(170 days)
Multi Angled Abutment system is intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures.
The Multi Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. The Multi Angled Abutment is used with Esthetic -low Cylinders (only Non-Hex) in the US System, K62030 and connected to HTIII SA Fixture in the HTIII SA Fixture System, K101096. The Multi Angled Abutment system consists of Abutment combined carrier that is tool to carry Multi angled abutment. and Abutment Screw. The Multi Angled Abutment system is exactly same with Multi Angled Abutment (K123755) except combined carrier. Carrier is just to carry the Multi Angled Abutment to implanted Fixture.
The provided document is a 510(k) summary for the OSSTEM Multi Angled Abutment system. This submission does not describe a study to prove a device meets acceptance criteria related to its performance in terms of accuracy, sensitivity, specificity, or other similar metrics.
Instead, this 510(k) summary is for a medical device (dental abutment). The "study" described herein is a comparison to a legally marketed predicate device to establish substantial equivalence for market clearance. This is a common regulatory pathway for medical devices and does not involve the types of performance studies or acceptance criteria typically associated with artificial intelligence or diagnostic software.
Therefore, many of the requested sections (Table of acceptance criteria, sample sizes, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission and device.
Here's a breakdown of the relevant information from the document in response to your request:
1. Table of acceptance criteria and the reported device performance
Not applicable. This is a 510(k) submission for a mechanical dental device, not a diagnostic or AI-driven aid with performance metrics like sensitivity or specificity. The "performance" assessment here is focused on mechanical and material equivalence to a predicate device.
Instead, the submission states:
"The Multi Angled Abutment system is merely improved for movement convenience of abutment by combination of carrier therefore, The Multi Angled Abutment is nothing changed from predicated Multi Angled Abutment (K123755) except combined carrier"
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No "test set" in the context of performance metrics was used. The evaluation centered on design and material comparison to a predicate device.
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. No a "ground truth" or expert review of performance data was conducted for this type of device submission. The assessment was done by the manufacturer's engineers and subsequently by the FDA reviewers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" equivalent in this context is the design specifications, material properties, and intended use of the legally marketed predicate device (K123755). The new device is compared against these established characteristics to demonstrate substantial equivalence.
8. The sample size for the training set
Not applicable. No training set was used.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study/Evaluation for Substantial Equivalence:
The "study" or evaluation performed for the K132067 submission was a comparison of the Multi Angled Abutment system to a legally marketed predicate device (Multi Angled Abutment, K123755).
- Acceptance Criteria (Implicit for Substantial Equivalence): The primary "acceptance criterion" was to demonstrate that the new device is as safe and effective as the predicate device, or is substantially equivalent. This means:
- Same intended use.
- Same or similar technological characteristics.
- If there are differences in technological characteristics, those differences do not raise different questions of safety and effectiveness.
- Reported Device Performance (in context of substantial equivalence): The document reports that the Multi Angled Abutment system is "exactly same with Multi Angled Abutment (K123755) except combined carrier." The carrier is described as "just to carry the Multi Angled Abutment to implanted Fixture." This modification is stated to be "merely improved for movement convenience of abutment."
- Intended Use: Identical for both new and predicate device: "intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures."
- Abutment Angle (°): 17, 30 (same for both)
- Platform (Ø): 4.8 (same for both)
- Connection: The core abutment components are identical to the predicate (K123755). The only difference is the addition of a combined carrier.
- Nonclinical Testing: "The risks associated with the modification were evaluated via a DCAS table and it was determined that no performance testing is needed. However, minor modifications were made to the labeling." This indicates that the manufacturer determined the change (addition of a carrier) did not warrant new mechanical or material testing as the core functional components of the abutment remained unchanged from the predicate.
- Clinical Testing: "No clinical studies are submitted."
In essence, the entire argument for meeting the "acceptance criteria" for market clearance (substantial equivalence) is built on the claim that the device is fundamentally the same as its predicate, with a minor, non-performance-affecting addition.
§ 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.)