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The Alpha Infusion Pump is intended for the infusion of a local anesthetic into a surgical site or body cavity, post-operatively, for the relief of pain. Medication is intended to be delivered through a catheter containing a flow restriction element. The Alpha Infusion Pump is intended for use in the hospital or by an ambulatory patient.

The Alpha Infusion Pump consists of two elastomeric chambers, which pressurize the medication. These chambers are protected in a plastic housing. A one-way check valve is provided to fill these chambers. Medication delivered from the elastomeric chambers is filtered through a 5-micron filter and held in an outflow chamber. An internal pressure regulator maintains the pressure of the medication in the outflow chamber at 6 psi in order to provide a constant flow rate through each infusion catheter inserted through the septum into the outflow chamber of the pump.

This document is a 510(k) summary for the Alpha Infusion Pump and describes a change to the device, not a study evaluating acceptance criteria of a device's performance. Therefore, most of the requested information cannot be extracted from the provided text.

The primary purpose of this 510(k) submission is to demonstrate substantial equivalence of a modified Alpha Infusion Pump by changing the elastomeric chamber material. As such, it does not contain a study presenting acceptance criteria and device performance in the manner typically associated with clinical or standalone performance studies for AI/ML-based medical devices.

Here's a breakdown of what can be extracted based on the input text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable. The document describes a change in material for a component of an infusion pump and asserts substantial equivalence to a predicate device. It does not present specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity) or report device performance against such criteria for a new feature or algorithm. The "performance" being assessed here is the functional equivalence of the new material, not a clinical outcome or diagnostic accuracy.

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

• Not Applicable. This document does not describe a test set or data provenance for evaluating an AI/ML device.

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

• Not Applicable. Ground truth establishment by experts is not relevant to this type of device modification submission.

4. Adjudication method for the test set:

• Not Applicable. Adjudication methods are not described as there is no test set in the context of an AI/ML performance evaluation.

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:

• Not Applicable. This is not an AI/ML device, and no MRMC study is mentioned.

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

• Not Applicable. This is not an AI/ML device.

7. The type of ground truth used:

• Not Applicable. Ground truth is not relevant to this device modification. The "truth" being established is the functional equivalence of the new material to the old.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, so there is no training set mentioned.

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

• Not Applicable. Not an AI/ML device.

Key Information from the Document:

• Device Name: Alpha Infusion Pump
• Modification: The elastomeric chamber material is being changed from medical grade polyisoprene to medical grade silicone.
• Reason for Change: Silicone is already used elsewhere in the pump (septum, pressure regulator, check valve), and polyisoprene will no longer be used. Silicone elastomer chambers are also used in predicate devices (Accufuser and Accufuser Plus).
• Conclusion of the Manufacturer: The Alpha Infusion Pump with silicone elastomer chambers is "substantially equivalent" to the current Alpha Infusion Pump with polyisoprene chambers.
• FDA Decision: The FDA determined the device is "substantially equivalent" based on the provided information.

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