Search Results

The M5066A is designed to be used on a person in sudden cardiac arrest, who is:

• unresponsive when shaken, and
• not breathing normally. .
  If in doubt, apply the pads.
  If the victim is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), you should use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child's exact age or weight.
  The M5066A is intended for use by people who have been specifically trained in its operation. A M5066A user should also have training in cardiopulmonary resuscitation (CPR) or another physician-authorized emergency medical response program in accordance with local and state requirements.
  Caution: Federal Law (USA) restricts this device to the sale by or on the order of a physician.

The M5068A is designed to be used on a person who is in sudden cardiac arrest and who is:

• unresponsive when shaken, and
• not breathing normally. .
  The defibrillator should not be used on a person who is:
• responsive when shaken, or ●
• breathing normally.
  If you are not certain if the person is in sudden cardiac arrest, apply the defibrillator and follow its instructions.
  For children 8 years or older, or who weigh 55 pounds or more, use the M5068A with the adult pads that come with it. For younger children to those who weigh less than 55 pounds, the special infant/child pads should be used. When used with these pads, the M5068A delivers a lower energy appropriate for infants and small children.
  The M5068A is intended for use by people who have been specifically trained in its operation. The user should also have training in cardiopulmonary resuscitation (CPR) or another physician-authorized emergency response program in accordance with local and state requirements.
  Caution: Federal Law (USA) restricts this device to the sale by or on the order of a physician.

The M5066A/M5068A is an automated external defibrillator indicated to treat victims of sudden cardiac arrest (SCA). Features of the M5066A/M5068A includes self-testing and self-calibration, an impedance-compensating biphasic truncated exponential therapy waveform, a multi-parameter Patient Analysis System (PAS) for determining if a shock is required and integrated human factors designs to facilitate use by lay responders.
A non-rechargeable lithium manganese dioxide battery powers the M5066A/M5068A with a minimum capacity of 40 shocks and 30 minutes of operating time.
Except for specific programmed periods when a responder needs to deliver uninterrupted CPR, the M5066A/M5068A continuously and automatically analyzes the patient's ECG and alerts the responder when the ECG changes to a possible shockable rhythm. Analysis continues even after the M5066A/M5068A advises a shock and arms - if the ECG spontaneously converts to a non-shockable rhythm prior to a responder pressing the shock button, the M5066A/M5068A disarms.
If significant artifact is detected in the ECG, the PAS suspends further analysis until reliable data is available. When a shockable rhythm is detected, the M5066A/M5068A directs the responder to press the shock button to deliver a biphasic shock to the patient.
The M5066A/M5068A has an infrared communication port to facilitate data management. Event and incident data is recorded during use that can be retrieved later for viewing, printing, annotating and forwarding. Factory settings of the M5066A/M5068A can be customized. In addition, the M5066A/M5068A converts into a training device with selectable training "scripts" that simulate different SCA scenarios.

The Philips M5066A/M5068A Automated External Defibrillator is described as undergoing testing to demonstrate its performance meets specifications. However, the provided document does not contain specific acceptance criteria values or detailed results of a study proving the device meets them. It states that "Testing demonstrated that the performance of the M5066A/M5068A meets its specifications" and "additional bench testing will demonstrate that the M5066A/M5068A will meet its predefined criteria." This suggests that the detailed study information, including acceptance criteria and performance data, was likely submitted as part of the full 510(k) submission but is not elaborated upon in this summary document.

Therefore, many of the requested details about the study are not available in the provided text.

Based on the available information:

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

   • Acceptance Criteria: Not explicitly stated in the provided text. The document mentions "meets its specifications" and "meet its predefined criteria" without detailing what those criteria are.
   • Reported Device Performance: Not explicitly stated in the provided text. The document only states that performance "meets its specifications."

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

   • Not specified in the provided text.

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)

   • Not specified in the provided text.

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

   • Not specified in the provided text.

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

   • No mention of an MRMC study or human reader assistance. The device is an automated external defibrillator, implying standalone automated analysis rather than human-in-the-loop assistance for diagnosis.

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

   • Yes, implicitly. The device is described as having a "multi-parameter Patient Analysis System (PAS) for determining if a shock is required." It "continuously and automatically analyzes the patient's ECG" and "alerts the responder when the ECG changes to a possible shockable rhythm." This indicates a standalone algorithmic performance component. However, specific performance metrics for this standalone algorithm are not provided in the summary.

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

   • Not specified in the provided text. For an AED, ground truth would typically relate to the presence or absence of a shockable cardiac rhythm, which is determined by ECG analysis itself, often validated against established medical criteria.

8. The sample size for the training set

   • Not specified in the provided text.

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

   • Not specified in the provided text.

Ask a specific question about this device