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The Science Incorporated PDS Personal Infusor with Drug Disposal Septal Port is designed for the ambulatory infusion of physician-prescribed parenteral medications. The device is intended to be filled and prepared for administration by pharmacists, and provided to patients who have been trained in the pump's operation. The device is, also, designed to allow for the removal of parenteral medication to allow for the proper disposal of both the device and the medication where disposal of both together would be contrary to normal professional health care practice.

The flexibility offered by the PDS Personal Infusor with Drug Disposal Septal Port will enable physicians to choose from a variety of fluid flow rates and drug concentrations. It will provide clinicians and patients with a convenient and efficient option for administration of fluid medications to patients, as well as allow for proper disposal of device and unused fluid medications.

The Science Incorporated PDS Personal Infusor with Drug Disposal Septal Port is a self-contained, low-profile, disposable infusion device intended for the ambulatory delivery of physician-prescribed parenteral medications to patients. Its design engages three principle elements: a substrate base with molded ullage, a stored energy elastomeric film, and a preset rate control component with filter. Fluid medicaments are delivered to a patient via an attached 36-inch tubing set that adjoins a preexisting venous access site. The unit has a septal port which allows easy removal of unused medications to allow for proper disposal of both device and medication. The unit is disposable following a single use and features a novel visual flow status indicator that facilitates patient monitoring. The pump will be available in multiple volume/flow rate configurations, and prototype models have demonstrated unsurpassed accuracy and consistency of fluid flow over a broad gamut of operating temperatures and with solutions of widely varying viscosities. It has a drug disposal septal port for proper disposal of the unused drug per normal hospital practice.

Here's an analysis of the provided text, focusing on acceptance criteria and study details for the Science Incorporated Personal Infusor with Drug Disposal Septal Port:

The provided document is a 510(k) summary for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed technical report of a standalone clinical study with extensive acceptance criteria. Therefore, many of the requested categories for a comprehensive study will not be fully satisfied by this type of document.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size: Not explicitly stated in the provided text. The document mentions "In our studies" but does not quantify the number of devices or experimental runs.
   • Data Provenance: The studies were conducted by Science Incorporated as part of their 510(k) submission. The context suggests these were internal, non-human, laboratory-based performance tests rather than clinical trials. It's retrospective in the sense that the data was collected prior to the 510(k) submission. There is no information regarding the country of origin, but it is implied to be within the company's research and development facilities.

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

   • This question is largely not applicable to this type of performance study. The "ground truth" for device performance (flow rate, linearity) would be established by scientific measurement standards and instrumentation, not by expert human consensus or interpretation of medical images. Expert involvement would be in designing the test protocols and analyzing the objective physical data.

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

   • None applicable in the context of this document. Adjudication methods like "2+1" typically apply to studies where human interpreters (e.g., radiologists) review medical cases, and their disagreements are resolved by an independent third party. This document describes laboratory performance testing of an infusion pump, which involves objective measurements against predefined specifications.

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:

   • No, an MRMC study was not done. This type of study applies to diagnostic imaging devices or AI-assisted interpretation, where human readers (e.g., radiologists) interpret cases with and without AI assistance. The device in question is an infusion pump, not a diagnostic or AI-driven interpretative tool.

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

   • Yes, in spirit. The performance data presented (linearity of flow, temperature range) represents the standalone physical performance of the device itself, independent of immediate human intervention during its operation (beyond initial setup). This is a purely "device-only" performance assessment.

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

   • The "ground truth" for the performance claims (flow rate accuracy, linearity) would be based on objective physical measurements using calibrated instruments and standardized test methods. For example, a flow meter would measure the actual flow rate, and this would be compared against the target flow rate to determine accuracy and linearity.

7. The sample size for the training set:

   • Not applicable. This device is an elastomeric infusion pump, not an AI/machine learning algorithm that requires a "training set." The development process for such a device involves engineering design, prototyping, and iterative physical testing, not data-driven model training.

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

   • Not applicable. As stated above, there is no "training set" in the context of this device.

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The Science Incorporated Personal Infusor is designed for the ambulatory infusion of physician-prescribed parenteral medications. The device is intended to be filled and prepared for administration by pharmacists, and provided to patients who have been trained in the pump's operation.

The flexibility offered by the Personal Infusor will enable physicians to choose from a variety of fluid flow rates and drug concentrations, and will provide clinicians and patients with a convenient and efficient option for administration of fluid medications to patients.

The Science Incorporated Personal Infusor is a self-contained, low-profile, disposable infusion device intended for the ambulatory delivery of physician-prescribed parenteral medications to patients. Its design engages three principle elements: a substrate base with molded ullage, a stored energy elastomeric film, and a preset rate control component with filter. Fluid medicaments are delivered to a patient via an attached 36 inch tubing set that adjoins a preexisting venous access site. The unit is disposable following a single use and features a novel visual flow status indicator that facilitates patient monitoring. The pump will be available in seven volume/flow rate configurations, and prototype models have demonstrated unsurpassed accuracy and consistency of fluid flow over a broad gamut of operating temperatures and with solutions of widely varying viscosities.

The manufacturer, Science Incorporated, demonstrated the performance of their Personal Infusor through studies showing its flow linearity.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified in the provided text. The document refers to "our studies" and "prototype models" but does not give specific numbers for the test sets.
• Data Provenance: The studies were conducted by Science Incorporated ("In our studies"). The specific country of origin is not explicitly stated beyond Science Incorporated being located in Bloomington, MN, USA. The studies appear to be prospective as they were conducted by the manufacturer to demonstrate the performance of their new device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. This device is an infusion pump, and its performance is evaluated based on physical measurements of fluid flow and linearity, not on interpretation by human experts. Ground truth would be derived from calibrated measurement instruments, not expert consensus.

4. Adjudication Method for the Test Set:

Not applicable. Performance was measured objectively, not through human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

Not applicable. MRMC studies are relevant for diagnostic devices where human readers interpret medical images or data. The Personal Infusor is a drug delivery device, and its performance is assessed mechanically.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, the performance data presented is that of the device itself, functioning as a standalone unit. The description states, "The Science Incorporated Personal Infusor exhibits improved flow performance when compared to the predicate devices. In our studies, the new devices displayed linearity of ±10%..." This refers to the intrinsic performance of the pump.

7. The Type of Ground Truth Used:

The ground truth used would be based on objective measurements from calibrated laboratory equipment. For example, flow rate would be measured using precise mass balances or volumetric sensors over time, and temperature would be controlled and verified with calibrated thermometers. The linearity would be calculated based on these measured flow rates compared to the expected flow rates.

8. The Sample Size for the Training Set:

Not applicable. The Personal Infusor is a mechanical device, not an AI/ML algorithm that requires a training set. Its performance is based on its engineering design and manufacturing, not on learning from data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable for the same reason as point 8.

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