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The Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit is intended for use in regional anesthesia and pain therapy to locate peripheral nerves by transferring electrical impulses from a nerve stimulator, or to be seen by ultrasound visualization of the device. The need to inject and facilitate the continuous and/or internittent administration of local anesthetics or analgesics to the targeted nerve bundle in surgical procedures.

In packaged set configurations, the Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit, consisting of the peripheral nerve block needle, catheted peripheral nerve block procedural accessories, is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management during pre-operative and post-operative periods associated with surgical procedures. The catheter may remain indwelling for up to 72 hours.

Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit is a needle comprised of an open tip catheter over a needle. The Fascile kit is comprised of different key components required to complete the Peripheral Nerve Block procedure.

This document describes the Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit and its substantial equivalence to a predicate device (Complex® C Continuous Peripheral Nerve Block Needle, K121846).

The information provided focuses on demonstrating substantial equivalence through technological characteristics and performance (bench) testing, rather than a clinical study involving human readers or a standalone algorithm performance. Therefore, many of the requested items related to AI/algorithm performance are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

This submission is a 510(k) premarket notification for a medical device (Continuous Peripheral Nerve Block Catheter and Needle Kit), which is typically based on demonstrating substantial equivalence to a predicate device through bench testing and, if applicable, animal/clinical studies. It does not involve an AI/algorithm-driven device, therefore, many of the typical AI study parameters are not applicable.

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

• Test Set (Bench Testing): The document does not specify the exact sample size (number of devices tested) for each bench test, but it indicates that tests were performed to demonstrate compliance with ISO standards and internal test methods. For example, for "Tensile Strength Test Method" and "Catheter and Extension Set Flow Test Method," these would typically involve a statistically relevant number of units.
• Data Provenance: Not explicitly stated, but assumed to be from manufacturing/testing facilities of Solo-Dex, Inc. within the USA, given the submission location and company address. The studies are prospective in nature, as they involve testing newly manufactured devices against predetermined criteria.

2. 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)

• Experts for Bench Testing: For bench tests, the "ground truth" is defined by established international standards (e.g., ISO 10555, ISO 594-1/2, ISO 10993-1) and internal engineering specifications. There is no mention of "experts" establish ground truth in the context of clinical interpretation, as this is a device performance study.
• Experts for Human Factors Study: Qualified clinicians participated in the Human Factors study to confirm usability. The specific number or detailed qualifications beyond "qualified clinicians" are not provided.

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

• This concept is not applicable to the bench testing performed for this device. Bench tests have objective Pass/Fail criteria based on measurements against defined standards.
• For the Human Factors study, "qualified clinicians participating... confirmed the usability," suggesting a consensus or satisfaction-based assessment, but no formal adjudication method (like 2+1 or 3+1) is described.

4. 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 device is a physical medical instrument (catheter and needle kit) for anesthesia and pain therapy, not an AI or imaging-based diagnostic tool. No AI component is involved, and therefore, no MRMC study was conducted.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• For Bench Testing: The "ground truth" refers to the established specifications and limits set by international standards (e.g., ISO 10555, ISO 594, ISO 10993) and the manufacturer's internal engineering requirements (e.g., for echogenicity, electrical conductivity, tensile strength, flow rate, sharpness, depth marks, curvature, straightener tube functionality, packaging).
• For Biocompatibility: The ground truth is compliance with the requirements of ISO 10993-1, which involves standard biological tests.
• For Human Factors: The ground truth for usability was established by "qualified clinicians" confirming the device's usability according to ISO 10555-1.

7. The sample size for the training set

• Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning. The design and manufacturing process are validated through engineering principles and bench testing.

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

• Not applicable. As there is no training set for an AI/algorithm, this question is not relevant to this device.

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