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To remove plaque and food debris from the surface of the tongue and to help fight bad breath and promote oral hygiene.

The device is a natural polypropylene band. It is formed into a u-shape by holding each end with the finger tips. The device is then placed on the back of the tongue and pulled forward gently with either the flat or rippled edge down. There are no sharp edges on the device.

The provided document is a 510(k) summary for the "MiracleBreath Tongue Cleaner," a manual tongue scraper.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary focuses on the device description, contact information, and its substantial equivalence to predicate devices (other tongue cleaners) for its intended use (removing plaque and food debris from the tongue to help fight bad breath and promote oral hygiene).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study to prove they are met because this information is not present in the provided text.

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To remove bacterial plaque and food debris from the surface of the tongue, promoting clean mouth and fresher breath.

The Oralgiene Tongue Cleaner is a "T" shaped manual device used in the same manner as other items already in the marketplace. It is all in one piece and has mild ridges, but no sharp edges. It is composed of a durable and safe plastic.

The provided 510(k) summary for the Oralgiene Tongue Cleaner does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a premarket notification for a medical device (tongue cleaner) and primarily focuses on demonstrating substantial equivalence to predicate devices already on the market. This type of submission relies on comparing the new device's features and intended use to those of previously cleared devices, rather than presenting new performance data against defined acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and studies from the given input.

Here's what the document does provide:

• Intended Use: "The Oralgiene Tongue Cleaner is intended to be used to remove plaque and food debris from the surface of the tongue. The device is normally used in conjunction with cleaning the teeth and serves a purpose similar to brushing the tongue. Promotes a clean mouth and fresher breath."
• Predicate Devices: Tongue Klean (K973175) and Breath-So-Fresh Tongue Cleaner (K972644). The clearance of the Oralgiene Tongue Cleaner is based on its substantial equivalence to these predicate devices.

To answer your request, a different type of document (e.g., a clinical study report or a design verification report) would be needed.

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The intended use of the Unik Tongue Cleaner is to remove bacteria from and prevent plaque build-up on the tongue to help fight bad breath and promote oral hygiene.

This is a device consisting of a molded polypropylene plastic handle, similar in appearance to that of a toothbrush, and a U-shaped loop end made of either polypropylene plastic or stainless steel. The device is used by placing the loop end at the back of the tongue and gently dragging it toward the front. The device is designed so that there are no sharp edges.

This document is a 510(k) premarket notification for a medical device called the "Unik Tongue Cleaner." It primarily focuses on demonstrating substantial equivalence to a previously marketed predicate device rather than presenting a study for acceptance criteria.

Therefore, many of the requested sections regarding acceptance criteria and a study proving device performance cannot be extracted because such a study is not part of this 510(k) submission. 510(k) submissions for devices like tongue cleaners typically rely on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring new clinical studies with specific performance metrics.

Here's what can be extracted based on the provided text, and where fields cannot be filled due to the nature of the submission:

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

Explanation: The document does not define specific quantitative acceptance criteria (e.g., a certain percentage reduction in plaque, or a specific level of bacteria removal) that a study would then need to meet. Instead, the "acceptance criteria" for a 510(k) submission for this type of device are met by demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness principles.

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

• Sample Size (Test Set): Not applicable, as no dedicated performance study (clinical or otherwise with a test set) is described.
• Data Provenance: Not applicable.

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)

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable.

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

• MRMC Study: No. This device is a physical tongue cleaner and does not involve AI or human readers for diagnostic interpretation.
• Effect Size: Not applicable.

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

• Standalone Performance Study: No. This device is a physical tongue cleaner and does not involve an algorithm.

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

• Type of Ground Truth: Not applicable, as no performance study requiring ground truth is described. The "ground truth" equivalent in a 510(k) for this device is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable, as no AI/algorithm training is involved.

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

• Ground Truth Establishment (Training Set): Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as interpreted for a 510(k) submission):

The "study" in this context is the substantial equivalence comparison to the predicate device, not a performance study quantifying specific metrics.

• Comparison Basis: The Unik Tongue Cleaner is compared to the Breath-So-Fresh Tongue Cleaner (K972644).
• Key Arguments for Substantial Equivalence:
  • Same Intended Use: Both devices are intended "to remove bacteria from and prevent plaque build-up on the tongue to help fight bad breath and promote oral hygiene."
  • Similar Technological Characteristics: Both employ a handle and a loop end to gently scrape the tongue.
  • Similar Operating Principle: Both use a U-shaped loop (or spoon-shaped in the predicate) to scrape bacteria and plaque from the tongue surface.
  • Similar Use Manner: Both are used by placing the loop end at the back of the tongue and gently dragging it forward.
• Differences Acknowledged:
  • Loop Shape: Unik Tongue Cleaner has a U-shaped loop; Breath-So-Fresh is spoon-shaped. (This is deemed not to raise new safety/effectiveness issues.)
  • Materials: Unik Tongue Cleaner can be all plastic or plastic handle with stainless steel loop; Breath-So-Fresh is entirely plastic. (This is also deemed not to raise new safety/effectiveness issues.)
• Conclusion: The submission concludes that because the Unik Tongue Cleaner has the same intended use, similar design, and is used in the same manner as the predicate device, it introduces no new safety or effectiveness issues and is therefore substantially equivalent.

This type of submission relies on the FDA's regulatory framework for 510(k)s, where new clinical data or specific performance metrics are not always required if substantial equivalence to a legally marketed device can be demonstrated.

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The Breathtique Tongue Scraper is intended to be used to remove bacterial plaque and food debris from the surface of the tongue.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a device called "Breathtique Tongue Scrapers." This letter does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

The purpose of a 510(k) submission is to demonstrate that a device is substantially equivalent to a legally marketed predicate device, not necessarily to prove its effectiveness or safety through new clinical studies. The FDA's letter states that they have reviewed the submission and determined the device is substantially equivalent to legally marketed devices, allowing it to be marketed subject to general controls.

Therefore, I cannot provide the requested information based on the given input. The document is essentially an approval letter to market the device, based on its equivalence to existing products, and does not detail performance testing or clinical studies.

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Not Found

Not Found

I apologize, but the provided text does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, or study methodologies. The document is a 510(k) clearance letter from the FDA for a device called "BreathAid Tongue Scraper." It confirms that the device is substantially equivalent to a predicate device and can be marketed.

Therefore, I cannot fulfill your request for the detailed information on acceptance criteria and study design as it is not present in the given text.

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Copper Tongue Scraper's intend use is to remove bacteria and food debris from the tongue surface, hence promoting good oral hygiene. It is intended for over-the-counter point of sale as are other predicate devices.

This device is a U-formed design made of Copper.

The provided text does not contain any information about acceptance criteria or a study demonstrating that the device meets such criteria.

The document is a 510(k) summary for the Copper Tongue Scraper, which focuses on establishing substantial equivalence to predicate devices rather than presenting performance metrics against specific acceptance criteria.

Therefore, I cannot populate the requested table or answer the questions based on the provided input.

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Use to remove surface tongue debris, residue, plaque or filmy build-up that result from eating, drinking, smoking or other types of consumption which can lead to bad breath. Also may be used to remove salivary tongue plaques and residue that naturally accumulate during sleep or between cleanings.

Not Found

This document is a 510(k) clearance letter from the FDA for a device called "Cybersonic" with K980075. It does not contain information about acceptance criteria or a study proving that the device meets such criteria. The letter simply states that the FDA has determined the device to be substantially equivalent to devices marketed prior to May 28, 1976.

Therefore, I cannot provide the requested information from this document.

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To remove plaque and food debris from the surface of the tongue.

The Enfresh Tongue Brush and the predicate tongue brushes, tongue scrapers, and tongue cleaners have very similar principles of operation. They are all manual devices that are used by applying a brushing, scraping, or both brushing and scraping motion to the surface of the tongue to remove plaque and food debris from the surface of the tongue. The handle and the bristles of the Enfresh Tongue Brush and Garry Laboratories's The Tongue Brush are composed of plastic, rubber, and nylon, while Telefax International's OOLI-U (Tongue Scraper) is composed of stainless steel.

This document is a 510(k) premarket notification for the Enfresh Tongue Brush, submitted to the FDA in 1997. It declares substantial equivalence to previously cleared devices rather than providing a study proving specific performance acceptance criteria. Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or stated based on the given document:

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

The document does not specify quantitative acceptance criteria or report performance metrics for the Enfresh Tongue Brush. The basis for clearance is "substantial equivalence" to predicate devices, implying that its performance is presumed to be similar to those already on the market and considered safe and effective.

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

Not applicable. No specific test set or study data is presented for the Enfresh Tongue Brush. The argument for clearance relies on the long history of safe use of similar devices.

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. No ground truth establishment is mentioned as no specific study data is presented for the Enfresh Tongue Brush.

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

Not applicable. No test set or adjudication method is mentioned.

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 a manual tongue brush, not an AI-assisted diagnostic device.

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

Not applicable. This is a manual tongue brush.

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

Not applicable. No specific ground truth was used for this 510(k) submission, as it relies on substantial equivalence to predicate devices with a long history of safe use.

8. The sample size for the training set

Not applicable. This device does not involve a training set for an algorithm.

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

Not applicable. This device does not involve a training set for an algorithm.

Summary of the document's argument for acceptance:

The Enfresh Tongue Brush was cleared based on its substantial equivalence to existing predicate devices (Garry Laboratories's The Tongue Brush and Telefax International's OOLI-U (Tongue Scraper)). The argument for substantial equivalence is based on:

• Identical Intended Use: To remove plaque and food debris from the surface of the tongue.
• Very Similar Principles of Operation: Manual devices using brushing, scraping, or both motions.
• Very Similar Technological Characteristics: Composed of common, biocompatible materials (plastic, rubber, nylon, or stainless steel) with a long history of safe use in medical devices.

The document explicitly states: "The safety and effectiveness of the Enfresh Tongue Brush is based on the long history of safe use of tongue brushes, tongue scrapers, tongue cleaners, as well as the safe use of manual toothbrushes. ... Thus, the Enfresh Tongue Brush is substantially equivalent to the predicate devices, because the Enfresh Tongue Brush raises no new issues of safety or effectiveness."

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TONGUE KILEAN IS INDICATED AS PART OF THE ORAL HYSIENE DALLY TO REMOVE PLAQUE FROM THE SURFACE Of THE TONGUE

Softek's Tongue Klean is a simple device which is used to scrape build up of plaque from the surface of the tongue. Tongue Klean is easy to use and does not present any undue risk to the user of Tongue Klean.

The provided document is a 510(k) premarket notification for a medical device called "Tongue Klean," a tongue scraper. It primarily establishes substantial equivalence to a predicate device ("OOLITT") and details regulatory communication from the FDA.

Based on the content, here's an analysis against your requested information:

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

No explicit acceptance criteria or performance metrics (like sensitivity, specificity, accuracy, etc.) are provided in this document. The submission is for a simple, unclassified device (tongue scraper) and focuses on substantial equivalence rather than performance data from a clinical study.

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

Not applicable. No test set or clinical data is mentioned.

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. No ground truth establishment or expert involvement for a test set is mentioned.

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

Not applicable. No test set or adjudication method is mentioned.

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 manual tongue scraper, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a manual tongue scraper, not an algorithm.

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

Not applicable. No ground truth for performance evaluation is mentioned. The "ground truth" for this submission is based on the functional equivalence to a legally marketed predicate device for the purpose of removing plaque from the tongue.

8. The sample size for the training set

Not applicable. This device is a manual tongue scraper, not a machine learning model.

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

Not applicable. No training set is mentioned.

Summary of Device and Approval Context:

The "Tongue Klean" is a simple, unclassified medical device (tongue scraper) intended to remove plaque from the surface of the tongue as part of daily oral hygiene.

The approval for this device (K973175) is based on substantial equivalence to a predicate device, the "OOLITT." This means the FDA determined that "Tongue Klean" is as safe and effective as the predicate device because it has similar design, technological characteristics, and indications for use. For such a low-risk, unclassified device, extensive clinical trials or performance studies with acceptance criteria and ground truth are typically not required. The regulatory pathway relies on demonstrating that the new device is fundamentally no different in safety and efficacy than an already legally marketed device.

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To remove bacterial plaque and food debris from the surface of the tongue, promoting clean mouth and fresher breath.

The Breath-So-Fresh tongue cleaner is molded to a modified "spoon-shape". One end of the tongue cleaner is a handle. The other end is shaped as the bowl of the spoon. The tongue cleaner is held as a spoon, except upside down. The end tip of the spoon end is mildly rippled but has no sharp edges. The total length of the Breath-So-Fresh tongue cleaner is seven inches long and the cleaner is one and one-fourth inches wide at the widest portion.

The Breath-So-Fresh tongue cleaner is composed of a hard white plastic, either a polycarbonate plastic or a plastic similar to polycarbonate. This plastic is flexible as well as durable and is well suited to dental applications. The tongue cleaner is designed so that there are no sharp edges to the plastic.

The provided text is a 510(k) summary for the "Breath-So-Fresh Tongue Cleaner," which is a traditional medical device (a tongue scraper) and not an AI/ML powered device. Therefore, the information requested about acceptance criteria and studies related to AI/ML device performance (such as sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. The "acceptance criteria" in this context would be the FDA's determination of substantial equivalence, which is granted if the device's intended use and technological characteristics are similar enough to a legally marketed predicate device such that it raises no new questions of safety and effectiveness.

Here's the relevant information that can be extracted from the provided text, structured to align as closely as possible with your request, even though the core AI/ML metrics are not present:

1. Table of Acceptance Criteria and the Reported Device Performance (as infered for a traditional device):

The remaining points (2-9) are specific to studies for AI/ML device performance and are not found or applicable in this 510(k) summary for a manual tongue cleaner. No clinical trials or performance studies with "test sets," "ground truth," or "experts" in the context of diagnostic accuracy are described. The regulatory review for this type of device relies on the comparison to predicate devices, not on de novo clinical performance studies.

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