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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 Diamond Digital Sleep Orthotic (DDSO) is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The Diamond Digital Sleep Orthotic (DDSO) is a removable intraoral device intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward, (protrusive) position during sleep. This mechanical protrusion acts to increase the patient's pharyngeal space and decrease air turbulence, therefore improving their ability to exchange air during sleep.

The DDSO is a patient-matched prescription medical device, indicated for use during sleep to treat patients who snore and/or have mild to moderate obstructive sleep apnea. The design consists of two splints that fit independently over the upper and lower teeth and engage by means of an adjustable mechanism. This mechanism enables the practitioner to set the amount of mandibularadvancement at the time of fitting the device.

The amount of titration (mandibular protrusion) ranges from in 1.0 mm increments.

The provided text is a 510(k) summary for the Diamond Digital Sleep Orthotic (DDSO). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific quantitative acceptance criteria through a clinical study.

Therefore, many of the requested elements for describing acceptance criteria and a study that proves the device meets them (such as acceptance criteria table, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details, and ground truth establishment) are not explicitly present in this document.

The document states that:

• "Internal verification and validation testing demonstrate that product specifications are met and equivalent in design, performance, and technological characteristics." (Page 7)
• "Bench testing was conducted to determine the critical process parameters for Selective Laser Sintering... Results demonstrate that design outputs meet the design inputs and specifications for Diamond's additive manufacturing processes and control." (Page 7)
• "human clinical studies are not needed" (Page 7-8) because the device's design, technology, and indications for use are similar to previously cleared devices.
• "no new risks are introduced with the new device that are not present in the predicate device" (Page 9).

The document primarily relies on non-clinical performance testing (bench testing) and comparison to predicates to show substantial equivalence. It does not describe a clinical study designed to demonstrate quantitative performance metrics against pre-defined acceptance criteria for efficacy in reducing snoring or OSA. Instead, the "performance" discussed is related to mechanical properties, biocompatibility, and manufacturing process validation.

Given this, I will address the questions based on the information available in the document, and explicitly state when the requested information is not present.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Summary: The Diamond Digital Sleep Orthotic (DDSO) received 510(k) clearance based on demonstrating substantial equivalence to a predicate device (The Panthera Anti-Snoring Device, K143244) and a reference device (The Panthera Anti-Snoring X3 Device, K171576). The "study" proving the device meets acceptance criteria was primarily a series of non-clinical performance verification and validation tests (bench testing), along with biocompatibility testing and a risk analysis, rather than a clinical trial with pre-defined efficacy endpoints for snoring or OSA reduction. The acceptance criteria were therefore focused on demonstrating mechanical integrity, material safety, and comparable design/technology to the predicates, ensuring no new questions of safety or effectiveness.

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

The document does not provide a quantitative table of acceptance criteria or performance metrics for clinical efficacy (e.g., AHI reduction, snoring severity reduction). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence through:

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

• Sample Size: Not applicable in the context of a clinical test set for efficacy. The "test set" for performance was actual devices for bench testing (e.g., "fatigue testing was conducted on the new device," "a final custom load test was performed on the new device and the predicate"). The exact number of devices tested is not specified.
• Data Provenance: The testing was "Internal verification and validation testing" (Page 7) conducted by Diamond Orthotic Laboratory. No specific country of origin for data is stated beyond the company's US base. It was non-clinical bench testing, not human subject data, and thus neither retrospective nor prospective in the clinical sense.

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. This was bench testing and comparison to a predicate, not a study requiring expert readers or ground truth derived from clinical data labeled by experts.

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

• Not applicable. No expert adjudication process was described or required for this type of submission.

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

• No. This device is an intraoral medical device, not an AI system or an imaging diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI was not performed or relevant.

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 (expert concensus, pathology, outcomes data, etc)

• For the non-clinical performance and biocompatibility testing, the "ground truth" was established by engineering specifications, material science standards (e.g., ISO, ASTM), and comparative analysis against the predicate device's known characteristics. For example, biocompatibility was assessed against ISO standards, and mechanical performance was compared to the predicate.

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 no training set was used.

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