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The ApneaRx Pro is intended for use on adult patients 18 years of age or older as an aid for the reduction of mild to moderate obstructive sleep apnea (OSA), and/or snoring.

The ApneaRx Pro is an intraoral device that repositions the jaw anteriorly in order to increase the patient's pharyngeal space and minimizing air obstruction and turbulence. The device consists of two custom fabricated liners that fit separately over the upper and lower dental arches and engage in the posterior area of the mouth. The lower liner is snapfitted to a polycarbonate chassis that enables mandibular repositioning in 1 mm increments. The upper liner employs a hinged design to enable vertical movement of the jaws.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria for the ApneaRx Pro.

The document is a 510(k) summary for the ApneaRx Pro, which focuses on establishing substantial equivalence to a predicate device (ApneaRx). It describes the device, its intended use, and a comparison of technological features and materials between the new device and the predicate. Nonclinical testing for biocompatibility and physical properties of the materials is mentioned, stating that they met device specifications. However, there are no specific numerical acceptance criteria or details of a study designed to demonstrate performance against such criteria (e.g., clinical efficacy study for reduction of OSA or snoring, or a performance study with specific endpoints).

Therefore, I cannot provide the requested table or answer the specific questions related to acceptance criteria and a performance study.

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SilentZPro 2.0 is intended as an aid in the reduction of snoring for adults at least 18 years old.

SilentZPro 2.0 is an intraoral device composed of a maxillary and mandibular tray assembled to position the mandible forward relative to the maxilla to increase users' pharyngeal space and improve the ability to exchange air and decreases air turbulence, a causative factor in snoring.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) premarket notification from the FDA, and it focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against set acceptance criteria.

Specifically, the document states:

• "No clinical performance testing was conducted." This directly indicates that there was no study performed to evaluate the device's performance against specific clinical metrics or acceptance criteria.
• The comparison section (F. Comparison of Technological Characteristics) focuses on matching the proposed device's attributes (e.g., intended use, population, mechanism of action, materials, design) to those of the predicate and reference devices.
• The "Performance Testing" section (G.) only details non-clinical testing for biocompatibility (cytotoxicity, sensitization, irritation) and physical properties, concluding that the device "meets the applicable requirements of ISO 10993." This is about material safety, not device efficacy/performance.
• Risk analysis was conducted in accordance with ISO 14971:2007, but this is a process for identifying and mitigating risks, not a study proving functional performance.

Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment because this information is not present in the provided text. The submission relies on substantial equivalence based on technological similarities and non-clinical biocompatibility testing rather than clinical performance data against pre-defined acceptance criteria.

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The DaSoft Advanced Dental Appliance is indicated to reduce snoring in adult patients age 18 years or older.

The DaSoft Advanced Dental Appliance, previously cleared under K172991, repositions the tongue and related tissues anteriorly in order to increase the patient's pharyngeal space, which improves the ability to exchange air and decreases air turbulence; a causative factor in snoring. The device is manufactured using medical grade ethylene vinyl acetate (EVA) polymer, which is a material that has a "generally recognized as safe" (GRAS) designation from FDA.

The provided text is a 510(k) summary for the Advanced Dental Appliance, an anti-snoring device. However, it does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices based on:

• Intended Use: Reducing snoring in adult patients aged 18 or older.
• Mechanism of Action: Repositioning the tongue and related tissues anteriorly to increase pharyngeal space, reduce resistance, and decrease turbulent airflow.
• Technological Characteristics: Similar design, materials (medical grade ethylene vinyl acetate (EVA) polymer), and functionality (boil-and-bite method for customization).
• Nonclinical Testing: Material property testing (flexural modulus and strength, stress and strain at break, water absorption) on the tray material, meeting device specifications.
• Biocompatibility Testing: Cytotoxicity, irritation, and sensitization tests according to ISO 10993, showing the device is biocompatible.
• Usability Testing: A study following FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices," demonstrating that OTC consumers can appropriately prepare, fit, and adjust the device.

Since the document is a 510(k) summary for a Class II device (Intraoral device for snoring, 21 CFR 872.5570), the primary approach for market clearance is demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring a detailed clinical study with specific acceptance criteria as might be seen for novel or higher-risk devices.

Therefore, I cannot provide the requested information such as a table of acceptance criteria, device performance relative to those criteria, sample sizes for test sets, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance, as this type of information is not present in the provided text.

The "study" mentioned is the usability study, which focused on user comprehension and ability to use the device, not on its clinical efficacy in reducing snoring, or a comparison to specific performance metrics for snoring reduction.

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The Sapphire Dorsal Comfort Fit Appliance is intended for use in patients 18 years of age or older for the reduction of night time snoring and mild to moderate obstructive sleep apnea.

The Sapphire Dorsal Comfort Fit Appliance is an intraoral device used for reducing snoring and mild to moderate obstructive sleep apnea. It consists of fitted trays which fit over the upper and lower teeth. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep and improves their ability to exchange air during sleep. The device is made for each patient and has an expansion screw adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.

The provided text describes a 510(k) premarket notification for the Sapphire Dorsal Comfort Fit Appliance. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study to establish new performance criteria. Therefore, the information requested regarding acceptance criteria, specific study designs, sample sizes for test/training sets, expert qualifications, and adjudication methods for evaluating an AI-powered device is largely not applicable in this context.

Here's an breakdown based on the information available:

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

This document does not establish new acceptance criteria as it's a 510(k) submission seeking substantial equivalence. The "performance" is demonstrated through non-clinical testing and comparison to predicate devices, showing that the new device is as safe and effective as existing ones.

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

• Sample Size: Not applicable. No clinical test set involving human patients was used for performance evaluation in the context of an "AI software" or "diagnostic" device. The testing described is for material properties and device integrity.
• Data Provenance: Not applicable. The testing was conducted on material samples and a prototype device "assembly."

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

Not applicable. No expert review for ground truth was established as this is not an AI/diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 is 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 physical medical device (intraoral appliance), not an algorithm or software.

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

Not applicable. The "ground truth" for this device's safety and effectiveness is established by demonstrating its material properties, design features, and intended use are substantially equivalent to already cleared predicate devices.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable.

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PureSleep® (OTC) is indicated for use for adults 18 years and above as an aid in the reduction of snoring during hours of sleep

The PureSleep® device for Over-the-Counter (OTC) use is an intraoral mandibular repositioning device that increases the pharyngeal space to improve the user's ability to exchange air and to decrease air turbulence, a causative factor in snoring. The device consists of two dental trays designed to conform to the shape of the upper and lower jaws.

The provided text details a 510(k) summary for the PureSleep® (OTC use) device and its FDA clearance. However, it does not contain the specific acceptance criteria, detailed study design, or performance metrics that would typically be found in a comprehensive study report.

The submission focuses on demonstrating substantial equivalence to a predicate device (PureSleep® Rx) and a reference device (SnoreRx®) primarily based on technological characteristics and intended use. The supporting evidence mentioned is limited to non-clinical testing.

Here's an analysis of the requested information based only on the provided text, highlighting what is present and what is missing:

Acceptance Criteria and Study Details (Based on provided text)

1. Table of Acceptance Criteria and Reported Device Performance

No specific numerical acceptance criteria or quantitative device performance metrics are provided in the text. The submission focuses on demonstrating equivalence rather than meeting predefined performance thresholds.

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

• Test Set Sample Size: Not specified.
• Data Provenance: The text mentions "real-world data gleaned from actual use of the PureSleep® Rx predicate device" and a "Human Factors and Usability Engineering (HFE/UE) study."
  • The origin of the "real-world data" (e.g., country, retrospective/prospective) is not specified.
  • The HFE/UE study's detailed provenance is not specified beyond its purpose for OTC environment use.

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

• Not specified. The text does not describe a process for establishing ground truth for a test set in the context of clinical performance. The HFE/UE study would likely involve participants, but they are users, not typically "experts" establishing ground truth for clinical endpoints.

4. Adjudication Method for the Test Set

• Not specified. No clinical trial or test set with explicit adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No MRMC study was done. This device is an anti-snoring device, not an AI-powered diagnostic imaging tool that would typically involve human readers or AI assistance in interpretation. The provided text does not mention any AI component or human-in-the-loop interaction in its functionality.

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

• No standalone algorithm performance study was done (or none is mentioned). This is not an algorithmic device. Its performance is related to its mechanical function as a mandibular repositioning device.

7. The Type of Ground Truth Used

• The concept of "ground truth" as typically defined for diagnostic or AI performance studies (e.g., pathology, outcomes data) is not applicable or addressed for this device in the provided text. The "real-world data" mentioned would likely pertain to user experience, effectiveness in reducing snoring, or safety outcomes, but the specific "ground truth" methodology is not detailed.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical intraoral device, not an algorithm that requires a training set.

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

• Not applicable. As above, this is not an algorithmic device requiring a training set or associated ground truth.

Summary of Device Acceptance and Evidence:

The provided 510(k) summary indicates that the PureSleep® (OTC use) device was accepted by the FDA based on the following:

• Substantial Equivalence: The primary argument for acceptance is the device's substantial equivalence to the predicate device (PureSleep® Rx, K113022) and a reference device (SnoreRx®, K170825). The devices are "identical in all their technological characteristics (design, materials, functionality, principles of operations, etc.)."
• Non-Clinical Testing:
  • Biocompatibility: Materials meet ISO 10993-1 requirements for surface devices contacting mucosal membranes for prolonged durations.
  • Human Factors and Usability Engineering (HFE/UE) Study: Performed to support safe and effective use in an OTC environment without professional assistance. This study likely assessed ease of use, understanding of instructions, and ability for users to properly fit and use the device. The text does not provide specific outcomes or criteria for this study.
  • Risk Analysis: Conducted per ISO 14971:2007, addressing issues from FDA guidance. Risks were mitigated through design, verification/validation, or labeling.
• Clinical Performance Testing: The text states "Real-world data is included in support of this submission." This data was "gleaned from actual use of the PureSleep® Rx predicate device." No specific study design, sample size, or quantitative results from this real-world data are presented in the summary. The purpose of this data was to support the clinical safety of the device for OTC use.

In conclusion, the document's focus is on demonstrating similar characteristics and safety to previously cleared devices, rather than presenting a detailed clinical study with specific acceptance criteria related to a novel performance claim. The "study that proves the device meets the acceptance criteria" largely refers to the demonstration of substantial equivalence through non-clinical testing and leveraging existing real-world data from the predicate device, rather than a new, independent clinical trial with predefined performance endpoints for the OTC version.

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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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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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Bruxor™ is intended to protect teeth and reduce the damage caused by bruxing, or night time teeth grinding, and to prevent the noise associated with bruxing and grinding.

The Bruxor mouthguard consists of a single 'boil & bite' tray, fabricated from a thermoplastic resin, that fits over the upper dental arch.

The provided document is a 510(k) summary for the Bruxor™ mouthguard (K172452). It outlines the device description, intended use, and a comparison to a predicate device, but it does not contain a study that demonstrates device performance against specific acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer questions regarding sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or training set details as this information is not present.

The "Nonclinical Testing" section (page 5) mentions that biocompatibility was established in accordance with ISO 10993 requirements and device material physical properties (melting point, density, melt flow rate) were evaluated. However, it explicitly states: "Biocompatibility and physical properties of the thermoplastic resin material were previously established through the reference device (K170825). Additional test reports were therefore not submitted as a part of this filing." This indicates that no new study specifically proving the Bruxor™ device's performance against acceptance criteria was submitted or detailed in this 510(k) summary.

The primary method used for clearance of the Bruxor™ device is through demonstrating substantial equivalence to a predicate device (Custom Comfort Nightguard Version 2, K091660) and a reference device (SnoreRx, K170825). The substantial equivalence argument relies on the technological features, materials, and intended use being similar to already cleared devices, rather than new performance studies on the Bruxor™ itself.

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