(133 days)
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
| Characteristic | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (ES2® Neuromonitoring Accessory Instruments) |
|---|---|---|
| Neuromonitoring Accessories | Taps and Screwdriver (NuVasive® NVM5® System) | Awl, Taps, and Screwdriver. Used the same types of accessory instruments for neuromonitoring applications during bone preparation/pilot hole starter and bone screw placement. Employed and assembled in a similar manner with comparable set-up configurations to deliver electrical signals. Testing confirmed that the powered ES2® Screwdriver configuration does not interfere with the neuromonitoring signals and is safe and effective. |
| Use of Dilators | Dilators (NuVasive® NVM5® System) | Dilators or Tap Sleeve. |
| Compatibility with Neuromonitoring Consoles & Software | Compatible with NuVasive® NVM5® System | Compatible with FDA cleared neuromonitoring systems, including the NuVasive® NVM5® System. |
| Connection to Neuromonitoring Unit | Clip (NuVasive® NVM5® System) | Clip or Probe (based on Neuromonitoring System used). The clip or probe are attached to the accessory instrument on the exposed instrument contact area above the dilator or tap sleeve. |
| Materials | Unknown for NVM5® System. Assumed to be well-characterized and accepted biocompatible materials. | Awl, Taps, & Screwdriver: Surgical Grade Stainless Steel. Dilators & Tap Sleeve: RADEL®. Instruments composed of well-characterized and accepted biocompatible materials. Stable chemical and mechanical properties not affected by aging or storage conditions. |
| Indication for Use | Intraoperative neurophysiologic monitoring during spinal surgery; locating and evaluating spinal nerves (XLIF Detection, Screw Test); identifying spontaneous EMG activity (Free Run EMG); assessing neuromuscular block (Twitch Test); assessing acute dysfunction in corticospinal tract (TCMEP); assessing sensory spinal cord function (SSEP); remote access (Remote Reader); aid for pedicle cannulation (Guidance function). | 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 percutaneous posterior surgical approaches of the non-cervical spine. This is a subset of the predicate's indications, not resulting in a new or different intended use. |
| Sterilization | Validated to assure a SAL of 10-6 | Instruments provided as reusable non-sterile devices with validated sterilization parameters to assure a SAL of 10-6. |
| Surgical Approach | Open or Percutaneous/Minimally Invasive | Open or Percutaneous/Minimally Invasive. |
| Electromagnetic Compatibility & Electrical Safety | IEC 60601-1-2 (NuVasive® NVM5® System) | IEC 60601-1, IEC 60601-1-2, IEC 61000-3-2, IEC 61000-3-3. |
| Min. exposed surface area during tissue stimulation | Unknown (NuVasive® NVM5® System) | 0.53mm². Test data demonstrated that the design, exposed surface area, and neuromonitoring instrument set-up/configurations do not impact or interfere with electrical signaling and are comparable to predicate devices. |
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.
§ 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.