Search Results

The Easy Brush with fluoride is intended to mechanically remove plaque and food particles from between teeth to reduce tooth decay. It is to be used with an in and out motion to clean between interdental space as it is done with floss, and other interdental cleaners such as tooth picks.

The Easy Brush with fluoride is an interdental brush designed to clean between teeth. It is composed of 4 parts (a handle, a wire, bristles, and a cap). The wire is twisted around the nylon filaments to create the brush, and then is molded onto a plastic handle. It is then coated with a solution containing flavor and sodium fluoride and then capped off.

This document describes DenTek Oral Care Inc.'s Easy Brush with fluoride. However, the provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for a medical device (an interdental brush with fluoride) and focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. It covers:

• Device Identification: Name, classification, predicate devices.
• Intended Use: Mechanically remove plaque and food particles, reduce tooth decay.
• Technological Characteristics: Components (handle, wire, bristles, cap), coating with flavor and sodium fluoride.
• Substantial Equivalence: Comparison to existing FDA-cleared devices (Oral-B Woodsticks with Fluoride and Johnson & Johnson Fluoride Dental Floss, Mint Waxed).
• Biocompatibility: Justified by reference to existing approved devices and safe levels of sodium fluoride in public water.
• FDA Clearance Letter: Formal letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide a table of acceptance criteria or details about a study to prove the device meets them because this information is not present in the provided text.

To answer your request, the input text would need to include sections detailing performance specifications, study design, results, and expert involvement.

Ask a specific question about this device

The Beam Brush is a toothbrush to remove plaque and debris from its user's teeth and aide in the prevention of tooth decay. The Beam Brush collects brushing usage data and wirelessly transmits the data to a software application (Beam App) that runs on the user's own mobile device ("smartphone").

The Beam Brush is a manual toothbrush comprised essentially of a shaft with synthetic bristles on one end that are used to remove plaque and food debris from its user's teeth. The bristle material is Nylon 612 or Polyamide 612. The Beam Brush collects brushing usage data based on the principle that the human body possesses the property of being a good capacitor, such that the human body has a detectable capacitance. This capacitance is transferrable through a thermoplastic material. The Beam Brush comprises a capacitive sensor, which is completely enclosed in the toothbrush body. The capacitive sensor detects that the Beam Brush is in use based on the capacitance introduced by the human body when the Beam Brush is utilized for its intended purpose. The Beam Brush wirelessly transmits the collected data using radio frequency transmission, more specifically Bluetooth® radio. The Bluetooth® standard defines the parameters for transmission of data via radio frequency including a transmitting frequency of 2.4 GHz. The Beam Brush is a Class 2 Bluetooth® device, which has a transmission range of about 30 feet and a maximum power of 2.5 mW. The data is received by a user's own mobile device that runs a software application (Beam App), which is of a minor level of concern. The Beam App is an accessory to the Beam Brush and allows the user to view his/her brushing usage data for the user's convenience and education. The Beam App, collection of data, and transmission of data are not intended for the diagnosis and treatment of disease or to affect the structure or function of the body. The Beam Brush's capacitive sensor and Bluetooth® radio are powered by a single AA alkaline battery that is replaceable. The Beam Brush also comprises a replaceable brush head that connects to the handle at the base of the neck.

The provided text describes the Beam Brush/Beam App, a manual toothbrush with a capacitive sensor that collects brushing usage data and transmits it wirelessly to a mobile application. However, the document does not contain a study that proves the device meets specific acceptance criteria in the way typically required for a medical device that makes diagnostic or therapeutic claims.

The device is classified as a Class I manual toothbrush (21 CFR 872.6855) with the product code EFW. Class I devices are subject to general controls and typically do not require extensive clinical studies to demonstrate safety and effectiveness in the same way Class II or Class III devices do. The primary focus of the testing mentioned in this particular submission is on establishing substantial equivalence to a predicate device (Oral-B® "sub-brand" manual toothbrush, K073224) and ensuring electrical safety, electromagnetic compatibility, and software verification/validation.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of specific, quantifiable acceptance criteria for clinical performance (e.g., plaque reduction percentage) and corresponding device performance data in the context of a clinical study. Instead, the "testing" section focuses on demonstrating mechanical integrity, electrical safety, and software functionality to support substantial equivalence.

2. Sample Size for Test Set and Data Provenance:

No information is provided about a specific "test set" for performance evaluation in a clinical context. The testing described focuses on engineering and regulatory compliance rather than clinical efficacy.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. The device's primary function as a manual toothbrush for plaque removal is well-established, and the data collection/transmission feature is stated to be for "convenience and education," not for diagnosis or treatment. Therefore, the concept of establishing "ground truth" by experts for clinical efficacy (e.g., disease detection) is not within the scope of this submission.

4. Adjudication Method:

Not applicable. No clinical study with expert adjudication is mentioned.

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

No MRMC study was done. The device does not involve human readers interpreting data for diagnostic purposes with or without AI assistance.

6. Standalone Algorithm Performance:

The device has a "standalone" function in the sense that the sensor collects data and the app displays it, but this is not an "algorithm only" performance study in a diagnostic context. The software application is an accessory for displaying data, not a diagnostic or treatment algorithm. The Beam App is a minor level of concern software.

7. Type of Ground Truth Used:

The concept of "ground truth" (e.g., pathology, outcomes data) is not applicable in the context of this 510(k) submission. The device is a manual toothbrush, and its data collection feature is for user information, not for clinical decision-making. The ground truth for its basic function (plaque removal) is implicitly understood from the long history of manual toothbrushes.

8. Sample Size for the Training Set:

No training set is mentioned as the device does not employ machine learning or AI models that require training data for diagnostic or prognostic purposes.

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

Not applicable, as no training set is mentioned.

Summary of the Study and Device Justification:

The "study" or justification for the Beam Brush/Beam App's acceptance is based on demonstrating substantial equivalence to a legally marketed predicate manual toothbrush (Oral-B® "sub-brand" manual toothbrush, K073224). This substantial equivalence is primarily established through:

• Mechanical Testing: Demonstrating the brush head remains connected during normal use.
• Electrical Safety and EMC Testing: Compliance with international standards (IEC 60601-1 and IEC 60601-1-2) and FCC authorization for the electronic components.
• Software Verification and Validation: Ensuring the software accessory functions as intended and is of "minor level of concern."

The key takeaway is that the Beam Brush/Beam App is essentially a manual toothbrush with an added feature for collecting and displaying brushing duration data. The FDA cleared it as a Class I device based on its similarity to existing manual toothbrushes, with the data collection feature presented as an accessory for user education and convenience, explicitly not for diagnosis or treatment. Therefore, the acceptance criteria and supporting "study" are focused on regulatory compliance and basic functional safety rather than clinical efficacy against specific performance metrics for a diagnostic or therapeutic claim.

Ask a specific question about this device

The Silver Care Antibacterial Toothbrush is intended for over-the-counter use as a toothbrush. The antibacterial agent maintains the cleanliness of the brush by preventing the growth of bacteria on and between the filaments after use. The Silver Care is effective against E. coll (ATCC 25922), Klebsiella pneumoniae (ATCC 13388), Streptococcus mutans (ATCC 35668), and Pseudomonas aeruginosa (ATCC 27853) at 24 hours of exposure under moist conditions.

Not Found

The provided document is an FDA 510(k) clearance letter for the Silver Care Antibacterial Toothbrush. It does not contain the detailed study information required to answer the prompt.

Specifically, the document:

• Identifies the device, its regulation number, and regulatory class.
• States the device's indications for use, including claims about its antibacterial effectiveness against specific bacteria at 24 hours of exposure under moist conditions.
• Confirms a substantial equivalence determination.

However, it does not include:

1. A table of acceptance criteria and reported device performance: The letter mentions antibacterial effectiveness but doesn't provide specific quantitative targets or reported results from a study in a tabular format.
2. Sample size used for the test set and data provenance: No information about the sample size (number of toothbrushes, bacterial replicates, etc.) or where the data came from.
3. Number of experts and their qualifications for ground truth: This information is irrelevant for a device like a toothbrush where performance is measured by laboratory tests, not expert interpretation of data.
4. Adjudication method: Not applicable for this type of device testing.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this device does not involve human readers interpreting medical images/data.
6. Standalone performance: While the antibacterial claims are inherently standalone performance, no specific study details are provided.
7. Type of ground truth: The "ground truth" for the antibacterial claim would be the measured bacterial reduction, but the detailed methodology is missing.
8. Sample size for the training set: Not applicable, as this is a physical device tested in a lab, not an AI/ML model for which training data would be relevant.
9. How ground truth for the training set was established: Not applicable.

To provide the requested information, a different document, such as the actual testing report submitted to the FDA, would be necessary.

Ask a specific question about this device

To promote good oral hygiene including plaque removal and treating and preventing gingivitis.

The Oral-B® toothbrush is a manual toothbrush comprised of a shaft with synthetic bristles at one end. The bristles are arranged in a pattern to achieve effective mechanical plaque removal. Some of the bristle tufts have a wear indicator function. These Indicator bristles are colored with FDA approved colorant, FD&C Blue No. 2.

The provided text describes a 510(k) submission for an Oral-B® manual toothbrush, where the manufacturer is seeking to expand the indication for use to include "treating and preventing gingivitis." The core of the submission emphasizes that the device is substantially equivalent to legally marketed predicate devices, with no changes in material, design, or manufacturing process, but only an expanded indication.

However, the document does not contain specific acceptance criteria in a quantitative format (e.g., a specific percentage reduction in gingivitis or plaque). Instead, it states that numerous controlled clinical studies have been performed and "collectively, these studies demonstrate that Oral-B® manual toothbrushes are effective at treating and preventing gingivitis via the physical/mechanical removal of plaque."

Therefore, it is not possible to construct a table of acceptance criteria and reported device performance as requested, because specific quantitative metrics and thresholds for acceptance are not detailed in the provided text.

Furthermore, the document primarily functions as a 510(k) summary and the FDA's response, rather than a detailed study report. As such, many of the specific details about the studies (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not present in the given text.

Based on the provided information, here's what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance

As stated above, the document does not explicitly list quantitative acceptance criteria. Instead, it refers to a body of clinical evidence supporting the expanded indication. The reported "performance" is qualitative, indicating effectiveness in treating and preventing gingivitis and removing plaque.

Study Details

Due to the nature of the provided document (a 510(k) summary and FDA letter), many of the specific study details are not available in the text.

1. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not available in the provided text. The document states "numerous controlled clinical studies" but does not provide specific sample sizes for these studies, their design (retrospective/prospective), or their geographic origin. The bibliography lists several clinical investigations but does not offer these details in the provided snippets.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not available in the provided text. This type of detail is typical for device performance studies involving interpretation, but for a manual toothbrush assessing plaque and gingivitis, the "ground truth" would likely be based on clinical measurements (e.g., Gingival Index, Plaque Index) performed by trained dental professionals rather than "experts establishing ground truth" in the diagnostic imaging sense. However, no specific details on the assessors or their qualifications are provided.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not available in the provided text. Adjudication methods are typically relevant for studies where subjective assessments by multiple readers need to be reconciled, such as in diagnostic imaging. For clinical measurements of plaque and gingivitis, standard clinical protocols for measurement and inter-examiner reliability would be more typical, but no such details are provided.

4. 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 question pertains to AI-assisted diagnostic tools. The device in question is a manual toothbrush, which is a physical device, not an AI or diagnostic software. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

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

   • Not applicable. As above, this question is for AI/software devices. The manual toothbrush is a standalone physical device. Its performance is its intrinsic mechanical action.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Implied Clinical Measurements/Outcomes: While not explicitly stated, for plaque removal and gingivitis improvement, the ground truth would be based on clinical indices and outcomes data (e.g., Gingival Index scores, Plaque Index scores, bleeding on probing, etc.) measured by trained dental examiners.

7. The sample size for the training set:

   • Not applicable. This question is typically for machine learning models. For a physical device like a toothbrush, there isn't a "training set" in the machine learning sense. The clinical studies establish its effectiveness.

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

   • Not applicable. As above, this refers to machine learning models.

Summary of available information regarding the "study that proves the device meets the acceptance criteria":

• Device: Oral-B® "sub-brand" manual toothbrush.
• Expanded Indication: To promote good oral hygiene including plaque removal and treating and preventing gingivitis.
• Proof basis: "Numerous controlled clinical studies" have evaluated the effectiveness of the manual brush at removing plaque and improving and maintaining gingival health, and assessed soft and hard tissue safety.
• Conclusion: These studies "demonstrate that Oral-B® manual toothbrushes are effective at treating and preventing gingivitis via the physical/mechanical removal of plaque." The information "supports the safety and effectiveness" and "substantial equivalence to the predicate devices without raising any new safety and effectiveness issues."
• Underlying studies: A bibliography lists several clinical investigations conducted from 1996 to 2007, some of which compare power toothbrushes to manual toothbrushes, or compare different manual toothbrushes. These titles suggest that the studies indeed focused on efficacy in plaque removal and gingivitis reduction.

In essence, the 510(k) relies on a body of existing clinical evidence to support the expanded indication, rather than presenting a single, new, dedicated study with detailed acceptance criteria and performance metrics for this specific submission. The FDA's approval indicates they found this collective evidence sufficient to establish substantial equivalence for the expanded indication.

Ask a specific question about this device

The Zeodyne Toothbrush with AgION™ Antimicrobial is intended to remove adherent plaque and food debris from the teeth. The addition of the antimicrobial agent is to prevent the growth of bacteria on the toothbrush between brushings. The antimicrobial treatment is not intended to have any effect on the user.

The Zeodyne Toothbrush with AgION antimicrobial is a manual toothbrush consisting of a shaft with synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth. The toothbrush contains an antimicrobial agent to prevent the growth of bacteria on the brush between uses, maintaining the cleanliness of the brush.

The Zeodyne Toothbrush with AgION antimicrobial consists of a polymer based handle and either Nylon 6-12 or polybutylene terephthalate (PBT) bristles. The bristles contain 0.5% AgION antimicrobial.

The provided text describes a 510(k) premarket notification for a toothbrush, not an AI/ML device. Therefore, the questions related to AI/ML device performance, ground truth, expert opinions, and training/test set sample sizes are not applicable to this document.

However, I can extract information related to the device's functional performance criteria (as implied by its "antimicrobial" claim) and the study that supports it.

Here's the relevant information:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document mentions "Laboratory studies," but does not specify the sample size for these studies.
• The provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective). It simply states "Laboratory studies."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as this is not an AI/ML device and the ground truth for antimicrobial efficacy is typically established through standardized microbiological tests, not expert consensus on human-interpreted data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. The "study" here refers to laboratory tests of the antimicrobial efficacy, not a diagnostic or interpretive task that would require adjudication.

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 is not an AI-assisted device.

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

• Not applicable. This is a physical product (toothbrush) with an antimicrobial agent. Its performance is inherent to the substance, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The ground truth for the antimicrobial efficacy is based on whether the "product reduces the growth of bacteria on the surface of the fiber," which implies microbiological laboratory measurements and potentially quantitative bacterial count reduction compared to controls. The antimicrobial agent itself is registered with the EPA as a bacteriostat, suggesting established methods for proving such claims.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

Ask a specific question about this device

The Medoral Hygienic Toothbrush with DENTOSAN® Filaments is a toothbrush to remove plaque and debris from the teeth and prevent tooth decay. The antibacterial agent impregnated in the filament kills bacteria and prevents their growth on and between the bristles after and between uses.

The Medoral Hygienic Toothbrush is a toothbrush with DENTOSAN® filaments. The DENTOSAN® filament is a nylon filament impregnated with an anti bacterial agent to prevent the growth of bacteria on and between the filaments after use of the toothbrush.

The provided text refers to a 510(k) summary for a "Medoral Hygienic Toothbrush with DENTOSAN® Filaments," a manual toothbrush with antibacterial properties. The summary describes the device, its intended use, and its technological characteristics. It also states that "The effect of the antimicrobial agent was tested and found to be effective using worst case testing for useful life, simulated use extraction testing and antimicrobial effectivity. Additionally, the filament was determined to be biocompatible using the methods recommended in ISO 10993 Biological Testing of Medical and Dental Materials and Devices."

However, the provided document does not contain detailed information about specific acceptance criteria and a study proving the device meets those criteria in the format requested.

Here's an attempt to answer the questions based only on the provided text, highlighting the missing information:

1. A table of acceptance criteria and the reported device performance

The document mentions "worst case testing for useful life, simulated use extraction testing and antimicrobial effectivity." It also states "The antimicrobial agent used is the DENTOSAN® filament does not raise any new safety or effectiveness concerns." and "The biocompatibility and effectiveness of the antibacterial agent was tested using established scientific methods and test protocols."

However, it does not provide specific numerical acceptance criteria (e.g., "bacterial reduction by X%") or the reported device performance data against those criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the device is a toothbrush, and the testing described (antimicrobial effectivity, biocompatibility) typically involves laboratory assays rather than expert interpretation of images or clinical outcomes in the usual sense of "ground truth" for medical imaging AI. Therefore, no experts would be establishing "ground truth" in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the relevant studies described are laboratory-based antimicrobial and biocompatibility tests, not studies requiring human adjudication of results.

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

An MRMC study is not applicable or mentioned for this device. This type of study is relevant for diagnostic devices, particularly those involving human interpretation of medical images, where AI might assist readers. This device is a manual toothbrush.

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

This question is not applicable to a manual toothbrush. It refers to AI-driven algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the antimicrobial effectiveness, the "ground truth" would likely be established by quantitative measurements of bacterial reduction using standardized microbiology laboratory methods (e.g., colony forming units count).

For biocompatibility, the "ground truth" is established by validated biological assays as per ISO 10993, comparing the device's material with established safety benchmarks.

The document does not explicitly detail these "ground truth" methods but refers to "established scientific methods and test protocols" and ISO 10993.

8. The sample size for the training set

This question is not applicable to this device. A "training set" is relevant for machine learning or AI models, which are not described or implied for this manual toothbrush.

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

This question is not applicable for the same reasons as point 8.

Ask a specific question about this device

Ask a specific question about this device

This product is intended to be used as an accessory to cleaning a toothbrush.

Not Found

I am sorry, but based on the provided document, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The document is a 510(k) clearance letter from the FDA for a "Toothbrush Wash" device. It primarily states that the device has been found substantially equivalent to a predicate device and can therefore be marketed.

It does not contain any information regarding:

• Acceptance criteria for device performance.
• A study that demonstrates the device meets specific performance criteria.
• Sample sizes used for testing or training sets.
• Data provenance or details about ground truth establishment.
• Information about expert involvement or adjudication methods.
• Details on MRMC studies or standalone algorithm performance.

Therefore, I cannot populate the requested table and answer the subsequent questions.

Ask a specific question about this device

This device is intended to clean and sanitize toothbrushes before and after normal oral use.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a device named "Toothbrush Mate." This document does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement as described in the prompt.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study-related details based on the provided text. The document is a regulatory approval letter, not a study report.

Ask a specific question about this device

SEE ATTACHED DEVICE SAMPLE (WHEN AVAILABLE, BRISTLE SAMPLE WILL BE SUBMITTED UPON REQUEST. BLACK DOTS INDICATE LOCATION OF THE TOOTH BRUSH BRISTLES). OUR PERFORMANCE AND REFERENCE CLAIMS TO THE USE OF THE PLAQ-ATAQ-I ARE: - 1) USED AS A REGULAR TRADITIONAL AND CURRENTLY MARKETED TOOTH BRUSH (SEE ORAL B - CREST-COMPLETE - REACH - COLGATE PLUS - TOP CARE - ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ) - 2) OVER THE COUNTER DENTIFRICE. - 3) THE LIQUID SPRAY SYSTEM INCORPORATED IN THE TOOTH BRUSH BODY CAN BE EMPLOYED FOR THE VALUES THAT THE MULTI-JETS PROVIDE. - 4) THE PLAIN TAP WATER STREAM IS FINGER-TIP CONTROLLED BY AN EASY, HAND-HELD TURNING VALVE (SEE TELEDYNE WATER PIK(R) AND HYDRO-FLOU™ MODELS). - 5) THE LIQUID STREAM FLUSHES OUT LOOSE PLAQUE AND DEBRIS BETWEEN THE TEETH AND GUMS THAT THE TOOTH BRUSH CANNOT REACH.

Not Found

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study for the device mentioned in the provided text. The documents do not contain the necessary information to address your specific points about device performance, study details, ground truth establishment, or expert involvement.

The provided text is a "Substantial Equivalence" letter from the FDA for a device named "PLAQ-ATAQ™-1," which appears to be a toothbrush with a liquid spray system. This letter primarily focuses on the regulatory clearance of the device based on its substantial equivalence to previously marketed predicate devices. It does not include performance acceptance criteria or detailed study information.

The sections you've highlighted for inclusion in your request (1-9) are typically found in a clinical study report or a 510(k) summary that addresses performance testing, which is separate from the formal FDA clearance letter.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device