(149 days)
The intended use for the Nasal Mask Oral Appliance Holder is that is may be used with or without the complete Oral Appliance approved for Snoring and OSA to serve as an accessory to hold a Nasal Mask on a patient's face. The designed attachment can be fitted to hold the nasal mask in place via an oral appliance secured by the upper teeth of the patient. The accessory will have the same indications for use as those of the equipment to which it is an accessory.
- The Universal Nasal Mask Oral Appliance Holder includes the Extension Bracket with Mask Flange which attaches to the upper tray of the Oral Appliance, approved under K972061. This device would be considered an accessory to the Nasal Mask and is designed to hold the Nasal Mask in place. It is an alternative to the use of standard headgear. It is adaptable to several different nasal masks styles.
- In combination with the already approved, K972061, Oral Appliance which has both an upper and lower tray. The upper tray has a fitting which permits the attachment of the Extension Bracket with Mask Flange. This combined device permits therapy for OSA and snoring by an oral device and a positive airway pressure delivery device.
The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a clinical study with statistical endpoints. Therefore, many of the requested elements (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not typically included in this type of submission and are not present in the provided document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not outline specific numerical acceptance criteria or present quantitative performance data. Instead, it relies on a comparison of attributes and the assertion that "There is no significant difference" in performance relevant to safety and effectiveness compared to predicate devices. The "Performance Testing" section explicitly states "None applicable under Section 514" and "Equivalent leak rates," indicating that specific performance tests for this type of accessory device were not considered necessary beyond demonstrating functional equivalence.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Equivalence to predicate devices in function and intended use | "No significant difference between the intended device, Combination OA and Nasal Mask Holder and the Thornton TOA device approved under K972061 and the Respironics Head Gear." |
| "Equivalent leak rates" (Functional assertion, not quantified) | Stated as "Equivalent leak rates" without specific data. |
2. Sample Size and Data Provenance for Test Set
Not applicable. The document does not describe a clinical test set with a specific sample size. The demonstration of equivalence is based on a comparison of design attributes and intended uses with predicate devices.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. No ground truth establishment by experts is described, as this is a regulatory submission for device equivalence, not a performance study requiring ground truth.
4. Adjudication Method
Not applicable. There is no mention of adjudication, as this is not a study involving expert review or conflict resolution.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. No MRMC study was conducted or referenced. This type of study is more common for diagnostic or AI-driven devices where human interpreter performance is being evaluated.
6. Standalone Performance Study
Not applicable. No standalone performance study (algorithm only, without human-in-the-loop performance) was conducted or described. The device is a physical accessory, not an algorithm.
7. Type of Ground Truth Used
Not applicable. The submission relies on establishing substantial equivalence to existing, legally marketed predicate devices rather than validating performance against an independent "ground truth." The implicit "ground truth" is the established safety and effectiveness of the predicate devices.
8. Sample Size for the Training Set
Not applicable. This is a submission for a physical medical device accessory, not an AI or algorithm-driven device that typically requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).