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The McKinley Saturation Catheter™ is intended for continuous and/or intermittent infusion of pain medication to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative, subcutaneous or percutaneous.

The McKinley Saturation Catheter™ is a single patient use disposable infusion catheter, intended for connection to an infusion device, used to deliver pain medication to a patient for pain management. The McKinley Saturation Catheter™ is a flexible, tubular infusion catheter with multiple holes located throughout the fenestrated segment along the distal end of the catheter. The catheter will be available in different sizes (varying length of fenestrated segment, number of holes, diameter of catheter body), as appropriate for use in a variety of catheter placements. The McKinley Saturation Catheter™ connects to an infusion device via a proximal luerlock connector.

Here's an analysis of the provided text regarding the acceptance criteria and study for the McKinley Saturation Catheter, organized according to your requested format.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria through a clinical study. Therefore, many of your requested fields will reflect this rather than a typical performance study.

Acceptance Criteria and Study for the McKinley Saturation Catheter™

This 510(k) submission for the McKinley Saturation Catheter™ primarily relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing performance against new, quantitative acceptance criteria through a dedicated clinical study. The "acceptance criteria" here are implicitly about meeting the safety, effectiveness, intended use, function, materials, and performance standards of the chosen predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. This submission does not report on a specific "test set" of patients or data from a clinical performance study. The evaluation is based on a comparison to predicate device characteristics and existing regulatory approvals.
• Data Provenance: Not applicable for a performance study. The data provenance relevant to the 510(k) is the regulatory history and technical specifications of the predicate devices: Micor Wundcath Conduction Catheter (K031600 & K003966) and I-Flow Soaker Catheter (K994374).

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. There was no independent expert panel used to establish ground truth for a clinical test set for this 510(k) submission.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set requiring adjudication was performed or reported in this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. An MRMC comparative effectiveness study was not conducted or reported. This type of study is more common for diagnostic imaging devices where human interpretation is a key component, not for an infusion catheter.
• Effect Size of Human Readers Improvement: Not applicable.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Not applicable. The McKinley Saturation Catheter™ is a medical device (catheter), not an algorithm or AI system. Therefore, standalone performance in that context is irrelevant.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this 510(k) submission is the established safety, effectiveness, and regulatory compliance of the predicate devices. The substantial equivalence argument relies on the well-understood performance of the Micor Wundcath Conduction Catheter and the I-Flow Soaker Catheter, which have already gone through their own approval processes and have a history of safe and effective use.

8. Sample Size for the Training Set

• Sample Size: Not applicable. There was no "training set" in the context of an algorithm or machine learning model. The development of the catheter would be based on engineering design principles, material science, and manufacturing processes, guided by the characteristics of the predicate devices.

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

• Ground Truth Establishment: Not applicable. As there was no training set, there was no ground truth for it to be established. The design and development of the McKinley Saturation Catheter™ were guided by the known characteristics and approved uses of the predicate devices.

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The Accufuser and Accufuser Plus systems are intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into the intra-operative (soft tissue/body cavity) site. The Accufuser Plus is also intended for patient-controlled infusion using the integrated bolus button. General infusion uses include pain management for preoperative, perioperative, and postoperative surgery.

The Accufuser and Accufuser Plus systems are 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 Accufuser/Accufuser Plus system is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.

The Accufuser and Accufuser Plus systems are 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 Accufuser device consists of an elastomeric balloon medication reservoir with a flow rate-controlling administration set. The pressure that pumps the fluid is derived from the strain energy of the elastomeric membrane that is forced to expand when the pump is filled. The administration set includes a flow restrictor component with controlled internal diameter and length. The flow rate at which medication is dispensed from the system is a function of the pressure applied to the medication and the dimensions of the flow restrictor component. The medication may be dispensed from the system continuously and/or intermittently.

The size of the reservoir and the amount of flow restriction are determined to yield a variety of product codes with differing infusion volumes and flow rates. The physician variety of product on thow rate and reservoir size based on the individual patient needs.

Administration sets may incorporate a bolus feature, which may be used alone or in conjunction with basal (continuous) flow. The bolus device consists of a dosage reservoir that is filled when activated manually. After the bolus device has been rctivated, the bolus volume is infused at a controlled flow rate. The bolus device is integrated into the administration set and allows patient-controlled administration of medication as needed.

A procedure kit option provides various components that facilitate setup and use of the Accufuser system.

The Accufuser system is intended for single patient use.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary for modifications to an existing device, the McKinley Accufuser, Accufuser Plus, and Standard Procedure Kit.

The key points of this document are:

• Device: McKinley Accufuser, Accufuser Plus, and Standard Procedure Kit.
• Modification: Addition of an indication for use.
• Claim: The added indication states that the Accufuser and Accufuser Plus systems are intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves, compared with narcotic-only pain management.
• Basis for Clearance: Substantial equivalence to previously cleared devices (K003915, K023098, K033039) and predicate devices (McKinley's beeLINE system & standard procedure kit (K042228) and the I-Flow Elastomeric Pump (K040337)).
• Conclusion: The modified system "does not raise any new safety and efficacy concerns" and is "substantially equivalent to the named predicate devices."

The document does not contain:

• A table of acceptance criteria and reported device performance.
• Details of any specific study (like a clinical trial or performance study) designed to prove the new indication for use, including sample sizes, data provenance, expert qualifications, or adjudication methods.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• Details on ground truth types or how ground truth was established for any test or training sets.
• Sample sizes for training sets.

The 510(k) process often relies on demonstrating substantial equivalence to existing devices rather than requiring new clinical studies for every modification, especially if the modification is related to an indication for use that is generally accepted for similar devices. In this case, the claim of decreasing narcotic use and pain might be considered a clinical benefit inferred from the mechanism of action (delivering local anesthetics) and comparison to existing devices with similar functionalities, rather than requiring a dedicated, new clinical trial for this specific 510(k) submission.

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