(120 days)
BIOMET 3i Patient Specific Dental Abutments (Encode®) Designed Using Cadent iTero Scanner and inLab Software v3.5are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. These are intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.
Encode® Abutments are designed specifically for a patient in a CAD/CAM system. The abutments are designed from a three-dimensional intra-oral optical scan or resin model scan and then machined/milled according to the parameters created in a digital file which is derived from the scan. The abutments are manufactured from titanium alloy or ceramic.
The provided text is a 510(k) summary for a medical device and does not contain the detailed information required to answer all parts of the request. The document specifically states that "Validation performed on scanning equipment and software to ensure accuracy of scanning models to produce the intended design as cleared in K032263 & K052648." However, it does not provide specific acceptance criteria, study methodologies, sample sizes, ground truth details, or effectiveness study results in the format requested.
Therefore, the following information can be extracted based on the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The general criterion is to "ensure accuracy of scanning models to produce the intended design as cleared in K032263 & K052648." | The device design and manufacturing process were validated to ensure accuracy relative to previously cleared products. The submission states, "Validation data demonstrates that the modified process results in a finished device that is as safe and effective as BIOMET 3i 's Patient-Specific Patient-Specific Dental Abutments that are currently cleared with previous scanner systems." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "Validation performed on scanning equipment and software."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe the establishment of a ground truth by experts for the validation.
4. Adjudication method for the test set:
- Not specified.
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 comparative effectiveness study is mentioned. This device is an accessory to dental implants (abutments) designed using CAD/CAM, not an AI-based diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The performance validated relates to the accuracy of the CAD/CAM system (scanner and software) in producing the intended design. While the process is largely automated (algorithm only in terms of design generation post-scan), specific standalone algorithm performance metrics are not provided. The phrase "algorithm only" in the context of an "AI" evaluation is not applicable here as it is a CAD/CAM design and manufacturing process, not an AI diagnostic algorithm.
7. The type of ground truth used:
- The ground truth explicitly mentioned is "the intended design as cleared in K032263 & K052648." This implies a comparison to a predefined standard or previously cleared designs/specifications, likely through dimensional accuracy measurements or similar engineering validation methods, rather than clinical outcomes or pathology.
8. The sample size for the training set:
- Not applicable. This is not a machine learning model that undergoes a "training" phase in the conventional sense. The "training" here would refer to the historical data or engineering principles used to develop the CAD/CAM software, which is not detailed.
9. How the ground truth for the training set was established:
- Not applicable for the reasons mentioned in point 8. The "ground truth" for the CAD/CAM software development would be based on engineering specifications, dental anatomy, and functional requirements for abutments, but the document does not elaborate on this.
§ 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.)