(113 days)
Sherlock abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
All digitally designed CAD/CAM customizations for Sherlock abutments are to be sent to an Open Implants-validated milling center for manufacture.
Sherlock abutments are compatible with the implant systems listed in the Compatibility Table:
Compatibility Table
| Compatible Implant Systems | Implant Body Diameter (mm) | Restorative Platform Diameter (mm) |
|---|---|---|
| NobelActive® | 3.5 | 3.5 (NP) |
| 4.3, 5.0 | 3.9 (RP)
Open Implants' Sherlock abutments are a system of dental implant abutments which have an implant /abutment interface design compatible with the OEM Nobel Biocare NobelActive implant system. Each Subject device implant abutment has a pre-manufactured implant connection interface. The implant body diameters are 3.5 mm with a restorative diameter of 3.5 mm (NP), 4.3 and 5.0 mm with a restorative diameter of 3.9 mm (RP).
The Subject device abutments, multi-unit sleeves and corresponding abutment screws are all premanufactured from Ti-6Al-4V ELI (Grade 23) titanium conforming to ASTM F136 and provided nonsterile to the user.
Subject device abutments are available in two configurations; a customizable titanium blank abutment, and a multi-unit abutment.
The titanium blank abutments are intended to be customized by means of CAD/CAM technology to provide basis or support for single or multiple tooth prosthetic restorations. All digitally designed customized abutments from titanium blank abutments are to an Open Implant-validated milling center for manufacture.
The Multi-unit abutments are intended to provide support for multiple tooth bridge supported prosthetic restorations. Multi-unit Temporary Cylinders are intended to be used to fabricate temporary multi-unit prosthetic restorations. The temporary cylinder and associated prosthetic restoration have a maximum intended use of six months.
The provided document describes a 510(k) premarket notification for a dental implant abutment called "Sherlock." It does not contain information about a study with acceptance criteria and device performance in the context of a diagnostic AI device or a comparative effectiveness study. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on indications for use, technological characteristics, and non-clinical performance data.
Therefore, many of the requested items related to acceptance criteria for a study, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable or not explicitly detailed in this type of FDA submission.
However, I can extract the information available from the document that relates to the device's characteristics and the non-clinical performance data used to support its substantial equivalence.
Here's a summary based on the provided text, addressing the points where information is available and indicating where it is not:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria for a study in terms of metrics like sensitivity, specificity, or accuracy, nor does it report device performance against such criteria. Instead, it discusses "performance testing" to validate differences in design parameters for demonstrating substantial equivalence. The specific acceptance criteria for these non-clinical tests (e.g., fatigue testing, biocompatibility) are not explicitly detailed in a table format with corresponding results, beyond stating that they were performed according to specific ISO standards.
| Acceptance Criteria (Not explicitly stated for a "study" as per the prompt's likely intent for diagnostic AI) | Reported Device Performance (Non-Clinical Validation) |
|---|---|
| Sterilization validated according to ISO 17665-1 and ISO 14937 | Performed according to standards. |
| Biocompatibility evaluated according to ISO 10993-5 and ANSI/AAMI ST72 | Performed according to standards. |
| Compatibility confirmed through reverse engineering of OEM implant abutments and screws | Confirmed. |
| Fatigue testing according to ISO 14801 | Performed, validating differences in abutment design parameters, supporting substantial equivalence. |
| Abutment design parameters (e.g., minimum wall thickness, maximum angulation, min/max gingival height) | Differences have been validated through performance testing, supporting 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 provided. The document focuses on non-clinical performance data, not a clinical test set.
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. The document describes non-clinical performance testing and substantial equivalence, not a study requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of an adjudication process as no clinical test set requiring ground truth adjudication is described.
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 a 510(k) submission for a dental implant abutment, not an AI or diagnostic device that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a physical dental abutment, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical performance data, the "ground truth" would be the engineering specifications, material properties, and performance limits defined by the relevant ISO standards (e.g., successful sterilization, biocompatible materials, passing fatigue tests).
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
§ 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.)