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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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The Alpha Infusion Pump and associated Catheters are intended for intravenous, intra-arterial, subcutaneous, or epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates. Medications or fluids are intended to be delivered through a catheter containing a flow restriction element.

The Alpha Infusion Pump and associated Catheters are suitable for use as an ambulatory device and are intended for use in the home environment but not limited to use in the home environment.

The Alpha Infusion Pump is comprised of dual elastomeric chambers which hold the fluid to be infused under pressure. These chambers are contained within a hard shell case. The infusion pump also contains a luer lock checkvalve used to fill the chambers, a 5-micron fluid filter, a hydrophobic air vent filter, a pressure regulator, and an elastomeric septum for attaching infusion catheter(s) to the pump. The infusion pump is packaged as a kit in a tray containing an insertion needle used for placement of the catheter into the patient, a 60cc syringe used to fill the pump, a fabric belt used for holding the pump onto the patient, patient labels, and an Instructions For Use.

The Alpha Cath Infusion Catheters are micro-bore tubing catheters with a needle attached to one end for insertion of the catheter into the infusion pump septum. The internal diameter and length of the catheter tubing acts as the flow restrictor and determines the flow rate of the fluid through the catheter. The infusion catheters are packaged separately in Tyvek pouches and are contained in cartons along with Tegaderm adhesive dressings and an Instruction For Use.

This document is a 510(k) premarket notification for a medical device called the "Alpha Infusion Pump and associated Catheters." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving new device efficacy through clinical trials with detailed acceptance criteria and studies as one might find for a PMA application or a de novo submission.

Therefore, the information available in this document is not a detailed clinical study report proving the device meets specific acceptance criteria in the way you've outlined for a typical clinical or AI/algorithm performance study. Instead, it focuses on demonstrating equivalence to an existing device.

Here's an analysis based on the provided text, highlighting what can and cannot be answered:

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

• Acceptance Criteria: The document implies that the acceptance criteria are met if the revised Alpha Infusion Pump and Catheters are substantially equivalent to the currently marketed Alpha Infusion Pump and Catheters (K992551). This isn't a set of specific performance metrics with thresholds, but rather a regulatory standard.
• Reported Device Performance: The primary performance characteristic mentioned that relates to functionality is "Flow Rate & Profile: 0.5 ml/hr to 10 ml/hr Continuous." The document states that both the predicate device and the revised device have this identical reported performance. There is no detailed data showing how this performance was measured for the revised device beyond the claim of equivalence.

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

• Not applicable / Not provided. A 510(k) submission for an infusion pump typically involves bench testing to verify performance characteristics (like flow rate accuracy under various conditions, material compatibility, pressure resistance, etc.) rather than a clinical "test set" of patients in the way an AI diagnostic algorithm would have. The document does not describe such testing in detail, nor does it refer to patient data for performance evaluation.

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 applicable. This information pertains to studies where interpretations or diagnoses are made by experts, which is not the nature of this particular device's submission.

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

• Not applicable. This is relevant for studies involving human interpretation and ground truth establishment, which is not described here.

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. The device is an infusion pump, not an AI-assisted diagnostic tool.

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

• Not applicable. This device does not involve an algorithm with standalone performance.

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

• Not applicable in the typical sense. For an infusion pump, "ground truth" would relate to objective physical measurements (e.g., flow rate, pressure, material integrity) against engineering specifications or established standards. The document doesn't detail the experimental setup for such measurements but relies on the assertion that the revised device is "similar in design, construction, and operation" to the predicate.

8. The sample size for the training set

• Not applicable. This concept belongs to machine learning or AI models, which are not relevant to this device.

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

• Not applicable. As above, this pertains to AI/ML development.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

Based on the provided 510(k) summary, the "study" demonstrating the device meets "acceptance criteria" (which in this context is primarily substantial equivalence) is a comparison to a predicate device (K992551).

• The submission asserts that the revised Alpha Infusion Pump and associated Catheters are "substantially equivalent in intended use and is similar in design, construction, and operation to the currently marketed Alpha Infusion Pump and Catheters (K992551)."
• The table comparing the characteristics of the predicate device and the revised device shows that for key attributes like Pump Type, Intended Use, Flow Rate & Profile, Pumping Mechanism, and many Materials, they are identical or equivalent.
• The primary differences noted are the change in the filter type from "Nylon Filter" to "Versapore Filter" and the catheter material from "Polyimide Flow Restrictor / Polyurethane Catheter" to "Polyvinyl Chloride Catheter / Micro-bore Catheter" (where the flow restrictor is now part of the micro-bore catheter).
• The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This letter is the regulatory outcome indicating that the submission successfully "proved" (to the FDA's satisfaction for 510(k) clearance) that the device meets the criteria for substantial equivalence.

In essence, the "study" is the entirety of the 510(k) submission, providing a detailed comparison between the new device and a legally marketed predicate device, demonstrating that any differences do not raise new questions of safety or effectiveness. This type of submission relies heavily on non-clinical (bench) testing, material characterization, and engineering comparisons, rather than human clinical trial data, to establish equivalence for devices like infusion pumps.

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The Alpha Infusion Pump is intended for intravenous, intra-arterial, subcutaneous, or epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates. Medications or fluids are intended to be delivered percutaneously through a catheter. The Alpha Infusion Pump is suitable for use as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment.

The proposed device, the Alpha Infusion Pump, is an elastomeric chamber infusion pump intended to deliver medications or fluids to a patient by an intravenous, intra-arterial, subcutaneous, or epidural route. These pumps are ambulatory, external, disposable infusion pumps which deliver medication or fluids percutaneously to the patient via a catheter. They control flow rate using a flow restrictor.

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. The document is an FDA 510(k) summary and approval letter for an infusion pump, focusing on its substantial equivalence to predicate devices and regulatory compliance rather than performance study results.

Therefore, I cannot provide the requested table or answer the specific questions about the device's acceptance criteria and study that proves it meets them.

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