(294 days)
The i-ROOT 100 is intended for measuring the length of the root canal for the purpose of performing root canals and related dental procedures
i-ROOT 100 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.
The provided text, a 510(k) summary for the i-ROOT 100 Electronic Apex Locator, does not contain the detailed information necessary to fully answer all aspects of your request regarding a study that proves the device meets acceptance criteria.
The document is a premarket notification for a medical device seeking substantial equivalence to a predicate device. It primarily focuses on comparing the new device's technological characteristics to the predicate device and asserting that performance tests demonstrated safety and effectiveness. It does not present a formal clinical study with detailed methodology, results, or statistical analyses as would be expected for a comprehensive "study that proves the device meets the acceptance criteria."
Here's an attempt to extract and infer information based on the provided text, along with clear indications of what information is missing:
Acceptance Criteria and Device Performance (Based on available information and inferences):
Given that this is a 510(k) submission for substantial equivalence, the primary "acceptance criterion" is likely substantial equivalence to the predicate device (i-ROOT K100450). The performance criteria mentioned are largely those demonstrating equivalence in key functional aspects.
| Acceptance Criteria (Inferred from document) | Reported Device Performance (from F. Technological Characteristics) |
|---|---|
| Buzzer volume equivalent to predicate | Identical to predicate |
| Signal equivalent to predicate | Identical to predicate |
| Graph display equivalent to predicate | Identical to predicate |
| Intended Use equivalent to predicate | Identical to predicate |
| Frequencies used (500 Hz, 5 kHz) | 500 Hz ±0.2 Hz, 5 kHz ±0.002 kHz (Identical to predicate) |
| Patient auxiliary current (less than AC 10 µA) | Less than AC 10 µA (Identical to predicate) |
| Accuracy (±0.5mm) | ±0.5mm (Identical to predicate) |
| Power consumption (less than 0.27VA) | Less than 0.27VA (Identical to predicate) |
| Manufacturing and inspection quality standards | Follows documented procedures based on ISO 9001/ ISO 13485/ Medical Device Directives 93/42/EEC |
| Overall safety and effectiveness | "demonstrated that i-ROOT 100 is as safe, as effective and performs in a substantially equivalent manner to the predicate device" |
Missing Information/Cannot Be Determined from the Text:
The following information, which would typically be found in a detailed study report, is not present in this 510(k) summary:
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only mentions "performance tests" and adherence to quality systems.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. It's unclear if any human experts were involved in a formal ground truth establishment process for performance testing, as the focus is on technical equivalence.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a standalone measurement tool, not an AI-assisted diagnostic imaging device that would typically involve human "readers." Therefore, an MRMC study is not relevant to this type of device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a "standalone" Electronic Apex Locator. Its listed performance metrics (like accuracy ±0.5mm) imply a direct measurement capability, which is inherently algorithm/device-only performance. However, no specific study details are provided.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified. For an apex locator, ground truth would typically refer to the actual length of the root canal determined by a reliable method (e.g., direct measurement during an extraction, micro-CT, or a gold-standard clinical method). The document only states "Accuracy(±0.5mm)" but doesn't detail how this accuracy was verified against a ground truth.
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The sample size for the training set: Not applicable. This is a measurement device, not an AI/machine learning model that typically requires a "training set."
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How the ground truth for the training set was established: Not applicable, as no training set for an AI model is mentioned.
In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence of a new device to an existing one, primarily through technological comparison and general statements of performance. It does not present the detailed methodology and results of a clinical performance study that would provide the deep dive into acceptance criteria and their proof that your request seeks. This type of information would typically be found in a more detailed test report or clinical study summary, which is not part of this 510(k) summary.
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