(246 days)
The Zimmer Patient Specific Ceramic Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for single or multipleunit restorations in anterior and pre-molar regions.
The Zimmer® Patient-Specific Ceramic Abutment is a zirconia abutment for use with endosseous dental implants to provide support for prosthetic devices. The abutment is manufactured using individual patient-specific requirements to create a design that facilitates functional, as well as, esthetic restoration.
The provided text is a 510(k) premarket notification for a medical device, specifically a dental abutment. It establishes substantial equivalence to a predicate device, which is a regulatory pathway to market a device without a full clinical trial for safety and effectiveness.
This document does not describe a study that uses acceptance criteria and reports device performance in the way that would typically be done for a diagnostic or AI-driven device. Instead, it focuses on demonstrating equivalence through material and general design features, and mechanical testing to establish substantial equivalence to a legally marketed predicate device.
Therefore, many of the requested categories for a study involving acceptance criteria, expert ground truth, sample sizes for test/training sets, and AI performance metrics are not applicable to this type of regulatory submission.
However, I can extract the relevant information where it exists:
Acceptance Criteria and Device Performance (Not Applicable in the traditional sense for this 510(k))
For a 510(k) submission like this, the "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device, rather than meeting specific performance metrics against a defined ground truth for a diagnostic task. The study mentioned is "mechanical testing" to show equivalence.
| Acceptance Criteria Category | Reported Device Performance (Zimmer® Patient-Specific Ceramic Abutment) |
|---|---|
| Material composition equivalence to predicate device | Reported as "substantially equivalent to the predicate relative to material" |
| General design features equivalence to predicate device | Reported as "substantially equivalent to the predicate relative to... general design features" |
| Mechanical performance equivalence to predicate device | Reported as "substantially equivalent to the predicate as evidenced in mechanical testing" |
1. A table of acceptance criteria and the reported device performance:
As established, the criteria are for "substantial equivalence" rather than performance against a diagnostic gold standard.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for mechanical testing in this summary. Mechanical testing typically involves a number of units sufficient to provide statistical confidence in the material and design properties.
- Data Provenance: The mechanical testing would have been conducted by Zimmer Dental Inc. or a contracted lab. The document does not specify country of origin for the data or if it was retrospective/prospective, but mechanical testing is generally prospective in nature for a new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not a study assessing diagnostic performance against expert opinion. Mechanical testing results are objective measurements.
4. Adjudication method for the test set:
- Not Applicable. Mechanical testing does not involve adjudication of expert opinions.
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 a physical dental abutment, not an AI or diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not an algorithm.
7. The type of ground truth used:
- Not Applicable in the context of expert consensus/pathology/outcomes data. For mechanical testing, the "ground truth" would be established engineering standards and the measured physical properties of the device (e.g., strength, durability, fatigue resistance) as compared to the predicate device.
8. The sample size for the training set:
- Not Applicable. This device does not involve a "training set" in the context of AI or machine learning.
9. How the ground truth for the training set was established:
- Not Applicable. This device does not involve a "training set" or "ground truth" in the AI sense.
§ 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.)