(87 days)
The SPS SCALER SYSTEM is designed for use in general prophylaxis and periodontal treatments and other areas of operative dentistry. This SPS SCALER SYSTEM is used with scaling tips and a fine warm water spray for debriding light to heavy calculus and plaque deposits from tooth and root surfaces.
The SPS SCALER is a portable stand alone ultrasonic scaler. It operates with a fine, warm water spray, easily and effectively removing stubborn calculus and stains both supragingivally and subgingivally.
The SPS SCALER plugs into an ordinary electrical outlet and converts the 60 cycle AC house current into high frequency electro-mechanical vibrations. It consists of two parts: an electro-mechanical transducer and an electronic driving system. The electronic system incorporates two control loops: the first loop provides automatic frequency control driving each transducer at it's optimum operating frequency (nominally 30 kHz), while the second loop provides automatic stroke control to compensate for different transducer loading conditions. The SPS SCALER produces 30,000 microscopically small strokes each second at the transducer's tip. This, combined with acoustic effects of the coolant water, produces a synergistic action that sweeps away the heaviest calculus deposits while providing exceptional operator and patient comfort.
While the controls for the power and water flow of the SPS SCALER SYSTEM are located on the base unit, the on/off control used during operation is located on the foot pedal. When the foot pedal is pressed, the ultrasonic tip is activated and irrigation starts. The water from the irrigation system acts as both a cleaner and a coolant.
This document describes a 510(k) submission for the DENTSPLY® CAVITRON® SPS SCALER SYSTEM, a medical device. As such, the information provided is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study establishing new acceptance criteria or device performance in the way a novel diagnostic or AI device would.
Therefore, many of the requested categories for a study proving device meeting acceptance criteria (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and specific performance metrics like sensitivity/specificity) are not applicable to this type of regulatory submission. The assessment here is primarily about engineering specifications and comparative performance to an existing device.
Here's an attempt to answer the questions based only on the provided text, acknowledging the limitations for a 510(k) submission document:
Acceptance Criteria and Device Performance for DENTSPLY® CAVITRON® SPS SCALER SYSTEM
Given that this is a 510(k) submission for an ultrasonic scaler, the "acceptance criteria" are primarily related to conforming to DENTSPLY's internal specifications, meeting electromagnetic compatibility (EMC) standards, and demonstrating performance that is "as effective as" a predicate device, rather than specific clinical outcome metrics often associated with newer diagnostic technologies.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit in Text) | Reported Device Performance (from "Study") |
|---|---|---|
| General Performance | Performs within stated specifications | "Results of in-house testing indicated that the SPS SCALER SYSTEM performed within stated specifications" |
| Effectiveness Comparison | As effective as the predicate device (Cavitron Model 3000™) | "and was found to be as effective as the predicate device." |
| Material & Construction | Base unit capable of withstanding common wipe disinfectants without discoloring or deteriorating | "smooth or appropriately textured, white base unit capable of withstanding common wipe disinfectants without discoloring or deteriorating." |
| Electromagnetic Compatibility (EMC) | Meets EMC standards | "Underwriters' Laboratory conducted EMC testing on the SPS SCALER with positive results." |
| Qualitative Tooth Surface Impact | No significant qualitative difference on teeth compared to predicate device | "Results of SEM Analysis indicated that no significant qualitative difference was observed on the teeth following the use of the SPS SCALER SYSTEM compared to the predicate device." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "in-house testing" and "SEM Analysis," but no specific number of devices, teeth, or patients is provided.
- Data Provenance: The "in-house testing" and "SEM Analysis" likely refer to testing performed by DENTSPLY, the manufacturer. The country of origin for the data is not specified, but DENTSPLY is headquartered in York, PA, USA. The testing would be considered prospective in the sense that it was conducted specifically for this regulatory submission to evaluate the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/not specified. The "ground truth" for this device's performance is based on engineering specifications, material science, and comparative effectiveness against a predicate device, not on expert consensus for a diagnostic outcome.
- Qualifications of Experts: Not specified. Testers for "in-house testing" and "SEM Analysis" would typically have engineering, materials science, or dental expertise, but their specific qualifications or number are not mentioned.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Adjudication methods (like 2+1, 3+1) are relevant for studies where multiple readers or experts independently evaluate a case and their discrepancies need resolution, typically in diagnostic imaging or clinical assessment. This is not mentioned or relevant for the type of testing described (engineering performance, mechanical comparison, SEM analysis).
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done.
- Effect Size: Not applicable. This device is an ultrasonic scaler, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: Yes, in a sense. The described "in-house testing," "EMC testing," and "SEM Analysis" evaluate the device's technical performance and its effect on tooth surfaces directly, without human intervention in the diagnosis or interpretation of clinical images. The device itself is a "standalone" instrument. However, this is not a "standalone algorithm" in the context of AI.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" for this submission is established by:
- Manufacturer's Specifications: The device performing "within stated specifications" (internal DENTSPLY standards).
- Benchmarking/Predicate Device Performance: Comparison to the known, established performance of the DENTSPLY Cavitron Model 3000™ Ultrasonic Scaler (K864996).
- Standardized Testing: Conformance to EMC standards (Underwriters' Laboratory).
- Material Science Analysis: Qualitative evaluation of tooth surface changes via SEM analysis.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This
device is a mechanical medical instrument, not an AI or machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of 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.