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510(k) Data Aggregation
(219 days)
OPT96X Model: The F&P Optiflow+ Duet is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (10 years and up) and adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway. This device is designed to be used in a hospital, sub-acute facility, or long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.
MYDUETXXX Model: The F&P Optiflow+ Duet is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (10 years and up) and adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway. This device is designed to be used in a long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.
The F&P Optiflow+ Duet Nasal Cannula is a nasal cannula interface for use with a respiratory gas humidifier and flow generator to deliver Nasal High Flow (NHF) therapy to spontaneously breathing patients. The F&P Optiflow+ Duet Nasal Cannula is a prescription-only device, provided in a non-sterile state and intended to be used in a hospital, sub-acute facility, or long-term (managed) care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional. The device is single patient use only for up to 14 days in the hospital and up to 30 days in the home/long-term care facilities.
This document is a 510(k) Premarket Notification from the FDA regarding a medical device, the F&P Optiflow+ Duet Nasal Cannula. It focuses on demonstrating the device's substantial equivalence to a legally marketed predicate device, rather than proving that an AI/ML powered device meets specific acceptance criteria.
Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes for test/training sets, expert consensus for ground truth, and MRMC studies for AI assistance cannot be extracted from this document, as it pertains to a different type of device and regulatory submission.
The document provides information on the non-clinical performance tests conducted for the F&P Optiflow+ Duet Nasal Cannula to demonstrate its substantial equivalence to its predicate device (F&P Optiflow+ Nasal Cannula OPT94X, K162553).
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not present acceptance criteria in a quantitative table format that shows a direct "acceptance criteria vs. reported performance" for the device's primary function in terms of a specific output (like an AI model's accuracy, sensitivity, or specificity). Instead, the "performance" is demonstrated through compliance with various international standards and general performance specifications like flow ranges.
However, we can infer some "performance" aspects from the comparison table on pages 6-7, although they are mostly qualitative or specify operating ranges.
| Characteristic / Test | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (F&P Optiflow+ Duet Nasal Cannula) |
|---|---|---|
| Product Code | BTT (Same as predicate) | BTT |
| Device Classification | 21 CFR §868.5450 (Same as predicate) | 21 CFR §868.5450 |
| Classification Panel | Anesthesiology (Same as predicate) | Anesthesiology |
| Indications for Use (General Equivalence) | Equivalent to predicate | More specific than predicate, but within its scope |
| Availability | Prescription Use (Same as predicate) | Prescription Use |
| Patient Population | Pediatric (10+) to Adult (More specific than predicate) | Pediatric (10 years and up) to adult. |
| Patient Acuity | Spontaneously breathing (Same as predicate) | Spontaneously breathing patients. |
| Patient Monitoring | Appropriate monitoring required (Same as predicate) | Appropriate patient monitoring must be used at all times. |
| Use Environment | Home, Hospital, sub-acute, long-term care facilities | Home and Hospital environment, sub-acute facilities, long-term (managed) care facilities (OPT96X Series); Home and long-term (managed) care facilities (MYDUET Series) |
| Reusability | Single patient-use only, < 14 days in hospital, < 30 days in home/long-term | Single patient-use, < 14 days in hospital/sub-acute, < 30 days in home/long-term |
| Number of Cannula Sizes | Small, Medium, Large (Same as predicate) | Small, Medium, Large |
| Headgear Adjustment Method | Identical to predicate | Headstrap through slots on Headstrap Buckle |
| Size Identification Color Coding | Identical to predicate | Small: Orange; Medium: Blue; Large: Green |
| F&P Airvo 2 System Flow Range | Small: 10–50 L/min; Medium/Large: 10–60 L/min | OPT962 (Small): 10–50 L/min; OPT964 (Medium): 10–60 L/min; OPT966 (Large): 10–60 L/min |
| F&P Airvo 3 System Flow Range | Small: 10–60 L/min; Medium/Large: 10–70 L/min | OPT962 (Small): 10–60 L/min; OPT964 (Medium): 10–70 L/min; OPT966 (Large): 10–70 L/min |
| MR850 System Flow Range | All sizes: 5-60 L/min | OPT962 (Small): 5-60 L/min; OPT964 (Medium): 5-60 L/min; OPT966 (Large): 5-60 L/min |
| F&P 950 System Flow Range | (Predicate not cleared for this system) | OPT962 (Small): 5-70 L/min; OPT964 (Medium): 5-70 L/min; OPT966 (Large): 5-70 L/min |
| F&P myAirvo System Flow Range | Small: 10-50 L/min; Medium/Large: 10-60 L/min | MYDUETSMALL: 10-50 L/min; MYDUETMEDIUM: 10-60 L/min; MYDUETLARGE: 10-60 L/min |
| Shelf life | Not claimed on predicate labeling | 3 years |
| Transport and Storage Temperature Range | -10 °C to +50 °C | -10 °C to +50 °C |
| Sterility | Device not provided sterile | Device not provided sterile |
| Biocompatibility (ISO 10993-1:2018; ISO 18562-1:2017) | Compliance with standards | Tested to standards |
| Conical Connectors (ISO 5356-1:2015) | Compliance with standard | Tested to standard |
| Usability Engineering (IEC 62366-1:2015+A1:2020) | Compliance with standard | Tested to standard |
| Packaging Integrity (ISTA 2A:2011) | Compliance with standard | Tested to standard |
2. Sample size used for the test set and the data provenance:
- This document does not specify a "test set" or "sample size" in the context of an AI/ML study.
- The "testing" mentioned refers to non-clinical bench testing and compliance with recognized standards. For these types of tests, sample sizes would be determined by the specific standard's requirements for the particular test (e.g., number of devices for flow rate testing, number of samples for biocompatibility).
- Data provenance (country of origin, retrospective/prospective) is not applicable here as it's not a clinical data study for an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable. The device is a physical medical device (nasal cannula), not an AI/ML algorithm requiring expert ground truth for image or data interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable, as there is no "test set" adjudicated by experts for an AI/ML algorithm.
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 information is not applicable. This is not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This information is not applicable in the context of an AI/ML device. For this physical device, "ground truth" would equate to established physical, chemical, and biological properties, and performance characteristics measured against industry standards.
8. The sample size for the training set:
- This information is not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- This information is not applicable. This is not an AI/ML device.
In summary, the provided document is a 510(k) clearance letter and summary for a physical medical device (nasal cannula) demonstrating substantial equivalence to a predicate device through non-clinical performance data and compliance with standards. It does not contain information related to AI/ML device acceptance criteria or studies.
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