(205 days)
Single patient use manual resuscitator for use in hospital, transport, emergency, and post-hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: less than or equal to 10 kg Child: less than or equal to 23 kg Adult: greater than 23 kg
Disposable manual resuscitator is disposable, medical device, which temporarily augment ventilation in patients during ventilatory insufficiency or ventilator failure. Disposable manual resuscitator uses a duck-bill valve in the non-rebreathing valve assembly, attaches the non-rebreathing valve directly onto the resuscitation bag and includes an oxygen enrichment (reservoir) system. Disposable manual resuscitator may be used in hospital, transport, emergency, and post hospital care to temporary ventilate a patient. Disposable manual resuscitator is for single patient used. It comprises of mask, oxygen tube, reservoir bag and resuscitator bag. It is used to temporary ventilate a patient for the given body mass ranges of: Infant - Less than or equal to 10 kg Child - less than or equal to 23 kg Adult - Greater than 23 kg.
The provided text is a 510(k) premarket notification for a medical device (Disposable Manual Resuscitator). This document outlines the manufacturer's claim of "substantial equivalence" of their device to a legally marketed predicate device.
Crucially, this document is NOT a study report for an AI/ML powered medical device, nor does it contain information about establishing ground truth, multi-reader multi-case studies, or training sets in the context of AI/ML.
The "Performance Data" and "Summary of Device Testing" sections refer to the physical and functional performance of the manual resuscitator as per established medical device standards (e.g., ISO 10651-4, ISO 5356-1, ISO 10993). These are tests for mechanical and material properties, not an AI algorithm.
Therefore, I cannot extract the information required for bullet points 1 through 9 from the provided text, as those points are specific to the validation of AI/ML systems.
Here's a breakdown of why the requested information cannot be found in this document:
- Acceptance Criteria for AI/ML and Reported Device Performance (Table 1): The document's "Performance Data" section in Table 1 refers to physical characteristics of a manual resuscitator (e.g., "Ventilation Bag Volume," "Max Delivered Volume," "Expiratory resistance," "Supplemental Oxygen%"). These are not acceptance criteria or performance metrics for an AI/ML algorithm.
- Sample Size for Test Set and Data Provenance: This pertains to data used to evaluate AI. The document describes testing of physical products, not data sets.
- Number of Experts and Qualifications for Ground Truth: No AI is involved, so no ground truth established by experts is mentioned.
- Adjudication Method: Not applicable for a non-AI physical device.
- Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: This is for evaluating changes in human performance with AI assistance. Not relevant here.
- Standalone (Algorithm Only) Performance: Not applicable as it's not an algorithm.
- Type of Ground Truth Used: Not applicable.
- Sample Size for Training Set & How Ground Truth for Training Set was Established: These concepts are central to AI/ML model development. The document describes product manufacturing and testing processes, not AI training.
In summary, the provided document details the regulatory submission for a physical medical device (a manual resuscitator) and demonstrates its substantial equivalence to a predicate device based on physical and functional testing. It does not involve any artificial intelligence or machine learning components, and thus the requested details regarding AI/ML acceptance criteria and validation studies are not present.
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).