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510(k) Data Aggregation
(257 days)
On1 Concept
The On1™ device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation.
The On1 Concept is a 2-piece dental implant abutment system. It is intended to be used with the Nobel Biocare dental implants that have the internal conical connection. The On1 Concept features the On1 Base that once placed on the dental implant is not intended to be removed. The top portion of the On1 Clinical Screw incorporates threads to accommodate the On1 Healing Cap and On1 Prosthetic Screw allowing the On1 Clinical Screw to remain in position after placement and securing of the On1 Base. The On1 Concept system includes a healing cap, temporary abutment and esthetic abutments which all fit onto the On1 Base. The esthetic abutments are available in both titanium alloy and zirconium oxide.
This document is a 510(k) premarket notification from the FDA for a dental implant abutment system, the "On1 Concept." It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets them in the way one might expect for a diagnostic AI device.
Therefore, much of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, and ground truth establishment is not available in this document. This document describes a medical device (dental implant abutment), not a software or AI device that would have performance metrics like sensitivity, specificity, or AUC.
However, I can extract the relevant information that is present and indicate where information is absent based on the nature of this document.
1. A table of acceptance criteria and the reported device performance
Based on the document, the primary "acceptance criterion" is demonstrating substantial equivalence to predicate devices, particularly regarding fatigue limit. The reported performance focuses on this.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Fatigue Limit (per ISO 14801) | The fatigue limit of the On1 Concept was determined using the methods described in ISO 14801. (The actual numerical result is not explicitly stated in this summary, but it was presumably deemed sufficient to demonstrate substantial equivalence). |
| Sterility | Sterilization method (Gamma radiation, pre-vacuum & gravity moist heat) validated in accordance with ANSI/AAMI/ISO 11137 and ANSI/AAMI/ISO 17665-1. |
| Packaging Integrity | Packaging is the same as the predicate (thermoform tray with peel top lid). No additional testing required. |
| Shelf Life | Packaging is the same as the predicate and labeled with a 3-year expiration after real-time aging. No additional testing required. |
| Biocompatibility | Device manufactured from the same material with the same process, intended use, patient contact type and duration as the predicate. No additional testing required. |
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: Not specified in this document. The fatigue testing refers to "methods described in ISO 14801," which would define the number of test pieces, but the specific count is not reported here.
- Data Provenance: Not specified. The document outlines regulatory submission information, not the detailed origin of testing data.
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)
- Not Applicable. This document describes a physical medical device (dental abutment), not a diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for a mechanical device is often determined by physical measurements and standardized testing procedures (e.g., force applied until fracture, stress cycles).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As per point 3, this is not a diagnostic study with human readers and adjudication. The "adjudication" for mechanical tests would typically refer to the pass/fail criteria defined by the ISO standard.
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 a physical medical device, not an AI or software device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical performance data (specifically fatigue testing) would be established by the physical and mechanical properties of the device measured against engineering standards (e.g., ISO 14801) and internal specifications. For other criteria like sterility, biocompatibility, packaging, and shelf life, the ground truth is established by validated testing methods against relevant international or national standards (e.g., ANSI/AAMI/ISO standards).
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI or machine learning model that would have a "training set."
9. How the ground truth for the training set was established
- Not Applicable. As per point 8, there is no "training set" for this type of device.
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