(127 days)
CAMLOG® Abutments PS are intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the maxillary and/or mandibular arch.
The CAMLOG Implant System CAMLOG Abutments PS (Platform Switching) allows the treatment option of using a smaller abutment interface diameter than the platform diameter of the implant. The system includes a series of permanent abutments, temporary abutments and healing caps.
The provided text is a 510(k) summary for the Altatec GmbH CAMLOG® Abutments PS, which is a dental implant abutment. This type of regulatory submission is focused on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or performance through clinical studies with acceptance criteria in the way a novel drug or high-risk medical device might.
Therefore, the document does not contain information regarding a study with specific acceptance criteria, sample sizes for test or training sets, expert ground truth establishment, or comparative effectiveness studies in the way you've outlined. The FDA 510(k) process for a device like this relies heavily on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through design, material, and manufacturing similarities, and often through bench testing rather than human-centric clinical trials.
The provided text only includes the following relevant information to your request:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the document. The 510(k) focuses on equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No information on a test set sample size or data provenance is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
No information on experts establishing ground truth is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
No information on an adjudication method is provided.
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 MRMC study information is provided. This device is a physical dental abutment, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
No information on ground truth is provided.
8. The sample size for the training set:
No information on a training set sample size is provided.
9. How the ground truth for the training set was established:
No information on ground truth for a training set is provided.
Summary of available information:
- Intended Use: Used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the maxillary and/or mandibular arch.
- Device Description: The CAMLOG® Abutments PS (Platform Switching) allows the treatment option of using a smaller abutment interface diameter than the platform diameter of the implant. The system includes a series of permanent abutments, temporary abutments, and healing caps.
- Equivalence to Marketed Product: The submission demonstrates that the device is substantially equivalent to predicate devices based on:
- Same operating principle.
- Same basic design.
- Same materials.
- Same packaging and sterilization methods.
In conclusion, the 510(k) summary for Altatec GmbH CAMLOG® Abutments PS does not contain the type of detail you are requesting regarding acceptance criteria, study methodologies, and ground truth establishment because it's a submission focused on substantial equivalence for a physical medical device, not an AI/diagnostic tool.
§ 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.)