(258 days)
The F&P Optiflow™™ 3S nasal cannula is a 14 day single use nasal cannula interface for use with specified respiratory gas humidifiers to deliver Nasal High Flow (NHF) therapy to spontaneously breathing adult patients. This product is designed to be used by appropriately qualified healthcare professionals in a hospital / institutional environment.
The F&P Optiflow™ 3S Nasal Cannula is intended to be used in a hospital / institutional environment. A dual 22 mm male ISO taper and AIRVO™ specific connector allows connection to breathing circuits to receive humidified breathing gases from F&P 850™ and AIRVO™ systems. The F&P Optiflow™ 3S Nasal Cannula is offered in three sizes being small (S), medium (M) and large (L). The F&P Optiflow™ 3S Nasal Cannula is a prescription only device, provided in a nonsterile state.
The provided document (FDA 510(k) clearance K191818 for the F&P Optiflow 3S Nasal Cannula) focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data and a comparison of technological characteristics. It does not contain information about acceptance criteria, human study data (like MRMC studies), ground truth establishment by experts, or training set details for an AI/algorithm-based device.
This device is a medical accessory, a nasal cannula, and its clearance relies on demonstrating that its physical and functional properties, and biocompatibility, meet established standards and are comparable to a previously cleared device. The type of "performance data" presented is related to engineering and material testing, not diagnostic AI performance metrics.
Therefore, I cannot answer most of your questions based on the provided text. The document does not describe a study involving an algorithm or AI that requires the establishment of ground truth by experts, sample sizes for test/training sets in an AI context, or MRMC studies.
Here's what I can extract or infer based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implied by testing standards and comparison to predicate):
- Shelf life: Demonstrate a 3-year shelf life.
- Transportation robustness: Withstand transportation stresses (based on ISTA 2A).
- Humidification Output and Thermal Overshoot: Performance within acceptable limits.
- Gas path and headgear joint and connection strength: Maintain integrity under stress.
- Gas path leak: Maintain integrity to prevent leaks.
- Accumulated and emitted condensation: Remain within acceptable limits over 24 hours.
- Biocompatibility: Meet ISO 10993 series and ISO 18562 series requirements.
- Conical connectors: Comply with ISO 5356-1:2015.
- Functional equivalence to predicate: Perform similarly to the F&P Optiflow+ Nasal Cannula (K162553) in terms of flow ranges, system compatibility, and intended use.
- Reported Device Performance: The document states that "Performance testing of the F&P Optiflow™ 3S Nasal Cannula was completed to demonstrate substantial equivalence of the F&P Optiflow™ 3S Nasal Cannula to the predicate device." And "The comparison of features, performance, and intended use demonstrate that the F&P Optiflow™ 3S Nasal Cannula is substantially equivalent to the predicate F&P Optiflow+ Nasal Cannula (K162553)."
- Specific quantitative performance data for these tests (e.g., exact leak rates, condensation levels, strength values, or thermal overshoot figures) are not provided in this summary, but the conclusion is that the device met the criteria. The document states a claim of "3 years" shelf life which implies it was demonstrated.
Regarding your questions directly asking about AI/Algorithm study specifics:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This is not an AI/algorithm device. The "performance testing" refers to physical product testing (e.g., durability, leaks, biocompatibility), not data analysis.
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 provided. Ground truth in the context of expert review for AI performance is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
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/Not provided. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable/Not provided. The "ground truth" for this device would be established engineering specifications and biological safety standards.
8. The sample size for the training set
- Not applicable/Not provided.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).