(25 days)
Used for: 1) Removal of extremely tenacious deposits of calculus in both non-surgical and surgically exposed cases; 2) Removal of overhangs and re-contouring of dental restorations (amalgam, gold, composite, acrylic and porcelain) in both non-surgical and surgically exposed cases; and 3) Soft tissue debridement-removal of tissue tags, particularly in an intrabony lesions.
DIAMOND COATED INSERTS are coated with a fine grit diamond powder. The diamonds are bonded by an electroplated metallic nickel. The se DIAMOND COATED INSERTS are designed for use in applications where an instrument with aggressive cutting capability is necessary. The inserts are designed to be used with DENTSPLY's Handpieces.
The provided text is a 510(k) premarket notification for "DIAMOND COATED INSERTS" and a letter from the FDA confirming substantial equivalence. This type of regulatory submission does not typically include detailed studies or acceptance criteria tables for device performance in the way a clinical trial or performance study for a novel AI/medical device would.
The core of this submission is a claim of substantial equivalence to a predicate device (K923639), meaning the new device is essentially the same as one already legally marketed. Therefore, the information requested in your prompt (acceptance criteria, specific performance studies, sample sizes, ground truth establishment, expert qualifications, etc.) is largely not applicable or present in this document.
Here's an explanation based on the provided text, indicating what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
- Not applicable/Not provided. This document is a 510(k) summary for a diamond-coated dental insert, claiming substantial equivalence to a predicate device. It does not present specific quantitative performance metrics or acceptance criteria for a novel device that would typically be found in a clinical study report. The "performance" is implicitly deemed acceptable because it is substantially equivalent to a previously cleared device.
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable/Not provided. No "test set" in the context of a performance study (like an AI model or diagnostic device) is mentioned. The submission relies on demonstrating similarity to a predicate device, not on new performance data from a specific test set of patients or cases.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable/Not provided. There is no mention of establishing ground truth by expert consensus or any other method for a test set, as this is not a study assessing diagnostic accuracy or similar performance.
4. Adjudication Method for the Test Set
- Not applicable/Not provided. No test set or independent adjudication process is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable/Not provided. This is not a study assessing human reader performance or the impact of AI assistance. The device is a dental insert, not a diagnostic imaging or AI system.
6. Standalone Performance Study (Algorithm Only)
- Not applicable/Not provided. This device is a physical dental instrument, not an algorithm, so a standalone performance study in that context is not relevant.
7. Type of Ground Truth Used
- Not applicable/Not provided. As there are no performance studies described, there's no mention of ground truth (e.g., pathology, outcomes data).
8. Sample Size for the Training Set
- Not applicable/Not provided. This device is not an AI model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not provided. (See point 8)
Summary of Device and Rationale for Clearance Based on Provided Text:
The device, "DIAMOND COATED INSERTS," is a dental accessory with a diamond coating. It is intended for:
- Removal of tenacious calculus.
- Removal of overhangs and re-contouring dental restorations.
- Soft tissue debridement for tissue tags, especially in intrabony lesions.
The basis for market clearance (510(k)) is substantial equivalence to an existing predicate device (K923639). The manufacturer states:
- "Design modifications made to the DIAMOND COATED INSERTS (K923639) include a change in the grip material and a change in the amount of diamond coating on the inserts."
- "There are no changes in intended use, fundamental scientific technology, or principles of operation."
- "Because of the nearly equivalent material composition... no biocompatibility testing was necessary."
- The manufacturer believes "prior use of the components of DIAMOND COATED INSERTS in legally marketed devices and the data provided support the safety and effectiveness of DIAMOND COATED INSERTS for the intended uses."
The FDA's letter confirms this substantial equivalence determination, allowing the device to be marketed without the need for new, extensive performance studies, as its safety and effectiveness are inferred from 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.