(88 days)
The TELIGEN System is indicated to provide minimally invasive access, visualization, illumination, magnification and discectomy of the surgical area of the spine.
The TELIGEN Access Probe and TELIGEN Clear are Navigation Ready Instruments and when used with the compatible Universal Navigation Adaptor Set (UNAS) are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. The navigation feature is used in surgical spinal procedures, in which:
· the use of stereotactic surgery may be appropriate, and
· reference to a rigid anatomical structure, such as the pelvis or a vertebrac can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays.
These procedures include but are not limited to spinal fusion. TELIGEN Clear, when used with UNAS, can be precalibrated with the Brainlab Navigation System. TELIGEN Access Probe, when used with UNAS, can be pre-calibrated with the Brainlab Navigation System, where other navgation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.
The TELIGEN Access Probe is indicated for stimulation of peripheral motor nerves, including spinal nerve roots, for location and identification during surgery.
The TELIGEN Procedure Kit Pro is a sterile, single use kit intended for use in surgical spinal procedures allowing for access, visualization, discectomy, graft delivery, navigation and peripheral motor nerve stimulation.
The TELIGEN Procedure Kit Pro includes a camera, ports and port holder, TELIGEN Clear, an Access Probe, a soft tissue retractor, a port cutter cartridge and bone graft delivery instruments.
The TELIGEN Access Probe is part of the DePuy Synthes Navigation Ready Instruments Portfolio and is designed for navigated and non-navigated use. Navigation of this instrument is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS). For further details on UNAS, refer to the UNAS labeling.
The TELIGEN Access Probe is intended to stimulate peripheral motor nerves, including spinal nerve roots, for location and identification during surgery. It contains an insulated probe compatible with the SENTIO MMG System. The SENTIO MMG sensors serve to measure a mechanomyographic (MMG) response and the SENTIO MMG System's detection of this response alerts the surgeon of nerve location in the proximity of the TELIGEN Access Probe's distal tip.
The provided FDA 510(k) summary describes the TELIGEN System's "Peripheral Motor Nerve Stimulation Indications." This section details the acceptance criteria and the studies performed to demonstrate equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety Evaluation | In accordance with IEC 60601-1: 2005(R)2012 | All evaluations passed acceptance criteria. |
| Functional Performance Testing and Verification Analysis | Pass criteria for: Connector Compatibility, Insulation Effectiveness, SENTIO MMG System Compatibility, Electrical Stimulation Density | All samples and evaluations passed acceptance criteria. |
| Sterility | Ethylene Oxide sterilization validated per ISO 11135 | All samples passed acceptance criteria. |
| Biocompatibility (endpoints per ISO 10993-1) | Satisfactory results for: Physical/chemical information, Cytotoxicity, Acute Systemic Toxicity, Irritation or Intracutaneous Reactivity, Sensitization, Material mediated pyrogenicity | Leveraged existing data, testing, and assessments; all endpoints covered. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test listed (Electrical Safety, Functional Performance, Sterility). It refers to "All samples and evaluations passed acceptance criteria." The data provenance (country of origin, retrospective or prospective) is not specified, but these are typically in-house engineering and lab tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is a surgical instrument for nerve stimulation, and the performance evaluations are based on engineering and laboratory testing against established standards (e.g., IEC 60601-1, ISO 11135) and internal design specifications, not on clinical interpretation or expert consensus on a "ground truth" derived from patient data.
4. Adjudication Method for the Test Set
This is not applicable. The evaluations are objective measurements and assessments against predefined technical standards and specifications, not subjective interpretations requiring adjudication.
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
There was no MRMC comparative effectiveness study, as this device is a surgical instrument and not an AI-powered diagnostic imaging tool or a system involving human "readers."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical surgical instrument for nerve stimulation and does not have an "algorithm-only" performance component as understood in the context of AI/software as a medical device. Its performance is related to its physical and electrical characteristics.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance claims of the TELIGEN Access Probe as a nerve stimulator is based on established engineering and electrical standards, and the known physiological response of peripheral motor nerves to electrical stimulation. For biocompatibility, it's based on ISO 10993-1.
8. The Sample Size for the Training Set
This is not applicable. This device is a physical instrument, not an algorithm, and therefore does not have a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this 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.