(154 days)
Indicated to provide assisted ventilation to someone requiring assisted ventilation, breathing or resuscitation, by use of a mouth to mask method. Patient population is child / infant and adult. Those with oxygen port are prescription devices and those without the oxygen port are OTC.
The EMS Mouth to Mask resuscitators are a combination of components winion include a lave mask, one way valve, filter and mouthpiece offered with different sizes of face mask, packaging, clam shell and poly bag, and with or without flex tube extension. They are available in several styles - Flex Tube which is an assembly of a flex tube, mouthpiece, one way valve and face mask (can be different sizes). This product is preassembled and packaged in a poly bag. Collapsible style - This product includes a one way valve and a face mask which can be collapsed to fit into a "clam shell" style package. Besides the face mask being designed to collapse, the one way valve and mouthpiece can be removed so that all the components fit into the clam shell package. Each style - Flex Tube and Collapsible - can incorporate a supplemental oxygen delivery port. This port is located on the one way housing. This port is a standard tapered fitting which connects to standard oxygen tubing.
The provided documents describe a 510(k) submission for the EMS Mouth to Mask Resuscitators and primarily focus on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study proving the device meets specific performance acceptance criteria. Therefore, many of the requested sections (2-9) cannot be fully addressed from the given text.
However, based on the provided information, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the same way one might expect for a quantitative performance study (e.g., accuracy, sensitivity, specificity). Instead, the acceptance criteria are demonstrated through a comparative table showing the substantial equivalence of the EMS Mouth to Mask Resuscitators to predicate devices in terms of intended use, environment of use, and various physical characteristics and claims.
| Acceptance Criteria (Predicate Device Characteristics) | Reported Device Performance (EMS Mouth to Mask Resuscitators) |
|---|---|
| Indicated for use in resuscitation | Yes |
| To be placed in contact with the patient's face | Yes |
| Indicated for single use | Yes |
| Indicated population - adult and child / infant | Yes |
| Environment Home, EMS, Hospital | Yes |
| Unit with oxygen port prescription device | Yes |
| Unit without oxygen port is OTC | Yes |
| Utilizes a face mask for patient seal | Yes |
| Face mask cushion pre-inflated | Yes |
| Offered in 2 face mask sizes | Yes |
| Made in clear materials | Yes |
| Utilizes a one way valve to direct air flow from user to patient | Yes |
| Exhaled patient breath diverted to atmosphere away from giver | Yes |
| Has an integral particulate / barrier filter | Yes |
| Has a flex tube and mouth piece | Yes |
| Packaged in a "clam shell" or poly bag | Yes |
| Can incorporate an oxygen delivery port | Yes |
| Materials of filter media - 3 M Filtrete | Yes |
| Mask cushion - PVC | Yes |
| Duckbill valve / one way - SR synthetic rubber | Yes |
| Housing materials - Polycarbonate, K-resin | Yes |
| Extension tube - Polyethylene | Yes |
| Elastic band - polypropylene (PP), latex | Yes |
| Case - polyethylene (PE) | Yes |
| Meets appropriate sections of ASTM 920-93 | Yes |
| None required under Section 514 (regarding performance standards for non-rebreathing valve) | Yes |
| Filtration efficiency claims | None |
The study proving the device meets these "acceptance criteria" is the 510(k) submission itself, which demonstrates substantial equivalence to predicate devices. The document explicitly states: "There are no significant differences between the intended devices and the predicates." This statement implies that the EMS Mouth to Mask Resuscitators perform equivalently to the predicate devices, which are already legally marketed.
2. Sample size used for the test set and the data provenance
Not applicable in the context of this 510(k) summary. This document does not detail a study involving human subjects or real-world data collection for performance evaluation in the way a clinical trial or AI model validation would. The "test set" here refers to the comparison of the proposed device's specifications against those of predicate devices. The data provenance is implied to be internal documentation from Engineered Medical Systems, Inc. and publicly available information about the predicate devices (Formosa Health Partners - CPR Super - K953230 and Intertech - MTM - K871407).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this type of submission is the established performance and safety profile of the predicate devices and relevant regulatory standards (e.g., ASTM 920-93). There is no mention of external experts establishing a ground truth for a test set in this document.
4. Adjudication method for the test set
Not applicable. There was no explicit adjudication method for a test set mentioned in this document. The FDA's review process of the 510(k) determines substantial equivalence.
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
Not applicable. This device is a physical medical device (resuscitator), not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) submission is primarily based on the established performance and safety of legally marketed predicate devices and adherence to recognized performance standards (e.g., appropriate sections of ASTM 920-93). The comparison is largely based on specifications, materials, and intended use.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" in this context as it's a submission for a physical device, not a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable. (See answer to #8).
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).