(65 days)
The CAVITRON® JET WITH SPS SYSTEM is designed for use in general prophylaxis and periodontal treatments and other areas of operative dentistry. This CAVITRON® JET WITH SPS SYSTEM is used to debride light to heavy calculus and plaque deposits from tooth and root surfaces.
The CAVITRON™ JET WITH SPS SYSTEM is a portable stand alone multifunctional prophylaxis unit. It has two operating modes: an ultrasonic scaler mode and an air polishing (JET) mode. The ultrasonic scaler mode operates using a Gavitron ultrasonic scaling insert with a fine, warm water spray, easily and effectively removing stubborn calculus and stains both supragingivally and subgingivally. The JET mode operates using a Cavitron® JET Air Polishing Insert with an air/powder/water spray, easily removing gross stain and plaque from all exposed tooth surfaces.
The CAVITRON® JET WITH SPS SYSTEM has six components: electronic generator (contained in a base unit, foot control, handpiece and cable assembly, detachable line cord, DENTSPLY® Cavitron® Ultrasonic Sterilizable Inserts, and Cavitron® JET Air Polishing Inserts.
The CAVITRON™ JET WITH SPS SYSTEM plugs into an ordinary electrical outlet and converts the 60 cycle AC house current into either high frequency electromechanical vibrations in the scaling mode, or a spray mixture of air, water and powder in the JET mode. Mode selection occurs automatically when either a Cavitron ultrasonic sterilizable insert or a Cavitron® JET air polishing insert is placed into the handpiece. The device consists of three parts: an electromechanical transducer, an electronic driving system, and an air/powder module. The transducer converts electrical energy in the form of a magnetic field into mechanical motion. The electronic system, in addition to providing the magnetic field, incorporates two control loops, one providing 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 air/powder module consists of the automatic selection and control electronics, the pneumatic controls and a powder reservoir. In the scaling mode, the CAVITRON™ JET WITH SPS SYSTEM 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. In the JET mode, the CAVITRON™ JET WITH SPS SYSTEM produces a spray mixture of air, water and specially processed sodium bicarbonate required for cleaning, polishing and restoring the natural esthetics of tooth enamel.
While the controls for the power and water flow of the CAVITRON® JET WITH SPS 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 to the first position, the ultrasonic tip is activated and irrigation starts when in the scaling mode; only water flows when in the JET mode. The water from the irrigation system acts as both a lavage and a coolant.
When the foot pedal is pressed to the second position and the unit is in the scaling mode, power to the handpiece is increased slightly for the length of time the second position is engaged. Irrigation continues to flow. When the unit is in the JET mode, a spray mixture of water, air and powder is generated.
The provided text describes a medical device, the CAVITRON® JET WITH SPS SYSTEM, and its equivalence to a predicate device. However, it does not contain the specific information requested about acceptance criteria and a study proving the device meets them in the detailed format of the prompt.
Here's a breakdown of what is and is not available in the provided text, relative to your request:
1. A table of acceptance criteria and the reported device performance
- Not available. The document states "The CAVITRON® JET WITH SPS SYSTEM meets DENTSPLY Specifications" and "Results of in-house testing indicated that the CAVITRON™ JET WITH SPS SYSTEM performed within stated specifications." However, the specific acceptance criteria themselves (e.g., "accuracy > 90%") and the numerical performance metrics against those criteria are not provided.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available. The text mentions "Results of in-house testing" and "Results of SEM Analysis," but no sample sizes for these tests are given. Data provenance (country, retrospective/prospective) is also not mentioned.
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/Not available. This device is an ultrasonic scaler and air polisher. The "ground truth" concept as applied to diagnostic AI models (e.g., expert consensus on images) doesn't directly apply here. The testing involves performance against specifications and comparison with a predicate device (e.g., cleaning effectiveness, material impact on teeth). There's no mention of human experts establishing a "ground truth" in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not available. See point 3. This refers to diagnostic study designs, which do not seem relevant to the described testing.
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/Not available. This is not an AI-powered diagnostic device, and therefore MRMC studies with human readers assisting AI are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The "in-house testing" and "SEM Analysis" seem to be standalone tests of the device's physical performance, not involving human-in-the-loop diagnostic processes. The text focuses on the device's mechanical and operational characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Physical/Performance Specifications and Predicate Device Equivalence. The "ground truth" here is implied to be adherence to DENTSPLY's internal specifications and performance that is "as effective as the predicate device" based on observations like SEM analysis (examining teeth post-use). For a medical device of this type, ground truth is typically defined by engineering and performance criteria established during its design and manufacturing, often validated against established standards or predicate devices.
8. The sample size for the training set
- Not applicable/Not available. This device is not an AI/ML product developed using training data. Therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable/Not available. See point 8.
Summary of available information related to your request:
- The document largely relies on equivalence to a predicate device (DENTSPLY's Cavitron® JET Scaler K864996) and meeting internal DENTSPLY Specifications.
- Testing methods mentioned: "in-house testing" and "SEM Analysis."
- Key findings:
- Performed "within stated specifications."
- "As effective as the predicate device."
- "No significant qualitative difference was observed on the teeth following the use of the CAVITRON™ JET WITH SPS SYSTEM compared to the predicate device" (from SEM analysis).
- EMC testing by Underwriters' Laboratory with "positive results."
To fulfill your request, specific performance metrics, detailed acceptance criteria (e.g., "calculus removal efficiency > X%"), and detailed study designs (including sample sizes) would be needed, which are not present in this 510(k) summary. This summary focuses on establishing substantial equivalence rather than providing a detailed technical report of the validation studies with explicit criteria and outcomes.
§ 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.