(24 days)
The 3i Patient-Specific Dental Abutments and Overdenture Bars are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. It is intend 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.
The 3i Patient-Specific Dental Abutments are designed to match an individual patient. Since each 3i Patient-Specific Dental Abutment is manufactured to match a particular patient according to the doctor's requirements, a specific device description is not possible. However, the 3i Patient-Specific Dental Abutments are designed in keeping with the general descriptions presented in Section G, unless otherwise specifically requested by the doctor.
Here's an analysis of the provided information, focusing on the acceptance criteria and the study details as requested. It's important to note that the provided text is a 510(k) summary for a dental abutment, which is a physical device, not a software or AI-driven system. Therefore, many of the typical AI/software study criteria (like experts, ground truth, training sets, MRMC studies) are not applicable here.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | The 3i Patient-Specific Dental Abutments are substantially equivalent to the legally marketed 3i Patient-Specific Dental Abutments (K032263). |
| Intended Use | Intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. For single and multiple tooth prostheses in mandible or maxilla. Screw or cement retained. |
| Technological Characteristics | Contains features and functions similar to the currently available 3i Patient-Specific Dental Abutments (K032263). |
| Performance Standards | Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug and Cosmetic Act. (Implies meeting general safety and effectiveness requirements by demonstrating equivalence). |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable to this type of device submission. The 510(k) for a physical dental abutment relies on demonstrating equivalence to a predicate device, often through design comparison, material testing, and sometimes bench testing, rather than a clinical "test set" with patient data in the way an AI/software device would. The document does not specify any sample sizes for tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The concept of "ground truth" established by experts for a test set is relevant to diagnostic or interpretive AI systems, not a physical dental abutment.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are used in studies involving human interpretation or decision-making, especially in AI-assisted diagnostics, which is not the case here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, which does not apply to a physical dental abutment.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical dental abutment; there is no AI algorithm to evaluate in a standalone capacity.
7. The Type of Ground Truth Used
This information is not applicable in the context of this device. For a physical device, "ground truth" might refer to engineering specifications, material properties, or functional benchmarks, which are evaluated through design review and potentially bench testing, rather than expert consensus on data interpretation.
8. The Sample Size for the Training Set
This information is not applicable. Training sets are used for machine learning models, which are not relevant to this physical medical device.
9. How the Ground Truth for the Training Set was Established
This information is not applicable. As there is no training set for an AI model, the method of establishing ground truth for it is irrelevant.
Summary of Device Acceptance & Study Information (based on provided text):
The acceptance of the "3i Patient-Specific Dental Abutments" is primarily based on demonstrating substantial equivalence to an already legally marketed predicate device (3i Patient-Specific Dental Abutments, K032263). The study performed, implicitly, is a comparison of the new device's design, materials, and intended use against the predicate device to show that it raises no new questions of safety or effectiveness.
The document states: "The 3i Patient-Specific Dental Abutments contain features Technological and functions which are similar to the currently available 3i Characteristics Patient-Specific Dental Abutments [K032263]." and explicitly concludes: "The 3i Patient-Specific Dental Abutments are substantially equivalent to the legally marketed 3i Patient-Specific Dental Abutments."
This means the "study" for acceptance was a comparison study against a predicate device, focusing on design, materials, and intended use to establish substantial equivalence, rather than a clinical trial with a "test set" for performance metrics commonly associated with diagnostic or AI devices. The FDA's decision is based on agreement that the new device is as safe and effective as the predicate.
§ 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.)