(59 days)
The SPI® Customizable Gingiva Former is intended to be used in conjunction with SPI® System dental implants to provide temporary support for crowns or bridges in the maxillary and/or mandibular arch.
The Thommen SPI® Customizable Gingiva Former is a temporary endosseous dental implant component made from an acrylic-based polymer with a titanium base at the implant/abutment interface for a stable, precise connection. The SPT® Customizable Gingiva Former is used for maintaining gingival contour and as a base for fabrication of a temporary restoration.
This 510(k) submission (K092248) for the Thommen Medical AG SPI® Customizable Gingiva Former does not contain the type of study data and acceptance criteria that would typically be found for a device requiring performance evaluation against specific metrics, especially for AI/ML-enabled devices.
This submission is a Special 510(k) for a device modification, specifically for an "Endosseous dental implant abutment." Special 510(k)s often involve modifications to already cleared devices where the changes do not significantly alter the fundamental scientific technology or intended use. In such cases, the review focuses on ensuring that the modifications do not raise new questions of safety and effectiveness, often relying on comparisons to the predicate device and established performance standards, rather than new extensive clinical or performance studies with detailed acceptance criteria and statistical analysis.
Therefore, many of the requested data points (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone algorithm performance, etc.) are not applicable or present in this document.
Here's an analysis based on the provided text, addressing the requested information where possible:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly stated or applicable in the provided document. The submission focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific performance metrics with acceptance criteria for a new type of study.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This document does not describe a performance study with a test set of data in the context of an AI/ML device. The evaluation relies on the device description, intended use, and comparison to predicate devices, along with adherence to general controls.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. No ground truth establishment process is described, as there isn't a performance study generating new data for evaluation.
4. Adjudication Method
Not applicable. No performance study data requiring adjudication is presented.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI-assisted diagnostic or therapeutic device that would undergo such a study.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical dental implant component, not an algorithm.
7. Type of Ground Truth Used
Not applicable. There is no ground truth data in the context of a performance study for this device type.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of Device and Approval Context:
- Device Name: SPI® Customizable Gingiva Former
- Intended Use: Used with SPI® System dental implants to provide temporary support for crowns or bridges in the maxillary and/or mandibular arch.
- Classification: Class II (Endosseous Dental Implant Abutment)
- Nature of Submission: Special 510(k) for a device modification. This implies the core technology and safety/effectiveness principles were established by previous predicate devices.
- Key Argument for Equivalence:
- Same intended use
- Same operating principle
- Same or similar materials
- Same basic design
- Same packaging materials and processes
The FDA's letter explicitly states that they "have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination is the primary "acceptance criterion" for a 510(k) submission, and it is "proven" by demonstrating that the modified device does not raise new questions of safety or effectiveness compared to the predicates, as outlined in the "Equivalence to Marketed Product" section.
No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or mechanical strength limits with associated test results) are detailed in the provided portion, which is common for Special 510(k)s focusing on material or design modifications where existing general controls and predicate device performance are considered sufficient. If mechanical testing (e.g., fatigue, fracture) was performed to support the modification, the specific acceptance criteria and results would typically be in a separate section of the 510(k) submission, often referencing ISO or ASTM standards, but they are not provided in this excerpt.
§ 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.)