(77 days)
The INS-1 Intraoperative Nerve Surveillance System is intended to provide intraoperative electromyographic (EMG) surveillance to assist in the location and evaluation of spinal nerves during percutaneous surgery of the spine, by administration of low amperage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. The INS-1 System is designed for use in conjunction with the NuVasive Guided Spinal Arthroscopy System to assist in gaining controlled percutaneous access to the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior or posterolateral approach, where anatomical restrictions safely permit.
The subject INS-1 System is an electronic device which uses arthroscopic surgical instruments, electrodes, and probes to stimulate spinal nerves with electrical energy, and through the use of electromyography (EMG) electrodes. monitors the sensitivity, and assists in determining the location, of spinal nerves during percutaneous surgery of the spine. The device employs a "Status" routine to determine the baseline functional status of exiting spinal nerves in the area of the operative target, and directs low amperage current through the distal tip of the NuVasive Expanding Cannula as it penetrates tissue to the operative target. Through a series of EMG electrodes placed on the muscle groups associated with the spinal nerves at the operative level of the spine, the INS-1 System monitors EMG activity in these muscle groups and, when the Cannula tip draws sufficiently near to one such nerve that the electrical energy it emits is strong enough to depolarize the nerve and create an EMG response, alerts the surgeon that the Cannula tip is in proximity to that nerve. An additional feature of the INS-1 System is a hand-held electrical probe which can assist the surgeon in determining if a nerve lies directly in the path of the instrumentation, and may also be used to ascertain whether a transpedicular screw has violated the pedicle wall. The INS-1 System consists of a reusable Control Unit and PreAmp module, and an assortment of disposable and reusable conductive probe cables, electrodes, and electrode leads.
The provided text is a 510(k) summary for the NuVasive INS-1 Intraoperative Nerve Surveillance System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain detailed information about acceptance criteria, specific device performance metrics, or the design of a study to prove these criteria were met, as described in your request.
The document states:
- "Animal studies conducted in the porcine model have established that 1) the principle functions of the INS-1 System are effectively performed, such that spinal nerve status and location may be ascertained and monitored, and 2) that the data acquired by the subject device during simulated surgical use in the animal model correlate well with those acquired simultaneously by a predicate device." This is the extent of the performance data provided.
- "Summary of Clinical Tests (Not applicable.)" This indicates that no clinical tests were performed or required for this 510(k) submission.
Therefore, I cannot populate the table or answer most of your detailed questions because the necessary information is not present in the provided text.
Here is what can be inferred or explicitly stated from the document based on your request, with the understanding that key details are missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | 1. Principle functions (spinal nerve status/location) effectively performed in porcine model. |
- Data acquired in porcine model correlates well with a predicate device. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified beyond "the porcine model."
- Data provenance: Porcine model (animal study, explicitly stated as "non-clinical"). Country of origin not specified. Prospective (implied, as the study was conducted to demonstrate performance).
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)
- Not specified. The document only mentions "animal studies."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not specified.
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 MRMC study was done. This device is an EMG monitor/stimulator and not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device's performance demonstration appears to be standalone (algorithm/device only) in the porcine model, as there's no mention of human interpretation within the performance assessment. However, the device's intended use is to "assist in the location and evaluation of spinal nerves" by a surgeon (human-in-the-loop for clinical use).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the porcine model correlation study is implied to be actual spinal nerve response/location in the animal model, as well as comparison to a "predicate device" which served as a reference. The precise method of establishing what constituted an "effectively performed" function or "well correlated" data is not detailed.
8. The sample size for the training set
- Not applicable/Not specified. This document only describes a performance evaluation (test set) and does not mention a training set, which is typically relevant for machine learning or AI-based devices.
9. How the ground truth for the training set was established
- Not applicable/Not specified. (See point 8.)
§ 868.2775 Electrical peripheral nerve stimulator.
(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).