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The Herniatome Percutaneous Discectomy Device is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.

The Herniatome Percutaneous Discectomy Kit is comprised of an Introducer needle and a Herniatome Percutaneous Discectomy Device. The Herniatome Percutaneous Discectomy Device is a single-use disposable discectomy device that is designed to remove intervertebral disc nucleus pulpous material under CT and fluoroscopic guidance. Radiopaque marker bands are located on the Introducer needle and the Herniatome Percutaneous Discectomy Device. The Herniatome Percutaneous Discectomy Device contains a battery source DC motor that causes the internal double pitch mechanism to act as a screw conveyor to retrieve and remove the excised debris through the outer cannula and into the transparent collection container.

The Herniatome Percutaneous Discectomy Device is provided in two base models, a curved or straight distal end cannula with a lateral window and each model is provided with two different gage cannulas and two different cannula lengths for utilization in the specific region of the spine.

This document describes a 510(k) premarket notification for the "Herniatome Percutaneous Discectomy Device". The purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device. This is NOT a study about an AI/ML device, and therefore several of your requested categories (1, 2, 3, 4, 5, 6, 7, 8, 9) are not applicable as they relate to AI/ML device performance and testing.

Here's the relevant information that can be extracted from the provided text regarding the device and its performance testing:

Device Name: Herniatome Percutaneous Discectomy Device

Predicate Device: Stryker Instruments, Dekompressor™ Percutaneous Discectomy Probe, K032473

Intended Use: The Herniatome Percutaneous Discectomy Device is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.

1. Table of acceptance criteria and the reported device performance

The document does not provide a table of explicit numeric acceptance criteria for the performance tests, nor does it report specific numerical device performance metrics. Instead, it states that the device "successfully passed all of the following performance tests."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document lists performance tests conducted but does not detail sample sizes, data provenance (e.g., country of origin), or whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as it is a medical device submission, not specifically an AI/ML device performance study requiring expert ground truth for classification/detection tasks. The "ground truth" for this device would be its ability to physically perform its intended function, as demonstrated by engineering and biocompatibility tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for this type of medical device submission. Adjudication methods are typically associated with human-in-the-loop studies or clinical trials involving subjective assessments, which are not detailed here.

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

21 CFR 888.1100 (Arthroscope) is not an AI/ML device. Therefore, a multi-reader multi-case comparative effectiveness study with AI assistance is not applicable and was not performed.

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

This is not applicable. The Herniatome Percutaneous Discectomy Device is a mechanical surgical instrument, not an algorithm or AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this type of device, "ground truth" is established through engineering principles, material science, and adherence to performance standards and regulations.

• Biocompatibility: Demonstrated through validated laboratory tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity) against ISO standards.
• Electrical Safety & EMC: Demonstrated through testing against IEC standards.
• Performance (e.g., Volume Flow Rate, Radiodetectability): Demonstrated through specific engineering tests, where the "ground truth" is the established functional specification or expected physical behavior under test conditions.
• Shelf Life: Demonstrated through accelerated and real-time aging studies, ensuring the device maintains its performance and sterility over time, according to ISO 11607.

There is no "expert consensus" or "pathology" in the sense of diagnostic interpretation for this mechanical device's ground truth.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML system that requires a training set.

9. How the ground truth for the training set was established

This is not applicable as the device is not an AI/ML system that requires a training set or associated ground truth.

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