(187 days)
The Invacare Model Twilight Nasal CPAP Mask is intended to be used with positive airway pressure devices such as CPAP, to provide 3-20 cmH2O for the treatment of adult obstructive sleep apnea. The mask is to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single patient use.
The Twilight nasal mask is a prescription device intended for use with Continuous Positive Airway Pressure (CPAP), and Bi-Level devices. It is intended to provide a single patient use interface for the delivery of CPAP or Bi-Level therapy to adult patients (>30Kg). It is designed for use with CPAP and Bi-Level delivery systems having pressure ranges from 3-20 cmH2O.
The Twilight nasal mask consists of a mask that fits over the nose of the patient and a headgear to hold the mask in place. The mask has a removable molded silicone cushion that seals around the patient's nose. A standard and a large cushion are designed for use with the same mask. This also allows for replacement of a worn or damaged cushion without the need to replace the entire mask. The cushion mounts into a rigid polycarbonate shell by means of a flanged area that fits snugly between the wall of the mask shell and an inner retaining ring that is permanently mounted into the shell.
The mask includes an opening that accepts a standard, flexible, 22cm OD breathing tube. The breathing tube is connected to the output of the CPAP/Bi-Level delivery device, and to the input of the Invacare Twilight Nasal Mask. The mask is then placed over the users' nose and mouth. The flexible tube provides a transition between the more rigid output tube of the delivery device, and the mask, thus allowing freedom of movement while maintaining patient circuit integrity.
The provided text describes a 510(k) submission for the Invacare Model Twilight Nasal Mask. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance metrics described in typical AI/ML medical device studies.
Therefore, much of the requested information (acceptance criteria, performance tables, sample sizes for test/training sets, expert qualifications, ground truth methodology, MRMC studies, standalone performance) is not applicable or not provided in the context of this 510(k) summary.
Here's a breakdown of what can be extracted and what is not available:
1. Table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance. The "acceptance criteria" for a 510(k) submission are typically related to demonstrating substantial equivalence through comparison of technological characteristics and performance data to predicate devices.
- Reported Device Performance: The document states:
"A number tests were conducted on the Invacare Model Twilight Nasal Mask. In all cases the mask performed as designed and intended."
This is a general statement and does not provide specific performance metrics (e.g., leak rate, comfort scores, efficacy in treating OSA) that would typically be found in a clinical study report. It implies that the engineering and design validation tests were successful.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. The document mentions "a number tests" but does not specify the type of tests (e.g., patient trials, bench testing), the number of subjects/samples, or the nature of the data (prospective, retrospective, country of origin).
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 / Not Available. This device is a physical medical device (nasal mask) for CPAP therapy, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth for its performance evaluation in the way imaging algorithms do. Performance testing likely involved engineering validation and possibly limited human factors testing, but not "ground truth" establishment by experts in the sense of image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Available. As above, this concept (adjudication of expert readings) does not apply to the type of performance evaluation described for a CPAP nasal mask in a 510(k) 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. An MRMC study is relevant for AI-assisted diagnostic or interpretive tasks. This device is a CPAP nasal mask and does not involve "human readers" or "AI assistance" in that context.
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 consensus, pathology, outcomes data, etc.)
- Not Applicable. See points 3 and 4. The performance of a nasal mask is evaluated based on its physical properties, comfort, seal, and ability to deliver prescribed pressure, as demonstrated through engineering tests and potentially user feedback, rather than against a medical "ground truth" for diagnosis.
8. The sample size for the training set
- Not Applicable / Not Available. This device is not an AI/ML model; therefore, there is no "training set" in the computational sense.
9. How the ground truth for the training set was established
- Not Applicable. This device is not an AI/ML model.
§ 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).