(90 days)
BOMEDENT Apex locator and WISMY Apex locator support the determination of the working length during the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.
The proposed BOMEDENT Apex locator and WISMY Apex locator are microprocessor-controlled devices can support the dentist during endodontic treatments for the proximity of the file to the reference point for endodontic working length determination. To do so, the proposed BOMEDENT Apex locator and WISMY Apex locator assess the electrical resistance of the tooth and surrounding tissues while the file is inserted and moving along the root canal. The proposed BOMEDENT Apex locator and WISMY Apex locator products configuration consist of the following components: (1) Power Adapter (2) USB cable (3) Measuring cable A (4) File clip (5) Lip hook (6) Measuring cable C (Optional)
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: BOMEDENT Apex locator, WISMY Apex locator
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Performance Testing | Accuracy | Equivalent to primary predicate device (Propex IQ® Apex Locator, K191806) |
| Safety & Performance | Electrical Safety | Complies with IEC 60601-1:2005+A1:2012, IEC 80601-2-60:2012 |
| EMC | Electromagnetic Compatibility | Complies with IEC 60601-1-2:2014 |
| Battery Safety | Rechargeable Li-ion Battery Safety | Complies with IEC 62133:2012 |
| Biocompatibility | Irritation & Skin Sensitization | Complies with ISO 10993-10:2010 |
| Biocompatibility | In Vitro Cytotoxicity | Complies with ISO 10993-5:2009 |
| Software Validation | Software Safety | Complies with FDA Guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002" and "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate level of concern) |
| Reprocessing Validation | Cleaning, Low Level Disinfection, and Sterilization | Complies with FDA Guidance and standards (AAMI TIR 30, AAMI TIR 12, ISO 17665-1, and ISO17665-2) for lip clip and file clip |
Study Proving Acceptance Criteria:
The document states that multiple tests were conducted to demonstrate the device meets the acceptance criteria. These include:
- Internal test method for Accuracy Testing: This test shown that the performance of the proposed BOMEDENT Apex locator and WISMY Apex locator are equivalent to that of primary predicate device Propex IQ® Apex Locator (K191806).
- Compliance with International Standards:
- IEC 60601-1:2005+A1:2012 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance)
- IEC 80601-2-60:2012 (Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment)
- IEC 60601-1-2:2014 (Electromagnetic Compatibility)
- IEC 62133:2012 (Secondary cells and batteries safety requirements)
- ISO 10993-10:2010 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
- ISO 10993-5:2009 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)
- Compliance with FDA Software Guidance: "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002" and "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
- Cleaning, Low Level Disinfection, and Sterilization validation: Per FDA Guidance Document, AAMI TIR 30, AAMI TIR 12, ISO 17665-1, and ISO17665-2.
Detailed Information about the Study:
- The document mentions "Internal test method" for accuracy testing, but provides no specific details such as test parameters, methodology, or results beyond the claim of equivalence.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text for the accuracy testing.
- Data Provenance: Not specified. It only states "Internal test method." No information on country of origin or whether it was retrospective/prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable/Not specified. The accuracy testing seems to be a technical performance comparison against a predicate device, not involving expert-established ground truth in a clinical setting.
4. Adjudication Method for the Test Set:
- Not applicable/Not specified. This information is not relevant for the type of technical performance testing described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not done. The document states, "Clinical testing is not required."
- Effect Size: Not applicable.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
- Yes, a standalone performance test was done in the form of "Accuracy Testing" using an "Internal test method" which evaluated the device's ability to determine working length. The device itself (an apex locator) is a standalone measurement tool, indicating its performance without human intervention (beyond operating it).
7. Type of Ground Truth Used:
- Not explicitly stated as a "ground truth" in clinical terms. For the accuracy testing, the performance of the predicate device (Propex IQ® Apex Locator, K191806) serves as the benchmark against which the subject device's performance is compared for demonstrating equivalence. This implies a technical or simulated ground truth established by comparing measurement outputs, rather than a clinical outcome or pathology.
8. Sample Size for the Training Set:
- Not applicable/Not specified. The device is a measurement tool, not an AI/machine learning algorithm requiring a "training set" in the traditional sense.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no mention of a training set for an AI/ML algorithm, this information is not relevant.
N/A