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The AIR-FLOW PLUS Prophylaxis Powder is indicated for use with EMS dental handpieces for cleaning and preparation of teeth.

The proposed AIR-FLOW PLUS Prophylaxis Powder is an erythritol powder containing 0.05% Cetyl Pyridinium Chloride (CPC) as a preservative. This prophylaxis powder is intended to be used with all currently available EMS dental handpieces for AIR-FLOW and PERIO-FLOW treatments. The addition of CPC is to preserve the powder from bacterial contamination by humidity and microorganisms when the container is opened. Clinical studies have not been conducted to demonstrate that the presence of CPC in this device results in improved clinical outcomes.

The principle of operation of the proposed AIR-FLOW PLUS Prophylaxis Powder is identical to predicate and reference device powder is mixed with air and water in the dental handpiece nozzle to create a mechanically abrasive stream used in polishing procedures.

The device in question is the AIR-FLOW PLUS Prophylaxis Powder. It is an erythritol powder containing 0.05% Cetyl Pyridinium Chloride (CPC) used with EMS dental handpieces for cleaning and preparation of teeth. The provided document is a 510(k) summary for this device, determining its substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list specific numerical acceptance criteria in a table. Instead, it describes functional testing and biocompatibility assessments, concluding that "All tests were successfully performed and all acceptance criteria were met". Based on the descriptions, the implicit acceptance criteria are:

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

The document does not specify the exact sample sizes (e.g., number of test specimens, number of repetitions) for any of the performance tests.

• Shelflife testing: Not specified.
• Biocompatibility testing: Not specified (e.g., number of cell culture replicates, number of animal subjects if applicable).
• Comparison testing (Subgingival and Supragingival): Not specified (e.g., number of metal plates, number of PEEK samples, number of cleaning cycles).

The data provenance is from E.M.S. Electro Medical Systems S.A. (Switzerland), the manufacturer. The studies appear to be prospective in nature, as they were conducted specifically to support the 510(k) submission for the new device.

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

This device is not an AI/ML device that generates diagnoses or predictions. Therefore, the concept of "ground truth" established by experts in the context of clinical interpretation (e.g., radiologists interpreting images) does not directly apply. The "ground truth" in this context refers to the defined objective outcomes of the physical and chemical tests.

• Shelflife: Determined by laboratory testing following established protocols (e.g., stability assays over time).
• Biocompatibility: Determined by standardized laboratory tests conforming to ISO 10993-1, interpreted by qualified toxicologists or biocompatibility experts. The number of such experts is not specified.
• Comparison Testing: The "ground truth" for cleaning efficiency and abrasivity is based on objective laboratory measurements (e.g., visual assessment of paint removal, weight loss of PEEK, calculated cleaning efficiency). The "experts" in this case would be the laboratory personnel conducting and analyzing the tests, ensuring adherence to protocols and accurate data collection. Their specific qualifications and numbers are not mentioned.

4. Adjudication Method for the Test Set

Given that the studies are primarily about physical and chemical performance, and not diagnostic or interpretive tasks, a formal "adjudication method" like 2+1 or 3+1 by multiple clinical experts is not applicable. The results are based on objective measurements and established laboratory protocols. Any potential "adjudication" would involve internal quality control processes to ensure test validity and reliability.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML devices that assist human readers in diagnostic tasks, where the impact on human performance is measured. This device is a dental prophylaxis powder, and its performance is evaluated based on physical and chemical properties, not diagnostic accuracy or human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone AI/ML algorithm performance study was not done. This device is a physical product (prophylaxis powder), not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of the AIR-FLOW PLUS Prophylaxis Powder is based on objective laboratory measurements and established physical/chemical standards:

• Shelflife: Measured degradation or stability of the product over time.
• Biocompatibility: Results of standardized toxicology and irritation assays.
• Cleaning efficiency: Quantifiable removal of a paint layer from a metal plate using an automated test bench.
• Abrasivity: Measurable erosion of a standard material (PEEK).

This is not expert consensus, pathology, or outcomes data in the traditional clinical sense, but rather factual, measurable outcomes from controlled experiments.

8. The Sample Size for the Training Set

This question is not applicable. The AIR-FLOW PLUS Prophylaxis Powder is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The product's formulation and manufacturing processes are likely developed through research and development, but this is distinct from training an algorithm.

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

This question is not applicable, as there is no training set for an AI/ML algorithm.

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Whip Mix Preppies Plus ® is a device used as part of a professionally administered prophylaxis treatment. It is used on the tooth surface prior to;

• . Restoration cementation.
• Acid etching procedures: .
  • o Sealants
  • Orthodontic brackets o
  • 0 Composite restorations

Whip Mix Preppies Plus is an innovative blend of polishing and cleaning agents including 2% Chlorhexidine Gluconate (CHG) relative to liquid component and is in a paste form. Each cup provides enough flour of pumice paste for a single use. Preppies Plus has no fluoride, oils, or added flavoring agents.

The provided text is a 510(k) summary for a dental abrasive polishing agent, Preppies Plus®. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through quantitative metrics.

The document primarily focuses on demonstrating substantial equivalence to predicate devices, particularly regarding safety and intended use, rather than presenting a performance study with specific acceptance criteria and outcome metrics.

Here's a breakdown of what can be extracted from the text in relation to your request, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot be provided: The document does not define specific quantitative acceptance criteria (e.g., minimum abrasive effectiveness, maximum sensitivity reduction, etc.) or report detailed performance metrics against such criteria. The "Substantial Equivalence" table compares device characteristics and intended uses, but not performance against pre-defined success/acceptance criteria.

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

• Cannot be provided: There is no mention of a "test set" in the context of a performance study. The document refers to "non-clinical tests for bio-compatibility performed," but no details on sample size, methodology, or data provenance (country of origin, retrospective/prospective) are given for these tests.

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

• Cannot be provided: Since no performance study utilizing a "test set" with ground truth is described, information about experts or their qualifications is absent.

4. Adjudication Method for the Test Set:

• Cannot be provided: As no performance study with a test set is detailed, there's no mention of an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No: The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it refer to AI assistance or human reader improvement with AI. This is a medical device, not an AI/software device in the context of diagnostic imaging.

6. Standalone (Algorithm Only) Performance Study:

• No: This is a physical dental product, not an algorithm. Therefore, a standalone algorithm-only performance study is not applicable and not mentioned.

7. Type of Ground Truth Used:

• Cannot be provided: No performance study establishing ground truth (e.g., pathology, outcomes data, expert consensus) is described for this device. The closest concept is the "known risks associated with chlorhexidine in the FDA database," used as input for a risk management process, but this is not establishing ground truth for device performance.

8. Sample Size for the Training Set:

• Not Applicable/Cannot be provided: This is a physical dental product, not a machine learning model, so there is no "training set" in that context.

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

• Not Applicable/Cannot be provided: As there's no training set, there's no method for establishing its ground truth.

Summary of Device Safety and Effectiveness provided in the document:

The document states that the safety and effectiveness are established through:

• The established use of chlorhexidine in medical device applications since the 1970s and in many dental applications.
• A thorough search of the FDA database for known risks associated with chlorhexidine, which informed their risk management process.
• Adherence to ISO 14971 for risk management, identifying and mitigating known hazards to an acceptable level.
• Comparison to their existing 510(k) exempt device (Preppies Flour of Pumice), with the only difference being the addition of 2% Chlorhexidine Gluconate (CHG).
• "Acceptable results of the non-clinical tests for bio-compatibility performed." (No details on what these tests were, their methodology, or results are provided).
• The conclusion that the new device "introduces no new risks and is considered substantially equivalent" to predicate devices.

In essence, this 510(k) summary primarily asserts substantial equivalence based on material composition (addition of CHG), intended use, and a risk management process, rather than presenting a detailed performance study with quantitative acceptance criteria.

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NUPRO® Sensodyne® Prophylaxis Paste with NovaMin® is intended for cleaning and polishing procedures, including prior to and after scaling and root planing as part of a professionally administered dental prophylaxis treatment. Secondarily, NUPRO® Sensodyne® Prophylaxis Paste with NovaMin® can be used for the immediate relief of tooth sensitivity and for lasting sensitivity relief for up to 4 weeks (28 days) after just one application.

NUPRO® Sensodyne® is a premium prophylaxis paste containing NovaMin®, a calcium sodium phosphosilicate. The dye-free formulations are available in fluoride and non-fluoride formulations, with two different grits to gently remove dental plaque and stains. The Polish Grit is ideal for prophy procedures requiring minimal tooth abrasion. The Stain Removal Grit is suitable for most cleaning procedures where a high level of polish is desired for stain removal.

The provided text describes the NUPRO® Sensodyne® Prophylaxis Paste with NovaMin® and its substantial equivalence to a predicate device. However, it does not explicitly state acceptance criteria in a quantitative manner or present a table of acceptance criteria versus reported device performance against those specific criteria.

Instead, the submission focuses on demonstrating the device's safety and efficacy, particularly regarding its ability to reduce tooth hypersensitivity, to support an expanded indication for use.

Here's an analysis based on the provided text, addressing the requested information to the extent possible:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define quantitative acceptance criteria for cleaning, polishing, or sensitivity reduction. The study aims to demonstrate efficacy and safety, rather than meeting predefined numerical thresholds for device performance.

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

• Sample Size: 151 participants
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the study was described as a "single site" study. Given the submission is to the US FDA, it's highly probable the study was conducted in the US, but this is not explicitly confirmed.
  • Retrospective or Prospective: Prospective ("A single site, double-blind, randomized, three arm parallel group study to determine the efficacy...")

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

The text refers to "the examiner" for observing pathological conditions, but does not specify the number or qualifications of experts involved in establishing a formal "ground truth" for tooth hypersensitivity or other clinical outcomes beyond the study design itself. The judgment of hypersensitivity was based on qualifying responses to stimuli (tactile and air blast) from participants, which are direct patient responses, not expert consensus on an independent truth.

4. Adjudication Method for the Test Set

Not applicable. The study was a "double-blind, randomized, three arm parallel group study." The assessment of hypersensitivity was based on direct responses from participants to stimuli, and observations for adverse events by an "examiner." There is no mention of an adjudication panel or method for conflicting interpretations of objective data.

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 a medical product (prophylaxis paste), not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

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

Not applicable. This device is a medical product (prophylaxis paste) primarily intended for manual application by a dental professional, not an algorithm.

7. The Type of Ground Truth Used

For sensitivity reduction, the "ground truth" was based on patient-reported responses to standardized stimuli (tactile and air blast) at baseline and follow-up, which were qualified by specific criteria. For safety, it was based on direct clinical observation by an examiner for pathological conditions and adverse events.

8. The Sample Size for the Training Set

Not applicable. This device is a prophylaxis paste, not a machine learning model. Therefore, there is no "training set" in the context of an algorithm.

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

Not applicable, as there is no training set for an algorithm.

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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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Butler® Calci-Flor Prophylaxis Paste is designed to clean and polish teeth during professionally administered dental hygiene prophylaxis treatments.
Butler® Calci-Flor Prophylaxis Paste is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.

Butler® Calci-Flor Prophylaxis Paste is an oral cavity abrasive polishing agent that contains calcium and fluoride. This device is regulated by FDA as a Class I device.
Butler® Calci-Flor Prophylaxis Paste is an abrasive oral prophylaxis paste (available in one of several levels of grit coarseness), which contains fluoride, calcium, humectants, bulking agents for proper paste formation, a sweetener, flavor, color, and preservatives. This device is intended for use by dental professionals, during professionally administered dental prophylaxis treatment (tooth-cleaning), to remove stain from and polish the teeth. Paste application is designed for use with a prophy angle with suitable cup. The device is to be limited to individuals who are professionally trained to perform dental prophylaxis.

The provided document is a 510(k) premarket notification for a dental prophylaxis paste, Butler® Calci-Flor Prophylaxis Paste. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding clinical studies, ground truth, and expert adjudication is not present in this type of submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This type of data is not typically presented in a 510(k) submission for a Class I device seeking substantial equivalence based on material composition and intended use. The submission focuses on demonstrating that the new device is "at least as safe and effective as the legally marketed predicate device" through bench testing and comparison of characteristics.

• Acceptance Criteria (Implicit): The implicit acceptance criteria are that the device's characteristics (material composition, intended use, duration of patient contact) are substantially equivalent to predicate devices, and that any new testing (fluoride release) does not raise new questions of safety and effectiveness.
• Reported Device Performance:
  • Material Composition: "Butler® Calci-Flor Prophylaxis Paste is made of the same ingredient component materials that are used in lawfully marketed predicate devices..."
  • Intended Use/Indications: "...has the same indications for use and intended use as lawfully marketed predicate devices."
  • Patient Contact: "...with the same type and durations of patient contact."
  • Fluoride Release Data: "Bench testing was performed on the Butler® Calci-Flor Prophylaxis Paste to ascertain fluoride release data." The results "do not raise new questions of safety and effectiveness."

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

This information is not provided because a clinical test set, in the sense of a patient cohort or a large dataset, was not used. The testing described is "bench testing" for fluoride release. Details of this bench testing, including any sample sizes for the laboratory tests, are not elaborated upon in this summary document.

• Data Provenance: Not applicable as no clinical test set was described.

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

Not applicable. Ground truth, in the context of clinical studies with expert adjudication, is not relevant to this 510(k) submission, which relies on demonstrating substantial equivalence through material comparison and bench testing.

4. Adjudication Method for the Test Set

Not applicable, as no test set requiring clinical adjudication is described.

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

No, an MRMC comparative effectiveness study was not done.

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

This is not applicable, as the device is a prophylaxis paste, not an algorithm or AI system.

7. The Type of Ground Truth Used

The concept of "ground truth" as pathology, outcomes data, or expert consensus is not applicable here. The "truth" in this submission relies on:

• The known characteristics and regulatory history of predicate devices.
• The chemical composition of the new device.
• The results of basic bench testing (fluoride release).

8. The Sample Size for the Training Set

Not applicable. The device is not an AI/ML algorithm that requires a "training set."

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

Not applicable, for the same reason as point 8.

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VOCO Paste is intended to be used after professional tooth whitening, professional tooth cleaning and for prevention and control of hypersensitivities.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance for VOCO Paste. The document is an FDA 510(k) clearance letter, which primarily addresses the substantial equivalence of the device to a legally marketed predicate device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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PREVENTECH Prophylaxis Paste with Fluoride is intended to be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.
For cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.

PREVENTECH Prophylaxis Paste with Fluoride is an oral cavity abrasive polishing agent containing sodium fluoride in a blend of enamel polishing and cleaning abrasive agents in a paste form designed for professional application to the teeth during the course of standard dental hygiene procedures. PREVENTECH Prophylaxis Paste with Fluoride is sweetened with Xylitol and offered in various grit levels and various flavors.

The standard mode of application for PREVENTECH Prophylaxis Paste with Fluoride is by use of a low speed Dental Handpiece and accessories, (21 § CFR 872.4200) and a Prophylaxis Cup, (21§ CFR 872.6290).

The provided text is for a 510(k) summary for a prophylaxis paste, not a complex medical device with AI or software components requiring a detailed study of its performance against acceptance criteria in the way described in the prompt. Therefore, much of the requested information, such as sample size for test sets, expert-established ground truth, MRMC studies, or standalone algorithm performance, is not applicable or available in this document.

However, I can extract the relevant information from the document regarding the device's performance criterion and the study used to establish substantial equivalence.

Acceptance Criteria and Device Performance for PREVENTECH Prophylaxis Paste with Fluoride

The primary performance criterion for the PREVENTECH Prophylaxis Paste with Fluoride to establish substantial equivalence was its Relative Enamel Abrasion (REA). The predicate device's REA performance served as the acceptance criterion that the proposed device needed to meet.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Sample Size Used for the Test Set: Not specified in the provided summary.
• Data Provenance: The study "Relative Enamel Abrasion (REA) Study, REA09-284" was conducted. The country of origin of the data is not specified in the summary. The study appears to be laboratory-based rather than involving human subjects (retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth

• This is not applicable as the test evaluates a physical property (enamel abrasion) of a dental paste, not the interpretation of medical images or data by experts. The ground truth would be established through standardized laboratory testing protocols for REA.

4. Adjudication Method

• Not applicable for this type of laboratory performance study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation of medical images/data, which is not the case for a prophylaxis paste.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not applicable. This device is a dental paste, not an algorithm. The REA study is a standalone performance study of the paste itself.

7. Type of Ground Truth Used

• The ground truth for the REA study would be established through a standardized laboratory measurement of enamel abrasion, likely using a validated in-vitro method.

8. Sample Size for the Training Set

• Not applicable. This is a physical product, not a machine learning model, so there is no "training set."

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

• Not applicable, as there is no training set for this type of device.

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To be used for cleaning and polishing procedures as part of professionally administered prophylaxis treatment. To relieve dental hypersensitivity and for the management of tooth sensitivity following in-office bleaching procedures, ultrasonic, hand scaling or root planning.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental product. It primarily focuses on regulatory approval and substantial equivalence to a predicate device.

The document does not contain any information about clinical studies, acceptance criteria, device performance metrics, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot generate the requested table and answer the study-related questions based on this input.

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The OSspray Cleaning Compound is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment. The OSspray Cleaning Compound is also intended to provide relief from tooth sensitivity during the prophylaxis treatment.

The OSspray Cleaning Compound is a biocompatible calcium sodium phosphosilicate compound in powder form intended for cleaning and polishing procedures as part of a dental prophylaxis treatment to remove debris from tooth surfaces. The OSspray Cleaning Compound is also intended to physically occlude dentin tubules to provide relief from tooth sensitivity during the prophylaxis treatment. The process of cleaning the tooth surface with the OSspray Cleaning Compound physically occludes dentin tubules for the management of sensitive teeth. The OSspray Cleaning Compound is a dry inorganic particulate (calcium sodium phosphosilicate) composed of elements that occur naturally in the body's hard tissues (Ca, Na, Si, P, and O). When exposed to an aqueous environment, the OSspray Cleaning Compound undergoes a rapid surface reaction, allowing it to physically adhere to exposed root dentin and to physically occlude tubules. Within a short period of time, essentially all of the particles of the compound react to form hydroxycarbonate apatite (HCA), which is chemically similar to natural tooth mineral.

The provided text describes the OSspray Cleaning Compound, a product intended for dental cleaning, polishing, and relief from tooth sensitivity. However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria, particularly in the context of device performance metrics often associated with AI/ML devices (e.g., sensitivity, specificity, AUC).

The document focuses on:

• Device description and intended use.
• Comparison to predicate devices (Prophy Powder and BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN) for substantial equivalence based on technological characteristics.
• Biocompatibility testing (cytotoxicity, intracutaneous irritation, maximization sensitization tests) according to ISO 10993.
• Tubule occlusion efficacy evaluation using an in vitro dentin block model.
  The device's performance is discussed in terms of biocompatibility and in vitro efficacy for tubule occlusion, not in terms of traditional statistical performance metrics like sensitivity, specificity, or reader studies which are typically associated with diagnostic or AI/ML-driven devices.

Therefore, I cannot populate the requested table and answer many of the specific questions as the information is not present in the provided text.

Here's an attempt to answer what can be inferred from the text, with clear indications where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Biocompatibility tests: Sample sizes are not specified for L-929 cytotoxicity, intracutaneous irritation, or maximization sensitization tests.
• Tubule occlusion study: The sample size for the in vitro dentin block model is not specified.
• Data provenance: Not explicitly stated, but assumed to be from internal lab studies by OSspray Ltd. given the context of a 510(k) submission. No mention of country of origin for data; studies are likely conducted by or for the manufacturer. The studies are in vitro in nature, not retrospective or prospective patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The tests described are laboratory-based (biocompatibility, in vitro tubule occlusion) and do not involve human expert interpretation for establishing ground truth in the way a diagnostic imaging study would. The ground truth for biocompatibility is determined by standardized protocols (ISO 10993) and for tubule occlusion by quantitative microscopic analysis.

4. Adjudication method for the test set:

• Not applicable. This concept pertains to resolving discrepancies among multiple readers or experts in studies involving human interpretation. The described studies are laboratory-based.

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:

• No. An MRMC study was not done. This device is not an AI/ML diagnostic tool, and its performance is not assessed in terms of human reader improvement.

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

• Partially applicable, but for a different context. The tubule occlusion efficacy study and biocompatibility tests can be considered "standalone" in the sense that they assess the device's inherent physical/chemical performance, not its interaction or assistance with a human operator's diagnostic capabilities. However, this is not in the context of an "algorithm" or AI.

7. The type of ground truth used:

• Biocompatibility: Standardized test protocols (ISO 10993) where "ground truth" is defined by the absence of toxicity, irritation, or sensitization.
• Tubule occlusion: Quantitative measurement of occluded tubules using microscopy in an in vitro dentin block model. The "ground truth" is the objective measurement itself.

8. The sample size for the training set:

• Not applicable. This device is a physical compound, not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established:

• Not applicable. (See point 8).

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To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a dental product named "Enamel Pro." This document does not contain any information about acceptance criteria or a study proving that a device meets such criteria.

The letter's purpose is to inform the manufacturer that their device has been found substantially equivalent to legally marketed predicate devices, allowing them to market it. It discusses regulatory classifications, general controls, and compliance requirements, but it does not detail any performance studies, acceptance criteria, or specific performance metrics for the Enamel Pro device.

Therefore, I cannot provide the requested information based on the input text.

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