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BoneTrust® Dental Implants are medical devices intended to be surgically placed in the bone of the maxillary and/or mandibular arches to provide support for prosthetic restorations (crowns, bridges or overdenture) in edentulous or partially edentulous patients to restore a patients' chewing function.

BoneTrust® implants can also be used for immediate loading when sufficient primary stability is achieved and with appropriate occlusal loading.

BoneTrust® Short Dental Implants with length 6.5 mm are intended for delayed loading only

BoneTrust® Abutments and Prosthetic parts are intended for use with Bone Trust Dental Implants in the maxillary and/or mandibular arches to provide support for crowns, bridges or overdentulous or partially edentulous patients.

The BoneTrust® Implant System includes various sizes of threaded root-form dental implants and abutments intended to support prosthetic restorations in edentulous or partially edentulous patients.

The BoneTrust® Implants are bone level, root form implants constructed of commercially pure titanium (Grade 4) per ISO 5832-2, with a sand-blasted, acid-etched surface treatment. BoneTrust® Implants are screw- shaped dental implants with a Hexagon or conical torx internal connection.

BoneTrust® Dental Abutments are intended for cement-retained and screw-retained restorations. A cylindrical internal hexagon or conical torx allows connection to the BoneTrust® implant. BoneTrust® Dental Abutments are available in different designs

This document is a 510(k) summary for the BoneTrust® Implant System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a standalone study for novel performance metrics. Therefore, many of the requested sections about acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable.

However, I can extract the information provided regarding non-clinical testing used to support substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for a novel AI device. Instead, it relies on demonstrating "substantial equivalence" through non-clinical testing to legally marketed predicate devices. The "reported device performance" is essentially that the device performed comparably to predicate devices in the described tests.

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

The document does not provide specific sample sizes for the test sets in the non-clinical studies. It mentions "representative samples" for fatigue testing. Data provenance is not specified beyond being non-clinical testing performed to support substantial equivalence to legally marketed predicate devices.

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 physical medical device (dental implants and abutments), not an AI/software device requiring ground truth establishment by human experts for diagnostic or similar tasks. The "ground truth" for the non-clinical tests would be the measurement results from the tests themselves (e.g., cytotoxicity levels, fatigue limits, physical characteristics).

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

Not applicable, as this is for a physical device and involves objective non-clinical tests rather than subjective human interpretation needing adjudication.

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 not an AI-assisted diagnostic or interpretation device.

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 (expert consensus, pathology, outcomes data, etc.)

For the non-clinical studies performed, the "ground truth" would be objective measurements obtained through standardized testing methods, such as:

• Biocompatibility: Laboratory results (e.g., cell viability in cytotoxicity tests).
• Fatigue testing: Load cycles to failure or endurance limit under specified conditions, as per ISO 14801.
• Sterilization: Sterility Assurance Level (SAL), microbial ingress testing, package integrity.
• Implant Surface Analysis: Microscopic imagery (SEM, BSE) and elemental composition data (EDX).
• Short Implants Performance: Quantitative measurements from comparative surface area analysis, histological examination for bone-to-implant contact (animal study), and force measurements for pull-out strength tests.

8. The sample size for the training set

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

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

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

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Straumann® Variobase™ for Bridge/Bar Cylindrical prosthetic components directly connected to the endosseous dental implants are indicated for use as an aid in prosthetic rehabilitations. The patient-specific prosthetic restoration (bridge or over-denture) can be cemented on the Straumann® Variobase™ for Bridge/Bar Cylindrical prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion. Straumann® Variobase™ for Bridge/Bar Cylindrical and patient-specific restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed Straumann® Variobase® for Bridge/Bar Cylindrical prosthetic components are intended to be sent to Straumann for manufacture at a validated milling center.

The Straumann® Variobase™ for Bridge/Bar Cylindrical, see Figure 1 and Table 1, are non-engaging (without rotational lock) abutments made from Ti-6Al-7Nb (TAN) that support a bridge or bar reconstruction (framework or full contour) on two or more dental implants. The corresponding basal screw is delivered with the abutment for connecting the abutment to the implant. A dental laboratory technician designs and manufactures the bridge/bar reconstruction via their preferred workflow using traditional or CAD/CAM methods.

This document is a 510(k) premarket notification for a medical device called "Straumann® Variobase™ for Bridge/Bar Cylindrical". It does not describe a study that uses software, AI, or machine learning. Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies as these concepts are not applicable to the provided document.

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and bench testing (dynamic fatigue, software validation, sterilization validation, and biocompatibility testing) for a dental implant abutment. The "Software validation conforming to the requirements of IEC 62304" mentioned in the Performance Data section refers to the validation of software used in the manufacture of the device (specifically, for digitally designed components intended to be sent to a validated milling center), not a clinical performance or diagnostic AI component of the device itself.

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The Klockner Essential implant system is especially designed for surgical insertion into the bone using additional material to replace the root of the teeth, acting as the support for the dental implants formed by implant accessories.

The Essential Solid implants are fitted with an internal octagonal conical connection combined with an external octagonal connection measuring 1.2 mm in height.

The Essential Cone implants are fitted with an internal octagonal conical connection.

The Essential ECK implants are fitted with a larger internal octagonal conical connection than that of the Essential Cone implants.

Immediate loading is appropriate for the Essential Cone and Essential Cone and Essential ECK implants when good primary stability is achieved with appropriate occlusal loading. Abutments can be used in single tooth replacements and multiple tooth restorations.

8mm Implants are not indicated for use as unitary implants and for immediate load.

The Klockner Essential implant system consists of a group of implants, implant accessories and additional material to restore the mastication system. The different EC, ES and ECK models are available in three different diameters: 3.5mm, 4.0mm and the range of lengths varies between 8mm and 16mm. They are internally connected.

This document (K080224) is a 510(k) premarket notification for the Klockner Essential Dental Implants System. It aims to demonstrate substantial equivalence to previously cleared devices. Based on the provided text, the submission focuses on asserting equivalence based on intended use, composition, endosseous surface treatment, and design principles, rather than presenting a study with acceptance criteria and performance data in the way a diagnostic AI device would.

Therefore, a table of acceptance criteria and device performance, as well as details about sample sizes, expert adjudication, MRMC studies, standalone performance, training data, and ground truth for a study proving the device meets acceptance criteria, cannot be extracted from this document. These types of studies are typically not required or presented for dental implant submissions that demonstrate substantial equivalence through comparison to predicate devices, especially concerning their physical and material properties.

The relevant sections of the document are primarily focused on:

• Device Identification: Name, manufacturer, contact.
• Device Description: Physical characteristics (diameters, lengths, connection types) of the Klockner Essential implant system (EC, ES, ECK models).
• Intended Use: Surgical insertion into bone to replace tooth roots, acting as support for dental implants, with specific indications for different diameters and bone types, and considerations for immediate loading.
• Predicate Devices: Listing of previously cleared Klockner dental implants and other manufacturers' implants used for comparison.
• Basis for Substantial Equivalence: Stating that "the intended use, the composition and the endosseous surface treatment are identical to the Klockner predicate devices. The design principles are the same as the Klockner predicate devices."

In summary, this document does not contain the information requested in your prompt regarding acceptance criteria and a study demonstrating performance against those criteria because it's a 510(k) submission based on substantial equivalence to predicate devices, not a performance study of a novel diagnostic or AI-based device.

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Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges or overdentures.

The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments. The devices covered in this submission are abutments.

Abutments can have an engaging or non-engaging connection to the implant. The basal portion of the engaging abutment has 4 protrusions diametrically opposed that engage in the 4 grooves of the P.004 implant. Non-engaging abutments do not lock into the implant via the protrusion/groove connection. Both abutments are seated in the implant with a screw which is mounted in the basal portion of the abutment. The abutment is used for cemented and screw-retained restorations.

This is a 510(k) premarket notification for a dental abutment, not a study describing the acceptance criteria and performance of an AI/ML powered medical device.

Therefore, I cannot extract the information requested as it is not present in the provided document. The document describes a traditional medical device (dental abutment) and its substantial equivalence to previously marketed devices based on material composition, basic design, and intended use, not on performance metrics derived from a study comparing an algorithm's output to ground truth.

Specifically, the document contains:

• Applicant and Device Information: Name, address, device trade and common names, classification.
• Predicate Device: K062129 synOcta® Gold Abutment, K041295.
• Device Description: What the P.004 dental implant system is, and its components (implants, abutments, surgical/prosthetic parts). It describes the abutment's connection types (engaging/non-engaging) and its seating mechanism with a screw.
• Intended Use: Placed into dental implants to support prosthetic reconstructions (crowns, bridges, overdentures).
• Technological Characteristics: States substantial equivalence to marketed devices in intended use, material, design, and operating principles.
• FDA Clearance Letter: Confirms substantial equivalence and market clearance.
• Indications for Use Statement: Reiterates the intended use and specifies prescription use.

None of this information pertains to an AI/ML device study or its associated performance metrics, ground truth, sample sizes, or expert adjudication methods.

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