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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.

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:

2. 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.

3. 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.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.

5. 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.

6. 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.

7. 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.

8. 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."

9. 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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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.

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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