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Indications for Use for Eco Abutment

The Eco Abutment is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation.

Indications for Use for Multiunit Abutment

The Multiunit Abutment is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation.

The Eco Abutment is a two-piece abutment. It consists of a base abutment which is used with temporary post, cemented post, angled post and healing cap. The base abutment is first secured to the dental implant with a base screw and the post is secured to the base abutment with post screw. The Eco Abutment has 4.5, 4.8, 5.5 and 6.5 of diameter and consists of 0, 6, 12 and 18 degree.

The Multiunit Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of single unit loading (i.e., crown) or multi-unit loaded restorations (i.e., bridge, bars, overdentures). It is consists of Multiunit Straight Abutment, Multiunit Angled Abutment and Temporary Cylinder. The Multiunit Abutment has 4.8mm of diameter and consists of two kind of design that has three angles. The Multiunit Straight abutment has 0 degree and the Multiunit Angled abutment has 20 or 30 degree

The Eco Abutment and Multiunit Abutment are made from titanium alloy conforming to ASTM F136. It is provided non-sterile and is steam sterilized before use.

Non-Hex connection abutments are intended for multi-unit restorations only.

The provided text is a 510(k) summary for dental implant abutments, focusing on regulatory approval based on substantial equivalence to predicate devices. It does not contain information about a clinical study with acceptance criteria for device performance relevant to AI/ML devices or studies involving human readers.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size for the test set or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, effect size, or improvement with AI assistance.
• Standalone performance (algorithm only).
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on non-clinical testing (sterilization validation, biocompatibility, mechanical properties, MR environment condition) to demonstrate substantial equivalence to existing predicate devices, which is a common pathway for medical device clearances that do not involve AI/ML components or comparative effectiveness studies with human readers. The document explicitly states "No clinical studies are submitted."

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The ZENEX Implant System Narrow (3.0, 3.2mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

The implants may be restored immediately

1. with a temporary prosthesis that is not in functional occlusion,
2. when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
3. for denture stabilization using multiple implants in the anterior mandible and maxilla.
   The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

The ZENEX Implant System Narrow consists of dental implants, and screws for use in one or two-stage dental implant placement and restorations. The fixtures and abutments in this system are: ZENEX MULTI Fixture, ZENEX PLUS Fixture, Cover Screw, Healing Abutment, Cemented Abutment (Hex, Non-Hex), Angled Abutment (Hex, Non-Hex), Temporary Abutment (Hex, Non-Hex), FreeMilling Abutment (Hex, Non-Hex), CCM Cast Abutment (Hex, Non-Hex), and Abutment Screw. An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The implant-Abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the ZENEX MULTI and PLUS Fixtures are treated with SLA(sand-blasted, large-grit, acid-etched). The subject fixture, cover screw and healing abutment are provided sterile. Other abutments are provided non-sterile and packaged separately.

The provided text is a 510(k) summary for the ZENEX Implant System Narrow, a dental implant device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for 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.

The document details:

• Device Description: Components (fixtures, abutments), materials (Ti-6Al-4V ELI, Co-Cr-Mo Alloy), and surface treatments (SLA, TiN coated).
• Indications for Use: Single tooth replacement, multiple tooth replacement, denture stabilization.
• Predicate Devices: A list of previously cleared dental implants and accessories used for comparison.
• Substantial Equivalence Discussion: A comparative table outlining various characteristics of the subject device against its primary predicate and reference devices, focusing on design, connection, material, surface, sterilization, shelf life, and indications for use.
• Non-Clinical Data: Lists mechanical and material tests conducted (Bacterial Endotoxin, Fatigue Testing on fixture) and leveraged from predicate devices (Sterilization Validation, Shelf-Life, End User Sterilization Validation, Biocompatibility). It also mentions an MR environment review.

There is no information in this document about:

1. Acceptance criteria for an AI/ML device.
2. Reported device performance metrics (e.g., sensitivity, specificity, accuracy) of an AI/ML device.
3. Sample sizes for test sets in an AI/ML study.
4. Data provenance for an AI/ML study.
5. Number or qualifications of experts for AI/ML ground truth.
6. Adjudication methods for AI/ML ground truth.
7. MRMC comparative effectiveness study results for AI/ML.
8. Standalone performance of an AI/ML algorithm.
9. Type of ground truth used for an AI/ML study.
10. Sample size for the training set of an AI/ML model.
11. How ground truth for the training set was established for an AI/ML model.

This 510(k) summary is for a physical dental implant system, not a software or AI/ML-driven device.

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The Dentis s-Clean SQ-SL Narrow Implant System is intended for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The Dentis s-Clean SQ-SL Narrow Implant System is limited to the replacement of maxillary lateral incisors and mandibular incisors. It is intended for delayed loading.

The Dentis s-Clean SQ-SL Narrow Implant System may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

The implants may be restored immediately

1. with a temporary prosthesis that is not in functional occlusion,
2. when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
3. for denture stabilization using multiple implants in the anterior mandible and maxilla.

The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

The Dentis s-Clean SQ-SL Narrow Implant System is used to replace missing teeth in various situations ranging from a single tooth loss to the complete loss of incisors teeth. This system is restricted to substitute the maxillary lateral incisors and mandibular incisors. It is one and two stage endosseous screw type implant with internal connection, intended for single use. Dentis s-Clean SQ-SL Narrow Implant System is a suitable treatment option when the possibility of placing a standard implant is limited due to physical conditions, where the horizontal space is limited by adjacent teeth and roots, or in situations with a narrow alveola ridge.

The provided text is a 510(k) summary for a dental implant system. It focuses on demonstrating "substantial equivalence" to predicate devices, rather than presenting a study to prove a device meets specific performance acceptance criteria for a novel function. As such, the information required for a study proving device performance against acceptance criteria (sections 1-9 of your request) is largely absent from this type of regulatory document.

However, I can extract information related to the acceptance criteria for ensuring safety and performance based on the type of testing performed, which is primarily non-clinical (bench) testing.

Here's an attempt to answer your questions based on the provided text, highlighting where information is absent or not applicable to this type of regulatory submission:

Device: Dentis s-Clean SQ-SL Narrow Implant System

Indications for Use (from K230246): The Dentis s-Clean SQ-SL Narrow Implant System is intended for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The Dentis s-Clean SQ-SL Narrow Implant System is limited to the replacement of maxillary lateral incisors and mandibular incisors. It is intended for delayed loading.

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

The document does not provide a table of acceptance criteria with specific numerical performance metrics. Instead, it lists the types of tests performed and states that the device was found "substantially equivalent." For specific performance criteria, one would typically refer to the referenced ISO standards (e.g., ISO 14801:2016 for fatigue). The "reported device performance" is implicitly that it met the requirements of these standards.

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

• Sample Size: Not specified for any of the tests. For fatigue testing per ISO 14801, a minimum number of samples is typically tested, but the exact number isn't provided here.
• Data Provenance: Not specified, but the submission is from Dentis Co., Ltd. in Korea. The studies are described as "non-clinical test data," implying bench testing, not patient data. Therefore, "retrospective or prospective" is not applicable in the clinical trial sense.

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. This is a 510(k) submission for a dental implant system, demonstrating substantial equivalence through non-clinical (bench) testing, not through expert-reviewed clinical imaging data or diagnostic performance studies. "Ground truth" in this context refers to the defined metrics and standards of the bench tests (e.g., fatigue cycles to failure, material composition analysis).

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

Not applicable. This concept applies to clinical studies involving human readers and interpretations, not to non-clinical bench testing.

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. The device is a dental implant system, not an AI-powered diagnostic tool requiring human reader studies.

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

Not applicable. The device is a physical dental implant, not an algorithm.

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

The "ground truth" for this device's non-clinical testing is defined by international and national standards for material properties, mechanical performance, biocompatibility, and sterilization (e.g., ISO 14801:2016, ISO 10993-1:2009, ANSI/AAMI ST79). For the MR environment assessment, it relies on "scientific rationale and published literature."

8. The sample size for the training set

Not applicable. This is not a machine learning model.

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

Not applicable. This is not a machine learning model.

Summary of the "Study" (Non-Clinical Testing):

The "study" described in this 510(k) summary is a set of non-clinical (bench) tests designed to demonstrate that the Dentis s-Clean SQ-SL Narrow Implant System is as safe and effective as previously cleared predicate devices.

• Purpose: To demonstrate substantial equivalence to predicate devices (K161244, K182194, K210080, K171027, K171694) in terms of materials, design, mechanical performance, biocompatibility, and sterilization, rather than proving performance against novel clinical acceptance criteria.
• Key Tests Performed:
  • Fatigue Testing: Performed on the subject device according to ISO 14801:2016 under worst-case scenarios.
  • Biocompatibility Testing: Leveraged from predicate devices (K171694) and based on ISO 10993-1:2009. The rationale is that the subject device uses the same materials and manufacturing process.
  • End User Sterilization Validation: Leveraged from predicate devices (K171694 and K171027) based on ANSI/AAMI ST79, ISO 17665-1,-2, ISO 11737-1,-2, and ISO 11138-1. The rationale is similar product category, material, manufacturing process, facility, and packaging.
  • Surface Modification (TiN Coating): Data provided to compare chemical composition, SEM, EDS, adhesion, and thickness between subject and predicate (K171694).
  • MR Environment Compatibility: Non-clinical worst-case MRI review performed based on scientific rationale and published literature, referencing FDA guidance.
• Conclusion: The device "constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use," based on these non-clinical tests and comparisons to predicate devices.

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IS Multi Unit Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as bridges.

IS Multi Unit Abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant with internal hex connections (multiple tooth). IS Multi Unit Abutment System is made of Titanium ELI according to ASTM F136.

IS Multi Unit Abutment System is composed of IS Multi Unit Abutment, IS Multi Unit Angled Abutment, Multi Unit Abutment Cylinder, Multi Unit Healing Cap, Multi Unit Temporary Cylinder, IS Multi Unit Angled Abutment Screw and Cylinder Screw.

All Multi-Unit Abutments (Straight/Angled) are intended only for multi-unit loaded restoration.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets them in the context of an AI/ML medical device.

The document is a 510(k) premarket notification for a dental implant abutment system (IS Multi Unit Abutment System) and focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for traditional medical devices, not typically AI/ML-driven ones.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily details device descriptions, indications for use, material specifications, and comparisons to predicate devices in terms of physical characteristics and intended use. It also mentions non-clinical testing data related to sterilization and fatigue testing for the physical dental device components.

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UCLA CCM Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

UCLA CCM Abutment is used for prosthetic restoration. It is used for cases with path and aesthetic and spatial constrainsts. After customization, be sure to use only dental non-precious metal for casting to make the prosthesis. When cast a prosthesis with UCLA CCM Abutment, the post height above the transmucosal collar of UCLA CCM Abutment has to be taller than 4mm. The subject device is not to be used with any angulation and are straight only. UCLA CCM Abutment has Hex, Non Hex connection. Hex-type abutment should be used for single unit restorations and is not recommended for multiple tooth restorations. Non Hex-type abutment is for multiunit restorations only. Both abutments types are compatible implant bodies (K182194, K161987, K122519, K170608 and K173975). UCLA CCM Abutments are made from CCM Alloy. UCLA CCM Abutment consists of UCLA CCM Abutment and abutment screw. It is provided non-sterile, this should be user steam sterilized before use.

This document is a 510(k) Premarket Notification for a dental device, specifically an endosseous dental implant abutment. It does not pertain to an AI/ML medical device, and therefore does not contain the information required to answer the questions about acceptance criteria and a study proving device performance in the context of AI/ML.

The document discusses:

• Device Name: UCLA CCM Abutment
• Regulation Number: 21 CFR 872.3630 (Endosseous Dental Implant Abutment)
• Regulatory Class: Class II
• Indications for Use: Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
• Predicate Devices: NP-Cast Abutment System (K121843), UV Active Implant System, CCM Cylinder (K182194), DIO CAD/CAM Abutment (K181037), and various UF implant systems.
• Non-clinical Testing: Refers to in-vitro testing for fatigue (though none was done as the design does not include angulation), sterilization validation, and biocompatibility, leveraging data from predicate devices.
• Clinical Testing: Explicitly states, "No clinical testing was performed for this submission."

Therefore, I cannot provide details on acceptance criteria and study data related to an AI/ML device's performance, as outlined in your request, because this document describes a physical medical device (dental abutment) and not an AI/ML algorithm.

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