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In adult population

• · To reduce or alleviate snoring
• To reduce or alleviate mild to moderate obstructive sleep apnea (OSA)

SICAT OPTISLEEP is a pure hardware device. It is an oral appliance and will be manufactured by the SICAT dental laboratory to and on the order of a dentist, physician or licensed practitioner. Each appliance is customized for patients.

SICAT OPTISLEEP is fitted on the maxillary and mandibular arch covering all teeth. It consists of two main parts (upper and lower arch each) that are interconnected by exchangeable connectors. This 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 pharyngeal space, improving the ability to exchange air during sleep by reducing mechanical obstructions of the airway. Further this results in lower tendency to snore. The device has an adjustment mechanism, achieved by exchangeable connectors of different length, to adjust the mandibular advancement to be set by the dentist or physician at the time of fitting. The SICAT OPTISLEEP will be worn only during the sleep. The device will be used before replacement up to two years.

The provided document is a 510(k) summary for the SICAT OPTISLEEP device. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving the device meets specific acceptance criteria with performance metrics. Therefore, a table of acceptance criteria and reported device performance, and details on ground truth, sample sizes, and expert adjudication are not available in this document.

Here's what can be extracted based on the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided 510(k) summary. The document focuses on comparing the new device, SICAT OPTISLEEP, to predicate devices (Narval CC and SomnoDent Classic) to establish substantial equivalence. It does not present specific performance metrics against pre-defined acceptance criteria for the SICAT OPTISLEEP device itself. The "Non-Clinical Performance Testing and Verification and Validation Activities" section lists various standards and guidance documents that were followed, implying that compliance with these standards served as a form of acceptance criteria, but no specific quantitative performance results are reported.

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

This information is not available in the provided 510(k) summary. The document mentions "verification and validation activities" including "usability testing" and "bench testing," but does not specify the sample sizes or data provenance for these tests. In a 510(k) submission, clinical study details are often summarized if they are necessary to demonstrate substantial equivalence and typically involve comparing the new device to a predicate rather than a standalone performance study with a test set as described in the prompt.

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

This information is not available in the provided 510(k) summary. Given the absence of a detailed study on a "test set" with ground truth established by experts, this detail is not present.

4. Adjudication method for the test set

This information is not available in the provided 510(k) summary. Since there's no described test set with expert ground truth, an adjudication method is not mentioned.

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

A multi-reader multi-case (MRMC) comparative effectiveness study and details about human readers improving with AI assistance are not applicable to this device. SICAT OPTISLEEP is described as "a pure hardware device," an oral appliance that is custom-manufactured. It does not involve AI or human readers for interpretation, but rather a physical intervention.

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

A standalone algorithm performance study is not applicable to this device. As noted above, this is a physical, hardware-based medical device, not a software algorithm.

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

This information is not available in the provided 510(k) summary. Since no specific study establishing ground truth for a test set is detailed, the type of ground truth is not mentioned.

8. The sample size for the training set

This information is not available in the provided 510(k) summary. The device is a physical appliance, not an AI/ML algorithm that requires a training set.

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

This information is not available in the provided 510(k) summary. As no training set for an algorithm is applicable, the establishment of ground truth for it is also not applicable.

Summary of what is available from the document relevant to device equivalence:

The document focuses on demonstrating substantial equivalence of the SICAT OPTISLEEP to legally marketed predicate devices rather than proving performance against specific acceptance criteria in a clinical study for the new device.

• Predicate Devices: Narval CC (K113201) and SomnoDent Classic (K050592).
• Mechanism of Action: All three devices (SICAT OPTISLEEP and predicates) are mandibular repositioners that maintain the lower jaw in a forward position during sleep to increase pharyngeal space and improve air exchange, thereby reducing snoring and alleviating mild to moderate OSA.
• Materials: SICAT OPTISLEEP uses Polymethylmethacrylate and Polyamide. Predicates use Acrylic/Stainless steel (SomnoDent Classic) or Polyamide (Narval CC).
• Manufacturing: SICAT OPTISLEEP is produced by milling at a dental laboratory using CAD/CAM technology, similar to the Narval CC predicate (selective laser sintering of polymer) and the general "Dental laboratory" manufacturing for SomnoDent Classic.
• Key Verification/Validation Activities (Non-Clinical):
  • Evaluation of biocompatibility (following ISO 10993 series).
  • Usability testing.
  • Bench testing of compliance with specifications and handling.
  • Compliance with various ISO standards and FDA guidance documents related to medical device labeling, risk management, usability engineering, and biological evaluation.
• Conclusion for Substantial Equivalence: The FDA's review concludes that SICAT OPTISLEEP is substantially equivalent in design, material type, technological characteristics, and function to the predicate devices. Minor differences between the devices do not raise new questions concerning safety and effectiveness.

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The MICRODENTAL, Inc. MicrO2 device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The MicrO2 OSA device series consists of maxillary and mandibular devices that when interfaced together alleviate snoring and mild to moderate sleep apnea by holding the mandible forward during sleep, preventing the tongue and soft tissues of the throat from collapsing into the airway. 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, straps or repositioning elastics. The maximum protrusion of a MicrO2 archform is 6mm, which is comparable to the predicate device's 6mm advancement screw, measuring from plate to plate. This also negates the need for patients utilizing external controlling components such as keys, screwdrivers or ligature ties. The maximum protrusion of a MicrO2 archform is 6mm, which is comparable to the predicate device. 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 is identical to the Somnomed MAS RXA (Classic) except for the difference in the adjustment mechanism. Any differences introduced by these modifications when compared to the predicate device, do not introduce any new safety concerns.

The provided text describes a 510(k) summary for the MicrO2 Obstructive Sleep Apnea Device. This document focuses on demonstrating substantial equivalence to a predicate device through bench testing. It does not contain information about clinical studies with human participants to directly prove the device meets specific acceptance criteria related to its efficacy in reducing snoring or sleep apnea in patients.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) cannot be filled based on the provided text.

Here's an analysis of the available information:

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

The acceptance criteria are implicitly defined by performing "as well or better than the predicate device." The "reported device performance" is a qualitative assessment of "Yes" for improved or equal performance.

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

This information is not provided in the text. The testing described is bench testing, not clinical testing on a patient population.

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)

This information is not applicable as the provided text describes bench testing (mechanical and chemical property comparison), not a study requiring expert ground truth for clinical outcomes.

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

This information is not applicable as the provided text describes bench testing.

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

This information is not applicable. The device is a physical intraoral device, not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is a physical intraoral device, not an algorithm.

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

For the bench testing, the "ground truth" was established by comparing the mechanical and chemical properties of the MicrO2 OSA device directly against those of the predicate device (Somnomed MAS RXA). The predicate device's established performance served as the benchmark.

8. The sample size for the training set

This information is not applicable. There is no mention of a "training set" as this is not an AI/machine learning study. The document describes bench tests on physical devices.

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

This information is not applicable for the reasons stated above.

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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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