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The SMARTeZ Pump (Long infusion time article) is intended for continuous infusions for general infusion use, including pain management.
• Routes of administration: intravenous and subcutaneous.
The SMARTeZ Pump (Short infusion time article) is intended for continuous infusions for general infusion use, including antibiotic delivery.
· Route of administration: intravenous.
The SMARTeZ Pump (Chemotherapy article) is intended for continuous infusion of chemotherapy medications.
· Routes of administration: intravenous and intra-arterial.

The SMARTeZ Pump, is a single-use disposable, non-electric infusion pump that consists of an elastomeric fluid reservoir as energy source with an integrated administration line (see Figure 5-1). The constriction of elastomeric fluid reservoir drives the medication through the tubing and eventually through a flow restrictor out into the patient connection. Drug products should be stored in their approved containers and closures.

The SMARTeZ Pump, an elastomeric infusion pump, underwent a series of bench tests to demonstrate its performance and safety, aligning with ISO 28620:2010 standards. The study aimed to prove that the device consistently delivers medication within specified flow rate tolerances under various conditions, including nominal operation, changes in ambient temperature and solution viscosity, and after exposure to physical stresses like pressure, traction, and drops, as well as refrigeration. It also verified leak-proof integrity and the absence of retrograde flow.

Here is a summary of the acceptance criteria and the reported device performance:

1. Table of acceptance criteria and the reported device performance:

• At least 80% nominal volume delivered at instantaneous flow rate within ±50% of nominal. | Passed. All samples met both criteria. Statistical analysis confirmed flow accuracy within +/- 15% at 99% confidence (lower- and upper-bounds of -0.400% to +0.151%) when filled with nominal volume and delivering normal saline at 31°C with the pump 40cm below the catheter site. |
  | Flow Rate Test (Change of Ambient Temperature) | Mean flow rates should be no more than 15% slower when compared to those tested at 31°C. | Passed. Mean flow rate was 14.07% slower, confirming the IFU claimed temperature effect. |
  | Flow Rate Test (Change of Solution Viscosity) | Mean flow rates should be no more than 10% slower when compared to those tested with 0.9% NaCl as control solution. | Passed. Mean flow rate was 9.81% slower, confirming the IFU claimed fluid viscosity effect. |
  | Flow Rate Test after Resistance to Pressure Test | - Mean flow rate: ±15% compared to nominal.
• At least 80% nominal volume delivered at instantaneous flow rate within ±50% of nominal. | Passed. All samples met both criteria. Statistical analysis showed flow rate accuracy was not affected. |
  | Leak-Proof Test after Resistance to Pressure Test | Device shall remain watertight; solution shall not become colored. | Passed. All samples met the criterion. |
  | Leak-Proof Test after Drop Test | Device shall remain watertight; solution shall not become colored. | Passed. All samples met the criterion. |
  | Flow Rate Test after Resistance to Traction Test | - Mean flow rate: ±15% compared to nominal.
• At least 80% nominal volume delivered at instantaneous flow rate within ±50% of nominal. | Passed. All samples met both criteria. Statistical analysis showed flow rate accuracy was not affected. |
  | Leak-Proof Test after Resistance to Traction Test | Device shall remain watertight; solution shall not become colored. | Passed. All samples met the criterion. |
  | Flow Rate Test after Refrigeration | - Mean flow rate: ±15% compared to nominal.
• At least 80% nominal volume delivered at instantaneous flow rate within ±50% of nominal. | Passed. All samples met both flow rate and leak integrity criteria. Statistical analysis showed flow rate accuracy was not affected. |
  | Leak-Proof Test after Refrigeration | Device shall remain watertight; solution shall not become colored. | Passed. All samples met the criterion. |
  | Retrograde Flow of Infusate Test | Retrograde flow should not be observed when back pressure applied ≤ 0.34bar (5 psi). | Passed. Retrograde flow was observed at 0.8 bar (11.6 psi), which is double the acceptance criteria. |
  | Flow Rate Test under Non-Ambient Pressure (Influence of Routes of Administration) | - Mean flow rate: ±15% compared to nominal.
• At least 80% nominal volume delivered at instantaneous flow rate within ±50% of nominal, independent of IV, intra-arterial, and subcutaneous routes. | Passed. Flow accuracy of +/- 15% was maintained, independent of the 3 routes of infusion administered. |
  | Performance/Functionality Testing for Chemotherapy Articles | - Flow accuracies (nominal, after pressure/traction/refrigeration, non-ambient pressure): Mean flow rate ±15% of nominal, 80% nominal volume within ±50% instantaneous.
• Watertight after pressure, traction, drop, and refrigeration.
• No retrograde flow at back pressure ≤ 0.34bar (5 psi). | Passed. All samples met all acceptance criteria. |

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

The document does not explicitly state the specific sample size (number of devices) used for each individual bench test. However, it consistently refers to "All test samples" passing the criteria. It also mentions "The samples were tested."
The data provenance is from bench testing, which implies a controlled laboratory environment. There is no information regarding the country of origin of the data or whether it was retrospective or prospective, as these types of studies are typically not applicable to physical bench tests of device functionality.

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

This information is not applicable as the study described is a series of bench tests for device performance against predefined engineering and regulatory standards (ISO 28620:2010), not a study involving expert assessment or clinical ground truth.

4. Adjudication method for the test set:

This is not applicable as the study involves objective physical measurements and functional checks against quantitative acceptance criteria, not subjective human evaluations requiring adjudication.

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:

This is not applicable as the device is a physical infusion pump, not an AI-powered diagnostic or assistive tool.

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

This is not applicable as the device is a physical infusion pump, not an algorithm. The "standalone" performance here refers to the device's inherent mechanical and fluid dynamic performance.

7. The type of ground truth used:

The ground truth for the performance tests was established by objective measurements against quantitative engineering and regulatory standards (ISO 28620:2010), specifically defined numerical tolerances for flow rate, and observable physical properties like leak-proof integrity and retrograde flow.

8. The sample size for the training set:

This is not applicable as the device does not employ machine learning or AI models that require a training set.

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

This is not applicable as the device does not employ machine learning or AI models.

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The SA Ve II™ series are intended to provide short-term ventilatory support to adults during CPR or when Positive-Pressure Ventilation (PPV) is required to manage Acute Respiratory Failure (ARF). The SAVe 11™ series are appropriate for adults that weigh at least 45 kg. It is intended to be used in pre-hospital, field hospitals, and transport environments.

The SAVe II™ and SAVe II™ Basic ventilators are battery powered compressors to deliver automated, controlled positive pressure breaths with ambient air for up to 10 hours. It is designed to augment the capabilities of first responders by supplementing Bag Valve Mask (BVM) manual ventilation delivery with an automated solution that can be rapidly deployed by minimally skilled providers in environments where compressed oxygen is unavailable or ill-advised.

To support use in emergency situations, the SA Ve II™ is portable and easy to carry. Rapid initial setup is enabled by default ventilator settings based on adult patient's height, ranging from 4'6'' to 6'6" weighing at least 45 kg, organized in a circular-shaped graphic. To mitigate the risk of patient injury, airway pressure is monitored and users are alerted to potentially dangerous low and high pressure situations. Immediate patient injury due to high pressure is avoided by a pressure cut-off that triggers an exhalation if inspiratory pressure exceeds device settings. Rapid troubleshooting is enabled by visual alarm indicators located together at the bottom of the unit that identifies the most likely cause of the triggered alarm.

Here's a breakdown of the acceptance criteria and the study method for the AutoMedx SAVe II™ and SAVe II™ Basic devices, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria with specific acceptance thresholds. The "acceptance criteria" are implied by the features and performance characteristics of the predicate devices. The reported device performance aligns with these characteristics.

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

The document primarily describes bench testing rather than studies involving human subjects or real-world data.

• Sample Size: Not specified in terms of numerical units like "cases" or "patients." The testing involved "a complete set of performance testing to the device specifications" and "comparative bench testing to the predicate."
• Data Provenance: Not applicable in the traditional sense of clinical data. The data is generated from non-clinical bench testing performed by the manufacturer, AutoMedx, Inc. The nature of this testing does not involve country of origin in the context of patient data. It is prospective in the sense that the tests were conducted specifically for this submission.

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

Not applicable. The ground truth for bench testing is established by the device's technical specifications and the performance of the predicate device. It does not involve expert image interpretation or clinical diagnosis.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human readers or interpretation where adjudication would be necessary. Performance is measured against engineering specifications and comparison to the predicate's technical characteristics.

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 MRMC comparative effectiveness study was done. This medical device (a ventilator) is not an AI-assisted diagnostic or interpretive tool where human reader performance would be a primary metric.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the primary evaluation involved standalone bench testing of the device's performance against its specifications and comparison to predicate devices' technical characteristics. This is an "algorithm only" performance (referring to the device's internal software controlling ventilation parameters), without a human in the loop for interpreting the device's output in the way one would for an AI diagnostic tool. Instead, the device itself delivers the therapy.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was based on:

• Device specifications: The SAVe II™ and SAVe II™ Basic were tested to ensure they met their own predefined performance requirements.
• Predicate device characteristics: The performance of the SAVe II™ models was compared against the known characteristics and performance of the predicate devices (Impact Instruments - Uni-Vent Model 754 - K931473 and AutoMedx - SAVe™ - K071221). Substantial equivalence was claimed if the device performed comparably or better (e.g., in terms of battery life or alarms).

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set" in the context of data-driven model development. The device's operation is based on pre-programmed logic and control algorithms.

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

Not applicable, as no training set was used.

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