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This breathing set is an accessory to the F&P 950 Respiratory Humidifier to be used within the limits of its stated technical specifications.

It is intended for delivery of heated humidified high flow respiratory gases to adult patients in a hospital.

This product can be used on multiple patients when used with a hydrophobic filter between the product and the patient interface for a maximum of 24 hours after setup.

This product is for use by appropriately qualified healthcare professionals who perform anesthesia care and airway management.

The Fisher & Paykel Healthcare (F&P) Optiflow™ Oxygen Kit is a multiple-patient use breathing tube kit. This F&P Optiflow™ Oxygen Kit is presented as the AA451J.

The kit consists of a dry line, water bag, humidification chamber, inspiratory limb, tubing clips and datechange stickers.

The flow source delivers gas through a dryline to a humidification chamber that sits on a humidifier. As the gas passes through the chamber, it is heated and humidified. The gas then flows through the inspiratory limb, through a hydrophobic filter and then through a patient interface into the patients' upper airway via the nose.

The AA451J kit delivers humidified respiratory gases at flows from 5 to 70 L/min. When used with an FDAcleared hydrophobic filter, the AA451J kit can be used on multiple patients. The kit is reprocessed between each patient. The kit can be exposed to a maximum of 30 reprocessing cycles and used for a maximum of 24 hours after setup.

The scope of this 510(k) submission is limited to the AA451J, F&P Optiflow™ Oxygen Kit. The flow source, humidifier, hydrophobic filter and interface are not in the scope of this submission.

The provided text does not contain information about the acceptance criteria or a study proving that a software device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a physical medical device, the "F&P Optiflow Oxygen Kit (AA451J)," which is a breathing set accessory for a respiratory humidifier.

The sections titled "PERFORMANCE DATA" (Section VII) and "CONCLUSION" (Section VIII) discuss performance testing, but this refers to non-clinical tests for the physical device's safety and effectiveness, such as biological evaluation, electrical safety, and respiratory humidifying equipment standards (e.g., ISO 10993-1, ISO 80601-2-74, IEC 60601-1). These tests are typically laboratory-based and relate to the device's physical properties, material compatibility, and functional performance (e.g., flow rates, humidification).

Therefore, I cannot provide the requested information regarding acceptance criteria for a software device based on the given input, as the document pertains to a hardware medical device.

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This product delivers respiratory gases to adult patients. It is intended for use with an MR810 humidifier at flows from 5 to 70 L/min. This product can be used on multiple patients when used with a hydrophobic filter between the product and the patient interface for a maximum of 24 hours after set-up.

This product is indicated for the delivery of Nasal High Flow (NHF) by appropriately qualified healthcare professionals under the direction of a physician anesthesiologist in a medical room. Qualitative carbon dioxide sampling can be used at nasal cannula flow rates from 5 to 50 L/min.

This product can be used for pre-oxygenation and short-term supplemental oxygenation (up to 10 minutes) during intubation in operating rooms under the direction of a physician anesthesiologist.

This product is not intended for apneic ventilation.

The Fisher & Paykel (F&P) Optiflow™ Oxygen Kit consists of a dry line, humidification chamber inspiratory tube, and tubing clips. The dryline transfers the respiratory gases from a flow source to the humidification chamber. The humidification chamber provides a reservoir filled to an indicated maximum level with sterile water. As the humiditier heats the water in the chamber, water vapor is formed, which heats and humidifies the respiratory gases delivered from the dryline. The respiratory gas is then transferred to the inspiratory tube. The inspiratory tube (also known as inspiratory limb) electrically heats the respiratory gas utilizing a heater wire to maintain the temperature of the gas. The inspiratory tube delivers the gas through an FDA-cleared filter and interface. The filter and the patient interface are not in the scope of this submission. The tubing clips are attached to the inspiratory tube. They are used to connect the tube to the hospital bed sheet or pillow.

The device delivers gas at flow rates between 5 and 70 L/min. The device is to be used by medical professionals on multiple patients over a 24-hour period.

Only the Optiflow™ Oxygen Kit is part of this 510(k) submission. The flow source, humidifier, filter and interface are not in the scope of this submission.

The document provided is a 510(k) Premarket Notification from the FDA for a medical device called the "Optiflow™ Oxygen Kit." This type of document focuses on demonstrating substantial equivalence to a predicate device rather than explicitly detailing acceptance criteria and performance data in the context of an AI/ML medical device.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device is not available in the provided text.

The document describes the device itself, its intended use, comparison to a predicate device (AirSpiral Heated Breathing tube), and the non-clinical testing performed to demonstrate its safety and effectiveness for a respiratory gas delivery system.

Here's what can be extracted from the document, though it doesn't align with the specific AI/ML questions:

1. A table of acceptance criteria and the reported device performance:

The document does not present a table of acceptance criteria for an AI/ML model. Instead, it describes various performance tests for a respiratory device to ensure it meets safety and effectiveness requirements. These are primarily engineering and material performance criteria.

• Transportation testing: Performed following transport and storage simulation (ISTA 2A:2011).
• Mechanical strength testing: Performed following push, impact, drop, and mold stress relief conditioning (IEC 60601-1 15.3.2, 15.3.3, 15.3.4, and 15.3.5).
• Cleaning and low-level disinfection: Validated as per indications for use. |
  | Additional Performance Testing | - Permanent connections test
• Removable connections test
• Gas delivery test
• Resistance to flow test |
  | Standards Compliance | - ISO 80601-2-74:2017(E) (Respiratory humidifying equipment)
• IEC 60601-1-2 4th 2014 (Electromagnetic disturbances)
• IEC 62366-1:2015 (Usability engineering)
• ISO 5356-1:2004 (Anesthetic and Respiratory Equipment- Conical Connectors) |
  | Biocompatibility | - Evaluated according to ISO 10993-1:2018 and ISO 18562-1:2017. |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the device is a physical respiratory kit, not an AI/ML model that processes data. The tests are physical and laboratory-based.

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)

This information is not applicable. Ground truth, in the context of an AI/ML model, refers to validated data labels. For a physical device, testing involves standard engineering and medical device compliance procedures by qualified personnel (e.g., engineers, lab technicians), not medical experts establishing a "ground truth" for interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are relevant for human interpretation of data, often used in labeling datasets for AI/ML validation. This is not a component of testing a physical respiratory device.

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. MRMC studies are designed to assess the diagnostic performance of human readers, typically with and without AI assistance, for image-based or similar data. The Optiflow™ Oxygen Kit is a direct medical device for gas delivery, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This question pertains to AI/ML algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable. See point 3.

8. The sample size for the training set

This information is not applicable. This device does not use a "training set" in the AI/ML sense.

9. How the ground truth for the training set was established

This information is not applicable. This device does not have a "training set" or "ground truth" in the AI/ML sense.

In summary, the provided FDA 510(k) document concerns a traditional medical device (respiratory gas delivery kit) and its approval based on substantial equivalence and non-clinical performance testing. It does not contain any information relevant to the development, validation, or acceptance criteria for an AI/ML-based medical device.

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