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OSspray Sylc CR compound is a single-phase calcium phosphosilicate ceramic product intended for the removal of weakened or decayed small enamel lesions, in addition to the cleaning of enamel surfaces and providing relief of hypersensitivity associated with exposed dentin and open dentinal tubules.

OSspray Sylc CR is a biologically-compatible device designed to selectively remove weakened or decayed carious enamel without damaging underlying healthy enamel in addition to cleaning tooth surfaces and closing exposed dentine tubules. The device when applied as a dry powder via an air polishing or air abrasion delivery system to a decayed enamel surface will abrade away the decayed tissue. The process of cleaning the tooth surface physically occludes exposed dentin tubules for the management of sensitive teeth. OSspray cares removal powder is a dry inorganic particulate, (calcium phosphosilicate), composed of elements that occur naturally in the body's hard tissues (Ca, Na, Si, P, and O). To aid powder flow less than 2% by weight of silicon dioxide (Aerosil R972 Pharma) is added to the calcium phosphosilicate.

The provided document describes a 510(k) premarket notification for the OSspray Sylc CR device. It focuses on demonstrating substantial equivalence to a predicate device (OSspray Cleaning Compound) rather than establishing specific quantitative acceptance criteria or a comprehensive study proving performance against such criteria.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Generally, for a 510(k) submission, the "acceptance criteria" are often implicit: demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. Specific numerical performance targets (e.g., % reduction in pain, % tooth surface cleaned) are less explicitly stated as "acceptance criteria" in this type of submission, but rather as performance data supporting equivalency.

2. Sample Size Used for the Test Set and Data Provenance

• Biocompatibility: Not explicitly stated as a "test set" in terms of subject or case count. Standard in vitro tests (cytotoxicity, irritation, sensitization) typically involve cell cultures or animal models. The document does not specify the number of samples or subjects used for these in vitro tests.
• Tubule Occlusion Efficacy: In vitro dentin block model. The sample size for dentin blocks used is not specified in the document.
• Selective Enamel Removal/Cleaning: The document mentions "Bench testing has shown that Sylc CR is a more accurate method for selectively removing decayed dental tissue than traditional dental burs and aluminum oxide air abrasion." However, no sample size, specific study design, or provenance data are provided for this bench testing.

Data Provenance:

• All studies mentioned (biocompatibility, tubule occlusion) appear to be laboratory-based (in vitro or bench testing).
• The manufacturer is OSspray Ltd, based in London, UK. It's reasonable to assume the studies were conducted by or on behalf of the manufacturer, potentially in the UK or an affiliated lab. No specific country of origin for the data is explicitly stated, but the company's location suggests non-US origin.
• All data are retrospective in the sense that they were generated prior to this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of expert involvement or ground truth establishment in the context of human expert consensus for image review or clinical assessment. The studies described are in vitro bench tests (biocompatibility, tubule occlusion, general cleaning/abrasion). Therefore, this question is not applicable based on the provided text.

4. Adjudication Method for the Test Set

Not applicable. The studies described are not clinical trials or diagnostic accuracy studies requiring adjudication of human reader findings.

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. This device is an abrasive compound, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm. Its performance is inherent to its physical properties and mechanical action. The in vitro tests described assess the device's inherent performance.

7. The Type of Ground Truth Used

• Biocompatibility: Standardized in vitro assay results (cytotoxicity, irritation, sensitization).
• Tubule Occlusion Efficacy: Quantitative measures of tubule occlusion observed under microscopy in the in vitro dentin block model ("statistically equivalent number of tubules occluded").
• Selective Enamel Removal/Cleaning: The "bench testing" likely involved quantitative measurement of material removal and assessment of surrounding healthy tissue integrity, often by profilometry, microscopy, or other analytical techniques. The document refers to it being "a more accurate method," implying a measurable outcome.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not a machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, this device does not utilize a training set.

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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:

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.

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