(294 days)
The i-ROOT 100 mini is intended for measuring the length of the root canal for the purpose of performing root canals and related dental procedures.
i-ROOT 100 mini is Electronic Apex Locator and accessories to be used to treat of patients. It consists of the main unit and lip clip, Cable assembly and 2 kinds of File holder.
Here's an analysis of the acceptance criteria and study information for the i-ROOT 100 mini, based on the provided text:
Important Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It typically does not contain a detailed report of a new, standalone clinical study with extensive performance data, sample sizes, and expert qualifications for the new device. Instead, it often relies on demonstrating that the new device has identical or substantially similar technological characteristics and performance to an already cleared predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy | ±0.5mm |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify a sample size or data provenance (e.g., country of origin, retrospective/prospective) for a test set that directly proves the i-ROOT 100 mini meets the ±0.5mm accuracy criterion. The summary states that "The I-ROOT 100 mini is identical with predicate device in the following contents...Accuracy(±0.5mm)". This implies that the accuracy criterion is met because the device is technologically equivalent to the predicate, which presumably met this criterion in its own clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The provided document does not mention the use of experts to establish ground truth for a test set for the i-ROOT 100 mini. The "Performance" section points to an internal quality system rather than a separate clinical validation study.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as there is no specific test set described for the i-ROOT 100 mini's performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned. The device is an electronic apex locator, meaning it provides a direct measurement, and human reader interpretation (as in image-based diagnostics) is not a primary factor in its output. The study described is for device equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance mentioned (accuracy ±0.5mm) refers to the device's inherent measurement capability, which is a standalone performance metric. However, the document does not describe a new standalone study specifically for the i-ROOT 100 mini, but rather asserts its equivalence to the predicate's performance.
7. The Type of Ground Truth Used
For the accuracy of an apex locator, the "ground truth" would typically be a verified physical measurement of the root canal length (e.g., direct observation, radiography, or micro-CT scanning of extracted teeth or cadaver models where the actual length can be precisely determined). However, the document does not specify how the ground truth was established for the ±0.5mm accuracy figure, which is merely stated as a characteristic shared with the predicate device.
8. The Sample Size for the Training Set
The provided document does not mention a training set, as it describes a medical device (an electronic apex locator) rather than an AI/ML algorithm that typically requires a training set.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, there is no information on how its ground truth was established.
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