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The ON-Q SilverSoaker Catheter is intended to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for perioperative and postoperative pain management. The ON-Q SilverSoaker Catheter is contraindicated for the epidural space and in neonatal populations.
The ON-Q SilverSoaker Catheter contains an antimicrobial agent which may destroy or inhibit the growth of microorganisms on both the inner and outer surfaces of the catheter. The antimicrobial agent is intended to reduce the possibility that the catheter may become microbially compromised. The antimicrobial agent is not intended to be used as a treatment for existing infections.

The ON-Q SilverSoaker Catheter consists of two design options:
Fenestrated Catheter: a modified epidural catheter with multiple holes at the distal end up to a 10 inch infusion segment
Soaker Catheter: a modified epidural catheter with multiple holes at the distal end up to a 10 inch infusion segment. This version of the ON-Q SilverSoaker Catheter contains a hollow fiber along the inner lumen of the catheter to provide even distribution of medication along the infusion segment.
This 510(k) adds an antimicrobial agent which may destroy or inhibit the growth of microorganisms on both the inner and outer surfaces of the catheter. The antimicrobial agent is intended to reduce the possibility that the catheter may become microbially compromised. The antimicrobial agent is not intended to be used as a treatment for existing infections.

The provided text is a 510(k) Summary for the ON-Q SilverSoaker Catheter, which is an anesthetic conduction catheter. It describes the device, its intended use, and states that it is substantially equivalent to existing devices.

However, the document does not contain any information regarding acceptance criteria or the results of a study (clinical or otherwise) proving device performance against such criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device that does not require premarket approval. It's not typically a full clinical trial where specific performance metrics are measured against pre-defined acceptance criteria with detailed statistical analysis.

Therefore, I cannot provide the requested information in the structured format because the source document does not contain it. The 510(k) summary only states:

"The ON-Q SilverSoaker Catheter is substantially equivalent to the existing ON-Q Catheter product line and predicate devices."

This is the "conclusion" of the submission, based on technology comparison, not a study demonstrating new performance criteria.

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With I-Flow Corporation's ON-Q, PainBuster and C-bloc pain management kits; and As a stand alone device to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves. Routes of administration may be intraoperative, percutaneous, perineural. The Soaker version of the I-Flow Catheter is contraindicated for the epidural space.

The I-Flow Catheter consists of three design options which can utilize infusion segments ranging from epidural to 10 inches (same as the predicate devices with the exception of the 10 inch infusion segment): Standard epidural catheter: 3 radial holes at the distal end with an approximate 0.5 inch infusion segment. Fenestrated Catheter: a modified epidural catheter with multiple holes at the distal end up to a 10 inch infusion segment Soaker Catheter: a modified epidural catheter with multiple holes at the distal end up to a 10 inch infusion segment. This version of the I-Flow Catheter contains a hollow fiber along the inner lumen or along the outside diameter of the distal end of the catheter to provide even distribution of medication along the infusion segment.

This document is a 510(k) summary for a medical device (I-Flow Catheter) and does not contain the information requested in your prompt regarding acceptance criteria or a study proving device performance against such criteria.

The 510(k) submission process is for demonstrating substantial equivalence to a predicate device, not for proving performance against specific acceptance criteria in a clinical study as would be seen for new technology.

Therefore, I cannot extract the following information from 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
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

What the document does indicate:

• Device: I-Flow Catheter (including Soaker Catheter, Fenestrated Catheter, Epidural Catheter, and a new 10-inch infusion segment model)
• Purpose of Submission: Special 510(k) for a new 10-inch I-Flow Catheter model.
• Basis for Approval: Substantial equivalence to already legally marketed predicate devices (I-Flow Catheter K991543, K994374, and K022869).
• Technology Comparison: The new 10-inch model "utilizes the exact same technology as the existing I-Flow Catheter product line."
• Conclusion: The new model is "substantially equivalent to the existing I-Flow Catheter product line."

In essence, this submission argues that because the new device is fundamentally the same as devices already on the market, it does not require new performance studies against specific acceptance criteria. Its performance is implicitly considered equivalent to the predicate devices.

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

The Soaker Catheter has a closed end tip with multiple holes arranged radially along the lateral surface along the infusion segment at the distal end of the device. A membrane in the inner diameter of the catheter promotes even distribution along the infusion segment. This special 510(k) proposes a slight design change that has the membrane along the outside diameter of the catheter instead of the inside diameter.

The provided text is a Special 510(k) for a "Soaker Catheter" from I-Flow Corporation (K022869). This document describes a design change to an existing device, specifically moving a membrane from the inside to the outside diameter of the catheter.

Based on the nature of this submission (a Special 510(k) for a minor design change to an already cleared device), the typical detailed clinical studies and performance evaluations against specific acceptance criteria, as might be seen for a novel device or a device making substantial performance claims, are not present in this document.

Instead, the submission relies on demonstrating substantial equivalence to the predicate device (the earlier Soaker Catheter, K991543 and K994374). The justification for this substantial equivalence is that the "new Soaker Catheter utilizes the exact same technology for promoting even distribution along the infusion segment." This implies that the performance characteristics, and thus the "acceptance criteria," are inherently met by virtue of the device being functionally identical to the previously cleared version.

Therefore, many of the requested elements for a detailed study proving device meets acceptance criteria are not applicable (N/A) in this specific 510(k) summary.

Here's the breakdown of the information as requested, with explanations for why certain elements are N/A:

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

Explanation: This 510(k) is for a minor design modification where the manufacturer asserts that the fundamental technology and performance are unchanged. Therefore, explicit, quantitative acceptance criteria and a study dedicated to proving these new criteria are not typically provided in such a submission. The "acceptance" is that the device performs equivalently to its predicate, which has already been deemed safe and effective.

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

N/A. No specific test set or clinical data is presented for this Special 510(k) based on the provided text. The submission focuses on the engineering change and its lack of impact on existing performance characteristics.

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

N/A. No ground truth establishment by experts is described in this document.

4. Adjudication method for the test set

N/A. No test set or adjudication method is described in this document.

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

N/A. This is a medical device (catheter), not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

N/A. This is a medical device (catheter), not an algorithm. Standalone performance studies in this context are not applicable.

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

N/A. No ground truth is specified or needed for this type of device modification under a Special 510(k) that claims substantial equivalence based on an identical functional principle.

8. The sample size for the training set

N/A. As this is a physical medical device and not a machine learning model, the concept of a "training set" is not applicable.

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

N/A. Not applicable, as there is no training set for a physical medical device.

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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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