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The Focus™ Echogenic Nerve Stimulating Needle is intended for locating and stimulating peripheral nerves and nerve plexuses for nerve block anesthesia techniques using a Peripheral Nerve Stimulator and/or ultrasound guidance.

The Focus Needle is a sterile, single use FEP-coated stainless steel needle with a B Bevel tip. The needle contains black marker bands every 10 mm to aid in placement and echogenic dimpling on the distal 10 mm to enhance visibility under ultrasound guidance. An insulated wire is attached to the stainless steel cannula and can be connected to a peripheral nerve stimulator unit. The device will be available in the following gauge sizes: 20, 21, 22 and 23.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cook Incorporated Focus™ Echogenic Nerve Stimulating Needle:

Based on the provided text, the submission is a "Special 510(k): Device Modification," indicating that the device is an updated version of an already cleared predicate device (22 and 23 Gauge Focus Echogenic Nerve Stimulating Needle, 510(k) number K093209). The modification involves introducing new gauge sizes (20 and 21 Gauge) for the existing needle design. Therefore, the focus of the testing is to demonstrate that these new gauge sizes perform comparably to the predicate devices and maintain safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each test. Instead, it relies on demonstrating that the device reliably performs based on these tests. For a device modification, the implicit acceptance criterion is often that the results for the modified device are comparable to, or within acceptable limits of, the predicate device's performance for these tests.

Note: The provided text confirms that these tests were conducted and their results "provide reasonable assurance that the device is safe and effective," implying that the devices met the internal acceptance parameters for these tests, even if the specific numerical criteria are not detailed in this summary.

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

The document does not specify the sample sizes used for any of the tests (Leakage, Tensile strength, Cannula break strength, Penetration force, Sterilization testing, Biocompatibility testing).

The data provenance is also not explicitly stated. However, as this is a 510(k) submission from Cook Incorporated, it is highly likely that the testing was conducted prospectively by or for Cook Incorporated, likely in laboratories within the United States (where Cook is based), to support the substantial equivalence claim for the modified device.

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

The device being described is a physical medical device (needle) that undergoes engineering and biological performance testing, not an AI/software device that requires expert adjudication for diagnostic ground truth. Therefore, these types of experts and their qualifications would not be applicable to the studies described. The "ground truth" for these tests would be established through established engineering standards, laboratory protocols, and validated test methods.

4. Adjudication Method for the Test Set

Similar to point 3, an "adjudication method" like 2+1 or 3+1 is not applicable for the type of engineering and biological performance testing conducted on this physical medical device. The results are typically quantitative measurements against predefined specifications or qualitative observations (e.g., presence/absence of leakage, successful sterilization) based on established testing methodologies.

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 as the device is a physical echogenic nerve stimulating needle, not an AI-assisted diagnostic tool or a software device. Therefore, no MRMC study or AI assistance evaluation would have been conducted or is mentioned.

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

This is not applicable as the device is a physical echogenic nerve stimulating needle, not an AI algorithm.

7. The Type of Ground Truth Used

For the tests conducted:

• Leakage, Tensile Strength, Cannula Break Strength, Penetration Force: The ground truth would be established by engineering specifications, industry standards, and validated test methods, which dictate acceptable ranges and limits for these physical properties. For example, a tensile strength test would result in a specified force value, which is then compared against a minimum requirement.
• Sterilization Testing: The ground truth is confirmed through validated sterilization protocols (e.g., achieving a sterility assurance level – SAL) and methods like bacteriostasis/fungistasis tests for sterility, and endotoxin limits for pyrogenicity.
• Biocompatibility Testing: The ground truth is established by ISO 10993 standards and related biological evaluation tests, which determine if a material is biologically benign and does not cause adverse reactions.

8. The Sample Size for the Training Set

This is not applicable as the device described is a physical medical device, not a machine learning model that requires a training set. The "training" for such a device comes from engineering design principles, material science, and manufacturing processes.

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

This is not applicable for the reasons stated in point 8.

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