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The XTEND-ST Nucleus Removal System is intended to resect damaged or diseased nucleus pulposus material found in the adult lumbar disc space.
The XTEND-ST Nucleus Removal System is indicated to resect damaged or diseased intervertebral nucleus pulposus material found in the adult lumbar disc space.

The CoreSpine XTEND-ST Nucleus Removal System is a soft tissue removal device that is comprised of a disposable, sterile handheid nucleus tissue cutting device, a table-top electronic control unit, and a foot pedal. The tip of the XTEND-ST cutting device can articulate and extend within the disc cavity providing an ability to reach areas of the disc that are otherwise unreachable with a rongeur. Cut tissue is continuously suctioned through a central lumen using a standard vacuum designed to minimize clogging. The XTEND-ST Nucleus Removal System is intended to effectively and efficiently prepare the disc space without damaging the annulus or endplates in preparation for a spinal implant or other therapy.
The XTEND-ST cutting device is made from a stainless steel rotary cutting mechanism with a motor housed in a plastic handle.

The XTEND-ST™ Nucleus Removal System is a medical device intended to resect damaged or diseased nucleus pulposus material in the adult lumbar disc space. The provided text, a 510(k) summary, outlines the non-clinical testing performed to demonstrate its safety and performance and establish substantial equivalence to predicate devices. However, it does not explicitly define acceptance criteria in a quantitative table or detail a specific study proving the device met these criteria in a structured manner often seen with AI/software medical devices.

Instead, the submission focuses on demonstrating general safety and performance through a series of tests, concluding that these studies showed substantial equivalence.

Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) summary for a mechanical device, explicit quantitative acceptance criteria for each test are not listed. Instead, the "reported device performance" is largely qualitative, asserting that the device met the requirements.

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

• Sample Sizes: The document does not specify exact sample sizes for any of the tests (e.g., number of units tested for electrical safety, number of cadavers used, number of human factor participants).
• Data Provenance: Not explicitly stated, but clinical data (if any) would typically be from surgical settings. The stated tests are "non-clinical," implying laboratory or simulated environments. "Cadaver testing" implies biological samples, likely from human donors, but the origin country is not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable / Not Stated Directly: For this type of mechanical device submission, "ground truth" as it pertains to expert consensus on diagnostic imaging or clinical outcomes (as implied by the question) is not directly applicable in the same way it would be for an AI algorithm.
• The human factor analysis likely involved experts in human factors engineering and user experience, but their number and specific qualifications are not detailed.
• Cadaver testing would have involved medical professionals (e.g., orthopedic surgeons, anatomists) to assess the device's performance, but their number and qualifications are not mentioned.

4. Adjudication Method for the Test Set

• Not Applicable / Not Stated: The concept of an adjudication method (like 2+1 or 3+1 consensus) is typically used when establishing a ground truth from expert opinions, often for diagnostic accuracy studies. This is not described for the non-clinical testing of this mechanical device. The "conclusion" of each test (e.g., "met the test limits," "demonstrated appropriate levels") implies an evaluation against predefined benchmarks, but a multi-expert adjudication process is not mentioned.

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

• No: A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned. These studies are typically used for evaluating the impact of diagnostic aids (like AI) on physician performance. This device is a surgical tool, not a diagnostic aid.

6. Standalone (Algorithm Only) Performance Study

• No: This is a mechanical surgical device, not a software algorithm or AI. Therefore, a standalone (algorithm only) performance study is not applicable. The device's performance was assessed during "bench testing" and "cadaver testing," which are "standalone" in the sense that the device was evaluated without human-in-the-loop diagnostic assistance, but always with a human operating the device as it's a surgical tool.

7. Type of Ground Truth Used

• For Biocompatibility: Material specifications and ISO standards for biocompatibility (implied).
• For Electrical Safety/EMC: IEC 60601-1 standards and associated test limits.
• For Human Factors: Principles of human-device interaction, usability criteria (implied by "acceptable human factors features").
• For Performance (Bench/Cadaver Testing): Engineering specifications, anatomical integrity (e.g., not damaging annulus or endplates), effectiveness of tissue removal (implied by "effectively and efficiently prepare the disc space"), and comparison to predicate device performance. Direct "pathology" or "outcomes data" in the typical clinical trial sense are not described for these non-clinical tests.

8. Sample Size for the Training Set

• Not Applicable: This is a mechanical device, not an AI algorithm, so there is no "training set."

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

• Not Applicable: As there is no training set for an AI algorithm, this question is not applicable.

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