(115 days)
The CAM StructSURE® Precision Milled Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.
All CAM StructSURE® Precision Milled Bars (Dolder, Primary, Hader, Hybrid and Copy Milled) are designed to match an individual patient. The bars are designed from a three-dimensional optical and/or digital scanner system that scans the casting of a patient's impression and then is machined using a CADCAM software system. The bars are milled from titanium alloy or CP titanium.
CAM StructSURE® Precision Milled Bars:
CSHxx CAM StructSURE Hader Bar: 2-10 implants
CSPxx CAM StructSURE Primary Bar: 2-10 implants
CSDxx CAM StructSURE Dolder Bar: 2-10 implants
CSCMxx CAM StructSURE Copy Milled Bar: 4-10 implants
CSIYxx CAM StructSURE Hybrid Bar: 4-10 implants
The provided document is a 510(k) summary for a dental device (CAM StructSURE® Precision Milled Bars). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as typically found for complex AI/diagnostic devices.
Therefore, much of the requested information regarding acceptance criteria, study design elements (sample size, ground truth, experts, adjudication, MRMC, standalone), and training set details are not applicable or available within this specific document. This document is a regulatory submission for a medical device approval that is not based on a statistical study with specific performance outcomes.
Here's an analysis based on the provided text, highlighting where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in this context. This 510(k) submission for the CAM StructSURE® Precision Milled Bars focuses on demonstrating "substantial equivalence" to a legally marketed predicate device (K034035 3i Patient Specific Overdenture Bars) rather than meeting specific quantifiable performance metrics through a clinical trial or performance study with acceptance criteria.
The "conclusion" states: "Appropriate verification and validation activities were performed to provide assurance that CAM StructSURE® Precision Milled Bars remain substantially equivalent to the predicate and the modifications have not changed the intended use, altered the fundamental scientific technology or the safety and effectiveness of the device." This indicates general design control and validation rather than a study against a specific performance benchmark.
2. Sample size used for the test set and the data provenance
Not applicable. The document does not describe a "test set" in the context of a statistical study for device performance. It refers to "verification and validation activities" but provides no details on sample size, data origin, or retrospective/prospective nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" or expert review process is described for performance evaluation of this device as it is not a diagnostic or AI-driven device.
4. Adjudication method for the test set
Not applicable. No "test set" or adjudication method 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 device is not an AI-assisted diagnostic tool, and therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical dental overdenture bar, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The concept of "ground truth" as it applies to performance studies for AI/diagnostic devices is not relevant here. The substantial equivalence is based on comparison to a predicate device and adherence to design controls.
8. The sample size for the training set
Not applicable. This device is not an algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. Since there is no training set mentioned, the establishment of ground truth for it is also not applicable.
§ 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.)