(366 days)
The Clarissa Infant nCPAP Cannula is intended to be used for the administration of continuous positive airway pressure (CPAP) on continuously monitored neonatal and infant patients in the hospital/institutional environment.
The Clarissa Infant nCPAP Cannula is a soft hollow medical grade silicone coaxial pouch with protruding silicone cannula tips that fit into the infant's nares. Continuous flow circulates through the coaxial pouch under positive pressure from which the patient breathes via the cannula. The distal end of the pouch has a swivel adapter with three external ports and one external port. One external port is for pressure and the other two are in-flow and out-flow ports which are bi-directional. The internal port on the swivel adapter is the connection for the internal tube leading to the proximal cannula to minimize dead space.
The provided text is a 510(k) Summary for the Clarissa™ Infant nCPAP Cannula (K032922). It describes a medical device, and the data provided focuses on demonstrating substantial equivalence to predicate devices rather than detailing a study that establishes acceptance criteria and then proves the device meets those criteria with specific performance metrics and statistical analyses typically associated with AI/software devices.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details, ground truth for training set) are not applicable or cannot be extracted from this type of regulatory document for a physical medical device. The document emphasizes performance equivalency through physical testing rather than algorithmic performance evaluation.
Here's an attempt to answer the questions based only on the provided text, indicating when information is not available or not applicable:
Acceptance Criteria and Study Details for Clarissa™ Infant nCPAP Cannula (K032922)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Essentially equivalent flow resistance to predicate devices | "provides essentially equivalent flow resistance" |
| Essentially equivalent dead space volume to predicate devices | "provides essentially equivalent... dead space volume" |
| Functional equivalence to predicate devices (general performance) | "performance is essentially equivalent to the above listed predicate devices" |
| Appropriate for continuous positive airway pressure (CPAP) administration on continuously monitored neonatal and infant patients in the hospital/institutional environment. | Intended Use (as described) is supported by testing demonstrating equivalency to devices with this intended use. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document refers to "test data" but does not give specific numbers of devices or tests performed.
- Data Provenance: Not specified, but generally, such tests are conducted in-house by the manufacturer or by third-party testing labs. Given the nature of physical device testing, it would be prospective, directly testing the Clarissa™ device.
- Country of Origin: The manufacturer, Airways Development, LLC, is based in Kenilworth, NJ, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a physical medical device; its performance is assessed through objective physical measurements (like flow resistance and dead space volume) rather than subjective expert interpretation for ground truth.
4. Adjudication method for the test set
- Not Applicable. See explanation above. Physical measurements are typically compared directly to established benchmarks or predicate device results, not adjudicated by experts in the context of ground truth.
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. This is a physical medical device, not an AI or software device involving human readers or interpretation of data.
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
- Ground Truth: For performance metrics like "flow resistance" and "dead space volume," the "ground truth" would be the objective physical measurements obtained from testing the Clarissa™ device and comparing them to measurements from the legally marketed predicate devices. The equivalence to predicate device performance is the basis for regulatory clearance.
8. The sample size for the training set
- Not Applicable. This is a physical medical device; there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not Applicable. See explanation above.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).