(82 days)
Not Found
The new Model 7005 for which 510 ( k ) clearance is sought uses a microprocessor rather than discrete electronic components used in the earlier Model 8001 unit. The new model operates reliably with conductive fluids in the canal, for example sodium hypochlorite. Another advantage is a lower patient current, 3.5 microamperes as compared to 35 microamperes for the Model 8001.
This 510(k) notification for the Apex Finder Model 7005 does not contain the level of detail typically found in a clinical study report for medical device acceptance criteria. The document primarily focuses on establishing substantial equivalence to existing devices rather than presenting a standalone study with robust statistical analysis and a detailed description of acceptance criteria met through performance testing.
Therefore, many of the requested fields cannot be fully populated. However, I will extract relevant information where available and note where specific details are missing.
Acceptance Criteria and Device Performance Study for Apex Finder Model 7005
This document primarily describes the substantial equivalence of the new Model 7005 Apex Finder to previously cleared devices (ROOT ZX, ENDEX, and Model 8001). It does not present a formal, blinded clinical study with predefined acceptance criteria for its own performance in terms of accuracy in root canal length determination. Instead, equivalence is established based on shared technological principles and operational characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the submission (substantial equivalence), explicit acceptance criteria in a quantitative sense for device performance (e.g., "accuracy must be within X mm of actual length") are not provided. The "reported device performance" is framed in terms of shared characteristics with predicate devices.
| Feature/Characteristic | Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (Model 7005) |
|---|---|---|
| Patient Current |
N/A