(206 days)
Neoss TiBase:
Neoss Abutments are designed to be connected to the Neoss Implants and intended for use as an aid in prosthetic rehabilitation.
The Neoss TiBase is compatible with the Sirona Dental System inCoris ZI Meso L. All digitally designed copings and/or crowns for use with the Neoss TiBase Abutments are to be designed and milled using the Sirona Dental CAD/CAM System.
Neoss CoCr Abutments:
Neoss abutments are designed to be connected to the Neoss Implants and intended for use as an aid in prosthetic rehabilitation.
Neoss TiBase and CoCr Abutments are endosseous dental implant abutments used to support single tooth or multi-unit prosthetic restorations. All subject abutments have a platform interface that is compatible with Neoss implant diameters Ø3.5-5.5 mm. All Neoss implant sizes have a 4.1 mm implant platform regardless of endosseous implant diameter. Neoss TiBase abutments are provided in two prosthetic platform sizes, N (narrow) and W (wide), to accommodate different emergence profiles. The Neoss TiBase Abutment are patient specific abutments intended for the coping/crown to be designed using the Sirona CAD/CAM System. The Neoss TiBase Abutment can be screw retained.
Neoss CoCr abutments are available in two designs (Mono and Multi), one prosthetic platform size and one height (15 mm). The indexed Mono abutment can be used for single tooth screw-retained or cement-retained restorations. The non-indexed Multi abutment is used for multi-unit screw-retained restorations.
Neoss Crystaloc screw in TiN/Au coated titanium is used with the Neoss TiBase and CoCr Abutments.
The provided document is a 510(k) Premarket Notification for the "Neoss TiBase and CoCr Abutments." This type of submission focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than conducting new clinical studies to prove safety and effectiveness. Therefore, the document does not contain information typically found in a study demonstrating a device meets acceptance criteria, such as a table of acceptance criteria with reported performance, sample sizes for test sets, number of experts for ground truth, adjudication methods, or MRMC comparative effectiveness studies.
Instead, the document details non-clinical performance data (engineering analysis, dimensional analysis, static and dynamic compression-bending testing) and material biocompatibility to support the claim of substantial equivalence.
Here's an analysis based on the information provided, addressing the questions as much as possible, or indicating when the information is not present:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided document. The 510(k) submission model relies on demonstrating equivalence to predicate devices, and while it mentions "sufficient strength of the final finished device for its intended use" based on testing according to ISO 14801, it does not explicitly state quantitative acceptance criteria or a dedicated table of device performance against such criteria. The performance data is summarized qualitatively to support the claim of substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not explicitly stated for the non-clinical testing. The document mentions "non-clinical testing data submitted, referenced, or relied upon," which included "static and dynamic compression-bending testing according to ISO 14801 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants."
- Sample size: The specific number of abutments or test specimens used for the static and dynamic compression-bending tests is not provided in this summary.
- Data provenance: The document indicates the manufacturer is Neoss Ltd., located in Harrogate, UK. It's reasonable to infer the testing was conducted either internally by Neoss Ltd., or by a third-party lab on their behalf, likely within the UK or a region with equivalent testing standards. The data is non-clinical (laboratory testing), not patient data, so "retrospective or prospective" does not apply in the typical 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)
This question is not applicable as the document describes non-clinical performance testing (mechanical and biocompatibility), not a study involving human experts establishing ground truth for diagnostic or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as the document describes non-clinical performance testing. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints.
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
There is no MRMC comparative effectiveness study mentioned. This document pertains to dental implant abutments, a physical medical device, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is an endosseous dental implant abutment, not a software algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance data, the "ground truth" or standard for evaluation was:
- Engineering analysis and dimensional analysis: Based on design specifications and engineering principles.
- Static and dynamic compression-bending testing: "According to ISO 14801 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants." This international standard defines the methodology and acceptance criteria for mechanical performance in a laboratory setting.
- Biocompatibility: "Confirmed by conformance to FDA recognized consensus material standards (titanium alloy conforming to ASTM F136, and cobalt chromium alloy conforming to ASTM F1537)." These ASTM standards define the requirements for implantable materials.
8. The sample size for the training set
This question is not applicable. The document describes a 510(k) submission for a physical medical device. There is no "training set" in the context of machine learning or AI development.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated in point 8.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)