(115 days)
BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw or cement retained to the abutment. For compatibility of BellatekTM Patient Specific Abutments, please refer to the Table below.
BIOMET 3i Encode Patient Specific Abutment for Straumann Bone Level Connection can be compared to current Encode Patient Specific Abutment for Nobel Replace Connection. The change to this device is only to the connection that is intended to interface which is identical to the interface found on the STRAUMANN bone level Implant. This feature does not modify the intended functionality of the Implant. implant/abutment system. This device is also intended for dental laboratories to provide limited design input to match the anatomical requirements of the patient.
Here's an analysis of the acceptance criteria and study findings for the "Encode Patient Specific Abutment for Straumann Bone Level Connection", based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Integrity (Dynamic Fatigue) | Meets ISO 14801:2007 "Dentistry - Dynamic Fatigue Test for Endosseous Dental Implants" standards, including worst-case scenarios (30° pre-angled abutments). | All testing conducted met the acceptance criteria. Performance testing data indicates substantial equivalence to the predicate device. |
| Material | Ti-6Al-4V ELI (for both abutment and screw) | Ti-6Al-4V ELI |
| Biocompatibility | Biocompatible | Yes |
| Statistical Tolerance Analysis | Successful statistical tolerance analysis | Yes |
| Intended Use | Same as predicate device | Same as predicate device |
| Indications for Use | Same as predicate device | Same as predicate device |
| Technological Characteristics | Similar to predicate device, with primary difference only in the mating connection. | Similar to predicate device, with primary difference only in the mating connection compatible with Straumann Bone Level Implant. |
| Principles of Operation | Same as predicate device | Same as predicate device |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the specific number of units or samples used for the "Design Verification Testing" according to ISO 14801:2007. It only mentions that testing was conducted.
- Data Provenance: The data is a result of prospective bench testing conducted by the manufacturer, BIOMET 3i. There is no indication of country of origin for the data provided, but the submitter is based in Palm Beach Gardens, FL, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This evaluation is based on bench testing (mechanical performance), not clinical data or expert interpretation of patient data. Therefore, the concept of "ground truth" established by experts in the context of diagnostic accuracy for the test set is not applicable here. The "ground truth" for mechanical testing is adherence to the specified ISO standard and FDA guidance.
4. Adjudication Method for the Test Set
- Not applicable. As this is a bench test for mechanical performance, there is no adjudication method by experts for a test set in the way it would apply to clinical or imaging studies. The evaluation is based on objective measurements against a standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states "Clinical Data: N/A". This is a premarket notification focused on demonstrating substantial equivalence primarily through technical and performance characteristics (bench testing) to a predicate device, rather than a study involving human readers and clinical outcomes.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone algorithm performance study was not done. This device is a physical dental abutment, not an AI algorithm or software.
7. Type of Ground Truth Used
- The "ground truth" for the performance study (Design Verification Testing) was based on compliance with established mechanical testing standards and guidance:
- ISO 14801:2007 "Dentistry - Dynamic Fatigue Test for Endosseous Dental Implants"
- FDA Guidance Document: "Guidance for Industry and FDA Staff: - Special Controls Class II -Standards: Root Form Endosseous Dental Abutment/ Implant"
8. Sample Size for the Training Set
- Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
§ 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.)