(117 days)
The Cavitron® Prophy-Jet® Air Polishing Prophylaxis System is designed for use in general prophylaxis and periodontal treatments and other areas of operative dentistry. It can also be used for:
- . Stain removal,
- Prophylaxis of orthodontic patients, .
- Preparing tooth surfaces prior to bonding and sealant procedures, and ●
- Implant debridement .
The Cavitron® Prophy-Jet® Air Polishing Prophylaxis System is an air polishing unit that delivers an air/water/powder mixture at the air polishing insert tip that polishes the tooth enamel without direct contact of the device. The system is used with water-soluble prophy powders such as Cavitron® PROPHY-JET® Sodium Bicarbonate Prophy Powder (K970342) or Cavitron® JET-Fresh® Aluminum Trihydroxide Prophy Powder (K014188) (for patients with low sodium requirements). Updated design features on the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System include a Tap-On™ Wireless Foot Pedal, prophy mode auto cycles, an illuminated diagnostic display, automated purge function, Cavitron® JET-Mate™ detachable sterilizable handpiece (K023697), and a swivel handpiece cable with more precise lavage control. Upon installation, the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System unit is connected to external air and water lines, as well as an AC power cord.
Here's a breakdown of the acceptance criteria and study information for the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System, based on the provided text:
Important Note: The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed, novel clinical trial data. Therefore, many of the requested elements (especially those related to human reader studies, specific ground truth establishment for a test set, and detailed statistical results) are not available in this type of document. The study described here is primarily non-clinical performance testing.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the compliance with regulations and successful performance in the specified tests, which aim to ensure the device is safe and effective and substantially equivalent to predicate devices. The reported device performance is that it met these criteria.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Electrical Safety & Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 and IEC 60601-1. |
| Software Validation | Complies with FDA Guidelines for the Content of Premarket Submissions for Software Contained in Medical Devices. |
| Handpiece Operation (including Lavage Control) | Met Internal specifications and testing. |
| Autocycle Operation | Met Internal specifications and testing. |
| Indicator Lights & User Interface Functionality | Met Internal specifications and testing. |
| Radio Frequency Distance for Foot Pedal | Met Internal specifications and testing. |
| Stain Removal | Met Internal specification and third-party testing. |
| Enamel Abrasion | Met Internal specification and third-party testing. |
| Overall Function and Safety | Performance tests support substantial equivalence. |
Study Details
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set): Not explicitly stated for each test (e.g., number of samples for stain removal or abrasion tests). The document refers to "internal specification and testing" and "third-party testing" for these aspects. For electrical and software compliance, the "sample" is typically the device itself or its software.
- Data Provenance: The tests include "Internal specification and testing" and "third-party testing." The country of origin for the data is not specified, but the applicant is DENTSPLY International, located in York, PA, USA. The studies are prospective in the sense that they were conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not provided in the document. For non-clinical performance tests like stain removal and abrasion, ground truth might be established through standardized methods, quantitative measurements, or comparison to established benchmarks, rather than expert consensus on a test set in the way it might be for an imaging AI device.
4. Adjudication Method for the Test Set:
- Not applicable/Not provided. This type of detail is typically relevant for human review of data, such as in clinical imaging studies. For the described non-clinical performance tests, adjudication methods are not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. The document explicitly states: "No human clinical data has been provided to support substantial equivalence." Therefore, an MRMC study was not performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
- Not applicable in the AI sense. The device is a physical instrument, not an AI algorithm. The performance evaluation focuses on the device's physical capabilities (stain removal, abrasion, electrical safety, etc.) and software functionality as an integrated system, which is inherently "standalone" in its operation relative to human decision-making. No "algorithm only" performance would be separately evaluated in this context.
7. The Type of Ground Truth Used:
- Standardized Test Methods/Quantitative Measurements/Predicate Device Comparison: For non-clinical tests, ground truth is established by standardized testing protocols (e.g., for electrical safety, EMC), internal specifications, and performance against accepted benchmarks (e.g., stain removal effectiveness compared to industry standards or predicate device performance, enamel abrasion within acceptable limits). The core of this submission is showing substantial equivalence to predicate devices, implying their existing performance provides a "ground truth" for acceptable levels.
8. The Sample Size for the Training Set:
- Not applicable. This device is a physical instrument, not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for such a device involves engineering design, prototyping, and iterative testing, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, there's no "training set" in the context of an AI algorithm. The design and development process for a physical medical device relies on engineering principles, material science, previous device knowledge (predicates), and internal testing to ensure it meets its intended specifications and safety standards.
§ 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.