Search Results

The Paragon Bolus Accessory Set is intended to deliver fixed boluses of medication upon demand by the patient or healthcare provider. The routes of administration are intravenous, epidural, intramuscular and subcutaneous.

The Bolus Accessory may connect to any Paragon administration set to deliver fixed boluses of medication upon demand by the patient or healthcare provider. The Bolus Accessory consists of plastic housing, medication reservoir, bolus button activator and wrist bands. The bolus button allows patient controlled administration of medication as needed. The Bolus Accessory is available in 0.5 ml bolus volume. The Bolus Accessory is a mechanical device that requires no external power.

Here's a breakdown of the acceptance criteria and study information for the Paragon Bolus Accessory Set, based on the provided document:

Acceptance Criteria and Device Performance

Note: The document only explicitly states the accuracy acceptance criterion and then broadly confirms that all models performed within specified accuracy. Other operational specifications like "Refill Time: variable," "Operating Temperature: 90 ± 2°F," "Calibration Solution: 0.9% NaCl," "Operating Pressure: 6.0 psi pressure source," and "Head Height: 0" are listed as standard operating conditions under which performance was assessed.

Study Information

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified. The document states "All models performed within the specified accuracy," implying that multiple units were tested, but does not provide a specific number for the test set.
   • Data Provenance: Not specified, but likely obtained prospectively through in-house testing by I-Flow Corporation. No mention of country of origin for the data is made, but the company is based in Lake Forest, CA, USA.

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

   • This is a mechanical medical device (bolus accessory for an infusion system). The "ground truth" for its performance (e.g., bolus volume accuracy) would be established through instrumental measurements rather than expert human interpretation. Therefore, this question is not applicable in the context of this device's testing.

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

   • Not applicable as the testing involves direct measurement of mechanical performance, not expert review or adjudication of subjective data.

4. 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 mechanical accessory; it does not involve human readers interpreting images or data, nor does it incorporate AI.

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

   • Not applicable. This device is a mechanical accessory, not an algorithm. However, the performance data provided (accuracy) is for the device itself acting autonomously within its mechanical function.

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

   • For the performance testing, the ground truth would be based on physical measurements using calibrated instruments to determine the actual bolus volume delivered.

7. The sample size for the training set:

   • Not applicable. As a mechanical medical device, there is no "training set" in the context of machine learning or AI. Performance is based on physical design and manufacturing tolerances.

8. How the ground truth for the training set was established:

   • Not applicable for the same reasons as point 7.

Ask a specific question about this device