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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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OCT - 8 1996
ﭘﯿﺮ
510 ( k ) Notification for Apex Finder Model 7005
510 ( k ) Summary
Background:
In the practice of dentistry electronic apex locators have been used since 1960 to determine the length of a root canal. This is commonly done by measuring a weak electrical current flowing between two electrodes. The first electrode is a metal probe, for example a reamer or file inserted into the root canal, and the second a metal clip placed on the lip of the patient.Since the impedance between these two electrodes depends on the location of the probe tip within the root canal, the impedance can be used to estimate the location of the probe tip in relation to the apical foramen. The length of the root canal can therefore be obtained by measuring how far the probe is inserted into the canal.
The Model 8001 Endo Analyzer:
An apex finder marketed by Analytic Technology received 510 ( k ) clearance in March, 1987 with reference number K864500/A. It is sold under the name Endo Analyzer Model 8001. The Model 8001- is actulally a combination apex locator and tooth vitality scanner. Single purpose versions of this instrument are also marketed in different enclosures as Apex Finders Model 7001 and 7002. The subject of this application is an improved version of the model 8001 apex locator ..
The new Model 7005 Apex Finder:
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.
Substantial Equivalence Statement:
The Model 7005 is substantially equivalent to two units presently on the market - the ROOT ZX which is marketed by J. Morita USA Inc. and the ENDEX marketed by Osada Electric Co. Both units use patient signals which consist of two sine waves of different frquencies. The ROOT ZX uses 400 and 8000 Hz and the ENDEX uses 1000 and 5000 Hz. Furthermore both devices compare the amplitudes at the two signal frequencies to determine the length of the root canal.
The Model 7005 uses a substantially equivalent approach in that it compares sine waves of different frequencies in the range 500 - 8000 Hz. The patient current level of the Model 7005 is similar to those of the ROOT ZX and the ENDEX. All three units operate from low voltage batteries. The model 7005 uses three AA batteries, the ROOT ZX five AA batteries and the ENDEX rechargeble batteries.
Both the Model 7005 and the ROOT ZX use liquid crystal displays ( LCD ) while the ENDEX uses a meter. The display differences are of minor importance as all three devices have sound annunciation.
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The Model 7005 also has a "Condition" indicator not available with either the ROOT ZX or the ENDEX. This indicator displays the conductivity of the root canal and notifies the user of situations where the apex finder might fail to provide an accurate reading. The Model 7005 "Learn" function is the same as the manual calibration method used by the ENDEX. ﭘﯿﺴ
The Table below compares the Model 7005 with ROOT ZX and the ENDEX. The earlier Model 8001 is also included for completeness.
EQUIVALENCY COMPARISON TABLE
.. . . .
| Model 7005 | ROOT ZX | ENDEX | Model 8001 | |
|---|---|---|---|---|
| Patient Current | 3.5 μΑ | < 10μA | 2 μA | 35 μΑ |
| Frequncies | 500-8kHz | 400, 8kHz | 1kHz, 5kHz | 20 kHz |
| Batteries | 3 size AA | 5 size AA | Rechg. | 4 size AA |
| Display | LCD | LCD | Meter | LED |
| Sound | Yes | Yes | Yes | Yes |
... ...
N/A