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510(k) Data Aggregation
(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.
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(702 days)
The Airways Nasalflair is intended for use as a therapeutic device under the direction of qualified medical personnel. Nasalflair is used by patients who have been prescribed nCPAP as a treatment for Sleep Apnea. Nasalflair may be used with CPAP and flow generators capable of generating 20 t 2 cmH20 pressure via a 22mm I.D. main flow air supply tube.
Nasalflair is a device that fits into patient's nares in a way that makes a substantially airtight seal, which facilitates the delivery of nasal Continuous Positive Airway Pressure (nCPAP) The device has two cannulae that fit into the patient's therapy. nares. Surrounding the tip of each cannulae are cuffs that inflate to create a seal around the cannulae just inside the The cuffs are inflated through an aperture in the nares. cannulae wall with the same air and pressure the patient is Pressure inside the inflated cuffs is equal to the breathing. pressure in the airway, thereby providing an adequate airtight seal. The cuffed cannula tips are elliptical, and swivel for They snap onto and off of the J pieces maximum patient comfort. to facilitate cleaning and economical replacement. The J pieces They also have a fixed have a tab to hold a stabilizing strap. The J pieces curve orifice to provide a vent for exhalation. back up over the nose to the forehead area where they connect to A corrugated tube connects the Y piece to the flow a Y piece. generator.
Prescribed positive pressure is produced and regulated by the flow generator. Gas flow travels from the flow generator through a 22mm I.D. corrugated tube that connects to the Nasalflair wye piece which splits the flow and sends it through two flexible lSmm I.D tubes, each connects to a J shaped piece having cuffed cannulae that fit into patient's nares directing the air flow into the nasal passage, oral pharynx, trachea, and into the lungs .
The Y piece is attached to a soft nylon lined foam pad that rests on the patient's forehead and is held in place with adjustable hook/loop straps. Different types of head gear may be used depending on individual patient preference.
Despite the request for a comprehensive analysis, the provided text for K951944 on the "Nasalflair" device is a 510(k) summary from 1997, focusing on substantial equivalence to a predicate device rather than rigorous efficacy or safety studies with specified acceptance criteria.
Therefore, many of the requested categories for device acceptance criteria and study details cannot be fully or accurately addressed from the provided limited information.
Here's an attempt to extract and infer information based on the provided text, highlighting what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Explicitly Stated or Inferred) | Reported Device Performance (Nasalflair) |
|---|---|---|
| Flow and Pressure Equivalence | Sufficient flow to maintain desired CPAP pressure and satisfy peak inspiratory demands at rest across various CPAP generators and pressure levels (5, 10, 15, 20 cmH2O). | "Nasalflair and Adams Circuit are substantially equivalent at providing flow and pressure appropriate for nCAPA therapy." (Based on performance testing) |
| Airtight Seal Mechanism | Ability to create a "substantially airtight seal" for nCPAP delivery. | Achieves airtight seal with an inflatable cuff on the inner wall of the nares. (Mechanism different from predicate but achieves same function) |
| Patient Comfort/Toleration (Inferred) | Improved patient comfort/toleration compared to predicate, especially at higher CPAP pressures. | 10 patients intolerant to Adams Circuit due to mechanical pressure/discomfort tolerated Nasalflair. "Have found Nasalflair to be a safe and effective interface..." |
| Long-term Use (Inferred Safety/Effectiveness) | Safe and effective for extended use. | 10 patients used Nasalflair for >24 months, finding it safe and effective. |
| Nasal Dryness (Mitigation) | Ability to address potential nasal dryness. | Initial reports of nasal dryness mitigated by adding humidity, which is routine with predicate. Label cautions for optional humidity. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 10 patients for the clinical "effectiveness" evaluation. Performance testing (flow and pressure) used "five different commercially available CPAP flow generators" and "four different pressure levels" within a lab setting, not a patient-specific test set.
- Data Provenance: The clinical evaluation involved patients who "consented to use it as such" (not FDA approved at the time of the study), implying a prospective, small-scale clinical observation within a clinical setting. The country of origin is not explicitly stated, but the submission is from a US company (Matawan, NJ). It's likely a small-scale, internal clinical observation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "effectiveness" section describes a clinical observation with patients but does not detail how ground truth regarding their comfort, tolerance, or perceived effectiveness was formally established (e.g., through structured assessments by independent experts).
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the "clinical trials" (more an observational patient series), a formal adjudication method for patient outcomes or "ground truth" is unlikely to have been documented or implemented in the way it would be for a modern clinical trial assessing specific endpoints.
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
This is not applicable to this device. The Nasalflair is a medical device (nasal cannula for CPAP), not an AI diagnostic or interpretive system involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable to this device. The Nasalflair is a physical medical device, not an algorithm. Performance testing on flow and pressure was a standalone evaluation of the device's physical properties.
7. The Type of Ground Truth Used
- For Performance Testing (Flow and Pressure): "Substantial equivalence" to the predicate device's flow and pressure characteristics was the "ground truth" or benchmark. This was measured against established physical principles of fluid dynamics.
- For "Effectiveness" (Clinical Observation): The "ground truth" was largely anecdotal and observational:
- Patients' inability to tolerate the predicate device due to mechanical pressure.
- Patients' reported tolerance, comfort, and ongoing use of the Nasalflair, indicating perceived safety and effectiveness for positive pressure breathing therapy.
- Observation of mitigation strategies for side effects (e.g., adding humidity for dryness).
8. The Sample Size for the Training Set
This concept is not applicable in the context of this 1997 medical device submission. The Nasalflair is a physical device, not an AI model requiring a training set. The clinical observations were more akin to pilot testing or early user feedback, not a "training set" for an algorithm.
9. How the Ground Truth for the Training Set was Established
As above, this is not applicable as there was no "training set" for an AI model. For the clinical observations, the "ground truth" was established through direct patient experience and feedback (e.g., "Patients were selected who could not tolerate the mechanical pressure..."), and the clinicians' observations of continued use and reported satisfaction.
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