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The ARROW FlexBlock Continuous Peripheral Nerve Block Kit/Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, lower extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.

The Arrow® FlexBlock® Continuous Peripheral Nerve Block Catheter Kit/Set features a wire reinforced, polyurethane body with centimeter markings to facilitate placement for continuous plexus and peripheral nerve blocks. The catheter includes a SnapLock™ adapter to enable infusion of medications, and a stylet for enhanced maneuverability. Procedural trays also include a stimulating or non-stimulating plexus block needle, and other procedural components.

The provided document is a 510(k) premarket notification for the ARROW® FlexBlock® Continuous Peripheral Nerve Block Kit/Set. This submission focuses on updating the MR (Magnetic Resonance) Conditional statements in the Instructions for Use (IFU) based on new non-clinical testing. It explicitly states that "The device that is the subject of this submission is identical to its predicate in all other respects, including the technological characteristics, materials, indications for use, and FDA classification." Therefore, the study described here is not a clinical study involving human patients or a standalone algorithm performance study, but rather non-clinical testing to assess the device's compatibility with MRI environments.

Here's an analysis of the provided information based on your request:

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

The document does not explicitly state "acceptance criteria" in a quantitative manner for MRI compatibility. Instead, the non-clinical tests aimed to ensure the device could be labeled as "MR Conditional," meaning it can be safely used in a specified MRI environment under certain conditions. The reported device performance is that the tests concluded the FlexBlock Catheter should be labeled as MR Conditional and included labeling guidelines. This implies that the device successfully met the safety thresholds for MRI compatibility during the testing.

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

The document specifies "the test article in both cases was the 19 ga FlexBlock catheter." This implies that the testing was performed on one or more samples of the 19 gauge FlexBlock catheter. The exact number of individual catheter units tested is not provided, but it would have been a sufficient number to represent the product and ensure robust testing according to ASTM guidelines.

The data provenance is from non-clinical laboratory testing conducted by specialized third-party organizations:

• Shellock R&D Services (MRI Testing, 2011)
• Exponent, Inc. (MRI Testing, 2015)

The testing was retrospective in the sense that it was performed on existing device designs to update labeling.

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

This question is not applicable to the provided document. The ground truth for MRI compatibility testing is established by physical measurements and adherence to recognized standards (e.g., ASTM F2182), not by expert consensus on clinical findings. The entities performing the tests (Shellock R&D Services and Exponent, Inc.) are specialized in medical device MRI safety assessments, implying their expertise in the field.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to clinical scenarios where multiple human readers assess a case and a consensus or tie-breaking mechanism is used. Here, the "test set" involves physical measurements against technical standards for MRI safety. The "adjudication" is implicitly the adherence to and interpretation of the results according to the ASTM F2182 standard and other relevant guidelines by the testing facilities.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes non-clinical MRI compatibility testing of a medical device, not a comparative effectiveness study involving human readers and clinical cases.

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

No, a standalone (algorithm only) performance study was not done. This document is about the physical properties and MRI compatibility of a medical device, not a software algorithm.

7. The type of ground truth used

The ground truth used for this testing was based on established scientific principles, engineering measurements, and recognized industry standards for MRI compatibility, specifically:

• Physical measurements of magnetic field interactions.
• Measurements of temperature rise due to radiofrequency (RF)-induced heating.
• Evaluation of imaging artifacts.
• Methodologies prescribed in ASTM F2182 ("Standard Test Method for Measurement of Radiofrequency Induced Hearing Near Passive Implants During Magnetic Resonance Imaging") as a guide.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this document describes non-clinical physical testing of a medical device, not the development or evaluation of a machine learning algorithm.

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

This question is not applicable, as there is no training set.

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The ARROW FlexBlock Continuous Peripheral Nerve Block kit/set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, lower extremity, abdominal and paravertebral locations for periods not exceeding 72 Hours.

The catheter is designed to deliver anesthesia to manage perioperative pain and /or alleviate postoperative analgesia.

The ARROW FlexBlock Continuous Peripheral Nerve Block Catheter has the following characteristics:

• 19 Ga., 30 to 90 cm with at minimum one flashback window to visualize fluids inside . catheter
• . Offered in open and closed tip configurations
• Internal radiopaque, echogenic coiled reinforced wire to visualize under Ultrasound .
• Catheters are provided in sterile kit/set configurations or as a standalone replacement . catheter .

In this 510(k) summary for the ARROW FlexBlock Continuous Peripheral Nerve Block Catheter (K122027), the document describes a medical device, its intended use, and its substantial equivalence to predicate devices based on nonclinical testing. However, the provided text does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of clinical performance or a comparative effectiveness study involving human readers or AI.

The submission focuses on bench testing and biocompatibility. Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Comment: The document states that the "results of the performance testing, i.e. tensile strength, column strength and flow rate, demonstrate that the FlexBlock Continuous Peripheral Nerve Block Catheter is as safe, as effective and performs comparably to the primary predicate (K 103658) and referenced predicate (K121403)." However, specific numerical acceptance criteria (e.g., "tensile strength must be > X N") and their corresponding measured values are not provided. The general acceptance criterion appears to be "comparable to predicate devices" for physical characteristics and "safe and effective" for biocompatibility and material properties.

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

This information is not available in the provided 510(k) summary. The document describes "nonclinical testing" and "pre-clinical evaluations" but does not detail a "test set" in the context of clinical or diagnostic performance evaluation with human subjects or a dataset for an AI algorithm. The testing described focuses on bench and in vitro (extractables and leachables) studies.

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

This information is not applicable and not available in the provided 510(k) summary. The submission focuses on device characteristics and substantial equivalence based on engineering and biocompatibility testing, not on a diagnostic or interpretive task that would require expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not available in the provided 510(k) summary for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this 510(k) summary. Such studies are typically relevant for diagnostic imaging devices or AI-powered tools where human interpretation is involved. This device is a catheter for anesthesia delivery.

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

No. This question is not applicable as the device is a medical catheter, not an AI algorithm or a device that performs diagnostic interpretation independently.

7. The Type of Ground Truth Used

This information is not applicable in the context of a diagnostic or interpretive device. For the nonclinical testing described (tensile strength, flow rate, biocompatibility), the "ground truth" would be established by standardized measurement techniques and established safety limits for materials.

8. The Sample Size for the Training Set

This information is not applicable and not available as this device does not involve a training set for an AI algorithm.

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

This information is not applicable and not available as this device does not involve a training set for an AI algorithm.

Summary of Findings from the Document:

The K122027 submission for the ARROW FlexBlock Continuous Peripheral Nerve Block Catheter is a declaration of substantial equivalence based primarily on:

• Same Intended Use: To deliver anesthesia for continuous nerve blocks, comparable to predicate devices.
• Technological Characteristics: Similar materials (internal radiopaque, echogenic coiled reinforced wire), configurations (open/closed tip), and dimensions to predicate devices.
• Nonclinical Testing: Bench testing for physical properties (tensile strength, column strength, flow rate) demonstrating performance comparable to predicates.
• Biocompatibility: In vivo studies and extractable/leachable (E&L) studies demonstrating the safety of materials and compatibility with common anesthetic drugs, meeting ISO 10993 guidelines.

The document does not describe any clinical trials on human patience to demonstrate safety and effectiveness for a medical device that received 510(k) clearance. Instead, these are assessed through substantial equivalence to existing legally marketed predicate devices, supported by non-clinical (bench and in vitro) testing.

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