(395 days)
A patient interface accessory for use with CPAP and bi-level systems used in the treatment of adult OSA and / or ventilatory support. A minimum pressure of > 3.0 cm H₂O at the mask is required. Single patient, multi-use
The EMS Multi-strap Full Face mask covers both the nose and mouth and includes a nonrebreathing / anti-asphyxia valve, which is activated under flow / pressure from a CPAP or bilevel ventilator. It is open to ambient air when the ventilator is not ON allowing the patient to breath ambient air. It has a quick release mask harness system. It is single patient, multi-use.
The information provided describes the Engineered Medical Systems, Inc. Multi-strap Full Face Mask and its 510(k) summary for clearance. However, the document does NOT contain a study that proves the device meets specific acceptance criteria with reported device performance metrics in the way a clinical or performance study for an AI/ML medical device would.
Instead, this 510(k) summary focuses on demonstrating substantial equivalence to predicate devices for a physical medical device (a CPAP mask). The "acceptance criteria" here are characteristics and design features that are compared to legally marketed predicate devices, rather than performance metrics from a formal study with a test set, ground truth, or expert review as typically seen in AI/ML device submissions.
Therefore, many of the requested fields cannot be directly answered from the provided text, as they pertain to performance studies not conducted or reported in this type of submission.
Here's the breakdown based on the provided text, addressing the points where information is available or inferable within the context of a substantial equivalence claim for a physical device:
1. Table of Acceptance Criteria and the Reported Device Performance
For this type of device, "acceptance criteria" are typically defined by functional specifications and comparison to predicate devices, demonstrating that the new device performs as intended and is as safe and effective. The "reported device performance" is a demonstration that these specifications are met and that the device is substantially equivalent to predicates.
| Attribute / Acceptance Criteria (as per functional specifications and comparison to predicates) | Reported Device Performance / Status (as per 510(k) summary) |
|---|---|
| Indications for use: A patient interface accessory for use with CPAP and bi-level systems used in the treatment of adult OSA and / or ventilatory support. A minimum pressure of > 3.0 cm H₂O at the mask is required. | Meets this indication, as it is the stated intended use. Substantially equivalent to predicates for this use. |
| Single patient, multi-use | Yes (device is designed for this) |
| Prescription | Yes (device is intended for prescription use) |
| Intended population: Any patient | Meets this intention. |
| Intended Environment of Use: Hospital, Sub-acute Institutions, Home | Meets this intention. |
| Mask covers nose and mouth | Yes (design feature) |
| Quick release mask harness | Yes (design feature) |
| Non-rebreathing / anti-asphyxia valve | Yes (design feature) |
| Must be used with exhalation valve in circuit | Yes (design feature/requirement) |
| Open to ambient when ventilator off | Yes (design feature) |
| Valve opens at > 3 cm H₂O | Yes (design feature, aligns with minimum pressure) |
| Can be cleaned | Yes (design feature, implies reusability for single patient) |
| Materials: Mask cone and Elbow - PC; Mask cushion - PVC; Flap valve - Silicone | Yes (materials specified and used) |
| Performance Standards: None under Section 514 | No specific 514 standards apply or are cited as met. |
| Overall Safety and Effectiveness | Demonstrated safe and effective, substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission focuses on substantial equivalence based on design, materials, and intended use comparison to predicate devices, not on a formal clinical or performance test study with a "test set" in the context of an AI/ML device.
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/provided. There was no "test set" requiring expert ground truth in the context of this 510(k) for a physical medical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. No "test set" requiring adjudication was reported.
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/provided. This is a submission for a physical medical device (CPAP mask), not an AI/ML diagnostic tool, and therefore no MRMC study would be relevant or expected.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This is a physical medical device; there is no "algorithm" or "standalone performance" in the context described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable/provided. For this physical medical device, the "ground truth" for demonstrating equivalence largely relies on engineering specifications, material properties, and comparison of functional design features to existing legally marketed devices.
8. The sample size for the training set
This information is not applicable/provided. This document does not describe a training set as would be relevant for an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable/provided. This document does not describe a training set or its ground truth establishment.
§ 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).