(274 days)
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.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.