(68 days)
The Lyra™ Nasal Mask is intended for use with devices that deliver Continuous Positive Airway Pressure (CPAP) and bi-level positive airway pressure in treating adult patients.
The Lyra™Nasal Mask is intended for the delivery of air from either a CPAP or bi-level instrument (delivery device). The breathing circuit consists of the Lyra, which directly interfaces with the patient, and a pair of tubes, which connect the Lyra to the delivery device. The delivery device provides positive pressure air to the patient via the tubes and the Lyra™. Exhalation ports on the Lyra™ allows patient-exhaled gases to exhaust to the atmosphere.
The Lyra™ consists of the following:
- two nasal prongs, which are easily removed or installed into a mask body for the interchange of different sizes, and for easy cleaning of the device;
- adjustable head gear, which keeps the nasal mask in place during use;
- a pair of tubings, with one end of the tubings attached to the mask body;
- a standard 22-mm swivel which attached to the other end of the tubings.
The delivery device interfaces with the swivel via corrugated tubing, with a standard 22mm fitting.
The Lyra™ nasal prongs, made from a soft, flexible silicone, form a seal with the patient's nares. The nasal prongs come in different sizes for better and more comfortable fit for patients with varying nares sizes.
The Lyra™ is packaged, along with instructions for use and recommended cleaning instructions, in a poly bag. The Lyra™ can be completely disassembled for cleaning. Mild soap and water may be used to clean the device.
The provided text describes a medical device, the Lyra™ Nasal Mask, and its 510(k) submission for market clearance. While it discusses the device's description, intended use, and a comparison to a predicate device, it does not contain detailed information about a clinical study with specific acceptance criteria and performance metrics in the way that would typically be presented for an AI/ML device.
This submission is for a physical medical device (a nasal mask), and the "performance testing" described is much simpler and focuses on physical characteristics compared to a software-based diagnostic or prognostic device.
However, I can extract the information that is present and highlight what is missing based on your request.
Here's a breakdown based on the provided text:
Acceptance Criteria and Device Performance (Based on "LACK OF" detailed clinical study)
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Leak Rates | Comparable to Nasal Aire™ (predicate device, K022465). |
| Dead Space | Comparable to Nasal Aire™ (predicate device, K022465). |
| Environmental Performance | Within parameters as claimed in Nasal Aire™'s labeling. |
| Cleaning Performance | Within parameters as claimed in Nasal Aire™'s labeling. |
| Substantial Equivalence | The Lyra™ Nasal Mask is substantially equivalent to the predicate device (Innomed Technologies' Nasal-Aire™ Nasal Mask K022465) for its intended use, particularly through "comparative bench testing" of leak rates, dead space, environmental, and cleaning tests. This is the overarching "acceptance criterion" for 510(k) clearance for a physical device like this, rather than specific performance metrics from a full clinical trial. |
Missing Information (Not provided in the document for the Lyra™ Nasal Mask):
Many of your requested points relate heavily to the evaluation of AI/ML-based medical devices or more extensive clinical trials, which are not detailed in this 510(k) summary for a physical medical accessory.
- Sample size used for the test set and the data provenance: Not applicable in the context of this device's "bench testing." The "test set" here refers to the actual physical devices tested, not patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device parameters (like leak rates) in bench testing does not involve medical experts in the same way an AI diagnostic would.
- Adjudication method: Not applicable for bench testing of a physical device.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not mentioned. Such studies are typically for diagnostic AI systems.
- 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.
- The type of ground truth used: For physical parameters like leak rates and dead space, the "ground truth" would be objective measurements obtained through standardized bench testing methods, not expert consensus, pathology, or outcomes data.
- The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable for the same reason.
In summary: The provided text details a 510(k) submission for a physical nasal mask. The "study" proving it meets "acceptance criteria" is a comparative bench testing against a predicate device, focusing on physical parameters like leak rates, dead space, environmental performance, and cleaning. The primary "acceptance criterion" for 510(k) clearance in this context is demonstrating substantial equivalence to a legally marketed predicate device. The document explicitly states: "There are no known mandatory or voluntary performance standards applicable to this device classification."
§ 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).