(58 days)
The EMS Surface Mount Scaler is an ultrasonic scaler and is intended for the removal of supra and subgingival calculus deposits and stains from the teeth; periodontal pocket lavage with simultaneous ultrasonic tip movement; and scaling and root planing.
The EMS Surface Mount Scaler consists of a control unit housing containing the ultrasonic generator, a dental handpiece, scaler instrument, and torque wrench. The Scaler is designed to operate in conjunction with the office dental unit. The control unit housing is mounted under the control head of the dental unit and is connected to the water supply, hanger air supply, pneumatic foot switch, and electrical supply of the dental unit. The Scaler ultrasonic power and water flow are simultaneously activated by pressing the dental unit foot switch. Power output and water flow can be adjusted using the knobs on the front of the Scaler. The Scaler handpiece is designed to be placed in the dental unit's handpiece hanger when not in use.
The provided 510(k) summary for the EMS Surface Mount Scaler does not contain specific acceptance criteria or a detailed study proving the device meets them. This type of regulatory submission often focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive performance studies with predefined acceptance criteria as would be expected for novel devices or AI/software as a medical device (SaMD).
However, I can extract information related to the device and its intended use, and then explain why the requested study-related details are not present in this document format.
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in the document.
- Reported Device Performance: Not explicitly stated in terms of quantitative metrics or a performance study. The document asserts that the device is "substantially equivalent" to a predicate device, implying similar performance.
Why this table cannot be fully completed from the provided text:
The 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device (EMS miniPiezon Ultrasonic Scaler, K953026). For devices like ultrasonic scalers, substantial equivalence is often established by demonstrating similar technological characteristics, intended use, and safety/effectiveness profiles to a predicate device, rather than through a new, extensive clinical performance study with predefined acceptance criteria. Testing for such devices typically involves verifying basic functionality, electrical safety, biocompatibility, and sterilization, which are not detailed in this public summary.
Regarding the other requested information, it is not present in this 510(k) summary because the nature of this submission (510(k) for an ultrasonic scaler) does not typically require such detailed clinical study information as would be seen for complex diagnostic devices or AI/SaMD.
Here's a breakdown of why each point is not addressed:
- 2. Sample sized used for the test set and the data provenance: Not applicable. No "test set" in the context of a performance study is described. The demonstration of equivalence relies on comparing the device's design and intended use to the predicate.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" or expert review process is described as part of a performance study.
- 4. Adjudication method for the test set: Not applicable. No test set requiring adjudication is described.
- 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 an ultrasonic scaler, not an AI/diagnostic imaging device that would involve human readers or AI assistance for image interpretation.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical ultrasonic scaler, not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth for a performance study is described.
- 8. The sample size for the training set: Not applicable. The device does not involve machine learning or AI with a "training set."
- 9. How the ground truth for the training set was established: Not applicable. The device does not involve machine learning or AI.
Summary of what is provided:
- Device Name: EMS Surface Mount Scaler
- Intended Use: Removal of supra and subgingival calculus deposits and stains from the teeth; periodontal pocket lavage with simultaneous ultrasonic tip movement; and scaling and root planing.
- Predicate Device: EMS miniPiezon Ultrasonic Scaler (K953026)
- Technological Characteristics Comparison: The document states "The Surface Mount Scaler is substantially equivalent to the EMS miniPiezon ultrasonic scaler. Both devices are intended to be used for the removal of calculus deposits and stains from the teeth. The devices use the same ultrasonic generator and handpiece. The main difference between the devices is that the miniPiezon is a stand-alone ultrasonic scaler while the Surface Mount Scaler works in conjunction with the office dental unit. Minor differences in the user interface, and in the power, air, and water supplies, do not raise new questions of safety and effectiveness, leading to a conclusion of substantial equivalence." This comparison serves as the basis for establishing that the device meets safety and effectiveness expectations, drawing upon the known performance of the predicate device.
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.