(174 days)
The BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe are indicated for pedicle pilot hole preparation, locating, and identifying cranial and peripheral motor nerves during surgery, including spinal nerve roots.
The BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe are single use devices composed of stainless steel and plastic and are sterile packaged. The devices are comprised of two main components: the cannula and stylet assembly. Also, in the package are two monopolar cables: a subdermal needle electrode and a connecting cable. The NIM® PAK devices are available in standard "NIM® PAK" or longer "NIM® XPAK" configurations with 3 different types of tips: bevel, trocar or blunt. The blunt tips are only offered for the NIM® XPAK. In addition, there are three (3) NIM Pedicle Probes in lumbar, straight, and thoracic configurations. The BE-ST NIM® product family has a total of four (4) pedicle access needle configurations, three (3) pedicle probe configurations, and one (1) blunt configuration. All configurations are packaged with two (2) accessory monopolar cables. One cable is used to ground the patient and the other cable is used to connect the device to a Medtronic Neural Integrity Monitor (NIM®). The connection to the NIM® allows the subject device to provide stimulation to nerves.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, structured as requested:
Acceptance Criteria and Device Performance Study
The provided document describes the BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe (the 'subject device') and its substantial equivalence to predicate devices. The studies conducted are primarily focused on demonstrating this equivalence through various performance and safety tests.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for each test. Instead, it indicates that each test was successfully passed, demonstrating substantial equivalence or meeting specified requirements.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Use & Reliability Testing | Substantial equivalence to predicate device in functional use. All tests passed including impact, Hipot, continuity, visual analysis, and insertion/removal testing. | All functional use and reliability testing passed. Substantial equivalence has been shown. |
| Mechanical & Electrical Safety Testing | Meet requirements of IEC 60601-1:2005 Ed. 3. | Subject devices passed electrical safety testing, demonstrating that the devices meet the requirements for the subject device. |
| Biocompatibility Testing | Pass ISO 10993 tests (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Material Mediated Pyrogen, Hemolysis). | All devices passed biocompatibility testing. |
| Sterility | Meet requirements of ISO 11137 for gamma sterilization validation using VDmax25 method. | Sterility validation met requirements of ISO 11137. |
| Transit Testing | Meet ISTA 1C Test requirements (pre-conditioning, compression, vibration, drop) and maintain visual integrity and seal integrity. | Packaging met transit testing requirements; transit testing adoption from PAK family of devices. |
| Sterile Barrier Heat Sealing | Successful validation of heat sealing process. | Heat sealing process successfully validated; packaging process adoption from the PAK family of devices. |
| Shelf Life Testing (Device) | Maintain functional use after 36-month accelerated aging. | Age testing in progress. (Note: This suggests criteria will be met upon completion) |
| Shelf Life Testing (Packaging) | Maintain seal strength, package conditioning, and seal integrity after 36-month accelerated aging. | 36 month shelf life successfully validated; packaging shelf life adoption from the PAK family of devices. |
| Cadaver Lab Test (Pilot Hole Preparation) | Successfully create a pilot hole, tapped, and fitted with a pedicle screw. Device design outputs met user needs (design inputs). | The device successfully created a pilot hole which was successfully tapped and fitted with a pedicle screw. Results validated design outputs met user needs. |
| Pyrogen Status Testing | Pass LAL test for general medical devices. | Pyrogen status for general medical devices was evaluated using the LAL test. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample sizes used for each test. For many tests (e.g., functional testing, electrical safety, biocompatibility, sterility), a sufficient number of devices would have been tested to ensure statistical validity and meet the requirements of the respective standards.
- Origin: The study was conducted by Boston-Endo Surgical Technologies, located in Bridgeport, CT, USA. The data provenance is presumed to be internal testing at their facility or through contracted testing laboratories.
- Retrospective/Prospective: The testing described appears to be prospective as it involves the physical testing of newly manufactured subject devices and their packaging to demonstrate their performance and safety.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of external experts or establishing ground truth through expert consensus for the presented performance data. The tests are primarily objective engineering and biological evaluations against established standards and predicate device performance. For the cadaver lab test, the "user needs (design inputs)" served as the "ground truth" criteria, but no specific number or qualification of experts is provided for its assessment beyond the internal team conducting the test.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) is mentioned or applicable as the tests performed are objective, quantitative, and standardized evaluations, rather than subjective assessments requiring expert consensus or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The device (a surgical nerve stimulator/locator and pedicle probe) is a physical tool, not an AI or imaging diagnostic device that would typically involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. The device is a physical surgical instrument. The concept of an "algorithm only" or "standalone" performance is not relevant to this type of medical device. Its operation is always "human-in-the-loop" as it is used by a surgeon.
7. The Type of Ground Truth Used
The "ground truth" for the various performance tests is based on:
- Established Standards: Adherence to international and national standards (e.g., IEC 60601-1, ISO 10993, ASTM, USP, ISO 11137, ISTA 1C).
- Predicate Device Performance: Demonstrating substantial equivalence to the performance characteristics of the legally marketed predicate devices (Medtronic Stimulation/Dissection Instruments, Ball-tip probes, K031003; Medtronic NIM Spine, K031510).
- Design Inputs/User Needs: For the cadaver lab, the successful outcome was measured against predefined user needs and design inputs (e.g., successfully creating a pilot hole, tapping, and fitting a pedicle screw).
8. The Sample Size for the Training Set
Not applicable. This device is a physical surgical instrument; therefore, there is no "training set" in the context of machine learning or AI models. The development and validation process involved engineering design, material selection, and rigorous physical testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As a physical device, no training set or its associated ground truth was established in the context of statistical modeling or AI.
§ 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.