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The SmartInfuser PainPump™ is intended to provide continuous delivery of a local anesthetic through a catheter inserted directly into the surgical site for postoperative pain management.

The device comprises of the following parts:

• SmartCatheter -
• SmartInfuser set with SmartReg flow regulator (regulating set) -
• Compression unit (pump) -
• 100 ml or 250 ml infusion bag (empty) -
• Peel-off introducer -
• -Medication label
• Pump label -
• Carrying pouch made of synthetic cloth -
  The empty infusion bag is included as a back-up container. Under normal circumstances, a standard solution bag filled by a pharmacist according to the physician's prescription will be used.

The provided text is a 510(k) summary for a medical device called the SmartInfuser PainPump™. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria based on performance metrics.

Therefore, much of the requested information regarding acceptance criteria, performance data, sample sizes, expert involvement, and ground truth establishment from a study proving criteria is not available in the provided document.

Here's an analysis based on the available information:

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

This information is not provided in the document. The 510(k) summary asserts "equivalent performance characteristics" to the predicate device, but it does not specify what those characteristics are, what the acceptance criteria for those characteristics would be, or the SmartInfuser PainPump™'s reported performance against them.

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 provided. The document makes no mention of a specific test set or clinical study. The substantial equivalence claim is based on the device's design and intended use being similar to the predicate.

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 provided. As no specific test set or study 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:

This information is not provided.

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 is not applicable to this device. The SmartInfuser PainPump™ is an infusion pump, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable. The device is a physical infusion pump.

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

This information is not provided as no specific study with ground truth establishment is described. The "ground truth" for a 510(k) submission like this is primarily the established safety and effectiveness of the predicate device and the demonstration that the new device shares those characteristics.

8. The sample size for the training set:

This information is not provided. There is no mention of a "training set" as this device is not an AI/ML algorithm.

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

This information is not provided.

Summary of available information related to equivalence:

• Acceptance Criteria Implied: The implicit acceptance criterion for this 510(k) submission is that the SmartInfuser PainPump™ is substantially equivalent to the predicate device, the Painbuster Infusion Kit (K982946), in terms of intended use and performance characteristics.
• Study Proving Equivalence: The "study" is the 510(k) submission process itself, where the manufacturer provides information and justification (as presented in the "Substantial Equivalence" section) that the new device has "equivalent performance characteristics" and "the same intended use" as the predicate. The FDA's review and clearance (indicated by the letter) constitute the acceptance that this "study" or review process successfully demonstrated equivalence.
• Reported Device Performance (against equivalence): The document explicitly states: "The SmartInfuser PainPump™ has the same intended use as the Painbuster Infusion Kit, cleared under 510(k) no. K9982946 and has equivalent performance characteristics. It is therefore substantially equivalent to that device." This is the core "performance" reported in the context of a 510(k) – that it performs equivalently to a legally marketed device.

In essence, for a 510(k) submission like this, the "acceptance criteria" revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than meeting specific quantifiable performance metrics through a novel clinical trial. The "study" is the comparison made by the manufacturer and accepted by the FDA based on the provided documentation.

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The Soaker Catheter is intended to be used as follows:

1. With I-Flow Corporation's PainBuster, ON-Q and Nerve Block pain management kits; and
2. As a stand alone device to provide continuous or intermittent delivery of local anesthetics or narcotics to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative or percutaneous.

The Soaker Catheter is identical to the predicate IntraOp Catheter (K991543). This premarket notification adds an additional model to the Soaker Catheter family of catheters. The Soaker Catheter consists of a Teleflex Medical (TFX) Epidural Catheter (K840202, originally submitted by Aries Medical) with the insertion of a hollow fiber membrane in the inner diameter of the distal end of the catheter. The catheter has a closed end tip with multiple holes arranged radially along the lateral surface at the distal end of the device.

The provided text is a 510(k) summary for the "Soaker Catheter." This document focuses on demonstrating substantial equivalence to pre-existing devices, not on proving performance against specific acceptance criteria through a study. Therefore, the information required to answer most of your questions (acceptance criteria table, study details, sample sizes, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth types for test and training sets) is not present in the provided text.

The document is a regulatory submission for a medical device, which typically relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than conducting new performance studies that would establish acceptance criteria for novel functionalities.

Here's a breakdown of what can be extracted and why other information is missing:

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

• Information Not Found: The document does not specify quantitative acceptance criteria or report performance data against such criteria. Its entire premise is based on substantial equivalence to predicate devices.

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

• Information Not Found: No mention of a "test set" or any clinical study from which such data would originate. The submission states the device's materials are "identical" to predicate devices and biological testing is in conformance with ISO 10993, but it doesn't describe a specific performance study in humans.

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)

• Information Not Found: Not applicable, as there's no described "test set" requiring ground truth establishment by experts for performance evaluation.

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

• Information Not Found: Not applicable, as there's no described "test set" 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

• Information Not Found: This is a physical catheter, not an AI-powered diagnostic device. MRMC studies are not relevant here.

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

• Information Not Found: This is a physical catheter, not an algorithm. Standalone performance as typically understood for AI/software is not applicable.

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

• Information Not Found: Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Information Not Found: Not applicable. There is no "training set" in the context of an AI/machine learning model. The device's design is based on existing, legally marketed catheters.

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

• Information Not Found: Not applicable.

Summary of what the document does provide regarding device characteristics and regulatory pathway:

• Device Name: Soaker Catheter
• Common Name: Anesthetic Catheter
• Classification Name: Anesthesia Conduction Catheter
• Predicate Devices:
  1. I-Flow IntraOp 1.1.1 Catheter (K991543)
  2. Teleflex Medical (TFX) Epidural Catheter (K840202)
  3. B. Braun Perifix Set (K813186)
  4. Epimed International FETH-R KATH catheter (K981329)
• Key Aspect of Substantial Equivalence: The Soaker Catheter is described as "identical" to the predicate IntraOp Catheter (K991543), with this submission adding an additional model (S1205: 20 GA with 12.5 cm (5.0 in.) infusion segment) to the existing S0605 model (20 GA with 6.5 cm (2.5 in.) infusion segment). The new model is "virtually identical" to the predicate 2.5-inch Soaker Catheter except for the longer infusion segment.
• Material Equivalence: "All materials in the catheter are identical in formulation to materials currently being used in other products with the same or similar uses and have a long history of use in those devices." (Section 3.1)
• Biological Testing: "Biological testing is in conformance with ISO 10993 Part 1 for fluid path components." (Section 3.2)
• Drug Compatibility: No specific drugs are referenced, and no drugs are included with the catheter. (Section 4.1)
• Intended Use:
  • With I-Flow Corporation's PainBuster, ON-Q, and Nerve Block pain management kits.
  • As a stand-alone device to provide continuous or intermittent delivery of local anesthetics or narcotics to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative or percutaneous. (Section 5.1 & Indication for Use statement)

In essence, this 510(k) asserts that the Soaker Catheter is substantially equivalent to existing, legally marketed devices. It does not present new performance data against specific acceptance criteria, but rather relies on the established safety and effectiveness of its predicate devices and the similarity of its design and materials.

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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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