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510(k) Data Aggregation
(581 days)
Meta Systems Co., Ltd
The EQ-M motorized handpiece can be used to enlarge and prepare root canals, remove gutta-percha points. When connected to Apex locator (EQ-PEX), the EQ-M can be used to measure the length of root canals.
EQ-M is micro motor needed to make canal enlargement for root canal treatment. The battery in the motor handpiece is used as a power source and the rotational power generated by rotating the micro motor is transmitted to the crown gear of the angle head through the bevel gear and shaft. The resulting rotational power is transmitted to the file to rotate the file. When connected to Apex Locator (EQ-PEX), the EQ-M indicates the position of the file tip inside the root canal.
The EQ-PEX is Electronic Apex Locator and accessories to be used to treat patients. It consists of the main body and lip hook, probe cord. The device is used to track the position of the file in the root canal based on the impedance of two different frequencies.
The screen displays measurement information of the root canal length at the current location of the file and displays a number and graph. Stainless steel hand files are intended to be used with the subject device. Lip hook is intended to be placed on the opposite lip of the tooth to be worked on. The file is slowly inserted into the root canal. When the file approaches the apex reference value and alarm will beep and the text apex will appear on the measurement screen.
The document provided is a 510(k) summary for a dental device, EQ-M, and does not contain the requested information regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/ML-based device evaluation.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and performance properties, rather than establishing and testing against specific acceptance criteria for AI/ML performance.
Therefore, I cannot provide the requested table and study information based on the given text.
Specifically, the document lacks information on:
- Acceptance criteria and reported device performance (for AI/ML): There are no specific quantitative acceptance criteria or corresponding reported performance metrics (e.g., sensitivity, specificity, AUC) for an AI/ML component. The "Performance 2 - apex locator" listed refers to the accuracy of the root apex locator function, which is a hardware/software integration feature, not an AI/ML performance metric.
- Sample size for the test set and data provenance: No information is provided about a test set for evaluating an AI/ML component.
- Number of experts and qualifications for ground truth: No mention of experts establishing ground truth for evaluating an AI/ML component.
- Adjudication method: Not applicable as there's no AI/ML test set adjudication described.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No such study is mentioned or implied.
- Standalone (algorithm only) performance: No standalone performance of an AI/ML algorithm is described.
- Type of ground truth used: Not applicable as there's no AI/ML component evaluation described.
- Sample size for the training set: Not applicable as there's no AI/ML component described.
- How ground truth for the training set was established: Not applicable as there's no AI/ML component described.
The non-clinical studies mentioned are related to electrical safety, electromagnetic compatibility, usability, software lifecycle, battery safety, and biocompatibility, which are standard for medical device approvals, but do not pertain to the performance evaluation of an AI/ML system.
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(218 days)
Meta Systems Co., Ltd.
EQ-PEX is an Electronic Apex Locator designed for use in measuring the working length of root canals.
EQ-PEX is Electronic Apex Locator and accessories to be used to treat of patients. It consists of the main body and lip hook, probe cord and 2 kinds of file holder. The device is used to track the position of the file in the root canal based on the impedance of two different frequencies. The device is intended for measuring the length of the root canal treatments. The components of the device include the main body, probe cord, lip book, file holder, AC adapter, and power cord.
The screen displays measurement information of the root canal length at the current location of the file and displays a number and graph. Stainless steel hand files are intended to be used with the subject device. Lip hook is intended to be placed on the opposite lip of the tooth to be worked on. The file is slowly inserted into the root canal. When the file approaches the apex reference value and alarm will beep and the text apex will appear on the measurement screen.
The provided text describes the 510(k) summary for the EQ-PEX Electronic Apex Locator. Based on the document, here's a description of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The primary performance criterion for the EQ-PEX, as stated and compared to the predicate device, is Accuracy of Apex.
| Acceptance Criteria | Reported Device Performance (EQ-PEX) | Predicate Device (I-ROOT 100) Performance |
|---|---|---|
| Accuracy of Apex |
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(274 days)
META SYSTEMS CO., LTD.
The EMS-200 is a dental device which combines in a single LCD unit an endo motor which ablates the tooth to expand the root canal, a dental obturator to fill and pressurize various shaped packing elements and an electronic apex locator which assists the operator the location of the front tip in the root canal, for use by trained dental professionals.
The EMS -200 dental unit is device that combines the 1) Endo-motor Handpiece (K133298) which ablates the tooth to expand the root canal, a 2) Endodontic Obturation Unit which is used to fill and pressurize various shaped packing elements, and 3) Electronic apex locator (K112508) which is used to ensure the location of the front tip in root canal through changes of electric resistance value into one unit. The working of each of the components is displayed through a single touch screen.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the EMS-200 dental device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantitative, pass/fail manner with specific thresholds. Instead, the document compares the EMS-200's functional specifications to its predicate devices. The primary 'acceptance' is that the new device is "substantially equivalent" to legally marketed predicate devices and introduces "no new issues of safety and efficacy."
| Component/Characteristic | Acceptance Criteria (Implied/Predicate-based) | Reported Device Performance (EMS-200) |
|---|---|---|
| Motor: File Rotation Speed | Similar to predicate ES-100: 250-800rpm | 250-800rpm |
| Motor: Torque Limit Value | Similar to predicate ES-100: 0.6-6.4Ncm | 0.6-5.0Ncm (Gear 16:1 basis) |
| Motor: Gear Ratio | Similar to predicate ES-100: 16:1 | 16:1 |
| Apex Locator: Accuracy (Working Length) | Less than ±0.5 mm (based on predicate i-Root 100) | Less than ±0.5 mm |
| Pack Tip Temperature | Similar to predicate EOU (30-600°C) | 140, 200, 300°C (Note: difference but argued as "safer" due to lower range) |
| Fill Heater Bobbin Temperature | Similar to predicate EOU (200°C) | 140, 160, 180, 200°C (Note: difference but argued as "safer" due to lower range) |
| Safety | Conformance to relevant IEC, ISO, EN standards | Conformance to IEC 60601-1, IEC 60601-1-2, ISO 10993-1,-10, EN 60601-1-6, EN ISO 14971, EN 62304, EN 1639, EN 62366, EN 1041, EN 980, ISO 9001, ISO 13485, ISO 11737-2, ISO 17665-1,-2. |
| Biocompatibility | Conformance to ISO 10993-1 | Biocompatibility testing performed on patient-contacting materials according to ISO 10993-1. |
| Software | Conformance to FDA Guidance Document for Software | Software documentation and validation for moderate level of concern. |
| Usability | Usability for the combined unit | Usability testing by the intended user performed to validate the user interface. |
| Sterilization | SAL of 10-6 | Sterilization validation per ISO 17665-1 and ISO 17665-2 to demonstrate SAL of 10-6. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state sample sizes for specific test sets in a detailed manner that would typically be found in a clinical study report.
- Test Set: For bench testing (e.g., ISO 14457 comparison), no specific "sample size" of devices or cases is mentioned. For usability testing, it states "testing by the intended user" but doesn't specify the number of users.
- Data Provenance: The studies appear to be non-clinical bench tests performed by the manufacturer, Meta Systems Co., Ltd., based in Korea. The document does not indicate the country of origin for any data related to user testing (e.g., where the "intended user" for usability testing was located). All testing described seems to be prospective in nature as it's for a new device submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications: "Intended user" for usability testing, but no specific professional qualifications (e.g., "dental professionals" as per Indications for Use) or experience levels are mentioned for those users. For other tests (e.g., bench tests), the "ground truth" is typically defined by the test standard itself or the specifications of the predicate device, not by expert consensus in this context.
4. Adjudication Method for the Test Set
No adjudication method is mentioned for any of the testing described. Decisions are based on conformance to specifications or standards.
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
No MRMC comparative effectiveness study was mentioned.
The EMS-200 is a dental device combining an endo motor, obturator, and electronic apex locator. These are mechanical/electronic tools for dental procedures, not an AI-assisted diagnostic or interpretative system that would involve "human readers" or AI for image analysis. Therefore, a study of this nature is not applicable to this device description.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation was implicitly done for each component (Motor, Apex Locator, Pack, Fill) through:
- Bench testing: "Bench testing for conformance to ISO 14457"
- Safety testing: Compliance with various IEC, ISO, EN standards.
- Biocompatibility testing: Compliance with ISO 10993-1.
- Software validation: "Software documentation and validation for software of moderate level of concern per the FDA Guidance Document for Software Contained in Medical Devices."
The device itself is a standalone system in the sense that the individual functions (e.g., apex location) operate based on the device's algorithms or mechanics. The "human-in-the-loop" for this device refers to the dental professional using the device, not assisting an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance evaluations (e.g., accuracy of apex locator, temperature ranges for pack/fill, motor speed/torque) is primarily established by:
- Predicate device specifications: The comparison table clearly shows the EMS-200's specifications are benchmarked against those of the K133298, K112508, and K031664 predicate devices.
- International standards: Conformance to relevant ISO, IEC, EN standards defines the "ground truth" for safety, electrical compatibility, software, and sterilization.
- Referenced literature: For Gutta percha temperature, "Referenced literature articles regarding the temperature of gutta percha" are cited.
8. The Sample Size for the Training Set
No training set is mentioned as this is not an AI/machine learning device. The device's operational parameters are based on engineering design and historical predicate device performance, not a learned model from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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