(245 days)
The Neoss Access Abutments are designed to be connected to the Neoss implants and intended for use as an aid in prosthetic rehabilitation.
Neoss Access Abutments represent a two piece abutment system and are designed to be connected to the Neoss implants, to receive another abutment or framework and intended for use as an aid in multiple-unit prosthetic rehabilitation such as dental bridge restorations.
The internal connection of the Neoss Access Abutment provides a solution with a minimum height of the complete prosthesis of 5 mm and allows an overall implant alignment of up to 60 degrees without restraining the fabrication of a multiple-unit screw-retained restoration.
The angulated 10°, 20° and 30° abutments are intended for multi-unit cases in order to improve the position of the screw access hole.
Restorations can be based on Neolinks being incorporated into gold or ceramic frameworks, or solid titanium and ceramics frameworks. The frameworks are then tightened with prosthetic screws onto the Neoss Access Abutments.
The Neoss Access Abutments are dental abutments.
Here's an analysis of the provided text regarding acceptance criteria and the study:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Recommended requirements per "Guidance for industry and FDA staff, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant Abutments, dated May 12, 2004" | The abutment fulfills the recommended requirements. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "performed testing" but does not detail the number of units tested.
- Data Provenance: Not explicitly stated. Given that the manufacturer is Neoss Ltd (UK) and the submission is to the FDA (USA), the testing was likely conducted in a controlled laboratory environment, but the location of the lab or the origin of any materials used is not specified. It is a prospective test specifically for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. This device is a physical dental abutment, and its performance is assessed against engineering and material requirements, not against human expert interpretation of data.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. Performance testing of a physical device against engineering standards typically involves direct measurement and comparison to predefined thresholds, not a multi-expert adjudication process.
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:
- MRMC Study: No. This is a physical medical device (dental abutment), not an AI/software device. Therefore, MRMC studies and AI assistance are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Ground Truth: The "ground truth" for this device's performance is established by the "recommended requirements" outlined in the "Guidance for industry and FDA staff, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant Abutments, dated May 12, 2004." These requirements specify the mechanical, material, and biocompatibility properties the abutment must meet.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is a physical device, and there is no "training set" in the context of machine learning. The design and manufacturing processes are likely informed by engineering principles, material science, and previous product development, but not a data-driven training set.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. (See point 8).
§ 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.)