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The Hushd Pro Avera device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The Hushd Pro Avera device series are a set of removable intraoral patient specific device used for treating snoring and mild to moderate obstructive sleep apnea. The device consists of number of custom made maxillary and mandibular splints fit over the upper and lower teeth. when interfaced together, functions as a mandibular repositioner holding the mandible forward during sleep thus preventing the togue and soft tissues of the throat from collapsing into the airway.

The Hushd Pro Avera device series are patient-specific devices, consisting of one or more maxillary device(s) and one or more mandibular device(s) that mates together. The sequential devices are CAD/CAM designed and manufactured according to the requested mandibular advancements position prescribed by the dentist or physician to provide a selection of gentle advancements according to patient comfort and need. As such, prescribed advancements can be achieved by simply removing current maxillary or mandibular device and inserting the next maxillary or mandibular device in the advancements series. The maximum protrusion of the device is 10mm.The Hushd Pro Avera device does not have any adjustment mechanisms to modify or maintain the mandibular position such as pistons, straps or repositioning elastics.

Based on the provided text, the device in question, Hushd Pro Avera, is an intraoral device for snoring and mild to moderate obstructive sleep apnea. The text does not describe acceptance criteria or a study that proves the device meets those criteria from a clinical performance perspective. Instead, it explicitly states that no clinical performance data was deemed necessary or performed for this submission.

The submission relies on a demonstration of substantial equivalence to predicate and reference devices, supported by non-clinical performance data (material properties and biocompatibility).

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a clinical study, nor specific details about sample size, expert ground truth establishment, or MRMC studies, as these types of studies were not conducted or reported in this 510(k) summary.

However, I can extract the information provided regarding the non-clinical testing and the rationale for not performing clinical studies.

Summary regarding Acceptance Criteria and Performance (based on provided text):

The provided 510(k) summary for the Hushd Pro Avera device focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing clinical performance against pre-defined acceptance criteria through a clinical study. The FDA's clearance (K232025) is based on this equivalence, along with successful non-clinical performance data and biocompatibility testing.

Here's an analysis of the requested information based on the document:

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

   • Clinical Performance: No clinical performance acceptance criteria or reported clinical performance data is provided in the document. The submission explicitly states: "The clinical performance of the subject device is deemed not necessary. The Hushd Pro Avera device has equivalent indication and method of use to its predicated and reference devices, therefore there was no clinical testing to support this device."
   • Non-Clinical Performance: The acceptance criteria for non-clinical testing are implied by the successful completion of the tests and the conclusion that the device "meets all design specification." The reported performance is that the tests were conducted and the device passed.

   Acceptance Criteria (Non-Clinical)	Reported Device Performance (Non-Clinical)
   Compliance with ISO 14971:2007 (Risk Analysis)	All identified risks have been addressed through device design, biocompatibility, and bench testing or through labeling provided to the consumer.
   Material Mechanical Properties	Tests conducted by the manufacturer for Flexural Modulus, Flexural Strength, and Impact Strength. (Details of specific values or thresholds are not provided, only that tests were done to "evaluate its ability to achieve its intended use.")
   Biocompatibility (ISO 10993-1)	Final finished device tested for: Cytotoxicity, Irritation, Sensitization, System Toxicity, Pyrogen. (Specific results are not provided, but the overall statement implies successful completion: "The subject device is able to achieve its intended use based on the same materials of construction, similar manufactory process and the identical application to the predicate device.")
   Design Specifications	The device "meets all design specification". (Specific design specifications are not enumerated.)

2. Sample sizes used for the test set and the data provenance

   • Clinical Test Set: Not applicable, as no clinical test set was used for performance evaluation (no clinical study was conducted).
   • Non-Clinical Test Set: The sample sizes for the non-clinical materials testing and biocompatibility testing are not specified in the document. However, these are generally standard tests conducted on representative samples of the device and its materials. The provenance is internal testing by the manufacturer.

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 human-established ground truth was used for performance evaluation.

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

   • Not applicable, as no clinical test set requiring adjudication 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, as this device is a physical intraoral device, not an AI/software product, and no clinical studies (MRMC or otherwise) were conducted.

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

   • Not applicable, as this is a physical device, not an algorithm.

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

   • Clinical Ground Truth: Not applicable, as no clinical studies were performed.
   • Non-Clinical Ground Truth: For mechanical properties and biocompatibility, the ground truth is established by validated laboratory testing methods and compliance with international standards (ISO 10993-1, ISO 14971:2007).

8. The sample size for the training set

   • Not applicable, as this is a physical device, not a machine learning model requiring a training set.

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

   • Not applicable, as there was no training set.

In conclusion, the core of this 510(k) submission and FDA clearance is based on the principle of substantial equivalence to existing devices, supported by non-clinical testing, rather than new clinical performance data or studies defining and meeting specific clinical acceptance criteria.

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The SomnoDent Avant is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

The SomnoDent Avant device is an intraoral device used for treating Snoring and Sleep Apnea. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The device is customized for each patient and has an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The SomnoDent Avant is a modification to the SomnoDent Flex (K073004). The SomnoDent Avant is identical to SomnoDent Flex, except for differences in the adjustment mechanism (strap set material), and a change in adjustable range from -1.0mm to +8.0mm.

Here's an analysis of the provided text regarding the SomnoDent Avant device, focusing on acceptance criteria and the study proving it meets them.

The provided document is a 510(k) summary for the SomnoDent Avant, which primarily focuses on demonstrating substantial equivalence to predicate devices. It does not contain information about a clinical study with human subjects to prove the device's performance against specific acceptance criteria for effectiveness (e.g., reduction in AHI, improved snoring). Instead, the performance evaluation relies heavily on bench testing and material conformance to show that the modified device (SomnoDent Avant) is as safe and effective as its predicate (SomnoDent Flex).

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC study, training set details) cannot be answered from the provided text, as such studies were not the basis for this 510(k) clearance.

Key takeaway: This 510(k) relies on demonstrating the new device is fundamentally similar to an already cleared device, not on new clinical performance data.

Acceptance Criteria and Device Performance (As Inferred from the 510(k) Summary)

Since a clinical performance study with acceptance criteria for clinical outcomes (e.g., AHI reduction) is not detailed, the "acceptance criteria" here are best characterized as design and material characteristics demonstrating substantial equivalence to the predicate, and bench test results confirming the safety and functional integrity of the modifications.

Study Details Proving Device Meets Acceptance Criteria

Given that this 510(k) relies on substantial equivalence and bench testing, direct answers to many of the typical clinical study questions are not available from the provided text.

1. Sample Size Used for Test Set and Data Provenance:

   • Test Set Sample Size: Not applicable in the context of clinical performance evaluation. The "test set" refers to materials or mechanical components undergoing bench testing. The specific number of samples for each bench test (biocompatibility, material conformance, adjustment mechanism) is not provided.
   • Data Provenance: The document does not specify a country of origin for the bench testing data. It mentions "Bench testing of the new adjustment mechanism and evaluation of the additional strap set material," implying laboratory testing. The studies were non-clinical (Summary of Non-Clinical Testing).

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

   • Not applicable. Ground truth for clinical performance was not established through expert consensus in this 510(k). The "ground truth" for material properties and functionality was established by adherence to specified ISO standards and validated test methods.

3. Adjudication Method for the Test Set:

   • Not applicable. This was not a human-reader study requiring adjudication.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. The submission focuses on substantial equivalence through design, materials, and non-clinical bench testing.

5. If a Standalone (Algorithm Only) Performance Study was done:

   • Not applicable. This device is a physical intraoral appliance, not an AI algorithm.

6. The Type of Ground Truth Used:

   • The "ground truth" for the acceptance criteria was based on established international standards (ISO) for biocompatibility, material properties, and risk management (ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 20795-1, ISO 14971) and engineering principles for mechanical function. This is consistent with a 510(k) for a physical device demonstrating substantial equivalence.

7. The Sample Size for the Training Set:

   • Not applicable. No "training set" in the context of machine learning or AI models was used. The device is physically manufactured based on patient scans and a prescribed design.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as no training set was used.

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The Panthera Anti-Snoring X3 Device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The Panthera Anti-Snoring X3 Device is a removable intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two customized splints that fit separately over the upper and lower teeth.

The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharvngeal space, improving their ability to exchange air during sleep.

The device is a prescription customized for each patient and has an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The maximum protrusion of the device is 5 mm in 1 mm increments.

This document is a 510(k) premarket notification for the Panthera Anti-Snoring X3 Device, seeking substantial equivalence to previously marketed devices. The document explicitly states that no human clinical study was deemed necessary to support substantial equivalence (page 12), and therefore, a study proving the device meets acceptance criteria based on human clinical data is not provided in this submission.

The acceptance criteria and device performance are instead established through non-clinical testing, primarily by demonstrating equivalence to a primary predicate device (The Panthera Anti-Snoring Device, K143244) and several reference predicate devices.

Here's a breakdown based on the provided text, addressing your points where possible, and indicating where information is not available due to the nature of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical study was performed, the "reported device performance" against clinical acceptance criteria is not applicable. Instead, the non-clinical testing focused on establishing substantial equivalence based on material properties, design, and mechanical strength.

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

• Sample size: Not applicable for a clinical test set as no clinical study was performed. For non-clinical testing, specific sample sizes for material and fatigue tests are not provided in this summary but would have been part of the underlying test reports.
• Data provenance: Not applicable in terms of country of origin or retrospective/prospective for a clinical study. The non-clinical testing was conducted by Panthera Dental Inc.

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

Not applicable. As no human clinical study was performed, there was no ground truth established by experts for a test set in this 510(k) submission.

4. Adjudication method for the test set

Not applicable. No human clinical study was performed with a test set requiring adjudication.

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 a physical intraoral device, not an AI or imaging diagnostic tool, and no MRMC study was performed.

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.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" was established by industry standards (e.g., ASTM D638, NISTIR 8059) and regulatory biocompatibility standards (e.g., ISO 14971, ISO 10993). Equivalence to predicate devices with established safety and effectiveness also serves as a form of "ground truth" for substantial equivalence.

8. The sample size for the training set

Not applicable. No machine learning algorithm or training set was involved.

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

Not applicable. No machine learning algorithm or training set was involved.

Summary of the Study (Non-Clinical Evidence for Substantial Equivalence):

The Panthera Anti-Snoring X3 Device's substantial equivalence was established through non-clinical testing and comparison to legally marketed predicate devices rather than a human clinical study.

• Non-Clinical Testing:

  • Material Equivalence: The device uses the same raw material (polyamide type 12), supplied by EOS, and the same proprietary manufacturing process (Selective Laser Sintering) as its primary predicate, The Panthera Anti-Snoring Device (K143244). This allowed for leveraging performance testing (orthosis polishing, static and dynamic compression resistance) from the predicate's submission.
  • Mechanical Testing: A specific test was conducted to determine build locations for 3-D printing in accordance with FDA guidance and standards (ASTM D638, NISTIR 8059).
  • Fatigue Testing: Because the mechanism for mandibular protrusion differed from the primary predicate (stop-clip system assembly vs. interlocking rods), dedicated fatigue testing was performed on the stop-clip system assembly. The results demonstrated sufficient mechanical strength for its intended clinical application.
  • Biocompatibility: Assessed and confirmed to be biocompatible based on the use of identical materials, supplier, and manufacturing process as the primary predicate device, following ISO standards (14971, 10993-1, 10993-5, 10993-10).

• Rationale for No Clinical Study: The FDA submission states that a human clinical study was "not deemed necessary" because the Panthera AS X3:

  • Does not use a design dissimilar from the reference predicate devices.
  • Does not use new technologies different from the primary and reference predicate devices.
  • Does not deviate from the indications for use identified in the primary and reference predicate devices.

In essence, the "study" proving the device meets its "acceptance criteria" here is a comprehensive non-clinical assessment demonstrating that the device is materially, technologically, and functionally equivalent or superior in specific mechanical aspects to its established predicate devices, which already have demonstrated safety and effectiveness through their own market history or prior submissions.

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The MICRODENTAL, Inc. Micr02 device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Optionally, if the DentiTrac® micro-recorder is completely embedded in the MicrO2 device, the microrecorder is intended to measure patient compliance to oral device/appliance therapy in combination with the DentiTrac® System

The MicrO2 OSA device series consists of maxillary and mandibular devices that when interfaced together reduce snoring and mild to moderate sleep apnea by holding the mandible forward during sleep, providing increased pharyngeal space. These separate upper and lower arch devices are designed with twin-mated posts and are CAD/CAM generated specifically for each prescription. Designed as a patient-specific device, the MicrO2 series consists of one or multiple lower device(s) together with one or multiple mated-post upper device(s) that are manufactured to the dentist prescriber's requested advancement positions to provide a selection of gentle adjustments according to patient comfort and need. As such, prescribed advancements can be achieved by simply removing the current upper or lower device and inserting the next upper or lower device in the mandibular advancing series. The MicrO2 does not have any adjustment mechanisms to modify or maintain the mandibular position such as pistons, screws, straps or repositioning elastics. The MicrO2's twin-mated post and lingualess design yields a small and a comfortable patient-specific mandibular advancement device. The design of the device maximizes tongue space and mandibular movement resulting in the ability to open and close during wear.

The Micr02 OSA device with Micro-recorder is identical to the primary predicate device, Somnomed with Micro-Recorder except for the difference in the adjustment mechanism. The MicrO2 uses twin mated posts to adjust whereas the Somnomed uses embedded screws. Without the compliance chip the subject device is identical in materials and manufacturing to the reference predicate MicrO2 OSA device. Any differences introduced by these modifications when compared to the predicate device, do not introduce any new concerns.

This submission adds the option for any clinician to decide to incorporate a DentiTrac® Microrecorder compliance chip embedded into a MicrO2 OSA device to record a patient's compliance to the prescribed oral appliance therapy. The MicrO2 OSA device with Micro-recorder is to be used in combination with the DentTrac® System which includes a base station at the provider's office used to upload the data from the chip to a web application for cloud based reporting and tracking. During scheduled visits, the data within the DentiTrac® can be uploaded to a web application for cloud-based reporting and tracking using a DentiTrac® Base Station at the clinician's office. The DentiTrac® micro-recorder monitors the wear time through the oral temperature, as well as tracks movements and head position. This is the identical chip that is included in the predicate device – the Somnodent with Micro-Recorder. The inclusion of the embedded DentiTrac® micro-recorder, provides additional information when used in combination with the DentiTrac® System, but does not impact the operating principles of the Micr02 OSA device as established by the reference device, the MicrO2 OSA without the DentiTrac® Micro-recorder.

This FDA 510(k) summary describes the MicrO2 OSA Device with Micro-recorder. However, it explicitly states, "Clinical testing was not conducted on the subject device." Instead, the submission relies on demonstrating substantial equivalence to predicate devices through technical characteristics, material composition, and non-clinical performance testing. Therefore, the information requested in the prompt related to acceptance criteria for clinical performance, sample sizes for test sets, ground truth establishment, expert adjudication, or MRMC studies for an AI device is not applicable to this submission.

The document focuses on the mechanical performance and biocompatibility of the device and the embedded micro-recorder, not on the clinical efficacy of an AI-driven component.

Here's a breakdown of the available information, addressing the prompt as best as possible given the provided text:

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

The document does not provide a table of acceptance criteria in the traditional sense of numerical clinical performance targets for an AI device. Instead, it relies on demonstrating substantial equivalence to predicate devices through various comparisons and non-clinical testing. The "performance" reported is primarily in terms of meeting manufacturing specifications and maintaining structural integrity and biocompatibility.

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

Not applicable. No clinical test set data is described for the subject device. Non-clinical testing refers to lab-based assessments of materials and mechanical properties.

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 test set with expert-established ground truth is described.

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

Not applicable. No clinical test set with adjudication is described.

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 not an AI algorithm and no MRMC study was conducted.

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

Not applicable. This device is not an AI algorithm.

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

Not applicable. For the non-clinical tests described, the "ground truth" would be established engineering specifications, material standards, and validated testing methods.

8. The sample size for the training set

Not applicable. The device is not an AI algorithm and does not have a training set.

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

Not applicable. The device is not an AI algorithm and does not have a training set.

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