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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 STA Cath® Attachable Infusion Catheter is intended for use with the Alpha Infusion Pump for the infusion of a local anesthetic into a surgical site or body cavity, post-operatively, for the relief of pain. The STA Cath Attachable Infusion Catheter is intended for use in the hospital or by an ambulatory patient.

The STA Cath® Attachable Infusion Catheter is an open end style catheter similar to the Alpha Cath™ Infusion Catheter. This catheter consists of a length of PVC tubing which functions as a flow restrictor. The proximal end of the tubing has a stainless needle for insertion into the Alpha Infusion Pump. The distal end of the tubing contains axial slit ports near the distal tip which are designed to infuse medication in case the end of the catheter becomes blocked.

The distal end of the catheter has a short length of tubing attached to it. A loop of monofilament extends beyond both ends of this attached tube, and is used by the physician to draw a 4-0 suture, placed at an attachment site in the patient, through the attached tube in order to temporarily hold the catheter in place.

The provided document is a 510(k) summary for the STA Cath® Attachable Infusion Catheter. This document is a regulatory submission to the FDA, detailing the device's characteristics and its substantial equivalence to existing predicate devices. It does not contain acceptance criteria for performance studies, nor does it describe specific studies proving a device meets such criteria in terms of quantitative performance metrics (e.g., accuracy, sensitivity, specificity).

The document's purpose is to establish "substantial equivalence" to predicate devices, which means demonstrating the new device is as safe and effective as a legally marketed device. This is typically achieved through comparisons of technological characteristics, intended use, and sometimes non-clinical performance data (e.g., biocompatibility, sterilization validation, mechanical testing), rather than clinical efficacy studies with acceptance criteria as one would find for an AI/ML medical device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. The other requested information regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance are also not applicable or present in this type of regulatory submission for a physical medical device.

To directly answer your request based on the provided document:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document establishes substantial equivalence to predicate devices, not discrete acceptance criteria for performance metrics.
2. Sample sized used for the test set and the data provenance: Not applicable. This document does not describe a test set or clinical study with sample sizes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a test set with ground truth established by experts.
4. Adjudication method for the test set: Not applicable.
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 described.
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.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

The "study" presented here is essentially the argument for substantial equivalence based on comparing the device's design and intended use to existing, legally marketed devices.

Key points from the document related to "proving" the device:

• Technological Comparison: The document states, "There is no new technology added in the construction of the STA Cath® Attachable Infusion Catheter compared to the Alpha Cath Infusion Catheter." The difference is an "attachment feature" which allows the catheter to be temporarily attached to body tissues.
• Substantial Equivalence Argument: The attachment feature is compared functionally to similar retention features on other catheters like "suture holes on the connectors of hemodialysis catheters, the implantable cuffs on hemodialysis and central venous catheters, the balloons on Foley catheters, and the pigtails on urethral catheters."
• Conclusion: "The STA Cath® Attachable Infusion Catheter is substantially equivalent to the existing Alpha Cath™ Infusion Catheter in design and operation and is substantially equivalent to other catheters such as Foley catheters which use a temporary means to hold the catheter in place during use."

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The Polyurethane Infusion Catheters are intended for use with the Alpha Infusion Pump for the infusion of a local anesthetic into a surgical site or body cavity, postoperatively, for the relief of pain. The Polyurethane Infusion Catheters are intended for use in the hospital or by an ambulatory patient.

The Polyurethane Infusion Catheter consists of two design options: Alpha Cath™ open end style catheter: this style catheter consists of a length of tubing which functions as a flow restrictor. The proximal end of the tubing has a stainless needle for insertion into the Alpha Infusion Pump. The distal end of the tubing contains axial slit ports near the distal tip which are designed to infuse medication in case the end of the catheter becomes blocked. Multi Drip® closed end style catheter: this style catheter consists of a length of tubing which functions as a flow restrictor. The proximal end of the tubing has a stainless needle for insertion into the Alpha Infusion Pump. The distal end of the tubing has a series of tiny ports along the distal portion of the catheter which are designed to spread medication along an infusion zone.

The provided FDA 510(k) K061356 for the "Polyurethane Infusion Catheter" does not contain information on acceptance criteria, a specific study proving the device meets acceptance criteria, or any of the detailed analytical performance metrics typically associated with AI/ML device studies. This document is a traditional 510(k) submission for a medical device that predates the widespread adoption and specific regulatory guidance for AI/ML-driven medical devices.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and AI performance metrics is not applicable or not present in this document.

The primary method of demonstrating safety and effectiveness for this device is substantial equivalence to predicate devices, focusing on material change from PVC to medical-grade polyurethane while maintaining the same intended use.

Here's an explanation based on the provided document:

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

• Not Applicable / Not Provided. This document does not specify quantitative acceptance criteria or performance metrics for the Polyurethane Infusion Catheter in the way an AI/ML device would. The "performance" assessment is qualitative, stating that the device is "substantially equivalent" to existing predicate devices based on its design and material change.

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. This 510(k) does not describe a clinical performance study with a test set of data. The submission is based on the technological comparison and substantial equivalence to existing devices.

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 / Not Provided. As no specific performance study or test set is described, there's no mention of experts establishing ground truth.

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

• Not Applicable / Not Provided. No test set or related adjudication method is mentioned.

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 / Not Provided. This is not an AI/ML device, and no MRMC study is described.

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

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

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

• Not Applicable / Not Provided. The concept of "ground truth" as it applies to AI/ML performance evaluation is not relevant to this type of device submission. The device's "truth" is its functional design and material properties, which are compared to legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable / Not Provided. This is not an AI/ML device, and therefore, no training set or machine learning model is utilized.

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

• Not Applicable / Not Provided. As there is no training set for an AI/ML model, this information is not relevant.

Summary of the K061356 submission:

The submission focuses on a material change for an existing "Infusion Catheter" from PVC to medical-grade polyurethane. The primary argument for market clearance is substantial equivalence to previously cleared predicate devices (K021964, K042246, K003915, K993691). The manufacturer asserts that the new polyurethane catheters are "the same as the current Alpha Cath™ and Multi Drip™ Infusion Catheters except that the catheter material has been changed." The intended use remains identical: "for use with the Alpha Infusion Pump for the infusion of a local anesthetic into a surgical site or body cavity, post-operatively, for the relief of pain."

Safety and effectiveness are presumed based on the predicate devices, with the material change being the primary technical difference addressed by the submission, usually supported by biocompatibility and functional testing data (though specific test results are not detailed in this summary).

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The Multi Drip™ Infusion Catheter is a single-use, short duration catheter intended for use with the Alpha Infusion Pump for the continuous infusion of medication directly into an intraoperative site for postoperative pain management. Infusions may also be administered percutaneously.

The Multi Drip™ Infusion Catheter is designed to be used with the Alpha Infusion Pump (K021964) to deliver a continuous infusion of medication to a patient at a predetermined flow rate. It is a sterile, non-pyrogenic, single use device for use in the hospital or by an ambulatory patient. Except for the size of the exit ports and the closed distal end of the catheter, the Multi Drip Infusion Catheter is identical in construction and operation to the previously cleared Alpha Cath Infusion Catheter series (K021964). Like the Alpha Cath Infusion Catheter, the proximal end of the Multi Drip™ Infusion Catheter has a stainless steel needle attached to it for insertion of the catheter into the outflow septum of the Alpha Infusion Pump. The flow rate of the fluid delivered from the Alpha Infusion Pump through the catheter is determined by the preset delivery pressure of the pump and the internal diameter and length of the micro-bore PVC tubing forming the catheter. The Multi Drip™ Infusion Catheters are available in a range of lengths and flow rates identical to the Alpha Cath Infusion Catheters. Both catheter series are packaged in individual Tyvek pouches and sterilized by gamma irradiation.

The provided document is a 510(k) summary for a medical device (Multi Drip™ Infusion Catheter) seeking substantial equivalence to existing devices. It does not describe a clinical study in the typical sense (e.g., comparing human readers with and without AI assistance). Instead, it focuses on demonstrating that the new device performs equivalently to previously cleared predicate devices through engineering tests and comparisons of design and materials.

Here's a breakdown of the information requested, based on the provided text:

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

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

• Sample Size: The document states that "Multi Drip™ Infusion Catheters are 100% tested for flow rate, as are the Alpha Cath Infusion Catheters, prior to release." This implies that every manufactured unit undergoes this specific test. For the flow distribution through ports, the statement "flow was achieved through at least 4 of the 6 holes present in all catheters" suggests that the testing of flow distribution was conducted on a sufficient number of catheters to make this generalization about "all catheters," although a specific sample size for this test is not explicitly given.
• Data Provenance: The data appears to be from internal testing conducted by the manufacturer, Advanced Infusion, Inc. The document does not specify country of origin for the data or whether it is retrospective or prospective, but it's presumed to be prospective testing of their own manufactured devices.

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

• This document describes performance testing of a medical device against engineering specifications and comparison to predicate devices, not a study involving human experts establishing ground truth for a test set in the context of diagnostic accuracy or AI performance. Therefore, this information is not applicable to this submission.

4. Adjudication method for the test set

• Given the nature of the testing described (physical and flow rate performance of a catheter), there is no mention of an adjudication method as would be used in expert consensus for diagnostic accuracy. The performance criteria are objective measurements. Therefore, this information is not applicable to this submission.

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

• A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to this device. This document describes the safety and effectiveness of a physical medical device (infusion catheter), not a diagnostic algorithm or AI system that assists human readers.

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

• This question is not applicable as the device is a physical infusion catheter, not an algorithm or AI system.

7. The type of ground truth used

• The "ground truth" for the performance of the Multi Drip™ Infusion Catheter is based on engineering specifications, objective physical measurements (like outer diameter, length, breaking strength, bond strength), and functional test results (flow rate accuracy, flow distribution through ports). The comparison to predicate devices also serves as a benchmark for "equivalent performance." It is not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic study.

8. The sample size for the training set

• This document does not describe a machine learning or AI model, thus there is no training set in this context.

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

• As there is no training set for a machine learning model, this question is not applicable.

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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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