(279 days)
The PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1-AU451) and Cannulated PediGuard® Needle#2 (model P2ND1002) are 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 PediGuard 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 PediGuard® 2.5mm XS and PediGuard® Curv XS are single use, single piece devices composed of stainless steel and plastic that are provided sterile, and consist of a handle containing the electronics and a stainless steel shaft with distal sensor for measuring electrical impedance of the tissues immediately in contact with the sensor during use. The devices product visual and audible signal to indicate changes in impedance associated with possible vertebral perforation.
The Cannulated PediGuard® Needle #2 is the needle part of a single-use modular device provided sterile, consisting of a handle containing the electronics, a stainless steel cannulated outer shaft and a stainless steel inner sensor needle for measuring electrical impedance of the tissues immediately in contact with the sensor during use.
PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1-AU451) and Cannulated PediGuard® Needle#2 (model P2ND1002) provide realtime visual and auditory feedback to the surgeon during the preparation of the pedicle screw pilot holes, sounding an alert when the tip of the sensor senses a change in the impedance of the surrounding tissues, which may indicate that the tip is in contact with soft tissues and a possible vertebral cortex perforation.
The provided text describes different models of SpineGuard's PediGuard devices and their substantial equivalence to a predicate device, the PediGuard Nerve Detector (K030526). This submission is for a 510(k) premarket notification, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to establish new safety and effectiveness criteria.
For this type of submission, "acceptance criteria" are usually based on meeting established standards (e.g., ISO, ASTM, IEC) and demonstrating comparable performance to the predicate device in specific technical and functional aspects, rather than clinical efficacy metrics like sensitivity or specificity. The "study" here refers to the various verification and validation tests performed.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance for SpineGuard PediGuard Devices
The acceptance criteria for the PediGuard® 2.5mm XS, PediGuard® Curv XS, and Cannulated PediGuard® Needle#2 are primarily based on demonstrating substantial equivalence to their predicate device, the SpineGuard S.A., PediGuard Nerve Detector (K030526). This involves meeting relevant industry standards and showing comparable performance in key areas.
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are implicitly defined by compliance with recognized standards and demonstration of performance comparable to the predicate device. The device performance listed below demonstrates this equivalence.
| Aspect | Acceptance Criteria (Deemed Met by Substantial Equivalence and Standards) | Reported Device Performance |
|---|---|---|
| Intended Use / Indications | Maintain the same intended use/indications for use as the predicate device: providing visual and audible feedback during pedicle screw pilot hole drilling to indicate changes in impedance at the tip, potentially indicating contact with soft tissues and possible vertebral cortex perforation. Also, for intraoperative EMG surveillance to assist in nerve location and evaluation during spinal surgery. | The PediGuard® 2.5mm XS, PediGuard® Curv XS, and Cannulated PediGuard® Needle#2 have the same intended use/indications for use as the predicate. |
| Technological Characteristics | Maintain similar technological characteristics and principles of operation to the predicate device, with minor differences not raising new safety/effectiveness questions (e.g., shaft diameter, shaft materials, electronics firmware/power source). | The devices have similar technological characteristics and principles of operation as the cleared PediGuard Nerve Detector. The impedance detection algorithm is identical. Minor differences in shaft diameter, materials, or electronics are stated not to raise any new questions of safety or effectiveness. |
| Biocompatibility | Compliance with ISO 10993 -1, ISO 10993-5, ISO 10993-10, and ISO 10993-11 for devices in limited (≤ 24 hours) contact with tissue/bone. | Non-cytotoxic, Non-irritating, Non-sensitizing, and Not systemically toxic as demonstrated by ISO 10993-5, 10993-10, and 10993-11 testing. |
| Mechanical Performance | Maintain structural integrity and perform as intended under mechanical stress (e.g., bending). | Static bending testing showed all device models performed as intended in a manner directly comparable to the predicate devices. |
| Electrical Performance | Emit electrical signals comparable to the predicate device, accurately measure changes in impedance, and convey changes via audible signals with comparable volume. | Electrical signal emission was directly comparable to the predicate. The ability to measure impedance changes and the volume of the audible signal were also measured and found to be directly comparable. Firmware verification and validation testing completed. |
| Material Standards | Compliance with material specifications for implantable stainless steel (e.g., ASTM F138, ASTM F899). | Compliance with ASTM F138-08 and ASTM F899-11 demonstrated. The materials in the modified devices are directly comparable to the predicate. |
| Electrical Safety | Compliance with general safety requirements for medical electrical equipment (e.g., IEC 60601-1 and its collateral standards). | Compliance with IEC 60601-1 and IEC 60601-1-4 demonstrated. |
| Sterilization & Packaging | Compliance with standards for sterilization, residuals, microbiological methods, and packaging for terminally sterilized medical devices (e.g., ISO 11135-1, ISO 10993-7, ISO 11737-1/2, ISO 11607-1/2, ASTM F88, F1929, F1980, D4169). | Devices are sterile and were tested against ISO 11135-1, ISO 10993-7, ISO 11737-1, ISO 11737-2, ISO 11607-1, ISO 11607-2, ASTM F88, ASTM F1929, ASTM F1980, and ASTM D4169. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a distinct "test set" sample size in terms of clinical cases or patient data, as this is a 510(k) submission primarily relying on design verification and validation (bench testing, material compliance) rather than a clinical trial with a patient cohort. The testing involved various quantities of the devices themselves for mechanical, electrical, and biocompatibility evaluations. For "Surgeon testing," the number of surgeons or cases is not specified.
- Data Provenance: The studies are primarily in-house design verification and validation activities conducted by SpineGuard or contracted laboratories.
- Country of Origin: France (SpineGuard, S.A. is located in Saint Mande, France).
- Retrospective or Prospective: These are laboratory and bench tests, not clinical studies. Therefore, the terms "retrospective" or "prospective" as applied to patient data do not directly apply. They are prospective tests conducted on the devices as part of their development and regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in a way that aligns with establishing ground truth for a clinical test set. The document refers to "Surgeon testing" but does not specify the number or qualifications of surgeons involved or how their input was used to establish a "ground truth." For biocompatibility, testing was conducted under 21 CFR, Part 58, Good Laboratory Practices, implying certified labs and personnel, but not "experts establishing ground truth" in a clinical sense.
4. Adjudication Method for the Test Set
- Not applicable in the context of this 510(k) submission, which focuses on device performance validation against engineering and safety standards, and equivalence to a predicate, rather than human expert adjudication of clinical outcomes or images.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance
- No MRMC or comparative effectiveness study involving human readers or AI assistance was mentioned or conducted, as this device (PediGuard) is a surgical tool providing real-time feedback, not an imaging or diagnostic AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- The device explicitly provides "real-time visual and auditory feedback to the surgeon." The "impedance detection algorithm is identical" to the predicate. The device is designed to be used with a human surgeon in the loop. Therefore, a standalone algorithm-only performance assessment in the absence of human interaction (as understood in AI/imaging contexts) is not relevant or described. The firmware of the device, which contains the algorithm, underwent verification and validation.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is based on engineering and performance standards, and comparison to the predicate device.
- Biocompatibility: Based on established biological response criteria (e.g., absence of cytotoxicity, irritation, sensitization, systemic toxicity) as defined by ISO 10993 standards and tested in GLP-compliant laboratories.
- Mechanical & Electrical Performance: Based on objective measurements against engineering specifications and direct comparability to the predicate device's measured performance (e.g., bending strength, electrical signal emission, impedance detection actability, audible signal volume).
- Material Composition: Based on compliance with ASTM material standards.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI algorithm in the contemporary sense requiring a "training set" of data to learn from. The impedance detection algorithm is stated to be "identical" to the predicate and is based on established principles of electrical impedance measurement. The firmware itself was subject to verification and validation, but this does not involve a "training set" as understood in AI.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" for the type of device and submission described.
§ 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.