(243 days)
Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
The Prosthetic System is device made of titanium, titanium alloy, Gold alloy, POM and PC intended for use as an aid in prosthetic restoration. It consists of Abutments, Protect caps and Abutment Screws. Its surfaces are partially Tin coated and uncoated.
The provided document describes a 510(k) submission for a medical device, the "Prosthetic System," which is a dental abutment. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics.
Therefore, the requested information elements related to acceptance criteria, diagnostic performance, sample sizes, expert involvement, and ground truth for a study proving device performance are largely not applicable (N/A) in the context of this 510(k) submission.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as diagnostic performance metrics. Instead, the acceptance criteria are based on demonstrating substantial equivalence to predicate devices in terms of:
- Material composition
- Intended use
- Design
- Technological characteristics
- Performance characteristics
- Safety (biocompatibility)
- Mechanical fatigue testing according to relevant standards.
- Reported Device Performance:
Performance Aspect Description Substantial Equivalence The device is deemed substantially equivalent to the HU/HS/HG Prosthetic System (K081575) and HS/HG Prosthetic System (K100245) of Osstem Implant Co., Ltd. for the intended use and technological characteristics. Fatigue Testing Conducted for Custom Abutment and Multi Angled Abutment according to "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801. Results are reported to be in compliance. Biocompatibility Performed to ensure compliance with applicable international and US regulations. Results implied compliance. Other Safety/Performance The Prosthetic System has been "subjected to safety, performance, and product validations prior to release," with an overall conclusion that it is "safe and effective."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. No diagnostic performance test set is described as this is not a diagnostic device and the submission focuses on mechanical and material equivalence, not clinical diagnostic accuracy. The fatigue testing would involve a certain number of samples, but the specific sample size is not detailed in this summary. The tests were likely conducted in a lab environment.
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)
- N/A. Not applicable as there is no diagnostic test set or ground truth established by experts in the context of diagnostic accuracy. The "ground truth" for the fatigue test would be the standard's pass/fail criteria, derived from engineering principles and industry consensus, not expert medical opinion.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not applicable as there is no diagnostic test set requiring expert adjudication.
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
- N/A. This is a dental prosthetic system (abutment), not a software or AI-enabled diagnostic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical prosthetic device, not an algorithm, so standalone performance in the context of AI/software is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- N/A for diagnostic ground truth. For the fatigue testing, the "ground truth" would be the engineering specifications and pass/fail criteria defined by ISO 14801 and FDA guidance documents. For biocompatibility, it would be the compliance with relevant international and US regulations.
8. The sample size for the training set
- N/A. There is no "training set" in the context of an AI/machine learning model for this physical medical device.
9. How the ground truth for the training set was established
- N/A. Not applicable, as there is no training set for an AI/machine learning model.
In summary: The provided 510(k) summary is for a physical medical device (dental abutment) and focuses on demonstrating substantial equivalence to existing predicate devices through material, design, and limited performance (fatigue, biocompatibility) testing, rather than a clinical study evaluating diagnostic accuracy against specific performance criteria. Therefore, most of the requested information regarding AI/diagnostic performance studies is 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.)