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510(k) Data Aggregation
(279 days)
EMS MINIMASTER LED
The miniMaster LED is an ultrasonic scaler that is intended for the following:
- Removing supra and subgingival calculus deposits and stains from the teeth
- Periodontal pocket lavage with simultaneous ultrasonic tip movement
- Scaling and root planning
- Releasing crowns, bridges, inlays and posts as well as condensing gutta percha
- Plugging for amalgam condensation
- Amalgam burnishing
- Preparing, cleaning, and irrigating root canals
- Preparing approximal cavities
- Cementing inlays and onlays
- Retrograde preparation of root canals
The miniMaster LED is an ultrasonic scaler consisting of a main chassis containing an external electric power supply, controls and displays, ultrasonic generator, and a bottle-fed irrigation system. A 2-step footswitch is connected to the main chassis by a footswitch cord. A handpiece is connected to the main chassis by a handpiece cord, with irrigant flow control located on the cord itself. Instruments designed for specific dental procedures are attached to the distal end of the handpiece.
The miniMaster LED is a modification of the miniMaster Ultrasonic Scaler that was the subject of K050710. The overall design of the miniMaster LED is identical to the design of the miniMaster. The introduction of Piezon handpiece LED, materials changes to the peristaltic pump tubing, and design modifications implemented for the miniMaster LED were made to improve the functional performance and ease of use of the ultrasonic scaler. These design changes are listed in Table 1.
The provided text describes the 510(k) summary for the miniMaster LED Ultrasonic Scaler, which is a medical device. The information below is extracted and organized to answer your specific questions.
Acceptance Criteria and Device Performance Study for miniMaster LED Ultrasonic Scaler
The miniMaster LED Ultrasonic Scaler is a modified version of the miniMaster Ultrasonic Scaler (K050710), with enhancements primarily focused on illumination and material changes for improved functional performance and ease of use. The acceptance criteria for this device were met through non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Electrical Safety | UL 60601-1, "Medical Electrical Equipment—Part 1: General Requirements for Safety" (2nd edition including amendments 1&2) | The device met the general requirements for safety as defined by UL 60601-1. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2, "Medical electrical equipment. Part 1 General requirements for safety - Part 2 Collateral standard: Electromagnetic compatibility: Requirements and Tests" (1993) | The device met the electromagnetic compatibility requirements as defined by IEC 60601-1-2. |
| Package Integrity | ISTA 2A, "Packaged-Products 150 lb (68 kg) or Less" | The packaging met the standards for integrity during transport as defined by ISTA 2A. |
| Sterilization Validation | ANSI/AAMI ST79:2006, "Comprehensive guide to steam sterilization and sterility assurance in health care facilities" (for reprocessing instructions) | Reprocessing instructions for reusable components (handpiece, instruments, accessories) were validated to ensure sterility assurance. |
| ANSI/AAMI/ISO 17665-1:2006 "Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices" (for steam sterilization process) | The steam sterilization process was validated to achieve a Sterility Assurance Level (SAL) of $10^{-6}$ using a half-cycle method. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical data, as no clinical testing was submitted. For the non-clinical tests, the sample size is not explicitly mentioned, but it would typically involve a statistically relevant number of devices or components to demonstrate compliance with the referenced standards. The data provenance is derived from non-clinical laboratory and engineering testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No clinical testing was performed, and therefore, no expert-established ground truth for a clinical test set was required or reported. The ground truth for the non-clinical tests were the measured values and compliance with the specified engineering and safety standards.
4. Adjudication Method for the Test Set
Not applicable. As no clinical testing was performed, there was no need for an adjudication method by medical experts. Compliance with non-clinical engineering and safety standards is typically determined through direct measurement and comparison to predefined thresholds.
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 miniMaster LED is an ultrasonic scaler, a physical dental device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm-only) performance study was not relevant or performed. This device is a physical, electromechanical tool used by a human operator, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this device was engineering standards compliance and objective measurements during non-clinical safety, performance, and sterilization validation tests.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML product and does not involve a "training set" in the machine learning sense. The "training" in the context of a medical device refers to the design, development, and iterative testing process, not a data-driven training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no "training set" in the AI/ML context, there is no ground truth established for it. The performance of the device is assessed against established engineering and safety standards.
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