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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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