(115 days)
The Cavitron Steri-Mate Handpiece Sterile Lavage Kit is indicated for use with the DENTSPLY Cavitron Ultrasonic Scaler in general prophylaxis and periodontal treatments, and other areas of operative dentistry for the supragingival and subgingival removal of calculus, plaque and stain from teeth with sterile fluid delivery.
The Cavitron® Steri-Mate® Handpiece Sterile Lavage Kit is an accessory for Cavitron® Ultrasonic Scalers that use the 30K Steri-Mate® Sterilizable Handpiece. This kit is intended to provide the clinician with a method to use sterile lavage with a Cavitron® Ultrasonic Scaler. The kit consists of a pressurized infuser bag and a Steri-Mate Handpiece Adapter. The Pressurized Infuser bag can be hung from a standard IV pole or similar device. The Steri-Mate Handpiece Adapter is easily installed between the handpiece cable and the Steri-Mate Handpiece. The adapter does not affect the operation of the Cavitron® Unit or the Steri-Mate Handpiece.
The provided document is a 510(k) summary for the Cavitron Steri-Mate Handpiece Sterile Lavage Kit, which is an accessory for ultrasonic scalers used in dentistry. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and quantitative results for a specific performance characteristic (like diagnostic accuracy).
Therefore, many of the requested elements for describing a study proving acceptance criteria cannot be extracted directly from this document. However, I can provide the available information based on the text.
Here's a breakdown of the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device functions with the Steri-Mate Handpiece for Cavitron Jet. | "The Adapter has been verified to function with the Steri-Mate Handpiece for Cavitron Jet." |
| Performance Equivalence: Maintains same performance for ultrasonic removal of material from dental surfaces as the predicate device. | "Additionally, comparative operations demonstrate that the Steri-Mate Handpiece Sterile Lavage Kit maintains the same performance to ultrasonically remove material from dental surfaces with the currently marketed device." |
| Sterile Fluid Delivery Capability: Capable of delivering sterile solutions. | "Validation of the ability of the Sterile Lavage Handpiece Adapter Kit to deliver sterile lavage was tested to the procedures described in the United States Pharmacopeia (31), National Formulary (26), 2008, Chapter Sterility Test. Results have documented that the system is capable of delivering sterile solutions when assembled as directed in the Directions for Use." |
| Electrical Safety: No active electronic components (implying no need for IEC 60601-1 testing). | "The Steri-Mate Handpiece Sterile Lavage Kit contains no active electronic components. The Steri-Mate Handpiece Adapter allows the use of an external sterile water source. The source is not supplied with the product. Therefore, testing to IEC 60601-1 was considered not necessary based on engineering considerations." |
| Safety and Effectiveness Equivalence: The use of sterile fluid as a source of lavage is as safe, effective, and performs as well as the predicate device. | "The results of testing demonstrate that the use of sterile fluid as a source of lavage is as safe, effective and performs as well to the currently-marketed predicate device." (This is a summary conclusion based on the noted functional and performance comparisons and sterile delivery validation.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "comparative operations" and "testing to the procedures described in the United States Pharmacopeia (31), National Formulary (26), 2008, Chapter Sterility Test." These typically involve controlled laboratory tests rather than human subject test sets with "samples."
- Data Provenance: The sterility testing refers to the United States Pharmacopeia, implying performance was validated according to US standards. The nature of the "comparative operations" data provenance (e.g., in-house testing, external lab) is not specified. It is likely retrospective in the sense that the device was developed and then tested.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The tests performed are engineering/performance validations (e.g., functionality, sterility), not diagnostic accuracy studies requiring expert-established ground truth on a test set (e.g., imaging review).
4. Adjudication Method for the Test Set
Not applicable, as this was not a study requiring adjudication of expert opinions (e.g., 2+1, 3+1). The testing involved objective measurements and procedures (e.g., sterility test, functional verification).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This sort of study is not relevant to this device, which is an accessory for an ultrasonic scaler and not a diagnostic or AI-based image interpretation tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is an accessory to a human-operated medical device. There is no algorithm, and therefore no a standalone algorithm performance measurement.
7. The Type of Ground Truth Used
- For the sterile fluid delivery capability, the ground truth was established by following the procedures and standards outlined in the United States Pharmacopeia (31), National Formulary (26), 2008, Chapter Sterility Test. This is a laboratory-based, objective standard for sterility.
- For functional and performance equivalence, the ground truth was established by direct comparison to the performance of the predicate device. This would involve quantifiable measures of operation (e.g., ultrasonic vibration, fluid flow) relative to the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
§ 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.