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The Stryker KWIC Needle is a manual surgical instrument intended to be used in spine surgery to facilitate placement of guidewires. The device may also be used to aspirate autologous blood or bone marrow by use of a syringe. The blood or bone marrow may be combined with bone graft or bone void filler.

The Stryker KWIC Needle may be used as part of a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The KWIC Needle is indicated for use in spinal surgical procedures in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure, such as the skull or vertebra, can be identified relative to medical images.

The Stryker KWIC (K-wire Insertion Cannulated) Needle is a manually operated needle that is used to assist in the placement of guidewires (e.g. K-wires) and/or the aspiration of autologous blood or bone marrow for orthopedic surgery. The Stryker KWIC Needle is designed to interface with already-cleared Stryker navigation systems.

This device is to be manually calibrated and used with Stryker navigation systems. This device is intended to be used in spine applications to perform general manual functions within the orthopedic environment including the placement of guidewires (e.g. K-wires) or to draw bone marrow. Guidewires may be used to place other hardware utilized in orthopedic procedures including pedicle screws.

Here's an analysis of the acceptance criteria and study information for the Stryker KWIC Needle based on the provided 510(k) summary:

This device is a manual surgical instrument and not a software-driven AI device. Therefore, many of the typical questions for AI devices regarding statistical metrics, ground truth, expert adjudication, MRMC studies, and standalone performance are not applicable. The performance data focuses on demonstrating mechanical and functional equivalence to predicate devices, as is common for physical medical instruments.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated with a numerical value. The study refers to "simulated cadaveric testing." It does not specify the number of cadavers or individual tests performed.
• Data Provenance: Not explicitly stated. Given the nature of a 510(k) submission for a physical device, the testing would have been conducted internally by the manufacturer or a contracted lab. The location (e.g., country of origin) of the cadaveric testing is not provided. The testing is retrospective in the sense that it's performed as part of the device development and submission process, not as a real-world, prospective clinical trial.

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

• Not Applicable. For a manual surgical instrument, the "ground truth" is typically established by the physical verification of its function (e.g., did the guidewire pass, did the system recognize the instrument). There is no mention of human experts interpreting data or images to establish ground truth in the way one would for an AI diagnostic device. The performance is assessed by direct observation of the device's mechanical and functional capabilities.

4. Adjudication method for the test set:

• Not Applicable. There is no mention of an adjudication process, as the performance tests are functional and objective (e.g., the needle either works with the navigation system or it doesn't; the guidewire either can be placed or it cannot).

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:

• No. This is a manual surgical instrument, not an AI or imaging device that involves human readers interpreting diagnostic results. Therefore, an MRMC study is not relevant or mentioned.

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

• No. This device is a physical instrument, not an algorithm. Its performance is always tied to human use (manual operation) and, in some cases, integration with other systems (Stryker Navigation System), which themselves are tools for human surgical guidance.

7. The type of ground truth used:

• For the functional testing (guidewire placement, navigation system compatibility): The ground truth is established by direct observation and successful completion of the intended physical function in a simulated environment (cadaveric testing).
• For the aspiration function: The ground truth is derived from demonstrated capability of the predicate device paired with material/constructive equivalence of the current device.

8. The sample size for the training set:

• Not Applicable. This is not an AI or machine learning device that requires a training set.

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

• Not Applicable. As there is no training set mentioned or implied for this physical device.

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