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· Professional cleaning of teeth: Removal of subgingival and supragingival plaque-biofilm and stains

· Professional cleaning of teeth including patients with dentin hypersensitivity

· Treatment of dentin hypersensitivity by blockage of the dentin tubules

· Can also be used in the presence of fixed orthodontic devices (brackets), restorative and prosthetic materials, and implants

· For maintenance in periodontitis therapy after completion of initial treatment - when using standard devices - for gingival pockets up to 5 mm in depth

· For maintenance in perimplantitis therapy after completion of initial treatment - when using standard devices - for gingival pockets up to 5 mm in depth

Clean & More is classified as airbrush (21 C.F.R. § 872.6080) because it is a powder to be used with air polishing devices in the professional tooth cleaning.

Clean & More is a prophylactic powder for gentle and professional sub- and supragingival cleaning of teeth, including the removal of plaque-biofilm and stains, using commercially available air polishing devices.

Clean & More is a glycine based air polishing powder containing functionalized tri-calcium phosphate, a substance which blocks open dentin tubules on the tooth surface, thereby contributing to a reduction in dentin hypersensitivity.

Here's an analysis of the acceptance criteria and study information for the "Clean & More" device, based on the provided document:

The document (K151748) describes a 510(k) premarket notification for "Clean & More," a prophylactic powder for professional tooth cleaning. The primary purpose of the submission is to demonstrate substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria. Therefore, the "acceptance criteria" for the device are largely implied by its performance being equivalent to the predicate devices and demonstrating safety and efficacy for its stated Indications for Use.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) summary demonstrating substantial equivalence, formal, quantitative acceptance criteria are not explicitly stated in the same way they would be for a direct performance claim against a specific standard. Instead, the "acceptance criteria" are implied by the requirement for the new device to perform equivalently to its predicate devices in various aspects.

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

• Clinical Study Test Set:
  • Sample Size: A total of 40 subjects were enrolled.
  • Data Provenance: The document does not explicitly state the country of origin for the clinical study. It was conducted "according to ISO 14155:2011 - Good Clinical Practice (GCP)," which suggests international standards were followed. It is a prospective study, as subjects were enrolled, treated, and followed up at specific intervals (10 days, 4 weeks, 3 and 6 months).
• Non-Clinical (In vitro) Test Set:
  • Sample Materials: Bovine enamel, composite materials, bovine dentin, zirconia surfaces, and titanium surfaces.
  • Data Provenance: Not specified, but generally in vitro studies are conducted in a controlled lab environment. This data is prospective in the sense that the experiments were designed and executed to test the device.

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

• Clinical Study:
  • Dentin Hypersensitivity: Ground truth for hypersensitivity was "predetermined hypersensitivity on at least two teeth determined by air blast and tactile scoring." The document does not specify the number or qualifications of the experts (e.g., dentists, hygienists) who performed these initial assessments or subsequent evaluations.
• Non-Clinical (In vitro) Studies:
  • The "ground truth" for these studies is the experimental measurement and comparison to the predicate device's performance. Experts would include the researchers conducting the tests and analyzing the data, but no specific number or qualifications are provided.

4. Adjudication Method for the Test Set

• Clinical Study: Not explicitly stated. The determination of "predetermined hypersensitivity" and subsequent assessment of "incidence and degree of dentinal hypersensitivity" would imply a clinical evaluation, but no multi-reader adjudication method (like 2+1 or 3+1) is mentioned. "Air blast and tactile scoring" are common methods, and typically, the assessing clinician's findings serve as the "ground truth" for that individual.
• Non-Clinical (In vitro) Studies: Not applicable in the same way as clinical adjudication. Data analysis of measurements and observations (e.g., Keyence microscope observation, statistical evaluation) would be the method to determine "truth."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not explicitly done or mentioned.
  • The clinical study focused on the effectiveness of Clean & More in reducing dentin hypersensitivity in a cohort of patients. It describes the device's performance, not a comparison of human readers with and without AI assistance.
  • The non-clinical studies were direct comparisons of material properties and performance between the new device and its predicate, not involving human readers' diagnostic accuracy.

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

• Yes, in spirit, the clinical and non-clinical studies can be considered standalone performance for the device itself.
  • The in vitro tests directly assessed the physical and chemical performance of the Clean & More powder. This is an "algorithm only" type of test in the sense that it's the device's inherent performance being measured.
  • The clinical study evaluated the direct effect of the Clean & More treatment on patients' dentin hypersensitivity relief. This is the "standalone" performance of the therapeutic intervention itself; it's not assessing a diagnostic algorithm or a human reader's interpretation.

7. The Type of Ground Truth Used

• Clinical Study: The ground truth for dentin hypersensitivity was established by expert clinical assessment (air blast and tactile scoring) of pre-existing hypersensitivity and subsequent changes after treatment. This effectively represents a clinical outcome and patient-reported state (pain level).
• Non-Clinical (In vitro) Studies: The ground truth was based on objective laboratory measurements of physical properties (e.g., surface roughness, abrasion levels, plaque removal efficiency) using scientifically accepted methods and instrumentation.

8. The Sample Size for the Training Set

• The document does not explicitly mention a "training set" because this product is a physical dental device (prophylactic powder), not a software algorithm that requires machine learning training data. The studies conducted are for performance validation, not for training an AI model.

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

• As there is no mention of a "training set" in the context of an AI/ML algorithm for this device, this question is not applicable. The device's formulation and design would be based on prior scientific research and development, not on a machine learning training process.

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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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