(56 days)
The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The Atlantis™ Abutments for Straumann Interface and abutment screws are made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with Straumann Standard Regular Neck (RN) implants with 3.3, 4.1, and 4.8mm diameters; Standard Plus Regular Neck (RN) with 3.3, 4.1, and 4.8mm diameters and the Tapered Effect Regular Neck (RN) with the 3.3 and 4.1mm diameters.
The provided document is limited in scope and does not contain detailed information about acceptance criteria, a specific study proving device performance, or the methodologies typically associated with such studies (like sample sizes, ground truth establishment, or expert involvement).
The document is a pre-market notification (510(k) summary) for the Atlantis™ Abutment for Straumann Interface. It primarily focuses on establishing substantial equivalence to a predicate device (Atlantis Abutment and Abutment Screw, K981858) based on intended use, material, design, and performance.
Therefore, I cannot provide a detailed response to most of your questions as the information is not present in the provided text.
Here's what can be extracted based on the given document:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The filing focuses on substantial equivalence to a predicate device rather than presenting specific quantitative acceptance criteria and performance data from a new study.
2. Sample size used for the test set and the data provenance
This information is not provided in the document. No specific test set or study data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. No information about ground truth establishment or expert involvement in a study is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document. No adjudication method is mentioned as there's no described test set or study requiring it.
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
This information is not provided in the document. The device is a dental implant abutment, not an AI-assisted diagnostic tool, so an MRMC study related to AI assistance would not be applicable or expected.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical dental abutment, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the document. No ground truth is discussed as there is no mention of a study to validate performance against a ground truth. The basis for clearance is "substantial equivalence" to a predicate device.
8. The sample size for the training set
This information is not provided in the document. There is no mention of a training set as this is not a machine learning device.
9. How the ground truth for the training set was established
This information is not provided in the document. There is no training set and thus no ground truth establishment for one.
In summary, the provided document is a 510(k) summary for a physical medical device (dental abutment) seeking clearance based on substantial equivalence to a predicate device. It does not describe a new clinical study with acceptance criteria, performance data, or ground truth establishment in the manner requested by your questions, which are more typically associated with software as a medical device or AI-driven diagnostic tools.
§ 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.)