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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

Additional Study Information:

1. 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.

2. 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).

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set for this type of device.

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The ES2® Awl, ES2® Taps, and ES2® Screwdriver can be used 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 perculaneous minimally invasive posterior surgical approaches of the non-cervical spine.

The ES2® Neuromonitoring instruments (Awl, Taps, and Screwdriver) are accessory devices 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 are provided non-sterile.

The neuromonitoring application is a surgical option that allows the surgeon to locate the spinal nerves by providing proximity information during bone preparation and placement/insertion of bone screws. The ES2® Awl and ES2® Taps facilitate bone preparation, and the ES2® 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 neuromonitoring accessory instrument can be used with or without a

The Stryker Spine ES2® Neuromonitoring Accessory Instruments are intended to assist in locating spinal nerves by providing proximity information during bone preparation and placement of bone screws in posterior spinal surgical approaches.

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

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: A "porcine animal study" was conducted. The document does not specify the exact number of animals or the number of data points collected during this study.
• Data Provenance: The study was an animal study (porcine), which is a prospective, controlled experimental setting. The country of origin is not explicitly stated, but given Stryker's location (Allendale, NJ, USA) and the US FDA submission, it's highly probable the study was conducted in the US or under US regulatory guidelines.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• The document does not explicitly state the number of experts or their qualifications used to establish ground truth in the porcine study. However, for a study assessing neuromonitoring performance, it is implied that experienced veterinary surgeons or neurophysiologists would be involved in conducting the procedures and evaluating the nerve proximity information.

4. Adjudication method for the test set:

• The document does not specify an adjudication method like 2+1 or 3+1. The assessment of performance, functionality, and safety was likely based on the observations and data collected by the surgical team and neuromonitoring specialists during the animal study.

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:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical instrument (neuromonitoring accessory instruments) that directly assists in nerve location during surgery, not an AI-powered diagnostic imaging tool that would involve "human readers" or AI assistance in interpreting data in the traditional sense.

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

• Not applicable in the context of this device. The ES2® Neuromonitoring Accessory Instruments are physical surgical tools. Their function is directly integrated with a human surgeon and a neuromonitoring system. There is no "algorithm only" or "standalone" performance to measure without human-in-the-loop, as the device's purpose is to provide real-time feedback to a human surgeon.

7. The type of ground truth used:

• The ground truth in the porcine animal study would have been established through direct observation during surgery and potentially histological examination or direct nerve stimulation protocols used to confirm nerve location and proximity. It relates to the physiological response to electrical stimulation for nerve localization.

8. The sample size for the training set:

• The document does not describe a "training set" in the context of machine learning. This device is a physical medical instrument, not a software algorithm that requires a training set. The performance evaluation was based on bench testing and an animal study.

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

• Not applicable, as there was no training set in the machine learning sense. The ground truth for the performance evaluation was established through the methodologies of the porcine animal study and bench testing, as described above.

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