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The XY cor™ Spinal Implant is indicated for use as a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The XYcor™ Spinal Implant is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The XYcor™ Spinal Implant is intended for use with bone graft and supplemental internal fixation for vertebral body replacement. The supplemental internal fixation systems that may be used with the XYcor™ System include Medtronic Sofamor Danek TSRH 3D, DePuy Spine Expedium or Monarch pedicle screw fixation systems, Biomet, Polaris, Array or Omega-21 pedicle screw fixation systems, and other pedicle screwrod/plate fixation systems that have biomechanical properties similar to those of the above-listed systems, including trans-facet fixation systems but excluding semi-rigid or flexible rod-screw systems.

The XY cor™ Spinal Implant is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e., facet screw fixation systems, facet compression devices, and posterior pedicle screw and rod systems).

The XY cor™ Spinal Implant is a spinal implant fabricated from titanium that can be used as a vertebral body replacement device or an intervertebral body fusion device. The XYcor™ Spinal Implant deploys with a self-locking mechanism. The footprint of XYcor™ Spinal Implant V2-25 before and after deployment is of comparable size and shape to the other sizes of the XY cor™ implant.

The provided text describes a 510(k) submission for the XYcor™ Spinal Implant, focusing heavily on its intended use, design, and claiming substantial equivalence to a previously cleared device. The "Performance Data" section specifically mentions mechanical testing.

Here's an analysis of the acceptance criteria and study information based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not explicitly state numerical or specific pass/fail criteria for the mechanical tests (e.g., "must withstand X N of compression"). However, it does report that the device "demonstrated sufficient strength" and "resistance," implying these were the criteria evaluated. The final statement regarding safety and effectiveness acts as an overarching acceptance criterion.

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

• Sample Size: Not specified. The document only states "Mechanical testing was performed on the XY cor™ Spinal Implant V2-25." It does not provide the number of devices tested.
• Data Provenance: The document does not specify the country of origin of the data. Given it's a 510(k) submission to the FDA, it can be inferred the data was generated to meet US regulatory requirements, but the physical location of the testing is not stated. The study is prospective in the sense that the testing was conducted specifically to support this regulatory submission for the V2-25 small size implant.

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

• This information is not applicable as the study described is a mechanical testing study, not a clinical study involving expert interpretation of data (e.g., imaging). The "ground truth" for mechanical testing is based on engineered specifications and physical measurements, not expert consensus.

4. Adjudication Method for the Test Set

• This information is not applicable for the same reasons as point 3. Mechanical test results do not typically involve adjudication by experts in the way clinical data might. The measured outcomes are objective physical properties.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in the provided text. The submission focuses on mechanical testing.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• This information is not applicable. The device is a physical spinal implant, not an algorithm or AI software. Therefore, the concept of "standalone (algorithm only)" performance does not apply.

7. Type of Ground Truth Used

• The ground truth for this device's performance is based on mechanical engineering principles and measurements. The "sufficient strength" and "resistance" claims are derived from objective physical testing against established biomechanical standards and possibly comparison to the predicate device's performance.

8. Sample Size for the Training Set

• This information is not applicable. There is no mention of a "training set" because the device is a physical implant, not an AI/machine learning model.

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

• This information is not applicable for the same reasons as point 8.

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The XY cor™ Spinal Implant is indicated for use as a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The XYcor™ Spinal Implant is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The XY cor™ Spinal Implant is intended for use with bone graft and supplemental internal fixation. The supplemental internal fixation systems that may be used with the X Y cor™ System include Medtronic Sofamor Danek TSRH 3D, DePuy Spine Expedium or Monarch pedicle screw fixation systems, Biomet, Polaris, Array or Omega-21 pedicle screw fixation systems, and other pedicle screw-rod/plate fixation systems that have biomechanical properties similar to those of the above-listed systems, including trans-facet fixation systems but excluding semi-rigid or flexible rod-screw systems.

The XYcor™ Spinal Implant is a vertebral body replacement device fabricated from titanium. The XYcor™ Spinal Implant deploys with a self-locking mechanism. The footprint of XY cor™ Spinal Implant prior to deployment is of comparable size and shape to the DEVEX™ System and, after deployment, is of comparable size to the InFix® System.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are largely implied from the "Performance Data" section. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed, explicit acceptance criteria with specific numerical thresholds typical of a full design verification report.

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

The document does not specify a sample size for a test set. The reported "Performance Data" refers to "Mechanical testing" but does not detail the number of units tested. This is a common characteristic of 510(k) summaries where detailed testing protocols and results (including sample sizes) are typically found in the full submission, not the summary.

Furthermore, there is no information provided on data provenance (e.g., country of origin, retrospective or prospective nature of clinical data). The evaluation appears to be based solely on mechanical testing, not clinical studies involving patient data in the typical sense.

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

This information is not provided and is not relevant for the type of study described. The study is a mechanical engineering test on a medical device, not an image-based diagnostic or clinical study requiring expert ground truth for interpretation.

4. Adjudication Method

This information is not provided and is not relevant for the type of study described (mechanical testing).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission relies on mechanical testing to demonstrate substantial equivalence to predicate devices, not improvement in human reader performance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a standalone performance study in the form of mechanical testing was performed. The "Performance Data" section states, "Mechanical testing was performed on the XYcor™ Spinal Implant and the results are presented." This implies the device was tested independently of human interaction in simulating its intended biomechanical function.

7. Type of Ground Truth Used

The "ground truth" for this study is based on engineering standards and established biomechanical testing methodologies for vertebral body replacement devices. The performance metrics (strength for static/dynamic loading, resistance to subsidence/expulsion) are evaluated against pre-defined engineering requirements and comparison to predicate devices, rather than expert consensus, pathology, or outcomes data which are typically associated with clinical studies.

8. Sample Size for the Training Set

This information is not applicable as this is not a study involving machine learning or algorithms that require a training set. The study describes mechanical testing of a physical device.

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

This information is not applicable as there is no training set for this type of mechanical testing study.

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