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The Crosstrees® Pod device is intended to provide surgeons with a percutaneous means to deliver bone cement to painful pathologic compression fractures of the vertebral body in levels T4-L5 of the thoracic and lumbar spine. Pathologic fractures of the vertebral body may be caused by osteoporosis. It is intended to be used in combination with Crosstrees Fortibrae® Bone Cement when delivered by the Crosstrees CDrive® Bone Filler Delivery System.

The Crosstrees® PVA Pod device is designed to deliver bone cement to the fractured vertebral body in a controlled manner without the need for an additional permanent implant other than the bone cement. The device consists of a shaft assembly for delivery of PMMA cement to a fabric barrier. Following cement delivery, the fabric barrier is opened and withdrawn from the vertebral body. The Crosstrees® PVA Pod device is made from a variety of materials commonly used in orthopedic and radiological procedures including stainless steel and polymers. The device is available in either a 2.0 mL or 3.0 mL fill capacity. The device is provided with a number of class I tools that are used for surgical access and delivery of the Pod to the surgical site, as well as preparation and delivery of bone cement.

The provided text describes a 510(k) summary for the Crosstrees® PVA Pod Device, which is a medical device and not an AI/ML powered device. The document focuses on demonstrating substantial equivalence to a predicate device, as required for medical device clearance by the FDA. As such, the information you're looking for regarding acceptance criteria and study designs for AI/ML powered device performance (e.g., sample sizes for training/test sets, expert consensus for ground truth, MRMC studies, standalone performance) is not applicable to this type of medical device submission.

The "Performance Data" section explicitly states: "The Crosstrees® PVA Pod has the same sterilization process, same packaging, and is comprised of the same materials of construction as the predicate device. Device modifications have been assessed through Crosstrees design control process and the data generated demonstrates that the Crosstrees® PVA Pod device meets all performance characteristics and design specifications, thus supporting substantial equivalence to the predicate device. In all instances, the Crosstrees® PVA Pod device functioned as intended."

This indicates that the performance data for this device would relate to engineering specifications, material compatibility, sterilization validation, and functional testing to ensure it performs its intended physical function (delivering bone cement) safely and effectively, rather than validating an algorithm's diagnostic or predictive accuracy.

Therefore, I cannot provide the specific information requested in your numbered points as they pertain to AI/ML device validation, which is not relevant to this 510(k) submission.

However, I can provide a summary of the acceptance criteria and the study (or rather, "assessment" or "testing" in this context) that proves the device meets those criteria, based on the provided document:

Acceptance Criteria and Device Performance (for a Medical Device, not AI/ML)

The acceptance criteria for the Crosstrees® PVA Pod Device, as described in this 510(k) submission, are primarily centered around demonstrating substantial equivalence to its predicate device (Crosstrees® PVA Pod, K130089). This means proving that the minor modifications to the new device do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance:
This information is not applicable in the context of this medical device submission. The "testing" referred to is likely engineering verification and validation testing (e.g., mechanical strength, material compatibility, sterilization efficacy, dimensional checks) rather than a clinical "test set" involving patient data. The document does not specify sample sizes for such engineering tests or data provenance beyond stating that "design verification testing" was performed.

3. Number of Experts used for Ground Truth & Qualifications:
This information is not applicable. Ground truth in this context would refer to engineering specifications and performance metrics, not expert interpretations of medical images or clinical outcomes.

4. Adjudication Method for Test Set:
This information is not applicable.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
This information is not applicable. This is a medical device for delivering bone cement, not an AI/ML diagnostic or assistive tool for human readers.

6. Standalone Performance:
This information refers to the device's ability to perform its physical function as a standalone unit. The document states: "In all instances, the Crosstrees® PVA Pod device functioned as intended." This implies that the device performed its mechanical and functional role correctly in testing.

7. Type of Ground Truth Used:
The ground truth for this device submission would be the established engineering specifications, material properties, and functional performance benchmarks that the predicate device met. The new device's performance was measured against these predefined physical and functional requirements. It is a "device-focused" ground truth rather than a "patient outcome" or "expert consensus" ground truth.

8. Sample Size for Training Set:
This information is not applicable. There is no "training set" as this is not an AI/ML device.

9. How Ground Truth for Training Set was Established:
This information is not applicable.

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