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510(k) Data Aggregation
(82 days)
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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 | < 10 μA (based on ROOT ZX) or 2 μA (based on ENDEX) | 3.5 μA (Meets/Exceeds in terms of being low) |
| Frequencies Used | Dual sine waves, different frequencies (e.g., 400 & 8000 Hz, or 1000 & 5000 Hz) | Sine waves of different frequencies in the range 500 - 8000 Hz (Comparable approach) |
| Comparison Method | Compares amplitudes at two signal frequencies to determine length | Compares sine waves of different frequencies (Substantially equivalent approach) |
| Conductive Fluids Performance | (Implied: functional with presence of fluids if predicate device is) | Operates reliably with conductive fluids (e.g., sodium hypochlorite) |
| Microprocessor Use | (Not a direct acceptance criterion, but an improvement) | Uses a microprocessor (compared to discrete components of Model 8001) |
| Safety - Low Patient Current | Lower patient current compared to older models | 3.5 microamperes (compared to 35 microamperes for Model 8001) |
2. Sample Size Used for the Test Set and Data Provenance
Not provided in the document. The submission focuses on design and functional equivalence rather than specific clinical test data with a test set. There is no mention of a patient cohort or data collection for performance validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. As there is no described test set of patient data, there were no experts used to establish ground truth for such a set.
4. Adjudication Method for the Test Set
Not applicable. No test set or adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not describe an MRMC study comparing human readers with and without AI assistance. This device is a standalone electronic instrument, not an AI-assisted diagnostic tool that would typically involve human-in-the-loop performance evaluation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Information not explicitly provided as a formal study. While the device itself is a standalone algorithm (microprocessor-based apex locator), the document does not present a formal study detailing its standalone accuracy against a gold standard (e.g., histological measurements of actual root canal length). The demonstration of its performance relies on the described operational principles and comparison to predicate devices, rather than an independent validation study with performance metrics like sensitivity, specificity, or measurement error.
7. The Type of Ground Truth Used
Indirect/Implied Ground Truth: The ground truth for root canal length is inherently the actual anatomical length. However, the document does not explicitly describe a study where this ground truth was measured (e.g., histologically after extraction, or by expert radiographic measurement combined with tactile feedback during actual procedures) and then compared to the device's output. The "ground truth" here is assumed to be the established efficacy of the predicate devices that operate on similar principles.
8. The Sample Size for the Training Set
Not applicable. This device is a traditional electronic apex locator, not a machine learning or AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is involved.
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