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The Imbibe Needle is for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler.
The Imbibe Needle is also for use in the placement of guidewires (e.g. k-wires) during orthopedic surgery.

The Imbibe Needle is a manually operated surgical instrument to assist with the aspiration of autologous blood or bone marrow and/or placing guidewires (e.g. k-wires) for orthopedic surgery. These guidewires may be used to place other hardware utilized in orthopedic procedures including pedicle screws.

This document describes the regulatory submission for the "Imbibe Needle" and its substantial equivalence to a predicate device. It primarily focuses on the device's design and intended use, rather than a clinical study evaluating its performance against specific acceptance criteria in the context of an AI-powered device.

Therefore, many of the requested categories related to acceptance criteria, device performance, a study design (like sample size, ground truth, expert involvement, and MRMC studies) are not applicable or cannot be extracted from the provided text for this specific device. This is a medical device clearance, not an AI/software as a medical device (SaMD) submission.

Here's an analysis based on the provided text, indicating where information is present and where it is not applicable for this type of submission:

Acceptance Criteria and Device Performance

Since this is a submission for a physical medical device (a needle) and not an AI/software device, the concept of "acceptance criteria" and "device performance" as measured by metrics like sensitivity, specificity, or accuracy in a diagnostic context (which is typical for AI devices) does not directly apply here. Instead, the "performance" relates to its physical characteristics, safety, and functionality.

The document states: "Previous testing of the predicate device (i.e. mechanical, cadaveric testing and biocompatibility) has demonstrated that Imbibe Needle is safe and effective for its intended use." This indicates that the predicate device met certain performance criteria through those types of tests. The current submission's "performance data" is the assertion that the new device is the same as the predicate and therefore inherits its safety and effectiveness profile.

In summary, this document is a 510(k) summary for a physical medical device (Imbibe Needle) seeking substantial equivalence to a previously cleared predicate device. The primary "study" proving it meets criteria is the assertion that it is "the same device as the predicate" with only a packaging change, and thus inherits the safety and effectiveness demonstrated by the predicate through "mechanical, cadaveric testing and biocompatibility." The detailed aspects of an AI/SaMD performance study are not present.

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The Imbibe Needle is for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler.
The Imbibe Needle is also for use in the placement of guidewires (e.g. k-wires) during orthopedic surgery.

The Imbibe Needle is a manually operated surgical instrument to assist with the aspiration of autologous blood or bone marrow and/or placing guidewires (e.g. kwires) for orthopedic surgery. These guidewires may be used to place other hardware utilized in orthopedic procedures including pedicle screws.

This document describes a 510(k) premarket notification for the Stryker Imbibe Needle, a manually operated surgical instrument. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific performance metrics against pre-defined acceptance criteria. Therefore, several requested fields related to a detailed performance study are not applicable or cannot be extracted from the provided text.

Here is an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present explicit, quantifiable acceptance criteria with corresponding performance statistics. Instead, it relies on demonstrating "substantial equivalence" to a predicate device. The comparison points are primarily design features and intended uses, implying that if the new device shares these characteristics and performs similarly, it meets the "acceptance criteria" for substantial equivalence.

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

• Sample Size: Not explicitly stated as a numerical sample size for a "test set" in the context of a performance study. The document mentions "Preclinical bench data supplied including mechanical and cadaveric testing." However, the exact number of devices tested, samples used in mechanical tests, or cadavers utilized is not provided.
• Data Provenance: The testing appears to be internal preclinical bench and cadaveric testing conducted by Orthovita, Inc. (now Stryker). The country of origin is not specified but implicitly within the US given the FDA submission. It is retrospective in the sense that the data was collected prior to the submission, but the tests were presumably prospective in their execution.

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

• Not Applicable (N/A): This type of information is pertinent to studies involving human interpretation (e.g., imaging studies, diagnostic tools). The described tests are mechanical and cadaveric, which do not typically involve experts establishing a "ground truth" through consensus or interpretation. The performance is assessed against engineering specifications or physical outcomes.

4. Adjudication Method for the Test Set:

• N/A: As explained above, this concept is not relevant to the type of preclinical bench and cadaveric testing described.

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:

• N/A: This submission is for a surgical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related effectiveness are not applicable.

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

• N/A: This submission is for a physical surgical instrument. The concept of "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used:

• For the mechanical testing, the "ground truth" would be established by engineering specifications, material properties, and expected mechanical responses (e.g., force, torque, fatigue limits).
• For the cadaveric testing, the "ground truth" would be the observed physical outcome and ability to perform the intended surgical actions (e.g., successful aspiration, accurate guidewire placement) in a simulated anatomical environment. This is typically assessed against established surgical techniques and anatomical knowledge.

8. The Sample Size for the Training Set:

• N/A: This concept is relevant for machine learning or AI models. This submission is for a physical medical device and therefore does not have a "training set" in that context. The development process would involve iterative design, prototyping, and testing, but not a formally defined "training set" for an algorithm.

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

• N/A: As above, this concept is not applicable to the development and testing of a physical surgical instrument.

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