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510(k) Data Aggregation
(50 days)
O2 NASAL CANNULA WITH CO2 MONITORING
O2 Nasal Cannula with CO2 monitoring is intended for use in Adult patients who require supplemental oxygen delivery and CO2 monitoring
O2 Nasal cannula with CO2 monitoring that is intended to situate under the patients nose with the prongs of the cannula inserted into patients nostrils where oxygen is administered and CO2 monitored. The O2 Nasal cannula with CO2 monitoring has two co-extruded tubes
This document is a 510(k) Summary for the Flexicare O2 Nasal cannula with CO2 monitoring. It details the device's characteristics and its substantial equivalence to a predicate device, but it does not describe acceptance criteria for an AI/ML powered device nor a study proving performance against such criteria.
The document addresses a medical device that does not incorporate AI/ML. Therefore, much of the requested information regarding AI/ML-specific testing (e.g., sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable and is not present in the provided text.
Here's an analysis based on the information provided, highlighting the absence of AI/ML-specific details:
1. Table of Acceptance Criteria and Reported Device Performance
The document sets out various physical and functional tests, comparing the Flexicare O2 Nasal cannula with CO2 monitoring to established standards and the predicate device. The "acceptance criteria" here are generally compliance with physical dimensions, material properties, and functional performance as outlined by relevant EN and ISO standards, or as performing "at least as well as" the predicate device.
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance | Comments |
|---|---|---|---|
| Material & Physical Properties | |||
| Components | Co extruded O2/CO2 tubing, luer connector (male/female), Cannula delivery/cannula prongs, O2 Connector, Tube slide, Y-piece, Venturi barrel, Hydrophilic filter (option) | Matches predicate and described components. | Not explicitly stated as "passed," but implied by substantial equivalence claim. |
| Materials | PVC, Polypropylene, ABS | Matches predicate and described materials. | Not explicitly stated as "passed," but implied by substantial equivalence claim. |
| Assembly Method | Bonded - Solvent adhesive | Matches predicate and described method. | Not explicitly stated as "passed," but implied by substantial equivalence claim. |
| Dimensional Specifications | |||
| Color/Size/Material | Devices displayed a high level of substantial equivalence. All within 0.1mm of each other. ID's are classed as critical for resistance/rate through tube. All materials are the same, with any differences being minor (e.g., color/finish). | Met criteria. | "All Samples passed the performance testing." |
| O2 Tubing ID | 3.9mm | 3.9mm | Confirmed by dimensional inspection. |
| O2 Tubing OD | 5.0mm | 5.0mm | Confirmed by dimensional inspection. |
| O2 Tubing Length | 2100mm | 2100mm | Confirmed by dimensional inspection. |
| CO2 Tubing ID | 1.4mm | 1.4mm | Confirmed by dimensional inspection. |
| CO2 Tubing OD | 2.7mm | 2.7mm | Confirmed by dimensional inspection. |
| CO2 Tubing Length | 2100mm | 2100mm | Confirmed by dimensional inspection. |
| Functional Performance | |||
| Nipple dimensions (on venturi barrel supplied with cannula) | In-House Test | Passed. | "All Samples passed the performance testing." |
| Strength of nipple (on venturi barrel supplied with cannula) | BS EN13544-2: 2002 +A1:2009 Annex A5 | Passed. | "All Samples passed the performance testing." |
| Tubing flow resistance | In-House Test | Passed. | "All Samples passed the performance testing." |
| O2 Connector to tubing tensile strength | In-House Test | Passed. | "All Samples passed the performance testing." |
| O2 Connector to nipple tensile strength | In-House Test | Passed. | "All Samples passed the performance testing." |
| Tube resistance to kinking | In-House Test | Passed. | "All Samples passed the performance testing." |
| Dimensional inspection of luer conical | ISO 594-1 / BS EN 20594-1:1994 | Passed. | "All Samples passed the performance testing." |
| Gauging tests on luer | In-House Test | Passed. | "All Samples passed the performance testing." |
| Liquid leakage from luer | In-House Test | Passed. | "All Samples passed the performance testing." |
| Air leakage from luer | In-House Test | Passed. | "All Samples passed the performance testing." |
| Luer separation force | ISO 594-2 (BS EN 1707:1997) | Passed. | "All Samples passed the performance testing." |
| Luer unscrewing torque | In-House Test | Passed. | "All Samples passed the performance testing." |
| Compliance with Standards | BS EN 13544-2: 2002 +A1:2009 Annex A4 and A5 | Yes | Implied by the "Conforms to: Yes" statement and successful testing. |
The study proving the device meets these criteria is described as "Tests Performed" on page 3 and summarized on page 4. It states: "All Samples passed the performance testing when tested against methods House test methods and relevant BS EN standards. The results of this testing show that the O2 Nasal cannula with CO2 monitor...performs at least as well as marketed predicate dev Unomedical."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the "test set" (i.e., the number of cannulas tested). It generically refers to "All Samples."
- Data Provenance: Not applicable in the context of device performance testing. The tests are physical and functional evaluations of manufactured units, not data-driven intelligence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the device is a physical medical device, not an AI/ML system requiring expert ground truth for classification or diagnosis. The "ground truth" for this device's performance is objective measurement against engineering specifications and industry standards.
4. Adjudication Method for the Test Set
This is not applicable as there is no human interpretation or classification involved that would require adjudication. Performance is measured objectively.
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 was not done, and this question is not applicable because the device is a physical nasal cannula, not an AI-assisted diagnostic or clinical decision support system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on engineering specifications, dimensional tolerances, and compliance with recognized industry standards (e.g., BS EN 13544-2, ISO 594-1, ISO 594-2). In-house test methods are also used for aspects not covered by specific standards. The implicit ground truth for "at least as well as" is the performance of the predicate device.
8. The Sample Size for the Training Set
This information is not applicable as the device is not an AI/ML system and does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is not an AI/ML system and does not have a "training set."
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