(166 days)
Straumann® Screw Retained Abutments are indicated to be placed into the 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.
Straumann® Screw Retained Abutments include one-piece straight and angled (17° and 30°) abutments, basal screws and abutment carrier pin. The subject device is identical to the primary predicate, K133421, and subsequent premarket notification submissions K141871, K150814 and K151247 with the exception that the subject device will be delivered to the user sterile as opposed to non-sterile and a change in packaging to ensure sterility of the devices.
This document is a 510(k) premarket notification for the Straumann® Screw Retained Abutments. It aims to demonstrate substantial equivalence to previously cleared predicate devices. Since this is not a diagnostic device and doesn't involve an AI algorithm, the information requested in your prompt (acceptance criteria, study details, expert input, MRMC study, standalone performance, training set) typically applies to AI/ML-based medical devices or diagnostic tools.
This submission focuses on engineering, material, and sterilization equivalence for a dental implant component. Therefore, the detailed AI/ML-specific questions in your prompt are not applicable to this document.
However, I can extract information related to the device's technical characteristics and the claim of substantial equivalence.
Here's a breakdown of what is applicable from your prompt, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in the format typically used for performance metrics of diagnostic algorithms. Instead, it relies on demonstrating substantial equivalence to predicate devices. This means that the device's characteristics must be similar enough to the predicate to ensure equivalent safety and effectiveness.
The table provided (pages 5-6) serves as the primary evidence for this. It compares the Subject Device (Straumann® Screw Retained Abutments) to several Predicate Devices across various technical characteristics. The "performance" in this context is demonstrating that these characteristics are either identical or sufficiently similar to the legally marketed predicates.
| Feature | Subject Device Performance | Predicate Device Performance (K133421, K141871, K150814, K151247) |
|---|---|---|
| Indications for Use | Straumann® Screw Retained Abutments are indicated to be placed into the 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. (Identical to predicates) | Straumann® Magellan™ Screw Retained Abutments are indicated to be placed into the 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. (For K133421, K141871, K150814, K151247) |
| Implant-to-Abutment Connection | Narrow CrossFit (NC), Regular CrossFit (RC) (Identical to K133421, K151247; broader than K141871, K150814 which only list NC) | Narrow CrossFit (NC), Regular CrossFit (RC) (K133421, K151247) |
| Narrow CrossFit (NC) (K141871, K150814) | ||
| Interface Type | Engaging (Identical to all predicates) | Engaging (All predicates) |
| Platform Diameter(s) | NC Straight and Angled: Ø3.5 mm, Ø4.6 mm | |
| RC Straight and Angled: Ø4.6 mm (Comparable ranges; Subject device appears to cover the full range of predicates) | NC Straight: Ø3.5 mm, Ø4.6 mm | |
| RC Straight and Angled: Ø4.6 mm (K133421) | ||
| NC Angled: Ø3.5 mm, Ø4.6 mm (K141871) | ||
| NC Straight: Ø3.5 mm, Ø4.6 mm (K150814) | ||
| NC Angled: Ø3.5 mm, Ø4.6 mm | ||
| RC Angled: Ø4.6 mm (K151247) | ||
| Abutment Angulation(s) | 0°, 17°, 30° (Identical to K133421, K151247; broader than K141871 (17°, 30°) and K150814 (0°)) | 0°, 17°, 30° (K133421) |
| 17°, 30° (K141871, K151247) | ||
| 0° (K150814) | ||
| Gingival Height(s) | NC and RC Straight: 1.0, 2.5 and 4.0 mm | |
| NC and RC Angled: 2.5, 4.0 and 5.5 mm (Comparable and comprehensive ranges) | NC and RC Straight: 1.0, 2.5 and 4.0 mm | |
| RC Angled: 2.5 and 4.0 mm (K133421) | ||
| NC Angled: 2.5 and 4.0 mm (K141871) | ||
| NC Straight: 1.0 mm (K150814) | ||
| NC and RC Angled: 5.5 mm (K151247) | ||
| Orientation of Angulation to Engagement Features | Type A (45°), Type B (0°) (Identical to K133421, K141871, K151247; not applicable for K150814 as it's 0°) | Type A (45°), Type B (0°) (K133421, K141871, K151247) |
| N/A (K150814) | ||
| Device Material | Ti-6Al-7Nb titanium alloy (Identical to all predicates) | Ti-6Al-7Nb titanium alloy (All predicates) |
| Sterilization Status | End user receives product sterilized per Gamma Irradiation, 25 kGy minimum, Validated per ISO 11137-1 and ISO 11137-2 to an SAL of 10 x 10-6 (Key difference: Subject device is sterile upon delivery) | End user to sterilize product per IFU Method: Autoclave moist heat fractionated vacuum or gravity displacement Conditions: 134°C (273°F) for 5 minutes (All predicates are non-sterile; user is responsible for sterilization) |
| Packaging | Changed to ensure sterility. Equivalent to reference predicate device, Straumann® Healing Abutments, Healing Caps, Closure Screws (K130808) (Difference from non-sterile predicates, similarity to sterile reference predicate) | Not explicitly detailed for non-sterile predicates, but implied to be non-sterile packaging. K130808 (sterile reference predicate) has equivalent packaging. |
The study proving the device meets its "acceptance criteria" (i.e., substantial equivalence) is the comparison to predicate devices and the verification/validation activities for the changes (primarily sterilization and packaging). The document explicitly states: "The subject device is identical to the primary predicate, K133421, and subsequent premarket notification submissions K141871, K150814 and K151247 with the exception that the subject device will be delivered to the user sterile as opposed to non-sterile and a change in packaging to ensure sterility of the devices." And "Packaging materials and configuration is equivalent to reference predicate device, Straumann® Healing Abutments, Healing Caps, Closure Screws, K130808."
The substantial equivalence is primarily based on:
- Identical Indications for Use.
- Identical fundamental operating principles.
- Identical materials (Ti-6Al-7Nb titanium alloy).
- Comparable design features (Implant-to-Abutment Connection, Interface Type, Platform Diameter(s), Abutment Angulation(s), Gingival Height(s), Orientation of Angulation to Engagement Features).
- Validation of the sterilization process according to recognized standards (ISO 11137-1 and ISO 11137-2) and equivalence of packaging to a previously cleared sterile device (K130808).
The following points are not applicable to this 510(k) submission for a non-AI/ML dental abutment:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established
These points would be relevant for devices that involve algorithms, image interpretation, or diagnostics where a "ground truth" needs to be established and performance metrics (e.g., sensitivity, specificity, AUC) are calculated based on a test set. This submission is for a physical medical device (dental abutment) where the primary evaluation is based on engineering design, material properties, and manufacturing processes, demonstrated through comparison to legally marketed predicate devices and validation of changes like sterilization.
§ 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.)