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The Klinly Ultrasonic Tongue Cleaner is indicated to reduce plaque, food debris, and bacteria from the surface of the tongue, and also to help fight bad breath and promote oral hygiene.

The Klinly Ultrasonic Tongue Cleaner is a battery-operated device intended to be used to supplement daily oral hygiene care. It operates on two (2) AAA Alkaline batteries. All user-contacting components of the Klinly Ultrasonic Tongue Cleaner are constructed of injection-molded plastics which have demonstrated substantially equivalent biocompatibility according to ISO 10993-1.

The Klinly Ultrasound Tongue Cleaner device is comprised of three principles of operation to supplement daily oral hygiene by tongue cleaning. The device has a tongue scraping head, which:

• (1) Operates manually as a standard manual tonque scraper
• (2) Produces a low-frequency tactile vibration at 233 Hz, and
• (3) Emits ultrasound pressure waves at 1.6 MHz frequency.

The acceptance criteria and the study proving the device meets them are described below for the Klinly Ultrasonic Tongue Cleaner.

1. Table of Acceptance Criteria and Reported Device Performance:

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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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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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The Ayurvedic Tongue Cleaner is a device used to remove food particles and debris from the tongue. It is used to complement an overall oral hygiene program that includes brushing and flossing the teeth and gums. It is not a substitute for any other oral hygiene care such as brushing and flossing the teeth and gums.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding an "Ayurvedic Tongue Cleaner." This document primarily addresses the substantial equivalence determination of the device to legally marketed predicate devices, allowing its market entry. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment—all of which are typical components of a technical study report for a medical device.

Therefore, I cannot fulfill your request for this information based on the provided text. The document is regulatory approval, not a performance study.

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