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The Soundly Mandibular Advancement Device is intended to reduce or alleviate snoring and mild to moderate Obstructive Sleep Apnea (OSA) whilst sleeping, in adults

The Soundly Device is a mandibular advancement device to be worn by the patient in their own home at night whilst asleep. The advancement of the lower mandibular is an accepted method of reducing the incidence of light to moderate Obstructive Sleep Apnea (OSA). The Soundly Device consists of the following components:

• . A single lower jaw splint that covers the lower teeth to the gum line. The lower splint has two wedge-shaped projections on its upper surface. These indentations are shaped to receive complementary wedges on the upper splint and so advance the lower jaw compared to the natural positioning.
• . A set of three different upper jaw splints that cover the upper teeth to the gum line. Each upper jaw splint has a pair of wedges on its lower surface that interlock with the wedge indentation on the lower jaw. The set of three upper splints offer different amounts of mandibular advancement: They individually offer 40%, 60% or 70% of the maximum mandibular advancement that the patient's jaw can accommodate. The 70% value has an absolute maximum of 12 mm of mandibular advancement.

The dental impressions of the lower and upper jaw and a bite registration of the patient at maximum comfortable mandibular advancement are made by the prescribing dentist. The impressions are sent to the Soundly labs for processing. The impressions are turned into plaster models in the usual method and then the plaster models are subject to 3D scanning to make electronic 3D models of the mandibular arches. The 3D models are processed in 3D design software into the set of splints, which are then 3D printed in a biocompatible photopolymer. The finished set of splints are returned to the prescribing dentist for final fitting on the patient.

The provided FDA 510(k) summary for the Soundly Mandibular Advancement Device (K220330) primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and non-clinical testing. It does not include a clinical study detailing acceptance criteria for device performance in terms of reducing snoring or OSA with corresponding performance metrics.

Therefore, the following response will highlight that the document primarily relies on non-clinical testing and comparison to predicate devices, and that a clinical study with detailed acceptance criteria and performance results is not present in the provided text.

Summary of Device Acceptance Criteria and Study Findings (Based on Provided Document)

The provided submission does not contain a clinical study with acceptance criteria and measured device performance related to its intended use (reducing snoring and OSA). Instead, the submission relies on demonstrating substantial equivalence through a comparison of technological characteristics with predicate devices and non-clinical testing of the manufacturing process, physical properties, and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

As a clinical performance study with specific acceptance criteria is not detailed in the provided document, a table directly addressing that is not possible. The acceptance criteria and "device performance" in this context refer to the non-clinical testing outlined.

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

• For Additive Manufacture Consistency: The sample size is not explicitly stated as a number of devices. The description mentions "All splints printed" for accuracy and "The consistency of the printed splints... across three different print runs" for consistency. The data provenance is internal testing performed by Greystone IP Ltd.
• For Physical Properties (Drop Tests): "The same splints were used for all of the tests." A specific number of splints is not provided, but it implies a small sample. The provenance is internal testing by Greystone IP Ltd.
• For Biocompatibility: The biocompatibility data was provided by the material manufacturer (Formlabs) in a separate cover to the FDA. The sample size for their testing and provenance (country of origin, retrospective/prospective) is not detailed in this document.

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

• For Additive Manufacture Consistency: An "independent practicing Orthodontist" inspected the printed splints. The number of orthodontists is stated as one. Their specific qualifications (e.g., years of experience) are not provided.
• For other non-clinical tests (physical properties, biocompatibility): Ground truth was established through adherence to recognized standards and protocols (e.g., ISO for biocompatibility) and direct physical measurements/observations by internal personnel or testing labs. External expert involvement for establishing ground truth is not mentioned beyond the orthodontist.

4. Adjudication Method for the Test Set

• For Additive Manufacture Consistency: The orthodontist's inspection appears to be the primary adjudication. No explicit multi-reader/adjudication method (e.g., 2+1, 3+1) is described for these non-clinical tests.
• For other non-clinical tests: Adjudication would follow the protocols of the respective testing standards and internal quality control processes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was mentioned or performed. The submission does not include any clinical trial data or a study comparing human reader (patient) improvement with/without AI assistance. The device is a physical medical device, not an AI diagnostic tool that assists human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. The Soundly Mandibular Advancement Device is a physical device, not an algorithm, and therefore a standalone algorithm performance study is not relevant to this submission.

7. Type of Ground Truth Used

• For Additive Manufacture Consistency: Ground truth was established by the 3D CAD file dimensions and the "fit for use" judgment of the independent orthodontist against the plaster models.
• For Physical Properties: Ground truth was established by direct observation of breakage and adherence to predefined drop test protocols.
• For Biocompatibility: Ground truth was established by the results of tests performed according to ISO 10993 and ISO 7405 standards.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set" in the conventional sense. The manufacturing process does not involve machine learning training on a dataset.

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

• Not applicable. As there is no AI/ML training set, this question is not relevant. The "ground truth" for manufacturing relies on initial design specifications (CAD files), material properties, and quality control checks.

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The Serena Sleep Appliance is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The Serena Sleep Block Mandibular Advancement is an intraoral device that treats snoring and sleep apnea through mandibular repositioning the lower jaw forward from its normal location, the patient's pharyngeal space is increased and their ability to exchange air during sleep is improved. This device consists of custom fitted trays which fit over the upper and lower teeth. Based on the physician's prescription, positioning blocks are built into the upper and lower trays The mandibular advancement is achieved through the physician's selection of a specific upper and lower tray that when fitted, sets the optimal mandibular advancement. The separate two-piece construction is desirable for patients that want greater range of motion and lateral movement.

The Elastic Mandibular Advancement model is similar to the Block Mandibular Advancement but has exterior pins that allow for the use of rubber bands rather than the blocks. These bands provide additional treatment options and forces for repositioning the bottom jaw.

The provided text describes the 510(k) premarket notification for the Serena Sleep Block Mandibular Advancement (BMA) and Elastic Mandibular Advancement (EMA) devices. The core of the submission is to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving a specific performance metric against acceptance criteria in the traditional sense of a new technology.

Therefore, the "acceptance criteria" here are based on the comparison to the predicate devices, showing that the Serena Sleep devices are as safe and effective as the existing ones. The "study" proving this largely involves bench testing and a detailed comparison of features.

Here's an analysis of the "acceptance criteria" and the "study" based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly met by demonstrating "equivalence" to the predicate devices across various specifications. The "reported device performance" is mainly shown through bench testing results.

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

The provided document does not mention a "test set" in the context of human subjects or a clinical study. It refers to "Performance Testing (Bench)" which would involve physical device samples.

• Sample Size for Bench Testing: Not explicitly stated how many devices were tested for compression, shear, bruxism, and durability.
• Data Provenance: The bench testing was conducted internally by the manufacturer (Serena Sleep). The document doesn't specify the country of origin of this testing data. The data is retrospective in the sense that it's reported after the testing completion.

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

This section is not applicable as there was no clinical test set involving human subjects requiring expert ground truth establishment. The ground truth for device performance was established through engineering and mechanical testing methodologies against known maximum jaw forces from literature.

4. Adjudication Method for the Test Set

Not applicable, as no human-in-the-loop clinical test set was conducted that would require 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 appliance, not an AI-powered diagnostic tool, 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 is not an algorithm-only device. The core "performance" was physical bench testing of the device for mechanical integrity and durability.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the bench testing, the "ground truth" for mechanical forces was established through:

• Literature search of maximum jaw strengths: This implies reliance on established scientific or engineering data regarding biomechanical forces in the human jaw.

For the comparison for substantial equivalence, the "ground truth" was the specifications and performance of the legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

Not applicable, as there was no training set.

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