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1. The I-Flow Variable Rate 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, intraarterial, subcutaneous, intramuscular and epidural.
2. The I-Flow Variable Rate 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 Variable Rate Elastomeric Pump consists of an elastomeric pressure source with an integrated administration line. This special 510(k) proposes a new component that incorporates a variable flow rate mechanism.

The provided document is a 510(k) summary for the I-Flow Variable Rate Elastomeric Pump. It establishes substantial equivalence to existing devices and approves the device for marketing. However, it does not contain any information about specific acceptance criteria, study data, or performance metrics that would be typically found in a clinical study report or a detailed validation summary.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on specific performance data against acceptance criteria.

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1. The Homepump C-Series is intended for continuous infusion of medications for general infusion use, including chemotherapy and pain management. Routes of administration include intravenous, subcutaneous, intramuscular and epidural.
2. The KVO model of the Homepump C-Series is intended for general purpose drug and/or diluent delivery at a sufficient flow rate to maintain a patient IV line open (i.e. keep vein open). The Y-site at the distal end of the administration set allows piggy back infusions. The routes of administration include intravenous, subcutaneous and intramuscular.

The Homepump C-Series is an elastomeric infusion pump with an integrated administration set. The elastomeric membranes function as the fluid reservoir and the pressure source. The pressure that pumps the fluid comes from the strain energy of the elastomeric membranes which are forced to expand when the pump is filled. The incorporation of fixed diameter flow control tubing or glass orifice combined with the elastomeric pressure source produces the desired flow rate. Homepump C-Series models are available in fill volumes from 50 to 500 ml and flow rates from 0.5 to 10 ml/hr. The One•Step KVO models of the Homepump C-Series have an optional Y-site and optional check valve attached to the distal end of the administration set. The following accessories are available: carry case, E-clip and power ring.

Here's a summary of the acceptance criteria and the study details for the I-Flow Homepump C-Series device based on the provided document:

Acceptance Criteria and Device Performance

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The Nerve Block Infusion Kit is intended to provide continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative general and orthopedic surgery. Additional routes of infusion include percutaneous, subcutaneous, epidural and into the intraoperative (soft tissue / body cavity) site and synovial cavity.

The Nerve Block Infusion Kit is nearly identical to the I-Flow PainBuster Infusion Kit with the exception of a new intended use, the addition of three new pump models and the addition of three new kit components (insulated Tuohy needle, hemostasis valve assembly and hookup wire). The kit is comprised of an elastomeric infusion pump (K944692) and various components such as catheter, needle, syringe, dressing, tape, gauze, hemostasis valve assembly, hookup wire and accessories such as carry case, power ring and clothing attachment clip (E-Clip). The Nerve Block pump is a disposable device intended for single patient use. The Nerve Block pump is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.

Here's an analysis of the provided text regarding the Nerve Block Infusion Kit, focusing on acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document mentions "nominal fill volumes for each model" but does not provide specific numbers of pumps or tests conducted.
• Data Provenance: Not explicitly stated, but it is implied to be internal testing conducted by I-Flow Corporation ("Testing occurred at standard operating conditions. Testing occurred at nominal fill volumes for each model."). There is no mention of external validation or data from specific countries. It is prospective in nature, as the testing was performed to support the premarket notification.

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

Not applicable. The study is a performance test of a medical device (infusion pump flow rate) and does not involve human expert interpretation or a "ground truth" in the clinical sense. The ground truth here is the physical measurement of the flow rate against a specified engineering tolerance.

4. Adjudication Method for the Test Set

Not applicable. This was a technical performance test, not a subjective assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is an elastomeric infusion pump, not an AI-powered diagnostic or assistive technology involving human readers.

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

Yes, a standalone performance test was done. The device (Nerve Block pump) was tested to measure its flow rate performance against pre-defined accuracy claims. This refers to the intrinsic performance of the pump itself, independent of human interaction during operation beyond initial setup.

7. The Type of Ground Truth Used

The ground truth used was engineering specification/measurement against a defined tolerance. The "ground truth" for flow rate accuracy is the desired flow rate, and the measured flow rate must fall within ±15% of that desired rate at a 95% confidence interval.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not a machine learning model, so there is no concept of a "training set."

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

Not applicable, as there is no training set for this type of device.

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The PainBuster is intended to provide continuous infusion of a local anesthetic directly into an intraoperative (soft tissue / body cavity) site for general surgery for postoperative pain management. Additional routes of administration include percutaneous and subcutaneous infusion.

The PainBuster Infusion Kit is nearly identical to the PainBuster Infusion System (K980558) marketed by I-Flow Corporation except for some labeling changes and the addition of new models and optional components. The kit is comprised of an elastomeric infusion pump (K944692) and various kit components such as catheter, needle, syringe, dressing, tape, gauze, carry case, Y Adapter, Power Ring and clothing attachment clip (E-Clip). The PainBuster pump is intended to attach to the kit catheter at the distal end of the administration set to provide continuous infusion of a local anesthetic directly into the intraoperative site for general surgery for postoperative pain management. The PainBuster is single patient use only. The PainBuster is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.

The document provided is a 510(k) premarket notification for a medical device (PainBuster Infusion Kit), which seeks to demonstrate substantial equivalence to previously marketed devices. It is not a clinical study report designed to prove the device meets acceptance criteria in the typical sense of a novel device undergoing extensive clinical trials for efficacy and safety from scratch.

However, based on the provided text, we can extract information regarding the device's operational specifications and the testing done to demonstrate these specifications. The "acceptance criteria" here refers to the specified performance accuracy for the elastomeric infusion pump's flow rate, and the "study" refers to the performance testing described.

Here's a breakdown of the requested information:

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

The primary acceptance criterion and performance data provided relates to the flow rate accuracy of the elastomeric infusion pump.

The document states: "Testing occurred at nominal fill volume for each models produced an average flow rate well within the ±15% accuracy claim."

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

• Sample sizes for flow rate performance testing (test set):
  • 60 ml x 2 ml/hr model: n=15
  • 110 ml x 0.5 ml/hr model: n=46
  • 125 ml x 5 ml/hr model: n=29
  • 270 ml x 1 ml/hr model: n=33
  • 270 ml x 2 ml/hr model: n=35
  • 270 ml x 5 ml/hr model: n=12
  • 270 ml x 10 ml/hr model: n=6
• Data Provenance: The data appears to be from internal laboratory testing conducted by I-Flow Corporation. There is no explicit mention of country of origin for the data or whether it's retrospective or prospective, but given it's a premarket notification for a new model/kit, it would generally be prospective testing specific to these models.

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 physical medical device (an infusion pump), not a diagnostic or AI-driven decision support system. Therefore, the concept of "experts establishing ground truth" in the context of medical imaging interpretation or similar fields does not apply here. The ground truth for flow rate is established by objective physical measurement using standard laboratory equipment.

4. Adjudication method for the test set

Not applicable, as this is objective device performance testing, not interpretation of medical data 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

Not applicable. This document pertains to the physical performance of an infusion pump, not an AI or diagnostic system involving human readers.

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

This refers to the performance of the device itself (the infusion pump) in a controlled laboratory setting. All the flow rate performance data listed in section 3.2 is standalone performance of the device without human intervention influencing the flow rate during the test.

7. The type of ground truth used

The ground truth for the flow rate performance testing was established through objective physical measurement of the fluid dispensed over time, in a controlled laboratory environment. The "test solution" used was 0.9% NaCl.

8. The sample size for the training set

Not applicable. This device is a physical pump, not an AI model requiring a training set. The various sample sizes mentioned in point 2 are for performance verification.

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

Not applicable, as there is no training set for this device.

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