(263 days)
The Inclusive® Titanium Abutments for Astra OsseoSpeed™ Implants are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the Astra Tech OsseoSpeed™ 3.0, 3.5, 4.0, 4.5, 5.0 implants.
Inclusive® Titanium Abutments for- Astra OsseoSpeed™ Implants are endosseous implant abutments which are placed in to the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. These abutments are made of titanium grade Ti-6Al-4V ELI (meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. These abutments are compatible with the Astra OsseoSpeed™ Implants.
This 510(k) summary (K100993) describes the submission for Inclusive® Titanium Abutments for Astra OsseoSpeed™ Implants. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with the detailed elements requested.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a pass/fail threshold for a new device's performance in a standalone study. Instead, it demonstrates performance by comparing fatigue strength to predicate devices.
| Device Feature/Performance Metric | Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Inclusive® Abutments) | Predicate Device Performance (Astra Tech AB OsseoSpeed™ Narrow, K081666) |
|---|---|---|---|
| Material | Equivalent or superior to predicate material. | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Platform Diameters | Match or encompass predicate platform diameters. | 3.0, 3.5, 4.0, 4.5, 5.0mm | 3.0, 3.5, 4.0, 4.5, 5.0mm |
| Indications for Use | Substantially similar to predicate. | Premanufactured prosthetic components directly connected to endosseous dental implants, aid in prosthetic rehabilitation, compatible with Astra Tech OsseoSpeed™ 3.0, 3.5, 4.0, 4.5, 5.0 implants. | - Atlantis Abutment: for endosseous implant to support prosthetic device in partially or completely edentulous patient, single and multiple tooth prosthesis (maxillary lateral incisors, mandibular lateral and central incisors), cement retained, compatible with Astra Tech OsseoSpeed 3.0mm Implant. |
- Astra Tech Implant – Dental System, K990304: For use in selected fully edentulous and partially edentulous arches. |
| Design | Similar design with internal hexagon connection. | Implant/Abutment assembly with abutment screw. Abutment connection to implant is an internal hexagon. | Implant/Abutment assembly with abutment screw. Abutment connection to implant is an internal hexagon. |
| Fatigue Strength (at 20° for Inclusive® / 30° for predicate) | Equivalent or superior fatigue strength. | 3.0mm: 166.8N
3.5mm: 244.7N | 3.0mm: around 110N
2.5mm: 125N (Note: different angle and 2.5mm not 3.5mm compared directly) |
Notes on Performance Comparison:
- The fatigue strength comparison is made between the subject device tested at 20° and a predicate device (Straumann® on stock Astra Tech TiDesign™ abutments and OsseoSpeed™ implants) tested at 30°. The document claims "higher fatigue strength results can be attributed to" (incomplete sentence in original document).
- The comparison is not directly apples-to-apples due to different angles and potentially different specific abutment designs even within the "Astra Tech" family. However, the submitter concludes that the device "performs as well or better than the predicate device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document mentions "worst-case samples" were selected for fatigue testing, but it does not specify the sample size (e.g., number of abutments tested for each platform diameter).
- Data Provenance:
- The fatigue testing for the subject device was "conducted at Engineering Materials Laboratory." The document does not specify the country of origin of this laboratory.
- The predicate device fatigue data was "conducted by Straumann®." Again, the country of origin is not specified.
- The data appears to be prospective non-clinical test data specifically generated for this submission.
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 this is a device for dental implant abutments, and the "ground truth" for its performance is established through non-clinical mechanical testing (fatigue testing) against recognized standards and predicate device performance, not through expert review of images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for non-clinical mechanical testing. Adjudication methods are typically used in clinical studies or studies involving human assessment of data.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML devices that assist human readers (e.g., radiologists for image interpretation). This submission is for a physical medical device (dental abutment) and relies on non-clinical mechanical testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a form of "standalone" evaluation was done in the sense that the device's mechanical performance (fatigue strength) was tested independently. However, this is not an algorithm's standalone performance, but rather a physical device's mechanical performance. No human "in-the-loop" is relevant for this specific type of testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on established engineering principles and FDA guidance for fatigue testing of dental implants and abutments (Class II Special controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments). The performance is then compared to a legally marketed predicate device, whose "ground truth" performance was previously accepted by the FDA.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This is not applicable as there is no training set.
§ 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.)