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510(k) Data Aggregation
(214 days)
Cordless Prophy System, Model: i-Polish
i-Polish is a cordless prophylaxis handpiece equipped with control buttons and wireless foot control for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing procedures on teeth surface and fillings.
The Cordless Prophy system is a cordless handpiece which is intended for use by dental professionals for cleaning and polishing teeth. This is a general hygiene procedure that is performed on people of all ages in a professional dental operatory.
The Cordless Prophy System is comprised of a cordless, battery-powered handpiece, a removable and autoclavable outer sheath, an AC powered battery charging station, a battery-powered wireless foot control and an AC adapter. Accessories to the Cordless Prophy System include three style of Disposable Prophy Angle (DPA), which is cleared as Class I, Product code ESG, under premarket notification K030603.
Additionally, the handpiece of Cordless Prophy System must be used with a Disposable Sleeve, which is cleared as Class II, Product Code PEM, under premarket notification K151123.
The handpiece features a removable outer sheath that is to be cleaned and steam sterilized prior to first use and after each patient use.
The i-Polish has two speed control mode for operation:
- . Foot control mode: One is using it with the wireless foot control, where the amount of vertical actuation on the wireless foot control correlates to the speed of the handpieces supplied to the DPA, the corresponding variable speed range of the DPA is controlled and adjusted through varying pressure on the foot control. The adjustable range is 500 rpm to 4000 rpm;
- . Handpiece control mode: And the other uses a Centralized control button located on the handpieces for six constant speed level, 500 rpm, 1500 rpm, 1500 rpm, 2000 rpm, 3000 rpm and 4000 rpm.
The provided text is a 510(k) summary for the Guilin Woodpecker Medical Instrument Co., Ltd. i-Polish Cordless Prophy System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving acceptance criteria for a novel AI/software device. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not available in this document.
However, I can extract information related to the device's performance, comparisons to predicate devices, and non-clinical testing.
Here's the information that can be extracted or inferred from the provided text, acknowledging that most of your request pertains to a different type of submission:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in the format of specific quantitative benchmarks. Instead, it details the device's technical specifications and compares them to a predicate device to argue for "substantial equivalence." The "performance" is described through these specifications and compliance with various safety and performance standards.
| Feature | Acceptance Criteria (Inferred from Predicate/Standards) | Reported Device Performance (i-Polish) | Conclusion/Note |
|---|---|---|---|
| Primary Indication of Use | Cleaning and polishing procedures on teeth surface and fillings. | i-Polish is a cordless prophylaxis handpiece equipped with control buttons and wireless foot control for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing procedures on teeth surface and fillings. | Same as predicate. |
| Regulation Number | 21 CFR 872.4200 (Dental Handpiece And Accessories) | 872.4200 | Same. |
| Product Code | EKX | EKX | Same. |
| Device Class | Class 1 | 1 | Same. |
| Handpiece Power | Lithium-ion Battery, rechargeable | Lithium-ion Battery, rechargeable multiple times by AC/DC power supply. | Same. |
| Foot Control Power | Lithium-ion Battery, rechargeable | Lithium-ion battery, rechargeable multiple times by AC/DC power supply. | Same. |
| Lubrication Method | Lubricant Free Motor | Lubricant Free Motor. Do not use Lubrication. | Same. |
| Mode of Operation | Rotary | Rotary | Same. |
| Charge time (Handpiece) | Approximately 2 hours | Approximately 2.5 hours | Different, but complies with IEC62133-2:2017 and electrical safety IEC 60601-1:2015. No new safety/effectiveness issues. |
| Charge time (Foot control) | Approximately 3 hours | Approximately 2 hours | Different, but complies with IEC62133-2:2017 and electrical safety IEC 60601-1:2015. No new safety/effectiveness issues. |
| Handpiece Dimension | 25mm Dia × 156mm | 27.6mm Dia × 192mm | Different, but allows for similar user interaction and complies with ISO14457-2017. No new safety/effectiveness issues. |
| Prophy Angle Fit | Doriot style, allows most prophy angles | Disposable prophy angle (cleared under K030603) | Different, but does not impact user experience. No new safety/effectiveness issues. |
| Speed Control (Handpiece) | Not explicitly detailed in predicate comparison | Six constant speed levels: 500, 1000, 1500, 2000, 3000, 4000 rpm (via centralized button). | Different but delivers similar torque/speed profiles to predicate. Lower than reference device (K983413). No new safety/effectiveness issues. |
| Speed Control (Foot Control) | Varying pressure on foot pedal | Varying pressure on foot control, adjustable range 500 rpm to 4000 rpm. | Different but delivers similar torque/speed profiles to predicate. Lower than reference device (K983413). No new safety/effectiveness issues. |
| Speed Range (±10%) | 500-3000 RPM | 500-4000 RPM | Top speed higher than predicate, but lower than reference device. Comparison test carried out. No new safety/effectiveness issues. |
| Maximum Torque (±10%) | 1Ncm | 1.2Ncm | Similar. |
| Operating Environment | Ambient temperature: +10°C ~ +35°C; Relative humidity: 15% ~ 80% | Ambient temperature: +5°C ~ +40°C; Relative humidity: 30% ~ 75%; Atmospheric pressure: 70kPa ~ 106kPa | Different, but tested to conform with IEC 60601-1. No new safety/effectiveness issues. |
| Transport/Storage Condition | Ambient temperature: -20°C ~ +60°C; Relative humidity: 8% ~ 80% | Ambient temperature: -20°C ~ +55°C; Relative humidity: 10% ~ 93%; Atmospheric pressure: 70kPa ~ 106kPa | Different, but tested to conform with IEC 60601-1. No new safety/effectiveness issues. |
| Safety Standards Compliance | IEC 60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, ISO 14457 | IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60, ISO 14457, ANSI/IEEE C63.27, FCC Part 15 Subpart C, IEC 62133-2, ISO 10993-5, ISO 10993-10 | Compliant with these and additional standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a premarket notification for a medical device (Cordless Prophy System) and focuses on demonstrating substantial equivalence through technical comparisons and non-clinical testing. It does not involve a "test set" of patient data as would be used for an AI/software device. The tests performed are engineering and biocompatibility evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI/software device relying on expert-annotated ground truth for performance evaluation on a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 is not an AI-assisted diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" here is compliance with engineering standards, physical specifications, and performance characteristics for a dental handpiece, as demonstrated through non-clinical testing (e.g., electrical safety, EMC, biocompatibility).
8. The sample size for the training set
Not applicable. There is no AI/machine learning component requiring a training set mentioned in this document.
9. How the ground truth for the training set was established
Not applicable.
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