(91 days)
The Straumann® Screw Retained Abutments are indicated to be placed into the NC and RC Bone Level implants of the Straumann® Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars.
The final processed devices have the purpose of restoring chewing function.
Straumann® Screw Retained Abutments are indicated for screw-retained restorations.
Here's an analysis of the provided text regarding acceptance criteria and studies, with the understanding that this document is a 510(k) summary for a medical device and not a report for an AI/ML device. Therefore, many of the requested fields related to AI/ML studies will not be applicable.
The document discusses the Straumann® Screw Retained Abutments, which are dental implant components.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for performance. Instead, it demonstrates substantial equivalence to predicate devices through material and technological characteristics, and performance data from bench studies.
| Feature / Criterion | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Material (Composition) | Conformance to ISO 5832-11 (Ti-6Al-7Nb) | Ti-6Al-7Nb titanium alloy conforming to ISO 5832-11 |
| Manufacturing Process | Precision machining from solid material (one-piece construction) | Precision machining from solid material (one-piece construction) |
| Mechanical Strength/Durability (Fatigue) | Consistent with FDA guidance and ISO 14801 | Dynamic fatigue test data consistent with FDA guidance and ISO 14801 was referenced. (Specific numerical results not provided in this summary) |
| Implant-to-Abutment Connection | Identical to predicate devices (NC, RC Cross Fit) | NC & RC Cross Fit |
| Platform Diameter(s) | Equivalent/Comparable to predicate devices | NC: Ø4.6 mm, RC: Ø4.6 mm (Note: Predicate had NC: Ø3.5 mm, Ø4.6 mm, RC: Ø4.6 mm) |
| Abutment Angulation(s) | Equivalent/Comparable to predicate devices | NC: 17°, 30°, RC: 17°, 30° (Note: Predicate had 0°, 17°, 30°) |
| Gingival Height(s) | Equivalent/Comparable to predicate devices | NC: 5.5 mm, RC: 5.5 mm (Note: Predicate had 1.0, 2.5 and 4.0 mm) |
| Orientation of Angulation to Engagement Features | Identical to predicate devices (Type A (45°), Type B (0°)) | NC: Type A (45°), Type B (0°), RC: Type A (45°), Type B (0°) |
| Primary Package | Medical grade polyethylene blister with a sealing lid | Medical grade polyethylene blister with a sealing lid |
| Sterilization | Non-sterile; intended for terminal sterilization via moist heat (autoclave) | Non-sterile; intended for terminal sterilization via moist heat (autoclave) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "bench studies" and "dynamic fatigue test data" but does not explicitly state the sample size (number of abutments tested) for these tests. There's no information about the country of origin of the data or whether it was retrospective or prospective, as these are typically not relevant for benchtop mechanical testing of physical devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the device is a physical dental implant abutment, not an AI/ML imaging analysis tool. "Ground truth" in this context would come from engineering specifications, material standards, and physical measurements/tests, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical device undergoing bench testing.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for showing substantial equivalence relies on:
- Engineering specifications and material standards: Conformance to ISO standards for material composition (ISO 5832-11) and mechanical testing (ISO 14801).
- Physical measurements: Dimensions (platform diameter, gingival height), angles, and connection types for comparison with predicate devices.
- Bench test results: Data from dynamic fatigue tests to demonstrate mechanical performance under simulated conditions.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. 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.)