(139 days)
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.
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”