(207 days)
Apex Locator is used to detect the apex of root canal. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
Apex Locator is an oral equipment used for root canal measurements. It features an LCD color display with functional buttons, enabling users to conveniently view parameters such as battery status, test wire connection status, and apex position etc. Users can easily adjust sound level, brightness, and reference settings using intuitive buttons, and perform functional checks of both the device and cable. The device is intended to be sterilized prior to use.
The provided text is a 510(k) summary for a medical device called "Apex Locator". It details a comparison to a predicate device and states that non-clinical tests were performed. However, it explicitly states that no clinical test data was used to support the decision of substantial equivalence. This means that a study proving the device meets acceptance criteria, as typically understood in the context of clinical trials or performance evaluations with human subjects/data, was not conducted or reported in this submission. The "acceptance criteria" and "device performance" mentioned here refer to specifications confirmed through non-clinical testing and comparison to the predicate.
Given this, I cannot provide information on:
- The study that "proves the device meets the acceptance criteria" in a clinical sense.
- Sample size used for the test set and data provenance (as no clinical test data was used).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth (as no clinical data).
- Sample size for the training set (as no clinical data).
- How ground truth for the training set was established (as no clinical data).
I can, however, provide the acceptance criteria based on the non-clinical tests and the device performance as reported in the comparison table and discussion of differences.
Non-Clinical Acceptance Criteria and Reported Device Performance
The provided document describes acceptance criteria and reported "performance" based on non-clinical tests and comparison to a predicate device. The primary method for demonstrating performance and safety was through compliance with recognized standards and verification that design differences do not affect safety and effectiveness.
Key takeaway: This submission focuses on engineering, safety, and functional conformance rather than clinical performance data.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard / Metric) | Reported Device Performance (Proposed Device) |
|---|---|
| Electrical Safety (Compliance) | Compliance with IEC 60601-1 |
| EMC (Compliance) | Compliance with IEC 60601-1-2 |
| Usability Engineering (Compliance) | Compliance with IEC 62366-1 |
| Software (Compliance) | Compliance with IEC 62304 |
| Biocompatibility (Compliance) | Compliance with ISO 10993-1 for patient-contacting components (Lip hook: Stainless steel; File clip: stainless steel, plastic PBT). Also meets ISO 10993-11. |
| Power Supply (Type) | Lithium battery (DC3.7V) |
| Charger Power Supply (Input) | AC100V-240V, 50Hz ~ 60Hz |
| Charger Output | DC 5V 1A, Class II (adaptor) |
| Components | Measuring wire, File clip, Lip hook, Touch Probe, Tester |
| Measurement Accuracy | ±0.5mm |
| Sterilization | Lip clip and file clip are user sterilized by steam sterilization. |
| Battery Safety (Compliance) | Li-ion battery complies with IEC 62133-2 |
| Function Test | Meets requirements of pre-defined acceptance criteria and intended uses. (Specifics not detailed beyond general statement). |
Explanation of "Study that proves the device meets the acceptance criteria":
The "study" referenced in the document is a series of non-clinical tests and a detailed comparison to a legally marketed predicate device. The conclusion of substantial equivalence is based on demonstrating that the proposed device:
- Complies with relevant recognized safety and performance standards: These include IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 62366-1 (usability), IEC 62304 (software), ISO 10993-1 and ISO 10993-11 (biocompatibility), and IEC 62133-2 (battery safety).
- Performs the same intended function as the predicate device.
- Has fundamental technological characteristics that are substantially equivalent to the predicate device.
- Any differences in technological characteristics (e.g., dimensions, weight, battery capacity, means of input) do not raise new questions of safety or effectiveness. For each noted difference, the submitter provided a justification that it "would not affect its safety and effectiveness" or "could not effects the performance and safety."
- Achieves the same specified performance metric as the predicate device where applicable (e.g., Measurement Accuracy: ±0.5mm).
The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." Therefore, there is no clinical study that "proves the device meets the acceptance criteria" in terms of patient outcomes or comparative clinical performance. The acceptance is based on engineering principles, compliance with standards, and a robust non-clinical comparison to a predicate device.
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