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The Abbott Spine Spinnaker System is intended for use as a stand alone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site.

When used as a cement dispenser, the Spinnaker System is intended to dispense cement cleared for use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.

The Abbott Spine, Inc. Spinnaker System is intended for use as a vertebral body biopsy and cement dispenser device. The system is comprised of aspiration/injection taps, handles, a targeting needle, a bone awl, ports and dilators, a Luer cap, and k-wire. The system provides the surgeon with a convenient method of performing vertebral body bone biopsy, as well as dispensing cement cleared for use in the spine into a vertebral body using a single system.

The Abbott Spine, Inc. Spinnaker System is a medical device intended for use as a vertebral body biopsy and cement dispenser. The provided documentation does not contain detailed acceptance criteria or a specific study proving the device meets quantitative performance metrics in the way that an AI/ML device study would. Instead, the summary focuses on substantial equivalence to predicate devices through mechanical testing.

Here's an analysis based on the provided text, using the requested categories where applicable:

Acceptance Criteria and Reported Device Performance

Note: The provided document is a 510(k) summary for a medical device that predates the common rigorous performance criteria and study formats seen for AI/ML devices. Therefore, the "acceptance criteria" are implied functional requirements and substantial equivalence rather than quantitative statistical metrics (e.g., sensitivity, specificity, AUC).

Study Details (Based on available information)

1. Sample Size used for the test set and the data provenance: Not applicable. This 510(k) summary refers to mechanical testing, not a clinical study involving a "test set" of patient data or clinical outcomes. The "test set" for mechanical testing would refer to the number of devices or components subjected to specific engineering tests. This information is not provided in the summary.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" in this context refers to engineering specifications and performance against those specifications, not clinical diagnostic accuracy or reader performance.
3. Adjudication method for the test set: Not applicable. Adjudication methods are typically used in clinical studies involving human interpretation or uncertain diagnoses. Mechanical testing relies on objective measurements against engineering standards.
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: No. This is a traditional medical device (biopsy tool and cement dispenser), not an AI/ML diagnostic or assistive device. Therefore, MRMC studies and AI-driven performance improvements are not relevant here.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device; there is no "algorithm" in the sense of AI/ML.
6. The type of ground truth used: For mechanical testing, the ground truth would be established engineering standards, material properties, and functional specifications defined by validated test methods.
7. The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of device submission.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The study described is mechanical testing. This testing evidenced that the Spinnaker System "exhibits the functional requirements" for its intended uses: vertebral body bone biopsy and cement dispensing. The specific parameters tested, the methodology, and the quantitative results of these mechanical tests are not detailed in this 510(k) summary, which is typical for such submissions where the focus is on the conclusion of meeting functional requirements for substantial equivalence. The overall determination of marketability was based on substantial equivalence to two predicate devices: the Stryker Capture Vertebral Body and Bone Biopsy Kit and the Parallax Medical Core-Assure Bone and Vertebral Body Biopsy Kit.

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The Spinnaker is indicated for use in facilitating access through distal, tortuous vasculature, and may be used for the controlled, regional infusion of diagnostic agents, such as contrast media and Target Therapeutics' Berenstein Liquid Coil -10 in the peripheral and neuro vasculature. It is not intended for use in the coronary vasculature.

Spinnaker Infusion Catheter is a single lumen device with a graded shaft stiffness, ranging from a highly flexible tip to a semi-rigid proximal section that allows ease of advancement by the physician. A lure fitting located on the catherer hub is used for the attachment of accessories. Spinnaker is manufactured with HYDROLENE®, a hydrophilic surface coating that reduces friction during manipulation in the vessel.

The Spinnaker Infusion Catheter will be made available as a system consisting of a Spinnaker Infusion Catheter, a stylet with a torque device attached, and a steam shaping mandrel.

SPINNAKER with HYDROLENE Infusion Catheter (SPINNAKER) is a single lumen device designed to aid the physician in accessing distal vasculature when used with a guiding catheter. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section allows ease of advancement by the physician. A luer fitting located on the catheter hub is used for the attachment of accessories. A radiopaque tip and body facilitate fluoroscopic visualization. SPINNAKER is manufactured with HYDROLENE, a hydrophilic surface that reduces friction during manipulation in the vessel. The stylet accompanying the SPINNAKER is used to increase rigidity of the distal section during introduction into the guiding catheter. The steam shaping mandrel packaged with the SPINNAKER is used when the physician desires to shape the catheter's distal end.

The provided text describes a medical device, the SPINNAKER™ Infusion Catheter, and its substantial equivalence to predicate devices based on performance and biocompatibility testing. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of typical AI/ML device evaluations (e.g., sensitivity, specificity, accuracy, or comparative effectiveness with human readers).

The document focuses on:

• Device Description: Physical characteristics, materials, and components.
• Intended Use: Facilitating access through vasculature and infusion of diagnostic agents.
• Predicate Devices: Balt Magic Infusion Catheter, Zephyr Infusion Catheter.
• Testing for Substantial Equivalence: Flow rates, tip flexibility, tensile, static rupture, coefficient of friction, and biocompatibility.

Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC/standalone study details because this information is not present in the provided text.

The 'testing in support of substantial equivalence' mentioned refers to engineering and bench testing relevant to the physical and functional aspects of a catheter, not clinical performance metrics typically associated with AI/ML diagnostic devices.

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