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Dentium Implantium® & SuperLine® Prosthetics are intended for use as an aid in prosthetic rehabilitation.

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This document is a 510(k) clearance letter for "Dentium Implantium® & SuperLine® Prosthetics." It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets them.

The letter primarily focuses on:

• Confirming the substantial equivalence determination.
• Outlining regulatory compliance requirements for the manufacturer.
• Identifying the product code and classification.
• Stating the intended use of the device ("intended for use as an aid in prosthetic rehabilitation").

Therefore, I cannot provide the requested information based on the text provided. This type of regulatory document typically follows the completion of such studies, but does not detail the studies themselves.

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Dentium Implantium® & SuperLine® Prosthetics are intended for use as an aid in prosthetic rehabilitation.

Dentium Implantium® / SuperLine® Prosthetics are intended for use as an aid in prosthetic rehabilitation. They consist of Dual Milling Abutment, Dual Abutment, Angled Abutment, Temporary Abutment, Direct-Casting Abutment and Metal Casting Abutment.

They are supplied non-sterile and sterilized by the recommended sterilization method in user's manual.

The materials of the Implantium & SuperLine Prosthetics are as follows; Pure Titanium Grade 4: Dual Milling Abutment, Dual Abutment, Angled Abutment and Temporary Abutment.

Co-Cr-Mo alloy (conform to ASTM F799) and Polyacetal (POM): Metal Casting Abutment,

Gold Alloy and Polyacetal (POM): Direct Casting Abutment.

This document is a 510(k) premarket notification for a dental prosthetic device, not an AI software. Therefore, the requested information about acceptance criteria, study design referencing AI/ML performance, and related ground truth establishment methods is not present in the provided text.

Specifically, the document focuses on demonstrating substantial equivalence of the Dentium Implantium® & SuperLine® Prosthetics to legally marketed predicate devices based on:

• Indications for Use: The devices are intended as an aid in prosthetic rehabilitation, matching the predicate devices.
• Design and Materials: Similarities in materials (Pure Titanium Grade 4, Co-Cr-Mo alloy, Gold Alloy, Polyacetal) and general shapes are emphasized. Minor differences in dimensions (total length, diameter, hex height) are noted but deemed not to affect application.
• Performance Bench Testing: Biocompatibility testing (ISO 10993-1) and mechanical performance testing (ISO Static compressive, ISO Fatigue, Corrosion Testing, Adaptation Accuracy) are reported.
• Non-clinical Testing: This includes "Reliability Calculation and Testing," "Fatigue Strength Testing," and "Static Load Failure Testing" in accordance with FDA guidance for dental implants/abutments.

The provided text does not contain:

• Any mention of acceptance criteria or performance metrics related to an AI/ML algorithm (e.g., sensitivity, specificity, AUC).
• Details on a test set's sample size for an AI/ML model, its provenance, or how ground truth was established by experts.
• Information on Multi-Reader Multi-Case (MRMC) studies or human-in-the-loop performance with AI assistance.
• Details about training sets for an AI/ML model.

Therefore, I cannot provide the requested table or study details specific to AI/ML device performance. The information in the document pertains to the physical and material characteristics and safety/performance of a traditional medical device (dental prosthetics).

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Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.

Dentium Implantium and SuperLine Abutments are intended for use an aid in prosthetic rehabilitation. The abutments were originally cleared under 510(k) K041358. The modified designs proposed in this submission consist of the Angled Screw Abutment, Cover Screw, and Screw Abutment Cylinders. Abutments are supplied non-sterile and autoclaved by the end user.

This document describes the Dentium Implantium® and SuperLine® Abutments, which are dental abutments. The information provided focuses on the device's technical specifications and performance testing, rather than a study on an AI/ML-driven device with acceptance criteria typically associated with diagnostic algorithms.

Therefore, the requested information on acceptance criteria, reported device performance, sample sizes for test and training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable in the context of an AI/ML evaluation study.

The document discusses performance testing in a general device context, not related to an AI/ML algorithm's diagnostic accuracy. It uses "acceptance criteria" in the sense of the device meeting established specifications through bench testing and biocompatibility assessments, rather than diagnostic performance metrics like sensitivity or specificity.

Here's a breakdown of the available information, noting where the requested AI/ML specific details are not present:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a traditional medical device (dental abutments), the "acceptance criteria" are related to mechanical and biological performance, not diagnostic accuracy.

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

• Test Set Sample Size: Not specified in terms of number of cases/patients. The "test set" here refers to physical abutment samples used for bench testing.
• Data Provenance: Not applicable in the context of patient data. The testing was conducted on device samples.

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

• Number of Experts: Not applicable. Ground truth for dental abutment performance (e.g., fatigue failure) is established through standardized engineering tests, not expert interpretation of cases.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Bench tests have objective Pass/Fail criteria based on physical and material properties.

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

• MRMC Study: No. This is not an AI/ML device.

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

• Standalone Performance Study: No. This is not an AI/ML device.

7. The type of ground truth used

• Type of Ground Truth: For biocompatibility, it's based on biological response to material samples (e.g., cell viability, immune reaction). For mechanical performance, it's based on physical failure thresholds and material integrity standards (e.g., absence of fracture after specified cycles, material composition specified by ASTM standards).

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is not an AI/ML device that requires training data.

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

• Ground Truth for Training Set: Not applicable. This is not an AI/ML device.

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