(329 days)
Endo Smart ES-100 Endo Motor is indicated for use in standard endodontic procedures using rotary endodontic files and rotary endodontic drills
Endo Smart, Model ES-100 is a controller for micro motor and contra angle headpieces which is designed to assist dentists and dental surgeons perform standard endodontic procedures. It provides power to the hand-held micromotor and contra angle which holds the drill bit and/or file used in endodontic procedures.
Endosmart is only intended to be used with motor hand piece (manufactured by Saeshin Precision Company; part name CUBE EP) and Contra angle headpiece (Manufactured by Saeshin Precision Company; part name ACL (B) - 42P) at 16:1 gear ratio.
The Metabiomed, Inc. Endo Smart, ES-100 is an endo motor designed to assist dentists and dental surgeons in standard endodontic procedures using rotary endodontic files and drills.
Here's an analysis of the acceptance criteria and the study presented:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance for Endo Smart ES-100 |
|---|---|---|
| Intended Use | - Indicated for use in standard endodontic procedures using rotary endodontic files and rotary endodontic drills. | - Endo Smart ES-100 Endo Motor is indicated for use in standard endodontic procedures using rotary endodontic files and rotary endodontic drills. |
| Patient Contacting Elements | - Patient contacting elements should have prior market clearance. | - Patient contacting elements supplied with Endo Smart ES-100 (motor hand piece, contra angle headpiece, and files) have been previously cleared for marketing (K111616). |
| Biocompatibility | - Biocompatibility testing should be performed for patient-contacting components. | - The Endosmart ES-100 Endo Motor (controller unit) does not contact patients, therefore no biocompatibility testing was performed on the controller. (This implies that the contacting elements, already cleared, met biocompatibility criteria under their previous clearance). |
| Electromagnetic Compatibility (EMC) and Electrical Safety | - Conformance to relevant IEC standards for medical electrical equipment. | - Conforms with IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance. |
| - Conforms with IEC 60601-1-2 Medical electric equipment, General requirements for safety collateral standard electromagnetic compatibility. | ||
| - Conforms with IEC 61000-3-2 Electromagnetic Compatibility (EMC) Part 3: Limits -Section 3: Limitations of Voltage Fluctuations. | ||
| Performance (Functional Equivalence to Predicate devices) | - Similar technological characteristics to predicate devices (e.g., torque range, mode of operation, accessories, display, protection type against electric shock). | - Torque Range: 0.6~6.4Ncm (Gear 16:1 basis) (Predicate E-CUBE: 0.6 to 5.2 Ncm (Gear ratio: 16:1)) - Mode of Operation: Rotary, Auto Stop/Forward and Reverse (Predicate E-CUBE: Rotary, Auto Stop/Forward and Reverse) - Micro motor Manufacturer: SAESHIN PRECESION CO., Ltd. (Same as predicate) - Micro motor Model: CUBE EP (Same as predicate) - Contra Angle: ACL(B)-42EP, 16:1 (Same as predicate) - Display: LCD (Same as predicate) - Protection type and level against electric shock: Class IIa /Type B applied part, internal powered device (Predicate E-CUBE: Class I/ Type BF) - Physical Characteristics (Size, Weight): (Close but not identical. ES-100: 110 x 134 x 116.5 mm, 443g. E-CUBE: 110 x 196 x 139 mm, 582g) - Power: Lithium Ion, DC 7.2V Rechargeable, 2.2 Amp (Predicate E-CUBE: AC or DC powered) |
| Software Validation | - Adherence to FDA Software Validation Guidance. | - Software Validation FDA Software Validation Guidance mentioned as performed. |
2. Sample size used for the test set and the data provenance
The document indicates that conformity to standards (IEC 60601-1, IEC 60601-1-2, IEC 61000-3-2, and FDA Software Validation Guidance) was used to establish performance and safety. There is no mention of a traditional "test set" in the context of clinical or diagnostic performance with a specified sample size of patients/cases. The studies performed are engineering tests demonstrating adherence to safety and performance standards for an electro-mechanical device.
Therefore, information on data provenance (country of origin, retrospective/prospective) is not applicable in the context of this 510(k) submission for this device type, as it relies on engineering testing rather than clinical study data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The performance testing described relates to adherence to technical standards and the functional characteristics of the device, not a diagnostic or clinical assessment where ground truth would be established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication pertains to clinical studies where expert consensus often establishes ground truth for diagnostic accuracy, which is not the nature of the testing described for this endo motor.
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. The device is not an AI-based diagnostic tool. It is an electro-mechanical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is not an algorithm, and its function inherently involves a human operator (dentist/dental surgeon).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's acceptable performance is established through adherence to recognized international and electrical safety standards (IEC 60601-1, IEC 60601-1-2, IEC 61000-3-2) and FDA Software Validation Guidance. For the functional aspects, the ground truth is comparative equivalence to legally marketed predicate devices in terms of intended use and technological characteristics (e.g., torque range, mode of operation, use of specific micro motor/contra angle).
8. The sample size for the training set
Not applicable. The device is not a machine learning or AI model that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. No training set for an AI/ML model is mentioned.
§ 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.