(261 days)
The DSG™ Threaded Drill System is intended to be used for the preparation of pedicle screw holes. The DSG™ Threaded Drill System is indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The DSG™ Threaded Drill System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. The DSG™ Threaded Drill System is also indicated for use with fluoroscopic guidance in percutaneous (MIS) surgical approaches to the spine.
The DSG™ Threaded Drill System also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves.
The DSG™ Threaded Drill System is designed to prepare pedicle screw holes. The sensor at the distal 3mm of the shaft detects the electrical impedance of the tissue immediately surrounding the sensor and provides real-time audio and visual information to the surgeon to assist the surgeon to determine the relative density of the tissue at the tip of the shaft. A skilled surgeon can interpret the varying pitch and cadence of the feedback to determine potential breaches of the cortical wall. The first 6mm at the instrument are very similar to the cleared PediGuard models, with a pointy awl type design to penetrate the bone. After that, a threaded portion of 25mm in length, featuring cutting flutes, allows for an easy insertion in bone. The threads allow for a smooth and progressive penetration in bone that results in steady and consistent readings of the impedance of the tissue, making the determination of potential breaches of the cortical wall easy for the surgeon.
The provided text describes the SpineGuard DSG™ Threaded Drill System (K152747) which is a modification to a previously cleared device, the PediGuard System (K143159). The document focuses on demonstrating substantial equivalence to the predicate device rather than presenting a standalone study with specific acceptance criteria for performance metrics like sensitivity and specificity. Instead, the "acceptance criteria" are implied by the demonstration of equivalence to the predicate device in terms of technological characteristics and performance tests.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission demonstrating substantial equivalence to a predicate device, the "acceptance criteria" aren't explicitly stated as quantitative targets (e.g., sensitivity > X%). Instead, the acceptance criteria are met by demonstrating that the new device's performance is equivalent to the predicate device, particularly in areas that could be impacted by the device modifications.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Mechanical Performance | The SpineGuard DSG™ Threaded Drill System was "tested mechanically (bending tests of the shaft) to show the sensor characteristics were identical to the predicate devices." |
| Detection Performance | "The detection performance of the new length of pins was also demonstrated to be equivalent to the predicates." This refers to its ability to detect impedance changes indicating tissue contact. |
| Durability | "In addition, the device durability was tested." (Demonstrated to meet predicate levels for similar use). |
| Cleaning and Sterilization | "Cleaning and sterilization validation demonstrated that the reusable components can be adequately cleaned and sterilized prior to reuse." |
| Compliance with Recognized Standards | The device complies with a list of ASTM, IEC, and ISO standards related to materials, electrical safety, biological evaluation, packaging, and sterilization (as listed on pages 4-5). This indicates that the device has met the requirements within these standards. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for performance testing (e.g., number of shafts tested for bending, number of trials for detection performance) or the specific data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned ("tested mechanically," "demonstrated to be equivalent," "device durability was tested") appear to be bench or lab-based tests confirming feature equivalency and safety, not clinical studies with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The document describes performance tests related to mechanical properties, detection equivalency, durability, cleaning, and sterilization, which do not typically involve human expert interpretation for "ground truth" in the way clinical diagnostic or AI performance studies would. The device provides "feedback to the surgeon via visual and audible alerts," and a "skilled surgeon can interpret the varying pitch and cadence of the feedback," but the 510(k) submission focuses on the device's functional equivalence, not a study of surgeon performance metrics.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the performance tests described are not clinical studies requiring adjudication of outcomes or diagnoses.
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 comparative effectiveness study is described in the provided text. The device is a surgical tool that provides real-time feedback, not an AI diagnostic tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
The device is inherently "human-in-the-loop," as its function is to provide real-time feedback to a surgeon during a procedure for their interpretation. Therefore, a standalone (algorithm only) performance assessment without human input would not be relevant or possible in its intended use context. The "detection performance" discussed relates to the sensor's ability to identify impedance changes, which is a standalone technical characteristic, but its clinical utility is always in conjunction with a surgeon.
7. The Type of Ground Truth Used
For the specific performance tests mentioned:
- Mechanical performance (bending tests): Ground truth would be defined by engineering specifications and physical measurements.
- Detection performance: Ground truth would be the known electrical impedance properties of different tissues or the physical presence of soft tissue/vertebral cortex perforation as confirmed by other means (e.g., direct observation in a test setup or anatomical models).
- Durability, cleaning, sterilization: Ground truth is established by relevant industry standards and test methodologies (e.g., sterility testing, material degradation analysis).
8. The Sample Size for the Training Set
Not applicable. The device described is a physical surgical instrument with sensors, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its "performance" is based on its physical and electrical characteristics as designed and manufactured, not on learning from a dataset.
9. 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.