(114 days)
The F&P Simplus™ Full Face Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The F&P Simplus™ Full Face Mask is intended for Single Patient Adult Use in the home and Multiple Patient Adult Use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
The F&P Simplus™ Full Face Mask is a non-invasive patient interface. The mask includes a silicone seal which covers the nose and mouth of a patient and is held in place by adjustable headgear straps. The mask connects to a single breathing tube via a swivel adaptor to receive pressurized gases. The gases delivered to the patient may be humidified and/or oxygen enriched. The exhaust holes on the mask housing allow exhaled air to be flushed out while the system is in operation. An oxygen pressure port accessory is available to be used with the device for oxygen therapy and/or gas monitoring.
The provided text describes the F&P Simplus™ Full Face Mask, a non-invasive patient interface for CPAP or Bi-Level Ventilator treatment. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way a clinical study or AI algorithm validation would.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. This means the device met existing standards and showed performance comparable to already approved masks, rather than proving novel performance against a new set of acceptance criteria.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable or not present in this type of regulatory submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance: Substantial equivalence to predicate K040506 Flexifit™ Series HC431 Full Face Mask for general performance. | Testing demonstrates substantial equivalence to predicate K040506 Flexifit™ Series HC431 Full Face Mask. |
| Material Biocompatibility: Substantial equivalence to predicate K121597 Eson Nasal Mask for biocompatibility. | Testing demonstrates substantial equivalence to predicate K121597 Eson Nasal Mask. |
| Adherence to Standards: Compliance with ISO 17510-2:2007 (Sleep Apnea Breathing Therapy - Part 2: Masks and Applications Accessories). | The device "has been tested to" ISO 17510-2:2007. |
| Adherence to Standards: Compliance with ISO 10993-1:2009 (Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process). | The device "has been tested to" ISO 10993-1:2009. |
Explanation of "Acceptance Criteria" here: The "acceptance criteria" are implied by the regulatory requirement to demonstrate substantial equivalence to legally marketed predicate devices and to comply with relevant consensus standards. The "reported device performance" is the conclusion that this equivalence and compliance have been met.
2. Sample size used for the test set and the data provenance:
- Not applicable / Not specified in this document. The document refers to "test reports" in Appendix A, but the content of these reports (including sample sizes and data provenance) is not provided in the summary. For devices like full face masks, "testing" often involves bench testing (e.g., pressure-flow characteristics, dead space, exhalation port performance) and biocompatibility testing on materials, rather than a clinical "test set" of patients with associated provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This type of information is relevant for studies validating AI algorithms or subjective diagnostic devices. For a physical medical device like a mask, "ground truth" often refers to objective measurements and adherence to engineering specifications and international standards, not expert consensus on medical images or diagnoses.
4. Adjudication method for the test set:
- Not applicable. See point 3.
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. This document describes a physical medical device (a mask), not an AI algorithm. Therefore, an MRMC study related to AI assistance is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI algorithm. The device is a physical mask for CPAP/Bi-Level ventilation.
7. The type of ground truth used:
- For performance, the "ground truth" is implied to be adherence to the performance characteristics of the predicate device (K040506 Flexifit™ Series HC431 Full Face Mask) and compliance with the technical requirements and safety limits defined in ISO 17510-2:2007.
- For biocompatibility, the "ground truth" is adherence to the material safety and biocompatibility standards demonstrated by the predicate device (K121597 Eson Nasal Mask) and compliance with ISO 10993-1:2009.
- The document implies that "test reports" (in Appendix A, not provided) contain the detailed data supporting these conclusions, likely involving objective measurements and laboratory analyses.
8. The sample size for the training set:
- Not applicable. This is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).