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The Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient's chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture.

Stella is a dental implant fixture that is implanted in the jawbone to support and maintain prosthetic restoration teeth or dentures in case of partial or total loss of teeth as a material for dental surgery. The fixture is made of titanium (ASTM F67, Grade 4), and the retention area is surface treated by spraying with Al2O3 (alumina) powder and then pickling to roughen the surface. The system incudes Healing Abutment, Simple Abutment, Duo Abutment, Contour Abutment, Angled Abutment, and Temporary Abutment.

The provided text describes the regulatory clearance for the "Stella" dental implant system. It does not contain information about acceptance criteria or a study demonstrating the device meets performance criteria in the context of AI/ML or diagnostic applications. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific acceptance criteria for a novel AI/ML algorithm.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert opinions, and MRMC studies for an AI/ML device is not present in the provided document.

However, I can extract the non-clinical testing performed to support the substantial equivalence claim for the Stella dental implant system.

Here's the relevant information that is available:

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

This information is not provided in the context of an AI/ML device's diagnostic performance. The document only lists types of non-clinical tests performed for physical characteristics of the dental implant system, and states that the "Stella" has "similar fatigue testing results to the predicate devices in the market" without providing specific acceptance criteria or quantitative results for these comparisons.

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

Not applicable to this document. The document describes a medical device (dental implant), not a diagnostic algorithm.

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 to this document.

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

Not applicable to this document.

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 to this document.

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

Not applicable to this document.

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

Not applicable to this document. The "ground truth" for a physical device like a dental implant would be engineering specifications and material properties, validated through physical testing, not expert consensus on images or pathology.

8. The sample size for the training set:

Not applicable to this document, as it does not describe an AI/ML algorithm.

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

Not applicable to this document.

Summary of Non-Clinical Testing (as described in the document for the physical device Stella, not an AI/ML component):

The document highlights the following non-clinical tests performed to support substantial equivalence of the Stella dental implant system:

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The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The Luna Dental Implant System is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading.

The Luna Dental Implant System is a device of pure titanium (ASTM F67) and titanium alloy (ASTM F1136) intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of fixture, abutment, mount screw, cover screw. This 510k is intended to add the new models of the following abutments to the Luna Dental Implant System: Healing Abutment I, Duo Abutment, Duo Plus Abutment, Temporary Abutment.

The document provided does not contain information about the performance of an AI/ML powered device, but rather pertains to the 510(k) clearance of the Luna Dental Implant System, which is a traditional medical device (dental implants and their components).

Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies for an AI/ML powered device from this document. The document describes the mechanical and material characteristics of dental implants and their substantial equivalence to previously cleared predicate devices, not AI/ML model performance.

To answer your request, I would need a document describing the study and acceptance criteria for an AI/ML powered medical device.

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The S-Mono is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. S-Mono is intended for single use only. It is intended for delayed loading.

The S-Mono is made of Titanium Alloy (ASTM F136) as the raw material. This device supports dental prosthesis such as an artificial tooth by surgically implanting it in the alveolar bone of the mandibular anterior region with a narrow tooth gap, and is intended to restore the patient's chewing function. It is one-body type which includes fixture and abutment. The surface of the fixture is treated using RBM (Resorbable Blast Media). It is roughened by blasting with hydroxyapatite powder and then pickling with nitric acid. The Temporary Cap is made of POM (Polyoxy Methylene) and intended to relieve the patient's foreign body sensation and protect the abutment part while the dental prosthesis is being manufactured. This cap is placed over the abutment part and is used temporarily before the dental prosthesis is placed. The material, dimension, and intended use of the subject devices are similar to devices currently marketed worldwide.

This document describes a 510(k) premarket notification for a dental implant system called S-Mono. The provided text, however, does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through a clinical or performance study involving human subjects or AI algorithm performance metrics.

The document focuses on demonstrating substantial equivalence to predicate devices. This means that instead of proving the device meets certain performance metrics through standalone testing, the manufacturer compares the new device (S-Mono) to existing, legally marketed devices (predicates) and argues that it is as safe and effective because of similar intended use, materials, and technological characteristics.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details because this information is not present in the provided text.

The "Non-Clinical Testing" section describes several tests performed on the S-Mono, but these are primarily material, sterilization, shelf-life, and biocompatibility tests, not performance studies that would typically define "acceptance criteria" through clinical outcomes or diagnostic accuracy.

Non-Clinical Testing Information Provided:

• Sterilization validation testing: Performed according to ISO 11137 (gamma sterilization) and ISO 11737, ISO 17665-1, ISO 17665-2 (steam sterilization).
• Shelf-life testing: Performed according to ASTM F1980, ASTM F1929, and ISO 11737-2.
• Fixture surface characteristics evaluation: EDS (Energy-dispersive X-ray spectroscopy), SEM Analysis, and Surface Roughness Analysis were performed after RBM treatment.
• Biocompatibility tests: Performed according to ISO 10993-1, 3, 5, 6, 10, 11, 12, and 33.
• MR Conditional labeling: A non-clinical worst-case MRI review was conducted using scientific evidence and published literature (Woods, Terry O., et al., 2019). Titanium alloy (Ti-6A1-4V, ELI) properties were assessed according to magnetic induction displacement force (ASTM F2052), magnetic induction torque (ASTM F2213), RF induction heating (ASTM F2182), and image artifact (ASTM F2119).

In summary, the provided text describes the regulatory filing for a dental implant and focuses on demonstrating substantial equivalence, not on providing the results of a performance study with acceptance criteria.

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The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

The Luna Dental Implant System - Healing Abutment is to be connected to the implant and is to heal gingiva before setting abutment on the implant in the oral cavity. It is made of commercially pure titanium alloy Gr4. It offers narrow and regular platform types, and the narrow type has anodizing surface treatment in purple to be distinguished from the regular type.

The provided text is a 510(k) summary for the Luna Dental Implant System - Healing Abutment, a medical device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed acceptance criteria and performance data from a clinical or non-clinical study designed to prove the device meets specific performance metrics.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to proving device performance against specific criteria.

The 510(k) summary explicitly states its basis for substantial equivalence:
"The Luna Dental Implant System - Healing Abutment is substantially equivalent to its predicate device (K123155) in terms of indications for use, raw material, and design. The differences are in body design and size range. The design change does not raise a question in substantial equivalence since the change is not significant. We have identified a reference device that encompass the size range of the subject device. Based on the information submitted here in we conclude that the subject device is substantially equivalent to the predicate devices."

The "Non-Clinical Testing" section merely states: "Risk analysis was conducted according to ISO14971 to evaluate the effect of the modification. The risk assessment did not show that the device changes affected biocompatibility, sterilization, and shelf life such that the testing in the prior (predicate) file is still applicable." This indicates that no new performance testing was conducted or deemed necessary to demonstrate the modified device meets specific acceptance criteria, as its equivalence to the predicate implies it meets the same criteria the predicate device did.

In summary, this 510(k) document is a declaration of substantial equivalence, not a report of a study designed to establish acceptance criteria for a novel device and prove its performance against those criteria.

Since the requested information (acceptance criteria, performance data, sample sizes, expert details, etc.) is not present in the provided text, I cannot complete the table or answer the specific questions about the study from this document.

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The MagDen Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The MagDen Fixture devices are specifically indicated for replacing maxillary lateral incisors and mandibular central and lateral incisors. The MagDen Fixture devices are indicated for immediate loading when good primary stability is achieved.

The MagDen Dental Implant System offers MagDen Fixture, two abutment types (MagDen Mini Abutment, MagDen Abutment), MagDen Implant Healing Abutment, and MagDen Implant Cover Screw. The MagDen Fixture is made of Titanium alloy (ASTM F136, Ti-6A1-4V ELI) with S.L.A surface treatment. MagDen Mini Abutment and MagDen Abutment are made of Stainless Steel (SUS444) with TiN coating. MagDen Implant Healing Abutment and MagDen Implant Cover Screw are made of titanium alloy (ASTM F136, Ti-6A1-4V ELI) with no surface treatment. The system provides immediate masticatory function for partially and completely edentulous patients.

This document is a 510(k) Premarket Notification for the MagDen Dental Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria and results for an AI/ML device.

Therefore, the requested information, which pertains to the acceptance criteria and study proving device performance (presumably for an AI/ML device, given the detailed questions on ground truth, human readers, and training sets), cannot be extracted from this document.

This document describes a medical device (dental implants) and its intended use, materials, dimensions, and biocompatibility and performance tests, but these are related to the physical properties and safety of the implant itself, and not to the performance of an AI/ML algorithm.

The sections regarding "Acceptance Criteria," "Study," "Sample Sizes," "Ground Truth," "Adjudication," "MRMC," and "Standalone Performance" are not applicable to the content of this 510(k) submission.

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The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The Luna Dental Implant System is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading.

Not Found

This document is a 510(k) clearance letter for a dental implant system. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. Therefore, I cannot provide the requested information from this document.

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The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient s chewing function

The Luna Dental Implant System is a device of pure titanium(ASTM F67) and titanium alloy(ASTM F136) intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of fixture, abutment, mount screw, cover screw. The fixture's surface is S.L.A(Sand-Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System fixture and healing abutment are supplied with gamma sterilization.

Fixtures consisted of mount type and mount free type. Abutments consisted of simple abutment, hex and non-hex duo abutment, hex and non-hex angled abutment (15° & 25°), hex and non-hex contour abutment, hex and non-hex temporary abutment screw abutment with titanium cylinder, ball abutment with socket assembly, healing abutment, screw abutment screw, and abutment screw. Fixture dimension is 3.7mm x 8.5-15mm and 4.2mm - 5.7mm x 7.0mm - 15mm and Abutment diameter is 4.0mm ~ 6.0mm

The Luna Dental Implant System, an endosseous dental implant, established substantial equivalence by comparing its performance to predicate devices (Dentium Implantium K041368 and Implantium Prosthetics K052957). The device, made of pure titanium and titanium alloy, is designed for surgical placement in the jaw to support prosthetic devices and restore chewing function.

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance testing conducted to demonstrate compliance with ISO standards and confirm performance characteristics. The specific quantitative acceptance criteria or thresholds for these tests are not explicitly stated. Instead, the document generally asserts that the device met the established specifications necessary for consistent performance.

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

The document does not specify the sample sizes used for any of the performance tests (biocompatibility or mechanical/physical). It also does not explicitly state the provenance of the data (e.g., country of origin, retrospective or prospective). However, the submission is from a South Korean company (SHINHUNG MST Co., Ltd in the Republic of Korea), suggesting that the testing and data likely originated in South Korea. The nature of the tests (bench testing and biocompatibility) suggests they are laboratory-based and controlled studies, rather than clinical trials with human subjects.

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

This section is not applicable to the provided document. The performance tests described (biocompatibility, mechanical bench testing) do not involve expert interpretation or subjective assessment of a test set in a clinical context to establish 'ground truth' in the way a diagnostic AI device would. The "ground truth" for these tests would be objective measurements against established engineering and biological standards.

4. Adjudication Method for the Test Set:

This section is not applicable as the testing described does not involve methods requiring expert adjudication for a test set.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human readers interpret medical images or data, and their performance with and without AI assistance is compared. The Luna Dental Implant System is a physical medical device, not a diagnostic AI tool, so this type of study is not relevant.

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

This section is not applicable. The Luna Dental Implant System is a physical dental implant, not an algorithm or AI system. Its performance is evaluated through bench testing and biocompatibility assessments, not through algorithmic performance.

7. The Type of Ground Truth Used:

The ground truth for the Luna Dental Implant System's performance testing is based on:

• Established ISO Standards: For biocompatibility (ISO 7405) and presumably for mechanical/physical properties, the 'ground truth' refers to compliance with the specific criteria and methodologies outlined in these international standards.
• Material Specifications: The chemical composition and physical properties of titanium and titanium alloy (ASTM F67 and ASTM F136) are known and serve as a baseline for material quality.
• Engineering Specifications: For mechanical tests, the 'ground truth' is determined by meeting predefined engineering specifications for strength, fatigue, torque, accuracy, etc., which are derived from industry standards and clinical requirements for dental implants.

8. The Sample Size for the Training Set:

This section is not applicable. The Luna Dental Implant System is a physical device being evaluated through performance testing, not a machine learning model that requires a training set.

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

This section is not applicable as there is no training set for a physical medical device like the Luna Dental Implant System.

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