(188 days)
The Nerve Monitoring Cable in conjunction with dilators, pedicle probes, taps, awls or screw drivers, are intended for tissue dilation/dissection and stimulation of peripheral nerves including spinal nerve roots for location and identification during spinal surgery.
The dilators are also intended for use in surgical procedures to provide surgical access by dilating the soft tissue to the intended surgical site to allow passage of current from a point on the proximal end to an uninsulated portion of the distal tip. The purpose of this is to allow controlled monitoring of neural elements near and around the point of access. The dilators are offered sterile/single use.
The Nerve Monitoring Cable System, which consists of Nerve Monitoring Cables in conjunction with various stimulation accessories, allow for tissue dilation and stimulation of peripheral nerve roots for location and identification during open and percutaneous / minimally invasive spinal surgery. The Nerve Monitoring Cable includes a 1.5 mm female DIN connector for use with a stimulating console with a Type BF or CF rating. The other end of the Nerve Monitoring Cable includes a clip for connection to the stimulation accessories of this system.
The stimulation accessories include general manual orthopedic surgical instruments previously cleared via K073227 (i.e. pedicle probes, taps, awls and screw drivers) and also include sterile/ single-use dilators which are subject of this submission. The subject dilators are a series of hollow tubes that fit over one another for the purpose of dilating tissue in preparation for spinal surgery. Similar to the predicate instrument accessories, they are made from a conducting metal (Aluminum 6061-T6) with an insulated outer coating (Parylene C) to allow passage of current from a point on the proximal end where it connects to the Nerve Monitoring Cable to an un-insulated portion of the distal tip. The purpose of this is to allow controlled monitoring of neural elements near and around the point of access. The subject dilators are offered sterile/single-use.
The provided text describes the 510(k) premarket notification for the Pioneer Surgical Technology, Inc. Nerve Monitoring Cable System (K142438). This submission focuses on demonstrating substantial equivalence to predicate devices, particularly for new sterile/single-use dilators.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating substantial equivalence to predicate devices across various characteristics, including safety, electrical performance, and biocompatibility. The performance data presented in the 510(k) summary serves as the "reported device performance."
| Acceptance Criteria Category | Acceptance Criteria (Implicit from Predicate Comparison) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-cytotoxic, non-irritant, non-sensitizing, not systemically toxic (per ISO 10993-1) | - Cytotoxicity: No evidence of cytotoxicity. Non-cytotoxic. |
| - Irritation: No evidence of irritation. Non-irritant. | ||
| - Sensitization: No evidence of sensitization. Non-sensitizing. | ||
| - Systemic Toxicity: No evidence of toxicity. Not systemically toxic. | ||
| Electrical Performance | Capable of transferring electrical current with little or no resistance; adequate insulation; electrical parameters within range of predicates. | - Electrical/Resistance Bench Testing: Confirmed capability of transferring electrical current with little or no resistance, similar to predicate devices. Confirmed adequate electrical insulation (in-process Hipot testing). |
| Max Charge Density (µC/cm²) comparable to predicates (e.g., K132373's 0.097, K140400's 0.306) | - Maximum Charge Density (µC/cm²): 0.108 | |
| Max Current Density (mA/cm²) comparable to predicates (e.g., K132373's 0.970, K140400's 3.057) | - Maximum Current Density (mA/cm²): 1.080 | |
| Max Power Density (500 Ω load) (mW/cm²) comparable to predicates (e.g., K132373's 0.079, K140400's 0.248) | - Maximum Power Density (500 Ω load) (mW/cm²): 0.087 | |
| Max Power Density (10kΩ load) (mW/cm²) comparable to predicates (e.g., K132373's 1.571, K140400's 4.952) | - Maximum Power Density (10kΩ load) (mW/cm²): 1.750 | |
| Electrical Safety | Compliance with IEC 60601-1 | - IEC 60601-1 testing: Supplied (implies compliance). Subject system compliant with applicable sections of IEC 60601-1. |
| Mechanical Performance | Adequate to perform intended function (tissue dilation/dissection, nerve stimulation) | - Engineering analysis: Confirmed maximum charge, current, and power densities of subject devices fall within the range of predicate devices. |
| Sterilization, Packaging, Shelf-life | Compliance with relevant standards (ISO 11137-2, ISO 11607, ASTM D4169) | - Validation studies: Sterilization, packaging, and shelf-life validations completed per applicable test standards (ISO 11137-2, ISO 11607, and ASTM D4169, respectively). |
| Functionality (in vivo) | Assess performance, functionality, and safety in a surgical setting; comparable to intended use | - Porcine animal study: Conducted to assess the performance, functionality, and safety of the subject dilators as neuromonitoring accessory instruments. (The specific findings/results beyond "assessed" are not detailed in this summary, but the conclusion is that the data confirmed substantial equivalence and that the devices perform as well as or better than predicates). |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size:
- Biocompatibility: Not explicitly stated, but typically involves a defined number of samples per test type (e.g., cytotoxicity, irritation, sensitization, systemic toxicity) as per ISO 10993-1.
- Electrical/Resistance Bench Testing: Not explicitly stated.
- In-process Hipot Testing: Not explicitly stated, but likely represents a portion or all units from a production run.
- Porcine Animal Study: Not explicitly stated, but standard animal study protocols would define the number of animals.
- Sterilization, Packaging, Shelf-life Validations: Not explicitly stated, but these involve statistical sampling as per the relevant ISO and ASTM standards.
- Data Provenance: The document does not specify the country of origin for the testing data. Given it's a U.S. FDA submission, it's highly probable the testing was conducted in the USA or by facilities recognized by the manufacturer as compliant with relevant standards. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate the device's performance characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This document describes a medical device seeking 510(k) clearance, which is based on demonstrating substantial equivalence to existing legally marketed predicate devices. It is not an AI/ML device that typically requires human expert consensus for "ground truth" to evaluate diagnostic or predictive performance.
- For Biocompatibility: Ground truth is established by standardized laboratory tests and interpretation by qualified toxicologists/biocompatibility specialists against ISO 10993-1 criteria.
- For Electrical Performance: Ground truth is established by physics principles, engineering specifications, and comparison against established predicate device performance specifications.
- For Animal Study (Functionality/Safety): Ground truth is established by observations and measurements taken during the veterinary surgical procedure, interpreted by veterinarians and potentially surgeons specialized in the relevant field.
Therefore, the concept of "number of experts used to establish ground truth" as it applies to AI/ML clinical studies is not directly applicable here. The "experts" would be the scientists, engineers, and medical professionals conducting and interpreting the various technical and animal studies.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies, especially those involving human judgment (like image interpretation in AI diagnostics), to resolve disagreements in ground truth determination. Since this 510(k) submission is for a physical device and relies on technical and animal studies, no such adjudication method is mentioned or typically required. The results of the technical studies (biocompatibility, electrical, mechanical) are generally objective measurements against predefined criteria or established scientific methods.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specific to diagnostic or interpretive AI/ML devices where human readers (e.g., radiologists) interpret cases (e.g., medical images) both with and without AI assistance to measure the impact of the AI on their performance. The Nerve Monitoring Cable System is a surgical accessory, not an interpretive diagnostic device, and therefore this type of study is irrelevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. Again, this device is a physical surgical accessory, not an algorithm or AI system. Its performance is evaluated through physical and biological testing, not through algorithmic output.
7. The Type of Ground Truth Used
The "ground truth" for evaluating this device primarily comes from:
- Standardized Test Results/Specifications: For biocompatibility (ISO 10993-1), electrical performance (IEC 60601-1, engineering calculations), mechanical durability, sterilization efficacy, packaging integrity, and shelf-life. These are objective measurements against established international and industry standards.
- Animal Study Observations: For in-vivo performance, functionality, and safety, observations from the porcine animal study serve as empirical ground truth.
8. The Sample Size for the Training Set
This device is not an AI/ML device and therefore does not have a "training set." The concept of a training set is specific to machine learning algorithms where data is used to teach the algorithm to perform a task.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this device, the question of how its ground truth was established is not applicable.
§ 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.