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Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of:
Infant: 23 Kg

Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of:
Infant: 23 Kg

This manual resuscitator is supplied with a single patient use positive end expiratory pressure (PEEP) valve for use hospital, transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions.

Single patient use device for use hospital, transport, emergency, and post hospital care for the elevation of lung pressure above atmospheric pressure at the end of exhalation.

GaleMed DISPO-BAG Manual Resuscitation Bags are disposable, medical devices which temporarily augment ventilation in patients during ventilatory insufficiency or ventilatory failure. GaleMed DISPO-BAG Manual Resuscitation Bags use a duck-bill valve in the non-rebreathing valve assembly, attaches the non-rebreathing valve directly onto the ventilation bag and includes an oxygen enrichment (reservoir) system.

GaleMed Disposable PEEP Valves are disposable medical devices which elevate the pressure in a patient's lungs above atmospheric pressure at the end of exhalation. The GaleMed Disposable PEEP Valve is a, spring actuated valve, which when placed into a circuit provides positive end expiratory pressure for the patient. The valve is provided in two pressure ranges (5-20 cmH2O and 2.5 - 10 cm H2O) and several connector sizes which comply to ISO 5356- I "Anesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets". Likewise the GaleMed single patient use fixed value PEEP valve is a, spring actuated valve, which when placed into a circuit provides positive end expiratory pressure for the patient. The valve is provided in two pressure settings of 2.4, 5.0, 7.5 and 10.0 cmHzO) also offered in several connector sizes which comply to ISO 5356- I "Anesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets".

The provided text describes a 510(k) premarket notification for the GaleMed DISPO-BAG Manual Resuscitator, the DISPO-BAG Manual Resuscitator with Disposable PEEP Valve, and the Disposable PEEP Valve. This document primarily focuses on establishing substantial equivalence to predicate devices, rather than detailing a specific study to prove the device meets acceptance criteria in the typical AI/CAD sense.

The "study" referenced here is the bench testing conducted to confirm the accuracy and compliance of the devices with relevant international standards.

Here's an analysis based on the provided text, structured to answer your questions where applicable. However, many of your specific questions related to AI/CAD system studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not relevant or applicable to this type of medical device submission. This submission is for a physical medical device (resuscitator/PEEP valve), not an AI/CAD diagnostic software.

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

The acceptance criteria are primarily defined by compliance with established international standards for resuscitators and connectors. The reported device performance is that the devices meet these requirements.

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

• Sample Size for Test Set: Not specified in the document. This would typically involve testing a statistically representative sample of physical devices according to the test protocols outlined in the relevant ISO standards.
• Data Provenance: The bench testing would have been conducted by the manufacturer, GaleMed Corporation, based in I-Lan, Taiwan. The data is prospective in the sense that the devices were manufactured and then tested to confirm their performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for this type of device. Ground truth for a physical device like a resuscitator or PEEP valve is established by meeting engineering specifications and performance metrics defined by international standards, not by expert interpretation of data or images. The "ground truth" is whether the device physically performs as required by the standards (e.g., delivers the correct pressure, fits correctly, etc.).

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

Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images where expert consensus is needed to establish ground truth for a diagnostic task. This document details bench testing of a physical 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

Not applicable. This is for a physical medical device, not an AI/CAD system. There are no "human readers" or "AI assistance" involved in its primary function.

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

Not applicable. This is not an AI algorithm. The device, when used by a healthcare professional, performs its function directly.

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

The ground truth used for this device is compliance with international performance standards (ISO 10651-4:2002 and ISO 5356-1:2004) and bench testing confirmed accuracy for stated pressure ranges. This is an engineering/performance-based ground truth, not a clinical diagnostic ground truth.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. There is no training set for this device.

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