(197 days)
The BE-ST NAV PAK is indicated for navigated pedicle pilot hole preparation. The BE-ST NAV PAK should only be used with a compatible Medtronic StealthStation® System.
The BE-ST NAV NIM® PAK is indicated for navigated pedicle pilot hole preparation, locating, and identifying nerves during surgery, including spinal nerve roots. The BE-ST NAV NIM® PAK should only be used with compatible Medtronic StealthStation® and Medtronic NIM® Systems.
The BE-ST Navigated PAK Needles are single use surgical instruments composed of stainless steel and plastic. They are sterile packaged. The devices are comprised of three main components: the cannula, stylet assembly, and tracker subassembly.
There are two devices in the family: the BE-ST Navigated NIM® PAK Needle and the BE-ST Navigated PAK Needle. The BE-ST Navigated NIM® PAK Needle is an accessory to the Medtronic StealthStation® System and is intended for use as a stimulating accessory to the Medtronic NIM® System. The BE-ST Navigated PAK Needle is an accessory to the Medtronic StealthStation® System.
The only significant differences between the two subject devices are the electrical insulation on the cannula and the connection to the NIM® System. The BE-ST Navigated PAK device has the same basic function and navigational capabilities as the BE-ST Navigated NIM® PAK device but is not an accessory to the Medtronic NIM® system and therefore cannot be used for nerve monitoring.
The provided document is a 510(k) Summary for the BE-ST Navigated PAK Needles. It describes the device, its indications for use, comparison to predicate devices, and performance data to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantitative manner for most tests (e.g., minimum tensile strength), but rather by concluding that the devices "passed" or "successfully completed" the tests. However, one specific quantitative acceptance criterion is mentioned: the device navigational accuracy met "the confidence/reliability tolerance interval requirement." Another is the "SAL of 10-6" for ETO sterilization.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional use and reliability: Withstand impact, maintain electrical integrity, proper insertion/removal. Assessed by comparison to predicate. | Devices passed all functional use and reliability testing. |
| Biocompatibility: Non-cytotoxic, non-sensitizing, non-irritating, non-systemic toxic, non-pyrogenic, non-hemolytic. | Devices passed biocompatibility testing. |
| ETO Sterilization: Achieved a Sterility Assurance Level (SAL) of 10⁻⁶. | ETO sterilization validation completed successfully, achieving a SAL of 10⁻⁶. |
| Packaging durability: Withstand shipping (environmental pre-conditioning, compression, vibration, drop), maintain seal integrity. | Devices passed ship testing. |
| Packaging process validation: Meet specified heat sealing parameters (width, visual, strength). | Packaging process validation completed successfully (Heat sealing OQ and PQ). |
| Age testing (device and packaging): Maintain functional use and packaging integrity after accelerated aging (36 months). | Devices and packaging passed age testing. |
| Surface area: Substantially equivalent to predicate. | Surface area found to be substantially equivalent. |
| Device navigational accuracy and compatibility with Medtronic StealthStation® System: Meet accuracy criteria for the StealthStation® System. | Devices passed accuracy testing, meeting the confidence/reliability tolerance interval requirement. Devices registered by the StealthStation® System. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for most of the performance tests. For "functional use and reliability testing," it mentions "the subject devices and the predicate devices" without specifying the number of units. Similarly, for biocompatibility, packaging, and age testing, only "finished devices" or "devices" are mentioned.
The data provenance is retrospective as the tests were conducted as part of the 510(k) submission process, using manufactured devices. There is no mention of country of origin of the data; it's implied to be from the manufacturer's testing or contracted labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable in the context of this device. The BE-ST Navigated PAK Needles are medical instruments for navigated pedicle pilot hole preparation and nerve monitoring. The "ground truth" for the performance tests is established through objective engineering and biological measurements (e.g., impact forces, electrical continuity, cell viability, sterility levels, accuracy measurements against a known standard from the StealthStation® System), not through expert consensus on diagnostic images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable to the type of testing described for this device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical data (e.g., radiology reads) where discrepancies between readers need to be resolved. The performance data here is based on objective bench and lab testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves multiple human readers evaluating medical cases, often to compare the effectiveness of a diagnostic tool or AI assistance. The BE-ST Navigated PAK Needles are surgical instruments, not diagnostic AI software, and their evaluation focuses on technical performance and safety, not human interpretation of cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone study, in the sense of an algorithm operating independently, was not performed because the device is a physical surgical instrument. However, the "device navigational accuracy and compatibility with Medtronic StealthStation® System" testing can be considered an evaluation of the device's technical performance in conjunction with the StealthStation® System, without explicit human variability being the primary focus of the test itself. The device's accuracy was tested against the StealthStation® system's inherent accuracy criteria.
7. Type of Ground Truth Used
For most tests, the "ground truth" refers to established engineering standards, material specifications, and biological safety limits.
- Functional Use & Reliability: Engineering specifications, predicate device performance, basic principles of mechanical and electrical integrity.
- Biocompatibility: ISO 10993 standards (e.g., in vitro cytotoxicity, irritation, systemic toxicity, hemolysis, sensitization, pyrogenicity).
- Sterilization: ISO 11135 standard (SAL of 10⁻⁶).
- Packaging: ISTA 1C Test standard, ISO 11607 standards, and typical packaging integrity tests (dye injection, seal strength).
- Age Testing: Controlled accelerated aging, followed by re-evaluation against functional and packaging integrity benchmarks.
- Surface Area: Dimensional measurements and comparison to predicate.
- Navigational Accuracy: The accuracy criteria set forth by the Medtronic StealthStation® System served as the ground truth/reference for navigational accuracy.
8. Sample Size for the Training Set
This information is not applicable. The BE-ST Navigated PAK Needles are physical medical devices, not AI/machine learning algorithms that require training sets. The development and testing revolve around engineering principles, materials science, and biological safety, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for a physical medical 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.