(71 days)
SylcTM SmarTip™ is a disposable, single-use device containing OSspray Cleaning Compound powder, intended for prophylaxis and polishing of dental enamel surfaces and rapid relief of hypersensitivity associated with exposed tooth dentin. Studies have shown that Sylc™ SmarTip™ is effective at occluding exposed dentinal tubules, which has been shown in the literature to be associated with a reduction in hypersensitivity.
Sylc™ SmarTip™ is a single-use, disposable hand-held device that utilizes a standard dental hand piece air source, and is designed to project a stream of dry particulate onto a tooth surface to clean tooth surfaces and close exposed dentin tubules. The process of cleaning the tooth surface physically occludes dentin tubules for the management of sensitive teeth. The powder chamber contains OSspray Cleaning Compound (K062502) which is a dry inorganic particulate, (calcium sodium phosphosilicate). When exposed to an aqueous environment, the material undergoes a rapid surface reaction, allowing it to physically adhere to exposed dentin and to physically occlude tubules. Within a short period of time, essentially all of the particles react to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.
The Sylc™ SmarTip™ device is intended for prophylaxis and polishing of dental enamel surfaces and rapid relief of hypersensitivity associated with exposed tooth dentin. The provided information details in vitro performance and biocompatibility data to demonstrate the safety and efficacy of the device.
Here's an breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Effectiveness of cleaning on extrinsic stains | Sylc™ SmarTip™ is effective at cleaning extrinsic stains on teeth. |
| Effectiveness of tubule occlusion on dentin slabs | Sylc™ SmarTip™ occludes a statistically significant number of tubules when compared with negative controls. The OSspray Cleaning Compound contained in the device undergoes a rapid surface reaction to physically adhere to exposed dentin and physically occlude tubules. This reaction forms hydroxycarbonate apatite (HCA), similar to natural tooth mineral. |
| Delivery of appropriate amounts of OSspray Cleaning Compound | Sylc™ SmarTip™ is effective in delivering appropriate amounts of the OSspray Cleaning Compound to the tooth surface. |
| Connection integrity at 45psi air pressure | Performance testing demonstrated that the connection of the SmarTip to the adapter and air hose remained intact when subjected to air pressure of 45psi. |
| No leaks at 45psi max pressure | Performance testing demonstrated no leaks in the units at 45psi max pressure. |
| Proper powder expulsion at 45psi max pressure | Performance testing demonstrated that powder was expelled properly at 45psi max pressure. |
| Biocompatibility for patient safety | The OSspray Cleaning Compound (K062502) has been evaluated for cytotoxicity (ISO 10993-5), intracutaneous irritation (ISO 10993-10), and sensitization (ISO 10993-10). The results indicated no evidence of hazardous effects to the patient if the product is used as directed. The materials used in the device (medical grade polypropylene and surgical grade 316L stainless steel) are also considered biocompatible components. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The performance testing for cleaning and tubule occlusion was conducted on a "statistically relevant number of samples." The exact numerical sample size is not specified in the provided document.
- Data Provenance: The studies were in-vitro studies conducted on "dentin slabs." The country of origin of the data is not explicitly stated. Based on the submitter's address (United Kingdom), it is reasonable to infer the studies might have been conducted there or by a contracted lab. The studies are by definition prospective as they were specifically designed experiments, although they used in-vitro models rather than human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document, as the studies are described as in-vitro performance tests and not human-read clinical studies requiring expert ground truth establishment for diagnostic accuracy.
4. Adjudication Method for the Test Set:
This information is not applicable as the studies described are in-vitro performance tests and not human-read clinical studies requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The performance testing described focuses on the device's technical capabilities (cleaning, occlusion, structural integrity) in an in-vitro setting, not on reader performance or improvement with AI assistance. The device itself is not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is not relevant as the Sylc™ SmarTip™ is a mechanical device for dental prophylaxis and hypersensitivity relief, not an algorithm or AI system. The performance tests described measure the device's intrinsic capabilities.
7. The Type of Ground Truth Used:
For the in-vitro performance studies:
- Cleaning Effectiveness: The "ground truth" would likely be established by objective measurements of stain removal (e.g., spectrophotometry or visual scoring against a validated scale by a trained observer), although specific methods are not detailed.
- Tubule Occlusion: The "ground truth" was established by comparing the number of occluded tubules in dentin slabs treated with Sylc™ SmarTip™ against negative controls. This would typically involve microscopic examination (e.g., scanning electron microscopy) and quantitative analysis.
- Mechanical Integrity (connections, leaks, powder expulsion): The "ground truth" was established by direct physical measurement and observation under specified air pressure (45psi).
8. The Sample Size for the Training Set:
This information is not applicable as the device is not an AI system that requires a training set. The descriptions are of direct performance testing.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as the device is not an AI system.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.