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1. The I-Flow Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural.
2. The 1-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of local anesthetics or narcotics to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia. Routes of administration may be intraoperative, perineural or percutaneous.
3. The I-Flow Elastomeric Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

The I-Flow Elastomeric Pump consists of an elastomeric pressure source with an integrated administration line. The current device has an optional Y-adapter that splits the administration line into two delivery sites. This special 510(k) proposes a multi-Y adapter that can provide 3 or more integrated administration lines for multi-site delivery.

The provided text describes a Special 510(k) submission (K052117) for a modification to the I-Flow Elastomeric Pump. This submission focuses on a design change, specifically the addition of a multi-Y adapter to allow for 3 or more integrated administration lines, as an extension of an existing product line (K040337).

Crucially, the provided document does not contain information about acceptance criteria or a study designed to prove the device meets those criteria.

Instead, it's a declaration of substantial equivalence to a previously cleared device. The rationale is that the new multi-Y adapter utilizes the same technology as the existing unmodified design, and therefore, no new issues of safety or effectiveness are believed to arise from this change.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.

Here's why and what information would typically be needed if a study were conducted:

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

• Missing Information: The document does not define any specific acceptance criteria (e.g., flow rate accuracy, pressure stability, material compatibility, bacterial ingress prevention) for the new multi-Y adapter, nor does it report any performance data.

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

• Missing Information: No test set is mentioned because no study was conducted for this specific submission to demonstrate performance against new criteria.

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)

• Missing Information: Not applicable, as no study requiring ground truth establishment was conducted for this submission. This type of information is usually relevant for studies evaluating diagnostic or AI-driven devices, not a simple accessory modification like this.

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

• Missing Information: Not applicable, as no study requiring adjudication was conducted.

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

• Missing Information: Not applicable. This type of study is for evaluating AI performance in diagnostic imaging, which is completely unrelated to an elastomeric pump accessory.

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

• Missing Information: Not applicable. This device does not involve any algorithms.

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

• Missing Information: Not applicable, as no study requiring ground truth was conducted.

8. The sample size for the training set

• Missing Information: Not applicable. This device does not involve a training set as there is no AI/ML component.

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

• Missing Information: Not applicable, as there is no training set mentioned.

Conclusion from the provided text:

The submission K052117 is a "Special 510(k)" which indicates a modification to an already cleared device (K040337). The nature of the change (adding more "Y" splices to an existing administration line) is deemed minor enough by the submitter and the FDA to not require new performance studies. The core argument is based on technological equivalence to the predicate device, implying that the established safety and effectiveness of the original pump apply to this modified version. The FDA letter confirms the determination of "substantial equivalence" based on this premise, allowing the device to be marketed without new clinical or performance studies.

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1. The I-Flow Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural.
2. The I-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.
3. The I-Flow Elastomeric Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

The current package labeling of the I-Flow Elastomeric Pump does not reference specific types of surgeries or potential benefits. This 510(k) proposes a labeling change that would reference the specific type(s) of surgery and potential benefits that are supported by published clinical studies.

This document, K040337, is a 510(k) premarket notification for a labeling change to the I-Flow Elastomeric Pump. It is not a study that proves the device meets acceptance criteria for a new device, but rather a notification to market an existing device with updated labeling based on a review of existing clinical studies. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for a new device evaluation is inherently not present in this type of submission.

Here's an analysis of what information can be extracted or inferred from the provided text, and where the requested information is absent due to the nature of the submission:

1. Table of acceptance criteria and the reported device performance

This information is not applicable/provided in this 510(k) submission. A 510(k) for a labeling change based on existing studies does not typically define new acceptance criteria for the device itself or report new performance data. The core of this submission is to demonstrate that the proposed labeling changes (referencing specific types of surgeries and benefits) are supported by already published clinical studies where the device was used according to its previously cleared indications.

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

This information is not applicable/provided for a new test set in this submission. The submission refers to "published clinical studies" that support the labeling changes. Details about the sample sizes, data provenance (e.g., country of origin, retrospective/prospective nature) of these individual published studies are not provided in this 510(k) summary. These details would be found within the referenced published studies themselves.

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)

This information is not applicable/provided for a new test set in this submission. Similar to point 2, the ground truth for the results of the referenced published studies would have been established within those studies. This 510(k) is a regulatory filing summarizing the existence and relevance of those studies, not establishing new ground truth for a new device test.

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

Not applicable/provided. As explained above, no new test set was established as part of this 510(k) filing.

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 submission is for an elastomeric infusion pump, not an AI-assisted diagnostic device or a system involving human readers. Therefore, an MRMC study or AI-related effectiveness is not relevant.

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

Not applicable. This submission is for an elastomeric infusion pump, not an algorithm.

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

Not applicable/provided directly by this document for a new test set. The ground truth (e.g., pain relief, decreased narcotic use) for the results of the "published clinical studies" would be defined within those studies themselves. The submission states that the labeling changes are supported by "published clinical studies in widely known and esteemed journals," implying that the outcomes and conclusions of those studies serve as the "ground truth" to support the new claims. These outcomes likely pertained to patient-reported pain levels, narcotic consumption, or other clinical measures.

8. The sample size for the training set

Not applicable. This submission is not about an AI/ML device that requires a training set. The "training" for the device's claims comes from the clinical evidence generated in the "published clinical studies," which are not referred to as a "training set" in this context.

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

Not applicable. As explained in point 8, there is no "training set" in the context of this device and submission. The "ground truth" for the claims in the new labeling is established by the findings and conclusions of the referenced "published clinical studies."

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• 1. The I-Flow Elastomeric Pump with Bolus is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, subcutaneous, intramuscular and epidural.
• 2. The I-Flow Elastomeric Pump with Bolus is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/c close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.

This special 510(k) proposes a new optional component for the I-Flow Elastomeric Pump that incorporates a bolus component. The bolus component offers the additional ability to deliver fixed bolus volumes of medication at fixed time intervals instead of just a continuous infusion rate.

The provided text is a 510(k) summary for the I-Flow Elastomeric Pump with Bolus. This document does not contain the detailed acceptance criteria and study information typically found in a clinical trial report or a comprehensive device validation study.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to an existing legally marketed device (the I-Flow Elastomeric Pump without the bolus component). The key argument is that the new bolus component "utilizes the same technology for dispensing medication as the existing unmodified design," implying that the safety and effectiveness are comparable and, therefore, extensive new performance studies (as outlined in your request) are not required for this type of submission.

Therefore, I cannot provide the information requested in your numbered list directly from the provided text because it's not present. The document explicitly states:

• "Conclusion: The I-Flow Elastomeric Pump with Bolus is substantially equivalent to the existing I-Flow Elastomeric Pump."
• "Technology Comparison: The new Bolus Component utilizes the same technology for dispensing medication as the existing unmodified design."

This type of submission relies on the predicate device's established performance rather than new, extensive studies for the modified device, particularly since the modification is described as an "optional component" that adds a specific function (bolus delivery) but uses the same fundamental technology.

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1. The I-Flow Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotheraly and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural.
2. The I-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.

The I-Flow Elastomeric Pump consists of an elastomeric pressure source with an integrated administration line. This special 510(k) proposes a change from latex to polyisoprene for the outer bladder. The outer bladder is not in contact with the fluid path and thus does not require biocompatibility. The inner bladder will remain the same and thus drug compatibility will not be affected.

The provided document is a 510(k) submission for a change in material for the I-Flow Elastomeric Pump, specifically switching the outer bladder from latex to polyisoprene. This is a "Special 510(k)," which indicates a modification to an existing device where the design control activities are sufficient to demonstrate substantial equivalence.

Given the nature of a Special 510(k) for a material change that does not contact the fluid path and where drug compatibility is not affected, the submission focuses on demonstrating that the new material (polyisoprene) has similar properties to the existing material (latex) and that the device still performs as intended. Therefore, the "acceptance criteria" and "study" are not presented as a traditional performance study with accuracy metrics, but rather as a demonstration of material equivalence and continued device functionality.

Here's the breakdown based on the provided information:

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

The document doesn't present explicit numerical acceptance criteria and a performance table in the typical sense of accuracy or precision. Instead, the acceptance criterion is implicitly that the device with the new material remains substantially equivalent to the predicate device. The performance is summarized by stating the two materials have "similar properties" and that the material change does not impact drug compatibility.

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

The document does not provide information on a specific test set sample size or data provenance for a performance study. As this is a material change for a non-fluid-contact component, the "study" appears to be more focused on material characterization and engineering assessment rather than a clinical or performance testing study with
patient samples.

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)

This information is not applicable and not provided. The context is a material change for a medical device's component. There's no "ground truth" to be established by experts in the sense of diagnostic accuracy or clinical outcomes. The assessment is likely performed by engineers and material scientists from the manufacturer.

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

This information is not applicable and not provided. There's no mention of an adjudication process as there is no "test set" in the context of diagnostic interpretation.

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 information is not applicable and not provided. The device is an elastomeric infusion pump, not an AI-assisted diagnostic tool.

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

This information is not applicable and not provided. The device is an elastomeric infusion pump, not an algorithm or AI system.

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

This information is not applicable and not provided. There is no "ground truth" in the clinical sense mentioned, as the study pertains to material properties and substantial equivalence, not clinical diagnosis or outcomes.

8. The sample size for the training set

This information is not applicable and not provided. There is no mention of a "training set" as this is not a machine learning or AI device.

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

This information is not applicable and not provided. As there's no training set, there's no ground truth establishment for it.

In summary, this 510(k) submission is for a material change that is considered minor because it does not affect device performance or patient contact. The "study" referenced is the demonstration that the new material is functionally equivalent to the old material and does not impact critical device features like drug compatibility. The typical metrics and study designs for diagnostic devices or AI systems are not relevant here.

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