(419 days)
The HypnosPad of mandibular advancement devices is intended for the treatment of night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
HypnosPad (HP01) is a home-use mouthpiece and indicated for the treatment of night-time snoring. It is suitable for mild to moderate obstructive sleep apnea (OSA) patients in adults. The accessories of HyponsPad are a storage box and a spatula. The device is made by thermoflexible and biocompatible material. The usage method of HyponsPad is custom fit after hot water bathing. The duration of HypnosPad is about 8-10 hours contacting in patient's oral cavity. The HyponsPad is intended for holding the mandible in a protruded position thus maintaining the airway open during sleep. The HypnosPad will be used the spatula help to operate the device during boil and bite process. The HypnosPad will be stored in the storage box.
The provided text describes the HypnosPad, an intraoral device for snoring and obstructive sleep apnea, and its substantial equivalence to a predicate device (SomnoGuard, K061688). However, it does not contain a study that directly proves the device meets specific performance acceptance criteria in terms of clinical effectiveness for treating snoring or sleep apnea.
The document primarily focuses on demonstrating substantial equivalence to the predicate device through comparisons of technological characteristics and various bench and usability tests. It does not provide clinical performance data with explicit acceptance criteria for treating the medical conditions it addresses.
Here's an analysis of the provided information based on your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., reduction in AHI, reduction in snoring events). Instead, the performance evaluation is based on demonstrating that the HypnosPad performs "as well as the noted predicate" in certain bench tests and usability, and that its technological characteristics are comparable, or differences do not raise new safety/effectiveness questions.
| Characteristic / Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Intended Use | Identical to predicate: Treatment of night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. | Identical to predicate. |
| Mechanism of Action | Identical to predicate: Extends lower jaw, opening upper airway, reducing snoring and breathing arrests. | Identical to predicate. |
| Biocompatibility | Meets ISO 10993-1, 10993-5, 10993-10 standards. | Pass: Biocompatibility testing based on ISO 10993-1, 10993-5:2009 (in vitro cytotoxicity), and 10993-10:2010 (irritation and skin sensitization) were performed. (Reported as "Identical" to predicate's approach). |
| Usability | Meets IEC 62366:2007; differences from predicate do not introduce additional risk. | Pass: Usability test based on IEC 62366:2007 was performed. Differences in human factors (e.g., "Design - Oral appliance size and outward") did not raise additional risk based on usability test (Appendix D). |
| Mechanical Strength & Fitting Process | Performance comparable to predicate; differences don't introduce additional risk. | Pass: Bench test for performance for fitting process and mechanical strength was performed. Differences in "Design - Mandibular Advancement Range" and "Design - Patient Contacting Materials" did not raise additional risk based on this test and material property evaluation (Appendix F). The new device "performed as well as the noted predicate." |
| Material Properties | Performance comparable to predicate; differences don't introduce additional risk. | Pass: Material property evaluation was performed. Differences in "Design - Patient Contacting Materials" and "Material Thermal properties" did not raise additional risk. The new device "performed as well as the noted predicate." |
| Thermal Properties | Performance comparable to predicate; differences don't introduce additional risk. | Pass: Thermal property test was performed. Differences in "Material Thermal properties" did not raise additional risk based on Thermal Property Test Report (Appendix H). The new device "performed as well as the noted predicate." |
2. Sample Size for the Test Set and Data Provenance
The document does not specify the sample size for any clinical test set, as no clinical performance study for the HypnosPad itself is presented in this summary.
For the bench tests, usability tests, and material property evaluations, the sample sizes are not explicitly stated, nor is the provenance of any data beyond what is implied by the testing standards (e.g., in-vitro cytotoxicity tests would involve cell cultures, mechanical tests would involve device units). There is no "country of origin of the data" or "retrospective/prospective" context for these engineering and safety tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided as there is no mention of a clinical study involving diagnosis or outcome assessment where experts would establish ground truth.
4. Adjudication Method for the Test Set
This information is not provided as there is no mention of a clinical study requiring adjudication of ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document does not describe any study comparing human readers' performance with and without AI assistance for this device, which is a physical medical device and not an AI-powered diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone performance study in the context of an algorithm or AI was not done. This device is a physical intraoral device, not a software algorithm.
7. The Type of Ground Truth Used
For the safety and performance tests mentioned (biocompatibility, usability, mechanical strength, material/thermal properties), the "ground truth" is established by adherence to recognized international standards (ISO, IEC) and performance benchmarks relative to the predicate device. There is no clinical "ground truth" (like expert consensus, pathology, or outcomes data) presented for the HypnosPad's effectiveness in treating sleep apnea or snoring.
8. The Sample Size for the Training Set
There is no mention of a training set as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established
This point is not applicable as there is no training set mentioned.
In summary:
The provided K152660 document is a 510(k) summary demonstrating substantial equivalence of a physical medical device (HypnosPad) to a predicate. It relies on non-clinical performance data (bench testing, usability, biocompatibility) to establish that the new device is as safe and effective as the predicate. It does not contain a rigorous clinical study with specific acceptance criteria that would directly prove the device's efficacy in treating snoring or sleep apnea in a clinical population or the other types of performance criteria listed in your request related to AI or expert-driven assessments.
§ 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.”