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ZQuiet Advance is intended as an aid in the reduction of snoring for adults at least 18 years old.

The ZQuiet Advance is an intraoral appliance designed to reduce snoring by advancing the lower jaw. The principal effect of mandibular advancement devices is the protrusion of the lower jaw, thereby widening the upper airway to decrease air turbulence, a causative factor in snoring. This device combines several essential functions: Separate upper and lower dental trays with thermal impression material to engage the upper and lower dentition, a mechanism to provide the forward positioning of the lower jaw relative to the upper jaw in 3 positions determined by the user's bite providing up to +6 mm of possible advancement. The design allows the maintenance of the forward positioning of the lower jaw while allowing minor sagittal and vertical movement. The ZQuiet Advance is a "Boil-and-Bite" device that uses thermal impression resin for device retention. The upper and lower trays are both constructed out of a rigid plastic outer tray to provide the device structure and attachment points for the connecting semi-rigid straps that provide the adjustability. Both the upper and lower trays are lined with material that is moldable when heated in a water bath and provides the ability to conform the device to the individual's teeth.

The provided text is a 510(k) summary for the ZQuiet Advance intraoral device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing the details of a study with specific acceptance criteria and performance metrics typically found for AI/ML-based medical devices or devices undergoing rigorous clinical trials to prove efficacy.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this document. The device in question is a physical intraoral device, not an AI/ML algorithm requiring such detailed performance characteristics.

The document explicitly states:

• "No clinical testing was performed in association with this submission." (Page 15, Section 3.13)
• The justification for clearance relies on "Substantial Equivalence" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics.

Instead of a study proving the device meets acceptance criteria in the sense of an AI/ML study, the non-clinical testing performed focuses on mechanical properties and human factors:

• Non-Clinical Testing (Page 15, Section 3.11):

  • Strap compression testing (compared to similar designs).
  • Physical properties testing (by material manufacturer).
  • Human Factors Evaluation: Concluded that identified risks associated with critical tasks were adequately mitigated.

• Biocompatibility (Page 15, Section 3.12):

  • Testing conducted by the device manufacturer.
  • Met requirements of ISO 10993-1 for mucosal membrane contacting devices with prolonged duration (cytotoxicity, sensitization, irritation).

Conclusion based on the provided text:

This document is a regulatory submission for a physical medical device. It does not provide the type of performance study details requested for an AI/ML-based device. The device's acceptance is based on demonstrating substantial equivalence to a predicate device through comparison of features, materials, and non-clinical testing (mechanical and human factors), rather than a clinical study with specific performance metrics against an established ground truth.

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Snore Bandit is intended for use by adult patients (18 years or older) as an aid to reduce snoring.

The Snore Bandit Anti-Snoring Appliance advances and holds the lower jaw forward during sleep which enlarges and stiffens the airway to alleviate or reduce snoring. The Snore Bandit uses the common 'boil-and bite' technique familiar to athletes who heat and mold their mouth guard to fit their teeth. In this process, the user softens the mouthpiece in hot water according to detailed directions provided with packaging. The user bites into the softened plastic and compresses the softened material to their teeth and gums while holding the jaw slightly forward until the material cools and stiffens. After cooling, the device maintains its shape and is used to hold the jaw open and forward during sleep to alleviate or reduce snoring. The product is non-sterile and provided in a sealed box with instructions.

The provided text is a 510(k) Summary for the Snore Bandit Anti-Snoring Appliance. It discusses the device's characteristics, comparison to predicate devices, and justification for substantial equivalence. However, it explicitly states, "No clinical testing was performed in association with this submission."

Therefore, I cannot provide the requested information about acceptance criteria or supporting studies because this document indicates that no such studies were conducted for the Snore Bandit device itself to demonstrate efficacy.

The document focuses on establishing substantial equivalence to legally marketed predicate devices based on similarities in design, materials, intended use, labeling, and technological characteristics, rather than direct performance testing of the Snore Bandit device.

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The SleepTight Mouthpiece (STZ) is intended for use by adult patients 18 years of age or older as an aid to reduce snoring.

The SleepTight Mouthpiece (STZ) is intended for use by adult patients 18 years of age or older as an aid to reduce snoring. The STZ advances and holds the lower jaw forward during sleep which enlarges and stiffens the airway to alleviate or reduce snoring. The STZ attaches to both upper and lower teeth which maintains a properly opened airway. The STZ utilizes a biocompatible thermoplastic mouthpiece material to treat snoring. The raw material is ethylene-vinyl acetate (EVA). The STZ uses the common boil and bite technique familiar to athletes who heat and mold their mouth guard to fit their teeth. In this process the user softens the mouthpiece in hot water according to detailed directions provided with packaging. The user bites into the softened plastic and compresses the softened material to their teeth and gums while holding the jaw slightly forward until the material cools and stiffens. After cooling, the device maintains its shape and is used to hold the jaw open and forward during sleep to alleviate or reduce snoring.

The provided document is a 510(k) Premarket Notification from the FDA regarding the "SleepTight Mouthpiece STZ." This document primarily focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than presenting a clinical study or performance data like those typically found in a clinical trial report for AI/machine learning devices.

Therefore, this document does not contain the information requested in your prompt regarding acceptance criteria and the detailed study that proves the device meets those criteria.

The document states:

• "Additional non-clinical testing was not performed for this submission as the performance of the STZ is identical to the previously cleared primary predicate STM." (Page 7)
• "The STZ, Substantial equivalence is based on non-clinical data as it relates to the historical use of cleared intraoral devices that reposition the jaw forward to alleviate or reduce snoring and to historical and ongoing documented scientific research confirming mandibular advancement devices to treat snoring." (Page 7)
• "Since the materials and methods of manufacture of the STZ are identical to the materials utilized in the STM K132506 predicate, no additional biocompatibility testing is provided. The STZ and STM are identical in terms of biocompatibility." (Page 8)

The core argument for clearance is that the SleepTight Mouthpiece STZ is technologically identical to a previously cleared prescription device (STM) and functionally similar to other cleared over-the-counter (OTC) devices (SnoreRx, ZQuiet), with the key difference being an update to labeling and inclusion of a "STOPBang" questionnaire to make it suitable for OTC use. The FDA's review in this context is about confirming this substantial equivalence, not evaluating new performance data from a dedicated clinical study against pre-defined acceptance criteria as would be done for a novel AI/ML device.

Therefore, it is impossible to extract the requested information from the provided text. The prompt's questions pertain to a type of study and data not present in this 510(k) submission.

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Zyppah® is intended for use by adult patients (18 years or older) as an aid to reduce snoring.

The Zyppah Anti-Snoring Appliance is a single piece tray system for intraoral use. The 'boil-and-bite' device is customized to each patient. It features an elastic strap that spans the device that is designed to keep the tongue in place during sleep, instead of blocking the airway and contributing to snoring. The product is non-sterile and provided in a sealed box with directions for use.

This 510(k) summary (K182312) describes the Zyppah® Anti-Snoring Appliance. It's important to note that the document does not describe a study that proves the device meets specific acceptance criteria in terms of clinical performance. Instead, it relies on substantial equivalence to predicate devices and non-clinical bench testing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria for clinical performance that the device was tested against. The acceptance is based on demonstrating substantial equivalence to predicate devices, primarily through comparison of technological characteristics, materials, and non-clinical testing.

The key "performance" reported is related to structural integrity:

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

• Test Set Sample Size: Not applicable for clinical performance. The only "test set" mentioned relates to non-clinical bench testing of the strap. No specific sample size for this bench test is provided in the summary.
• Data Provenance: The device performance data (tensile strength) is from non-clinical bench testing. The country of origin and whether it was retrospective or prospective is not specified, but it would be prospective for this type of bench test.

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

Not applicable. The ground truth for the tensile strength test is objective physical measurement, not expert assessment.

4. Adjudication Method for the Test Set

Not applicable, as no expert adjudication was involved for the non-clinical tensile strength testing.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The submission explicitly states: "No clinical testing was performed in association with this submission."

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

Again, no clinical testing (standalone or otherwise) was performed. This device is a physical appliance, not an algorithm.

7. The Type of Ground Truth Used

• For the non-clinical tensile strength test, the "ground truth" is the physical measurement of the force required to break the strap.
• The overall "ground truth" for marketing clearance is the substantial equivalence to predicate devices that have prior FDA clearance and a history of safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This device is a physical anti-snoring appliance, not an AI/ML algorithm that requires a training set.

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

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

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