture.

The ARi ExCon Implant is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be placed in the maxillary or mandibular areas to restore masticatory function.
The Abutments are prosthetic components directly or indirectly connected to the endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation, allows single & multiple prosthetic restorations.

The provided text is an FDA 510(k) premarket notification summary for the "ARi ExCon Implant System." It details various components of the dental implant system (implants, cover screws, healing abutments, etc.) and compares them to predicate and reference devices to demonstrate substantial equivalence.

However, the document does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI/human-in-the-loop performance study, such as an MRMC study. The "Performance test" section on page 25-26 only mentions fatigue testing according to ISO 14801 and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment" to evaluate the performance of subject devices (implant components), and that test results met pre-set criteria. This is a mechanical performance test, not a clinical or human-reader study.

Therefore, I cannot fulfill the request for information regarding:

1. A table of acceptance criteria and reported device performance (in the context of AI/human performance).
2. Sample size for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (clinical/AI performance).
8. Training set sample size.
9. How training set ground truth was established.

The document primarily focuses on demonstrating substantial equivalence of the dental implant components through material comparisons and mechanical bench testing to predicate and reference devices, not on the performance of a medical AI device or human-in-the-loop performance with AI assistance.

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