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

The ZQuiet is an oral appliance comprised of an upper and lower tray constructed in one piece and joined by a flexible hinge. The trays engage with the maxillary and mandibular dentition and the device maintains an anterior positioning of the mandible which widens the pharyngeal airway to prevent occlusion. The device is presented in varying protrusive sizes allowing the user to try different degrees of mandibular advancement to reduce snoring.

This document is a 510(k) Premarket Notification for the ZQuiet device, an intraoral device intended to reduce snoring. As such, the focus of the submission is to demonstrate substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

The document states, "No clinical testing was performed in association with this submission." and "Non-clinical testing was not performed for this submission." This indicates that the manufacturer did not conduct a study with acceptance criteria and reported device performance metrics for this specific 510(k) submission (K180124) to directly prove the device meets acceptance criteria in the way a clinical trial would.

Instead, substantial equivalence is argued based on the similarity of the ZQuiet device (K180124) to its predicate devices (ZQuiet K093407, ZQuiet K090503, and SnoreRx K170825) in terms of:

• Intended Use: All devices are intended for reducing snoring in adults.
• Technological Characteristics / Mode of Action: All are mandibular advancement devices that widen the pharyngeal airway.
• Design Principle: The ZQuiet devices (proposed and predicates) share a similar one-piece design with an upper and lower tray joined by a flexible hinge. While SnoreRx has a different adjustable design, its end result (mandibular advancement) is the same.
• Materials: The proposed ZQuiet uses the same thermoplastic elastomer as its ZQuiet predicates.
• Prescription Status: The change to OTC for the proposed ZQuiet is justified by comparison to the OTC SnoreRx predicate and by revised labeling including a STOP-Bang questionnaire.

Therefore, the following points address your specific questions in the context of this 510(k) submission:

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

   • Not Applicable. This 510(k) notification does not present a table of acceptance criteria and reported device performance from a clinical study for the K180124 device. The submission's goal is to demonstrate substantial equivalence to predicate devices, not to meet specific performance criteria from a de novo study. The document explicitly states "No clinical testing was performed in association with this submission." and "Non-clinical testing was not performed for this submission."

2. Sample sized 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 was generated for K180124 for this submission. The basis for substantial equivalence relies on the characteristics and established performance of the predicate 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. As no new clinical testing was performed for this 510(k) submission, there was no test set requiring expert ground truth establishment.

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

   • Not Applicable. No test set was used in this submission.

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 an intraoral appliance, not an AI-powered diagnostic imaging device. Therefore, MRMC studies are not relevant.

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

   • Not Applicable. This is a physical medical device, not an algorithm. Standalone performance as an algorithm is not relevant.

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

   • Not Applicable. No new ground truth was established for this submission. The "ground truth" for the device's safety and effectiveness is implicitly derived from the prior clearances and safe marketing history of the predicate devices.

8. The sample size for the training set

   • Not Applicable. This submission does not describe a training set for an algorithm or model.

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

   • Not Applicable. This submission does not describe a training set or its ground truth establishment.

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ZQuiet-SA is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in adults.

The ZQuiet-SA oral appliance consists of an upper and lower tray constructed in one piece and joined by a flexible hinge. The trays engage with the maxillary and mandibular dentition and the device maintains an anterior positioning of the mandible which widens the pharyngeal airway to prevent occlusion. The device is presented in multiple models allowing the dentist to recommend different degrees of mandibular advancement and preference of anterior posts.

The provided 510(k) summary for the ZQuiet-SA device does not contain acceptance criteria or a study proving that the device meets such criteria in the traditional sense of a performance study with defined metrics. This submission relies on demonstrating substantial equivalence to predicate devices. Therefore, the information requested in some categories cannot be extracted or is not applicable.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

Detailed breakdown of requested information:

1. A table of acceptance criteria and the reported device performance: See table above. It frames "acceptance criteria" as meeting the criteria for substantial equivalence.

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

   • No test set (clinical or performance) was used for this submission. The submission relies on substantial equivalence to predicate devices, which means no new clinical or non-clinical performance data was generated for this specific device to demonstrate its safety and effectiveness.

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 clinical or performance test set was used that required expert ground truth establishment.

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

   • Not applicable. No test set was used.

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. The ZQuiet-SA is a medical device (an intraoral appliance), not an AI/imaging diagnostic tool. No MRMC study was conducted.

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

   • Not applicable. The ZQuiet-SA is an intraoral appliance; it is not an algorithm and does not operate in a "standalone" or "human-in-the-loop" context in the way AI algorithms do.

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

   • Not applicable. No specific ground truth determination was made for this submission, as it relied on substantial equivalence. The "ground truth" for the predicate devices' effectiveness would have been established through clinical trials (e.g., outcomes data related to snoring and AHI reduction), but these studies were not conducted for the ZQuiet-SA as part of this 510(k) submission.

8. The sample size for the training set:

   • Not applicable. No training set was used as this is not an algorithm-based device.

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

   • Not applicable. No training set was used.

Summary of the K140777 Submission:

This 510(k) submission for the ZQuiet-SA device is a direct demonstration of substantial equivalence. The manufacturer asserts that the ZQuiet-SA possesses "identical technological characteristics" and "identical materials and methods of manufacture" to its previously cleared ZQuiet devices (K093407 and K090503) and also compares it to another predicate, TOMED SomnoGuard (K061688).

The "study" that proves the device meets the acceptance criteria is the comparison of its technical characteristics and intended use to those of legally marketed predicate devices. The acceptance criteria are, implicitly, that these characteristics and intended use are sufficiently similar to deem it substantially equivalent, thereby implying comparable safety and effectiveness without the need for new clinical data.

Specifically, the document states:

• "No additional non-clinical testing was performed for this submission."
• "No additional biocompatibility testing was conducted" because materials and manufacturing are identical to predicate devices.
• "No clinical testing was performed in association with this submission."

The FDA's letter concurs with the substantial equivalence determination, allowing the device to be marketed.

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The ZQuiet® Pro-Plus oral appliance is intended to reduce or alleviate nighttime snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.

The ZQuiet® Pro-Plus is an intra oral device used for treating snoring and sleep apnea. It functions to reposition the mandible to increase the patient's pharyngeal space to increase airflow, reduce the vibrations of the soft palate associated with snoring, and/or prevent the collapse of the airway associated with apneic events. The device consists of two (2) custom orthotics; one for the maxillary arch and one for the mandibular arch, made from acrylics widely used and approved for use in the dental industry. The orthotic employs a buccal cam mechanism, consisting of an apposing fin and buttress, that maintains the orthotics in an anteriorized relationship when worn during sleep.

The provided text is a 510(k) Summary for the ZQuiet® Pro-Plus oral appliance, seeking substantial equivalence to a predicate device. It defines the device, its intended use, and compares it to a legally marketed predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in terms of clinical outcomes.

Instead, the submission focuses on demonstrating substantial equivalence to an existing predicate device based on similar intended use, technological characteristics, and materials. The non-clinical testing mentioned is related to material properties rather than clinical performance for treating snoring or sleep apnea.

Therefore, the following information cannot be extracted from the provided document:

1. A table of acceptance criteria and the reported device performance: This document does not describe performance metrics and associated acceptance criteria related to reducing snoring or OSA, nor does it present results from a study designed to measure these.
2. Sample size used for the test set and the data provenance: No clinical 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 clinical test set with 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 device is an oral appliance, not an AI-assisted diagnostic tool for human readers.
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: Not applicable as no clinical study is detailed.
8. The sample size for the training set: Not applicable as there is no mention of a training set for a machine learning algorithm.
9. How the ground truth for the training set was established: Not applicable.

What the document does indicate regarding "study" and "proof":

• Non-Clinical Testing: The document mentions "Biocompatibility test results are known for this device as well as tests for tear resistance tear strength, tensile strength, elongation yield, and modulus of elasticity." These tests relate to the material properties and safety of the device, not its clinical efficacy in treating snoring or OSA.
• Proof of Substantial Equivalence: The primary "proof" presented in this 510(k) submission is the comparison to a predicate device, the SomnoMed MAS RxA (K050592). The conclusion states: "By comparing designs to the predicate device and the materials used it's concluded that the ZQuiet® Pro-Plus is as safe, as effective, and performs as well as the predicate device." This is a regulatory pathway that relies on the predicate device's established safety and effectiveness, rather than a new clinical study for the ZQuiet® Pro-Plus.

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The ZQuiet mandibular advancement device is intended for the treatment of nighttime snoring in adults 18 years or older.

The ZQuiet anti-snoring device is a single piece anti-snoring device, which moves the lower jaw forward and helps reduce the likelihood of snoring. This is achieved by covering the upper and lower teeth with a resilient non-toxic thermoplastic elastomer compound. The ZQuiet is easy to wear and simple to use. The single shot manufacturing process incorporates a resilient hinge in the molar area to provide a single piece device. The anti-snore device comprises an upper member adapted to engage the maxillary dentition of a human and a lower member adapted to engage the mandibular dentition of the human, the upper and lower members being resiliently hinged together.

The ZQuiet Mouthpiece is an anti-snoring device. The study performed for its clearance was a non-clinical evaluation rather than a clinical study. The device claims substantial equivalence to its predicate device (K090503 ZQuiet Mouthpiece) based on identical intended use and design, with a material change that was tested to ensure safety.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Agar Diffusion Test: Not specified (in vitro test).
• Primary Dermal Irritation in Rabbits: Rabbits (specific number not provided but typically a small group for such tests). The data provenance is pre-clinical animal testing.
• Guinea Pig Closed Patch Sensitization Test: Guinea pigs (specific number not provided). The data provenance is pre-clinical animal testing.
• Oral Mucosal Irritation Study: Not specified (likely animal model or in vitro, but typically animal models for irritation studies). The data provenance is pre-clinical testing.

The document does not specify country of origin for the data, but these are standard international bio-compatibility tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The tests performed were bio-compatibility and safety studies (in vitro and animal models), not human clinical studies involving expert interpretation of results. The "ground truth" was established by the scientific methodologies of the respective ISO standards and regulations.

4. Adjudication method for the test set:

Not applicable. These were laboratory tests with objective endpoints (e.g., cytotoxicity, irritation scores) rather than subjective assessments requiring adjudication by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

No. This was a non-clinical safety evaluation for a material change, not a study assessing diagnostic or treatment effectiveness involving human readers or cases.

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

No. This device is a physical anti-snoring mouthpiece, not a software algorithm.

7. The type of ground truth used:

The ground truth used was based on established scientific methodologies and standards for biocompatibility and safety testing (e.g., ISO 10993 standards, Federal Hazardous Substances Act Regulations). The "truth" refers to the cytotoxic, irritating, or sensitizing potential of the material under test.

8. The sample size for the training set:

Not applicable. This device does not use machine learning, so there is no "training set."

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

Not applicable. There is no training set as it's not an AI/ML device.

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The ZQuiet Anti-Snoring device is intended for the treatment of nightime snoring in adults.
The ZQuiet mandibular advancement device is intended for the treatment of nighttime snoring in adults.

The ZQuiet ® Mouthpiece is an Anti-Snoring device consisting of :

• Two trayed plates fitted in front and between the upper and lower teeth and gums . and integrated with each other with the same material as the upper and lower plates.
• The device is made of Thermoplastic elastomer .
• ◆ May be used as supplied

Here's an analysis of the provided text regarding the ZQuiet® Mouthpiece, focusing specifically on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary and subsequent FDA clearance letter. It is designed to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove efficacy or establish novel performance criteria through extensive clinical trials. Therefore, the information regarding acceptance criteria and performance studies will be limited by the nature of this regulatory submission.

Acceptance Criteria and Device Performance

Based on the provided text, specific quantitative acceptance criteria for device performance (e.g., reduction in snoring decibels, AHI improvement) are not explicitly stated or provided in a table format. The submission focuses on demonstrating substantial equivalence to a predicate device (SomnoGuard Series, K061688) based on shared intended use, materials, design, and theory of operation, implying that if the new device is substantially equivalent, it meets the inherent safety and effectiveness standards already established for the predicate.

Implicit Acceptance Criteria (based on substantial equivalence):

Study Details:

1. Sample Size and Data Provenance for Test Set:

   • The submission does not mention a clinical study with a "test set" or a comparison against a "ground truth" to establish the device's efficacy in reducing snoring.
   • The "Non-Clinical Performance Data" section only mentions "in vitro tests and animal safety studies" for biocompatibility. No sample sizes are provided for these.
   • This is typical for a 510(k) submission where substantial equivalence to a predicate device is the primary argument, rather than a de novo efficacy claim requiring human clinical trials for performance.

2. Number of Experts and Qualifications for Ground Truth:

   • Not applicable. There is no mention of establishing ground truth using experts for performance claims, as no performance study is described. The assessment focuses on the device's technical characteristics and safety relative to a predicate.

3. Adjudication Method for Test Set:

   • Not applicable. No test set or related adjudication process is described for performance evaluation.

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

   • No such study was done or is reported. This type of study is common for imaging or diagnostic devices where human interpretation is involved. The ZQuiet® Mouthpiece is a therapeutic device, and the submission does not involve human interpretation of data where MRMC would be relevant.

5. Standalone Performance Study (Algorithm Only):

   • No such study was done or is reported. This device is a physical medical device, not an algorithm or software. Its performance is directly tied to its physical interaction with the user's anatomy.

6. Type of Ground Truth Used:

   • For the non-clinical safety evaluation, the "ground truth" for biocompatibility would be established by standard biological safety testing protocols (e.g., ISO 10993 series), rather than clinical outcomes or expert consensus.
   • For the overall regulatory clearance, the "ground truth" is the legally marketed predicate device (SomnoGuard Series K061688), against which the new device is deemed substantially equivalent in terms of intended use, technology, and safety/effectiveness.

7. Sample Size for Training Set:

   • Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.

8. How Ground Truth for Training Set was Established:

   • Not applicable. As above, no training set is relevant to this type of device and submission.

In summary: The K090503 submission for the ZQuiet® Mouthpiece is a 510(k) premarket notification. Its "study" for acceptance criteria is primarily a comparison to a legally marketed predicate device to demonstrate substantial equivalence, rather than a clinical trial designed to prove independent efficacy against quantitative acceptance criteria. The acceptance criteria are implicit: that the device's characteristics (components, materials, intended use, mechanism of action, design) are sufficiently similar to the predicate that it raises no new questions of safety or effectiveness. The only explicit performance data mentioned are non-clinical (in vitro and animal safety studies) to assess biocompatibility, but no details or sample sizes are provided for these.

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