(29 days)
The ES2 Neuromonitoring instruments (Awls, Taps, Screwdriver and LITe Y-NEEDLE 200, 300 and 400) can be used by the surgeon to assist in location of the spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws in open and percutaneous minimally invasive posterior surgical approaches of the non-cervical spine.
The purpose of this submission is to introduce a line extension to the ES2 Neuromonitoring system to include the LITe Y-Needles.
The ES2 Neuromonitoring instruments (Awl, Taps, Screwdriver and LITe® Y-NEEDLE 200, 300 and 400) are accessory instruments to be used with FDA cleared neuromonitoring systems to deliver electrical stimulation to assist in location of the spinal nerves during intraoperative neurological monitoring of the non-cervical spine in open and percutaneous minimally invasive posterior surgical approaches. The instruments are manufactured from surgical grade stainless steel and Acrylonitrile Butadiene Styrene (ABS). The Awls, taps and screwdriver are provided non-sterile. The LITe Y-Needles are sterile packed and single use devices that must be discarded after use.
The neuromonitoring application is a surgical option that allows the surgeon to locate the spinal nerves by providing proximity information during targeting, bone preparation, and placement/insertion of bone screws. In addition to the neuromonitoring function: The LITe Y-Needles assist in targeting the pedicle and placing guidewires, the awl and taps facilitate bone preparation, and the screwdriver facilitates bone screw placement/insertion. The surgical accessories are compatible with commercially available FDA cleared neuromonitoring consoles/systems and associated electrodes. The nerves are stimulated using electrodes attached to the subject accessory devices. The screwdriver can be used with or without a powered option for bone screw placement.
The provided text describes specific performance tests and their results for the ES2 Neuromonitoring Accessory Instruments, particularly focusing on the newly introduced LITe Y-Needles.
Here's the breakdown of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit from "Passing Results") | Reported Device Performance |
|---|---|---|
| Biocompatibility | Acceptable biocompatibility profile commensurate with anticipated exposure (in line with FDA guidance June 16, 2016 "Use of International Standard ISO 10993-1" and ISO 10993-1:2009). | All samples passed, demonstrating an acceptable biocompatibility profile. |
| Sterility and Packaging | Packaging and sterilization appropriate for single-use, sterile-packaged devices (as per 2016 FDA Guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile", using "Established Category A" sterilization method, Gamma Radiation). This includes passing visual inspection, seal strength, bubble emission, and packaging aging tests. | All samples passed, demonstrating appropriate packaging and sterilization. |
| EMC and Safety | Device does not present a new worst case and meets all applicable UL Safety and EMC tests, as determined by EMC risk evaluation per IEC 60601-1. | Met all applicable UL Safety and EMC tests and did not present a new worst case. |
| Stationary Potential Generation Test | Generated stationary potential less than or equal to predefined acceptance criteria to prevent false positives during neuromonitoring. | Passing results demonstrated stationary potential less than or equal to predefined acceptance criteria. |
| Electrical Resistance | Resistance of conductive portion less than or equal to predefined acceptance criteria, and resistance of insulating portion greater than or equal to predefined acceptance criteria. | Passing results demonstrated resistance measurements met predefined acceptance criteria for conductivity and resistivity. |
| Current Variance | Current deviation less than or equal to predefined acceptance criteria along the axial length. | Passing results demonstrated current deviation less than or equal to predefined acceptance criteria. |
| Signal Conduction (amplitude change) | Signal loss less than or equal to predefined acceptance criteria along the axial length. | Passing results demonstrated signal loss less than or equal to predefined acceptance criteria. |
Additional Study Information:
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not explicitly state numerical sample sizes for each test (e.g., number of LITe Y-Needles tested for biocompatibility, sterility, etc.). It refers to "All samples" passing for several tests ("All samples passed acceptance criteria testing on subject device").
- Data Provenance: The studies were conducted by Stryker Spine ("Stryker Spine conducted Safety and EMC testing"). While the exact location of the testing is not specified, it is implied to be within the company's testing facilities or contracted labs, likely in the US, given the FDA submission. The nature of these tests (bench testing, material testing) means they are prospective in the sense that they were designed and executed specifically for this submission.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. These are engineering performance tests of the device itself (biocompatibility, electrical properties, sterility) rather than clinical studies requiring expert interpretation of medical images or patient outcomes to establish ground truth. The "ground truth" for these tests is defined by established engineering and medical device standards (e.g., ISO 10993, IEC 60601-1, FDA guidances).
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Adjudication Method for the Test Set:
- Not applicable. As these are objective performance tests based on measurable physical and chemical properties and adherence to standards, an adjudication method for test results by multiple experts is not described or typically required. The results are binary (pass/fail) based on comparison to predefined numerical criteria.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This device is an accessory instrument that assists surgeons in locating spinal nerves by delivering electrical stimulation. It does not involve human readers interpreting diagnostic images, nor does the document describe any clinical trials comparing human performance with and without the device. The device's function is direct electrical stimulation and measurement, not interpretation.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, the performance data presented is for the device itself ("algorithm only" in the sense of the device's inherent functionality without surgeon input during the testing phase) and its interaction with standard electrical and biological models. For example, the Stationary Potential Generation Test measured the device's electrical output when stimulated at clinical current levels in a biological simulant. These are standalone performance characteristics of the instrument.
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Type of Ground Truth Used:
- The "ground truth" for these performance tests is based on established scientific principles, international standards (ISO, IEC), and regulatory guidances (FDA). For instance:
- Biocompatibility: Adherence to ISO 10993-1.
- Sterility: Adherence to FDA guidance and "Established Category A" sterilization methods.
- Electrical Performance (EMC, Stationary Potential, Resistance, Current Variance, Signal Conduction): Adherence to IEC 60601-1 and predefined engineering specifications based on the device's intended physiological interaction.
- The "ground truth" for these performance tests is based on established scientific principles, international standards (ISO, IEC), and regulatory guidances (FDA). For instance:
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Sample Size for the Training Set:
- Not applicable. This is not a machine learning or AI device that requires a training set. The device's function is based on direct electrical stimulation and measurement, not on learned patterns from a dataset.
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How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this type of device.
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.