(274 days)
The i-ROOT is intended for measuring the length of the root canal for the purpose of performing root canals and related dental procedures
The subject device is a lightweight, fully-automatic, battery operated device that allows a dentist or oral surgeon to locate a patient's anatomical root canal apex and obtain accurate root canal length measurements
The provided document describes the i-ROOT Electronic Apex Locator, focusing on its substantial equivalence to a predicate device, the Navi ROOT (K083901). The information presented does not include a detailed study with acceptance criteria and reported device performance metrics in the way a clinical or standalone performance study would.
Instead, the document focuses on demonstrating substantial equivalence based on technological characteristics and intended use, aligning with the FDA 510(k) pathway. The "performance" section primarily refers to safety compliance with IEC standards and a general statement about equivalence.
Therefore, many of the requested elements for a detailed acceptance criteria study are not explicitly present in the provided text. However, an attempt to extract and infer information relevant to your request is made below, with clear indications where information is not available from the given document.
Acceptance Criteria and Device Performance for i-ROOT Electronic Apex Locator
The provided document describes the i-ROOT's performance in the context of demonstrating substantial equivalence to a predicate device (Navi ROOT, K083901) for its 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
The main performance metric explicitly stated for both the i-ROOT and its predicate device is accuracy in measuring the root canal length.
| Acceptance Criteria | Reported Device Performance (i-ROOT) |
|---|---|
| Accuracy | ±0.25mm |
Note: This "acceptance criteria" is derived from the predicate device's stated accuracy, which the i-ROOT is intended to match, thereby demonstrating substantial equivalence. The document implies that the i-ROOT meets this performance identical to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not explicitly stated in the provided document. The document describes a comparison between the i-ROOT and the predicate device at a technical specification level. It does not detail a specific test set of patients or measurements used to validate the ±0.25mm accuracy for the i-ROOT itself.
- Data Provenance: Not explicitly stated. Given it's a 510(k) submission and the manufacturer is based in Seoul, Korea, the "testing" (likely internal verification) would presumably occur there, but no details are provided. It does not specify if data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not available in the provided text. The document does not describe a study involving expert readers or ground truth establishment in this manner.
4. Adjudication Method for the Test Set
- This information is not available in the provided text. No multi-reader or adjudication process is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study is mentioned. The document focuses on the technical specifications and safety compliance of the device itself, not on its impact on human reader performance.
6. Standalone (Algorithm Only) Performance Study
- The i-ROOT device is a standalone device (an "algorithm only" or device-only performance in this context, without human-in-the-loop directly influencing its measurement output).
- The reported performance is its accuracy of ±0.25mm. This implies that the device, when used as intended, provides measurements within this tolerance. However, the study proving this specific standalone performance for the i-ROOT (beyond simply stating it's identical to the predicate) is not detailed. The document only states, "The performance tests demonstrated that i-ROOT is as safe, as effective and performs in a substantially equivalent manner to the predicate device."
7. Type of Ground Truth Used
- This information is not explicitly detailed for how the ±0.25mm accuracy was established or verified. Typically, for root canal length measurement ground truth might involve:
- Direct visual measurement: After tooth extraction, physically measuring the canal length.
- Radiographic measurement: Correlation with X-ray images.
- Surgical/Histopathological confirmation: In cases where direct access or removal allows.
- The document does not specify which method was used to validate the accuracy claim.
8. Sample Size for the Training Set
- This information is not available within the provided text. The i-ROOT is an electrical impedance-based device, not a machine learning or AI-based system that would typically have a "training set" in the conventional sense. Its "training" would be its design and calibration processes.
9. How the Ground Truth for the Training Set Was Established
- As the device is not a machine learning model, the concept of a "training set" and its associated ground truth establishment is not applicable in the context of this document.
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