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The Thermoformed Mouthguards are intended for protection against bruxism and nighttime teeth grinding. They create a barrier between the upper and lower dentition to protect the patient's overall occlusion.

The Thermoformed Mouthguards/Nightguards are designed to alleviate the pain and damage caused by bruxing or clenching of the teeth. These customized devices fit over upper or lower teeth during sleep and can offset the effects of bruxing or clenching while protecting teeth from daily wear and tear. The design of Thermoforming Mouthguards/Nightguards is the same, and the only difference is the material in terms of hardness, softness or semi-softness. Each Mouthguard/Nightguard is made with a standard flat occulusal plane and slight opposing cusp indentation to each patient's specific bite plane needs that could be determined by a dentist after diagnosis of bruxism. The Comfort H/STM Hard Soft Bite Splint is the most widely prescribed bite splint due to its comfort and fit. The soft internal surface rests comfortably against the teeth and gums, while the hard occlusal surface provides durability and bonds. Thermoformed Mouthguards/Nightguards are manufactured from biocompatible materials.

This document is a 510(k) summary for Thermoformed Mouthguards/Nightguards submitted by Glidewell Laboratories-Sleep Devices Group to the FDA. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving performance against acceptance criteria for a novel device.

Therefore, the specific information requested about acceptance criteria and a study proving the device meets those criteria (including details like sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not present in the provided text.

The document primarily addresses the following:

1. Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as pass/fail criteria for a new device's performance. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to legally marketed predicate devices in terms of intended use, indication for use, material, design, and performance.
• Reported Device Performance:
  • Material Properties Comparison (Table on page 2):

    Product	Melting Point	Density	Hardness Shore	Tensile Strength
    Glidewell Laboratories-Sleep Devices Group	>72 °C	> 0.92	> 82/	> 15
    Elvax (Predicate Material example used for comparison)	>72 °C	> 0.92	> 82/	> 15

  • Biocompatibility: The document states that the materials are "BPA-free and are approved for dental use. The biocompatibility of the materials is confirmed according to DIN/EN 30993-1." It also mentions "two test reports for Cytotoxicity" whose summary indicates "thermoformed materials do not release substances in cytotoxic concentrations during a permanent 24 h contact of 4.5 cm- surface area to 1 ml physiological fluid."

The following information is NOT available in the provided text:

2. Sample size used for the test set and the data provenance: No test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific test set requiring ground truth is described.
4. Adjudication method for the test set: 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: Not applicable. This document describes a physical medical device (mouthguard), not an AI system or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

(Self-Correction): The request specifically asks for acceptance criteria and the study that proves the device meets the acceptance criteria. The provided document explains the basis for substantial equivalence to predicate devices for regulatory approval, which is a different type of "proof." It relies on material properties, biocompatibility testing (cytotoxicity), and comparison of design and intended use with existing devices. It does not present a performance study with defined acceptance criteria and results from a clinical or analytical study in the way a novel diagnostic or AI device might.

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The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior locations.

For use in prosthetic dentistry to create porcelain (ceramic) prostheses.

For use only by or on the order of a dental professional such as a DDS or DMD. Not for use by the general public or OTC.

The device is comprised primarily of of dental porcelain zirconium oxide powder that is used in the form of blanks as a part of dental laboratory processes that are used to fabricate all ceramic dental restorations, reinforced with a hard ceramic core, that are custom fitted to conform precisely to patients' models.

This 510(k) submission for the Prismatik™ Clinical Zirconia (Prismatik™ CZ) porcelain powder does not include a specific study that outlines acceptance criteria and device performance in the same way a diagnostic AI device would. This device is a material used in the fabrication of dental restorations, not a diagnostic tool requiring performance metrics like sensitivity or specificity.

Instead, the submission relies on the concept of substantial equivalence to existing legally marketed predicate devices. This means that the manufacturer argues the new device is as safe and effective as similar devices already on the market without needing extensive clinical trials to prove efficacy.

Here's an breakdown based on the provided document, addressing the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This is a material device, not a diagnostic device tested on a "test set" of patient data.

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

Not applicable. Ground truth as typically defined for AI/diagnostic devices (e.g., patient diagnoses) is not relevant for this material device. The "ground truth" here is the long-standing safe and effective use of similar dental materials.

4. Adjudication Method for the Test Set

Not applicable.

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

No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not applicable to a dental material.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The ground truth is based on the established safety and efficacy of predicate dental materials (Cercon® base, Lava™ Frame, and IPS e.max ZirCAD) through their "wide, general use." The FDA's substantial equivalence determination implies that if the existing devices are safe and effective, and this new device is similar enough, then it is also considered safe and effective.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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The device is indicated for use by dental technicians in the construction of custom porcelain (ceramic) and porcelain (fused to metal) dental restorations for anterior and posterior locations.

For use in prosthetic dentistry to create porcelain (ceramic) and porcelain (fused-to-metal) prostheses.

The device is comprised of dental porcelain powder that is used in the form of powder or blanks as a part of dental laboratory processes that are used to fabricate porcelain (ceramic) and porcelain (fused-to-metal) dental devices that are custom fitted to conform precisely to patients' models.

The provided text is a 510(k) summary for a dental porcelain powder, not a medical device that would typically have acceptance criteria based on performance metrics like sensitivity, specificity, or accuracy, especially as demonstrated through a study with a test set, ground truth from experts, or MRMC studies.

The document discusses substantial equivalence based on the device's function and intended use being similar to predicate devices already on the market. It doesn't present a study designed to prove specific performance metrics against acceptance criteria that involve diagnostic accuracy or similar outcomes.

Therefore, most of the requested information (points 1-9) cannot be extracted from this document because it describes a different type of regulatory submission and device.

Here's an analysis of what can be inferred or stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of performance metrics like sensitivity, specificity, or accuracy. The "acceptance criteria" for a 510(k) submission for this type of device are primarily related to demonstrating substantial equivalence to predicate devices, meaning it functions similarly and has the same intended use without raising new safety concerns.
• Reported Device Performance: The document states, "The device functions in a similar manner to other comparative devices and the intended use is the same. The differences between comparative devices are minor and do not raise new safety concerns. The effectiveness and suitability to the intended purpose of the device is assured through wide, general use of similar other predicate devices, and demonstrates the safe use of the device to construct dental restorations." This is a qualitative statement of performance similarity rather than quantitative data.

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

• Not applicable. There is no mention of a test set, clinical data, or data provenance in the context of a performance study.

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

• Not applicable. No ground truth establishment for a test set is discussed.

4. Adjudication Method for the Test Set:

• Not applicable. No adjudication method is mentioned as there is no test set for performance evaluation.

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 diagnostic device, and no MRMC study or AI component is mentioned.

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

• Not applicable. This is a material (porcelain powder), not an algorithm or software.

7. The Type of Ground Truth Used:

• Not applicable in the context of a diagnostic performance study. The "ground truth" for this submission is implicitly established by the long-standing safe and effective use of similar predicate devices in the dental field.

8. The Sample Size for the Training Set:

• Not applicable. There is no mention of a training set for an algorithm or model.

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

• Not applicable.

In summary: The provided 510(k) summary for "Prismatik™ Ceramic" focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than presenting a performance study against specific, quantifiable acceptance criteria typical for diagnostic or AI-powered devices. The "study" mentioned is the general understanding and use of similar materials in the dental field, which is deemed sufficient to assure its safety and effectiveness.

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The SilentNite™ mandibular repositioning (MRP) device is indicated for persons who wish to prevent snoring and is available only from a dentist by prescription. It has been estimated that 6 million or more adults (with men outnumbering women 8 to 1) snores, and that 10% may have sleep apnea. If an examination of the patient, together with the patient's responses to a questionnaire, indicate the possibility of a more serious sleep disorder than "primary" or "social" snoring, the patient should be referred to a physician who can diagnose sleep apnea based on testing in a sleep laboratory and suggest treatment options. Necessary treatment for serious cases of sleep apnea may include surgery, or a medically prescribed treatment called nasal continuous positive airway pressure, or a MRP device. MRP devices may be appropriate treatment for persons with mild sleep apnea when surgical and other medical treatments are ineffective or not desired. Contraindications for use: Based on the dentists examination and the patient's responses the questionnaire, obstructive sleep apnea may either be indicated or cannot be excluded. In such event, an examination by a sleep disorder specialist is recommended before prescribing the SilentNite™ snoring device. If the dentist's examination and the patient's responses to the questionnaire indicate the possibility of disease or injury to the mandibular joint, the SilentNite™ snoring device is contraindicated and should not be prescribed, to avoid the possibility of further damage to the mandibular joint.

The SilentNite™ device is comprised of upper and lower frames that are attached with connectors. The frames are form fitted to the teeth and are meant to be worn at night while sleeping.

The provided text is a 510(k) Premarket Notification Submission for the SilentNite™ Snore Prevention Device, dated June 25, 1997. It describes the device, its intended use, and claims substantial equivalence to other legally marketed devices. However, it does not contain information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

The document is a regulatory submission for market clearance based on substantial equivalence, not a clinical study report that would detail the performance metrics you're asking for. The section on "Safety and Efficacy" explicitly states: "The effectiveness and suitability to the intended purpose of the product is assured through the wide, general use of similar other predicate devices and demonstrates the safe use of the device in many practitioner's hands." This indicates that a specific study proving the device meets defined acceptance criteria was likely not performed or submitted as part of this particular regulatory pathway.

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

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