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Silent Nite Sleep Appliance with the Glidewell Hinge is indicated to reduce snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older. It is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.

The Silent Nite Sleep Appliance with the Glidewell Hinge is a mandibular advancement device. It holds the mandible in a protrusive position to increase the patient's ability to exchange air and decrease air turbulence, thus improving airflow during sleep. The device consists of upper and lower trays, which are fabricated using a biocompatible dual-layered thermoplastic material, and an engaging mechanism, which is the Glidewell Hinge (biocompatible medical grade stainless steel bars), and band lugs and hooks for attaching the optional orthodontic (elastic) bands, which are provided as accessories. The trays consist of a soft polyurethane inner layer that provides patient comfort and a hard polyester outer layer for durability. The hinge is adjustable by turning an inner adjustment screw with a hex driver, enabling the amount of mandibular advancement prescribed by the clinician. The design allows for the advancement of the mandible to be adjusted (increased or decreased) in 0.25 mm increments up to 10 mm. The orthodontic bands accessories are used to aid in holding the mouth closed. The end result, a forward position of the jaw, is the same as the predicate, however, the method of action of the predicate device and subject device are slightly different. Silent Nite Sleep Appliance with the Glidewell Hinge's method of action is identical to the Reference device and both use orthobands. Without orthobands, the patient's mouth can open during sleep which allows the tongue to fall back into the airway. The orthobands help keep the mouth closed to avoid this. With just a slight protrusion, the orthobands can be placed on the provided hooks. More protrusion requires the orthoband to be placed on the forward hook and the band lug. The device is customized to conform to the patient's upper and lower dentition based on the clinician's prescription. Upon receipt of the prescription, models for the trays are made and used during the thermoforming fabrication of the upper and lower trays. The difference between the Silent Nite Sleep Appliance with the Glidewell Hinge and the Primary Predicate Silent Nite sl is the mechanism connecting the trays: The new device's stainless steel hinge allows adjustment within the mechanism, while the Predicate's adjustment requires changing the plastic connectors. This is a non-sterile device, to be used only by the single patient for whom it is custom-designed and is to be worn during sleep.

The provided text is a 510(k) Summary for a medical device called the "Silent Nite Sleep Appliance with the Glidewell Hinge." It describes the device, its intended use, and how it compares to a predicate device to establish substantial equivalence for FDA clearance.

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them, primarily focusing on the engineering and material performance rather than clinical efficacy studies, as this is a 510(k) submission for a physical device:

Acceptance Criteria and Reported Device Performance

The acceptance criteria detailed in the document are primarily related to the device's functional integrity, fit, and material biocompatibility. Clinical efficacy (e.g., reduction in AHI) is established through the similarity to the predicate device, not through new clinical trials described here.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Details Proving Device Meets Acceptance Criteria

2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify discrete sample sizes for the functional and manufacturing verification/validation tests. These types of tests typically involve testing a representative number of units from manufacturing runs.
The data provenance is from Prismatik Dentalcraft, Inc. (the manufacturer), indicating these are internal company tests, likely conducted as part of their quality management system for product development and release. The tests are prospective in the sense that they are performed on newly manufactured devices to confirm design specifications and manufacturing quality.
No specific country of origin for the data is mentioned, but the manufacturer is based in Irvine, CA (USA), implying the testing was conducted under US regulatory considerations.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This document details engineering and biocompatibility testing, not clinical studies requiring expert ground truth in the diagnostic sense. Therefore, experts in this context would be test engineers, quality control personnel, and lab technicians. Their qualifications are not specified but would be implicit in their roles within the manufacturing and testing environment (e.g., trained in verification/validation, ISO standards, good laboratory practices).

4. Adjudication Method for the Test Set:
Not applicable in the sense of clinical image review or diagnostic agreement. Adjudication would be based on objective criteria defined in the test protocols (e.g., measurement within tolerance, pass/fail result for biocompatibility tests). Deviations would be addressed through standard quality control and engineering procedures.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No MRMC comparative effectiveness study was described or required. This is a 510(k) submission for a physical medical device, not an AI/software device that would typically involve human reader performance studies. The substantial equivalence relies on the device's design, materials, and mechanism of action being sufficiently similar to a legally marketed predicate, backed by engineering and biocompatibility testing. The predicate device's clinical effectiveness is already established.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This isn't an algorithm or AI device. The testing described is for the physical device itself.

7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is established by engineering specifications, material standards (ISO 10993), and functional design requirements. For example, the ground truth for "mandibular advancement function correct" is that the device can reliably achieve the specified 0.25 mm increments up to 10 mm. For biocompatibility, the ground truth is "met requirements of each test" according to ISO 10993.

8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/machine learning product that requires a training set.

9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, no training set is relevant for this type of device.

In summary, this 510(k) submission establishes substantial equivalence for a physical medical device based on engineering verification and validation, biocompatibility testing, and comparison of design and intended use to a predicate device, rather than clinical efficacy trials or AI/software performance studies.

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Silent Nite® sl is indicated to reduce snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older. Silent Nite® sl is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.

Silent Nite® sl is a mandibular advancement device (MAD) intended to treat snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older who prefer it to CPAP or surgical treatment, or who do not respond to, are not appropriate candidates for, or who fail treatment attempts with CPAP or surgical treatment. Silent Nite® sl holds the mandible in a protrusive position to increase the volume of the nasopharynx and the oropharynx and improves airflow during sleep. It is meant to be worn during sleep by a single patient. It consists of one upper tray, one lower tray, and two connectors and is provided non-sterile. The trays are patient-specific and conform precisely to the patient's dentition. A biocompatible dual-layered heat sensitive impression material make up the upper and lower trays. The trays consist of a soft polyurethane inner layer that provides patient comfort and a durable hard polyester outer layer. A completely rigid polyester material is necessary for the fabrication of the lower tray when the patient has poor retention. The maxillary tray is connected to a mandibular tray by two connectors of the same length. Each connector is fixed to the anterior of the maxillary tray and the posterior of the mandibular tray, on the respective right and left buccal sides. The amount of mandibular protrusion is adjusted by varying the length of the connectors. The shorter the connector the more anteriorization. Silent Nite® sl connectors are available in six different lengths (21.0 mm, 22.0 mm, 24.0 mm, 24.0 mm, 25.0 mm, and 26.0 mm) to allow the device to be adjusted up to 6.0 mm, in 1.0 mm increments.

The provided text is a 510(k) summary for the Silent Nite® sl device. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence. However, this document does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria through clinical data or AI model performance metrics.

The "Performance Data" section explicitly states: "Prismatik Dentalcraft, Inc. relies on the existing predicated devices for the safety and effectiveness of the Silent Nite® sl for its intended use. Non-clinical (bench performance testing) data was used to support the substantial equivalency."

The listed tests (ASTM D570, ASTM D790, ISO 20795-1, ASTM D638, ASTM D412, ISO 179) are all bench (material and mechanical) tests, not clinical studies involving human subjects or AI model performance evaluation.

Therefore, I cannot fulfill the request for information regarding:

1. A table of acceptance criteria and reported device performance (for clinical/AI performance)
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method for the test set
5. MRMC comparative effectiveness study results or effect size
6. Standalone (algorithm-only) performance
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
8. Sample size for the training set
9. How ground truth for the training set was established

This 510(k) relies on the substantial equivalence principle based on design, materials, manufacturing process, and bench testing, rather than a new clinical study to establish efficacy or an AI model's performance.

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