(329 days)
The Ambu SPUR II resuscitator is a single patient use resuscitator intended for pulmonary resuscitation.
The range of application for each version is:
-Adult: Adults and children with a body weight more than 30 kg (66lbs).
-Paediatric: infants and Children with a body weights up to 30 kg (66lbs).
-Infant: Neonates and infant with a body weight up to 10kg (22lbs).
Ambu SPUR II Resuscitator is intended for manual pulmonary resuscitation. It is a disposable device intended for Single Patient Use only.
Ambu SPUR II Resuscitator is available in three sizes: Adult, Pediatric and Infant.
The main components of the product are a patient valve, a bag, an inlet valve, a reservoir bag/tube and an oxygen tube.
The patient valve directs the ventilation air through a patient connector into the patient airway and directs the patient expiration air through an expiration connector. The patient connector is constructed to turn around its own axis enabling the resuscitator to turn in relation to connected masks or endotracheal tubes.
A pressure limiting valve (40 cmHzO) with an override mechanism is placed in the patient valve housing of all Pediatric and Infant resuscitators. For the Adult resuscitators a pressure limiting valve is optional.
M-Port is mounted in the patient valve housing and provides access to the inspiratory and expiratory gas flow allowing connection of a syringe for drug delivery or a qas sampling line for measuring side stream EtCO2. When the M-Port is not used it is sealed with a cap and the resuscitator operates as a resuscitator without the M-Port. The M-Port is an optional feature.
The bag of the resuscitator is made of a flexible and elastic material. which ensures the bag to have sufficient compression and recoiling properties. When the bag is compressed, air is delivered via the patient valve to the patient.
The inlet valve allows ambient air to flow into the bag and prevents air flowing backwards from the bag through the inlet valve during ventilation.
The reservoir consists of either a reservoir bag (closed reservoir) or a reservoir tube (open reservoir) attached to the inlet valve.
Supplementary oxygen can be supplied through the oxygen tube attached to the oxygen connector (reservoir bag) or mounted inside the inlet valve assembly (reservoir tube). Supplementary oxygen flows into the reservoir attached to the inlet valve assembly.
A Face mask, Endotracheal Tube or Larynqeal Mask/Combitube can be connected to the patient connector of the resuscitator to ensure contact to the patient's airway.
The Ambu SPUR II Resuscitator complies with ISO 10651-4: Particular requirements for operator powered resuscitators.
The provided text is a 510(k) Premarket Notification from the FDA for the Ambu SPUR II Resuscitator. This document is a regulatory submission for a medical device and describes the device's technical specifications and how it demonstrates substantial equivalence to existing devices. It does not describe an AI/ML-driven medical device, nor does it detail a study that proves an AI/ML device meets specific acceptance criteria in the context of clinical performance or human reader improvement.
Therefore, the requested information, specifically regarding acceptance criteria and studies related to AI/ML device performance (like sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone algorithm performance, training set details, etc.), cannot be extracted from this document, as it pertains to a manual medical device (resuscitator) and not an AI-powered diagnostic or assistive tool.
The document primarily focuses on bench testing and compliance with recognized consensus standards to demonstrate the safety and effectiveness of the manual resuscitator in comparison to predicate devices, rather than AI-related performance metrics.
However, I can extract the acceptance criteria and performance data for the manual resuscitator itself, as presented in the document, though it won't be AI-related.
Here's an attempt to answer the request based only on the provided document, interpreting "acceptance criteria" as the performance parameters tested for this manual device:
Device: Ambu SPUR II Adult, Pediatric, and Infant Resuscitator (a manual medical device, not an AI/ML device)
The document describes the device's substantial equivalence to predicate devices based on its intended use, operation, technological characteristics, and performance testing. The "acceptance criteria" here refer to the successful passing of various performance tests as per recognized consensus standards for manual resuscitators.
Table of Acceptance Criteria and Reported Device Performance (for the Manual Resuscitator)
| Acceptance Criteria Category/Parameter | Reported Device Performance/Result |
|---|---|
| Compliance with Standards: | |
| - ISO 10651-4: Particular requirements for operator-powered resuscitators | Passed. All tests described in the standard were performed, and the device demonstrated conformity. |
| - ISO 5356-1: Anaesthetic and respiratory equipment Conical connectors - Part 1: Cones and sockets | Passed. All tests described in the standard were performed, and the device demonstrated conformity. |
| Connectors Functionality: | |
| - Patient connection port connector | Passed. Tested for functionality and compliance. |
| - Expiratory port connector for breathing gases | Passed. Tested for functionality and compliance. |
| - Face mask connectors | Passed. Tested for functionality and compliance. |
| - Oxygen tube connector and pressure gauge connector | Passed. Tested for functionality and compliance. |
| Operation Requirements: | |
| - Patient valve function after contamination with vomits | Passed. |
| - Mechanical shock | Passed. |
| - Drop test | Passed. |
| - Immersion in water | Passed. |
| Ventilatory Requirements: | |
| - Supplementary oxygen and delivered oxygen concentration | Passed. |
| - Expiratory resistance | Passed. (Adjusted to fulfill ISO 10651-4:2009 for Pediatric and Infant models). |
| - Inspiratory resistance | Passed. |
| - Patient valve malfunction | Passed. |
| - Patient valve leakage Forward leakage | Passed. |
| - Resuscitator dead-space and rebreathing | Passed. |
| Ventilation Performance: | |
| - Minimum delivered volume | Passed. (Stroke volume specification updated for Adult model to show compliance with ISO 10651-4:2009). |
| - Pressure limitation | Passed. |
| Storage and Operation (tested at time zero and after accelerated aging): | |
| - Inspiratory/Expiratory resistance test | Passed. |
| - Stroke volume test | Passed. |
| - Patient valve malfunction test | Passed. |
| - Supplementary oxygen and delivery oxygen concentration | Passed. |
| - Pressure limitation test | Passed. |
| Additional Performance Data: | |
| - CO2 monitoring (M-port suitability) | Passed with at least 0.4 liter of tidal volume. Acceptance criteria: Maximum deviation of 5% at a confidence level of 95% in comparison to the Philips Side Stream Adapter. |
| - MR Conditional properties (Magnetic Field Interaction Testing per ASTM F2503-05) | Passed. Ambu SPUR II is MR Conditional and can be used in a MRI environment under specified conditions. |
| Biocompatibility (compliance with ISO 10993-1): | |
| - Cytotoxicity (ISO 10993-5) | Passed. |
| - Sensitization (ISO 10993-10) | Passed. |
| - Intracutaneous reactivity test (ISO 10993-10) | Passed. |
| - Extractable and Leachable (E&L) testing | Passed. |
AI/ML Specific Questions (Cannot be answered from the provided document as it is for a manual medical device)
Since this document describes a manual medical device (resuscitator) and not an AI/ML diagnostic or assistive device, the following points regarding AI/ML studies are not applicable and thus, no information can be extracted:
- Sample sizes used for the test set and the data provenance: Not applicable. The document refers to engineering bench tests, not clinical data sets for AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI model is not relevant here.
- Adjudication method for the test set: Not applicable.
- 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 was not done as it's not an AI device. The document explicitly states "No Clinical tests are performed."
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance is objective measurements against engineering standards.
- The sample size for the training set: Not applicable. This device is not an AI/ML model that requires training data.
- How the ground truth for the training set was established: Not applicable.
In summary: The provided document is a regulatory submission for a traditional, manual medical device. It thoroughly outlines the bench testing and compliance with established standards to demonstrate safety and effectiveness. However, it does not contain any information related to AI/ML device performance, human-AI interaction studies, or the methodologies typically employed for AI/ML model validation.
§ 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).