(118 days)
The Straight Stud Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The attachment screws into SFI Abutments which are screwed into endosseous implants.
The Straight Stud Attachment is compatible with all Sterngold SFI Abutments.
The Straight Stud Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The attachment screws into SFI Abutments which are screwed into endosseous implants.
The attachment consists of a modified ball, which screws into an SFI Abutment and a retaining female, which is processed into the denture. The retaining female engages the outside of the ball shape and allows retention of the prosthesis to the denture.
Sterngold SFI abutments are compatible with several implant systems that have been previously cleared under K130183 and K132814 - SFI Bar® Implant Abutments.
The Straight Stud Attachment is a straight attachment and is not intended for angulation of divergent implants. It has a 0.048" hex for tightening to the SFI abutment.
The provided text is a 510(k) summary for a medical device (Straight Stud Attachment) and does not describe acceptance criteria or a study proving that the device meets those criteria in the way typically expected for an AI/ML medical device. This document is for a mechanical dental device and the "performance data" refers to mechanical testing.
Therefore, many of the requested fields cannot be answered as they pertain to AI/ML device studies.
Here's an attempt to answer the questions based only on the provided text, recognizing its limitations:
1. A table of acceptance criteria and the reported device performance
The document mentions "specifications for a reliable connection" and "retention force testing was conducted to ensure level of retention was acceptable" and "dimensional verification against drawing." However, specific quantitative acceptance criteria and corresponding performance metrics are not provided in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Reliable connection with SFI implant abutments | "connection was reliable and functional" |
| Acceptable level of retention force | "level of retention was acceptable" |
| Adherence to dimensional specifications | "dimensional verification against drawing" |
| Equivalent performance to predicate devices | "Testing has shown that the Straight Stud Attachment is equivalent in performance characteristics to the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: The document states "fit checks of attachment to SFI abutment on several samples." This is vague and does not provide a specific sample size.
- Data provenance: Not specified. The testing is described as "Non-Clinical Performance Data," implying lab-based mechanical testing rather than human clinical data.
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. This is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here would be the physical properties and performance characteristics of the mechanical device, verified through engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of mechanical device testing.
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
No. This is a mechanical dental device, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a mechanical dental device. The "standalone" performance would be its mechanical function, which was evaluated non-clinically.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's non-clinical performance data would be:
- Engineering specifications and drawings.
- Physical measurements (dimensions, forces, material properties).
- Functional requirements (e.g., ability to screw in, retention).
8. The sample size for the training set
Not applicable. This is a mechanical device, not an AI/ML algorithm that requires training data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a mechanical device. The design specifications and material properties are established through standard engineering practices and regulatory requirements.
§ 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.)