(164 days)
The AVS® ARIA Neuromonitoring Probe and AVS® ARIA Probe Dilators are indicated for use during surgery of the spine to deliver an electrical stimulus to the tissues and nerves at the operative site to assist in locating those nerves at risk during the surgical procedure.
The AVS® ARIA Neuromonitoring Probe (NM Probe) and AVS® ARIA Probe Dilators are used as instruments to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The NM Probe and probe dilators are available in monopolar configuration. These are made from stainless steel (NM Probe) insulated with either polytetrafluoroethylene or polyphenylsulfone (dilator tubes). The NM probe has a male 1.5mm DIN connector. The components are provided clean to users for sterilization prior to use. The components are not intended for cleaning, reprocessing, or reuse.
The provided text is a 510(k) summary for a medical device called the AVS® ARIA Neuromonitoring Probe and AVS® ARIA Probe Dilators. This document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to performance standards rather than presenting a study with specific performance metrics against acceptance criteria in the way a diagnostic AI device might.
Therefore, many of the requested fields (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not mentioned in this type of regulatory submission for this particular device.
However, I can extract the available information related to performance and testing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety/Compatibility | Compliance with IEC 60601-1-2: 2007 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests) | The device was tested in accordance with IEC 60601-1-2: 2007, and "the test results indicate that the AVS® ARIA Neuromonitoring Probe and AVS® ARIA Probe Dilators are substantially equivalent to predicate devices." |
| Material Standards (Stainless Steel) | Compliance with ASTM F899 (Standard Specification for Wrought Stainless Steels for Surgical Instruments) | "All stainless steel components, comply with ASTM F899." |
| Material Standards (PTFE) | Compliance with ASTM D4895 (Standard Specification for Polytetrafluoroethylene (PTFE) Resins Produced From Granular Molding Powders) | "all PTFE components comply with ASTM D4895." |
| Sterilization Assurance Level (SAL) | SAL of 10^-6 for both gravity and prevacuum steam sterilization, validated according to AAMI ST79:2010, AAMI A1:2010, AAMI TIR12:2010, and ISO 17665-1:2006. | "All devices have been validated... for a Sterility Assurance Level (SAL) of 10^-6 according to AAMI ST 79: 2010, AAMI A1:2010, AAMI TIR 12:2010, and ISO 17665-1: 2006." |
| Recommended Sterilization Parameters (Prevacuum) | Temperature: 132°C (270°F), Exposure Time: 4 Minutes, Dry Time: 20 Minutes | These parameters were validated to achieve the required SAL. |
| Recommended Sterilization Parameters (Gravity) | Temperature: 132°C (270°F), Exposure Time: 15 Minutes, Dry Time: 30 Minutes | These parameters were validated to achieve the required SAL. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not mentioned. This submission focuses on engineering and sterilization validation against established standards and substantial equivalence to predicate devices, not on clinical performance metrics derived from a "test set" of patient data in the context of diagnostic algorithms. The testing relates to the device's physical and functional properties, and its ability to be sterilized.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not mentioned. Ground truth in the context of this device's submission refers to compliance with engineering and material standards, and validated sterilization efficacy, which are established through laboratory testing and published standards, not through expert consensus on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not mentioned. This concept applies to clinical outcome or diagnostic accuracy studies, which are not detailed here.
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 MRMC study was not done. This type of study is relevant for AI-powered diagnostic aids, not for a neuromonitoring probe, which is a surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical surgical probe and dilators; there is no "algorithm only" performance to evaluate. Its function is to deliver an electrical stimulus under direct human control during surgery.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance claims in this submission is established engineering and material standards (IEC 60601-1-2, ASTM F899, ASTM D4895) and sterilization validation protocols (AAMI ST79, AAMI A1, AAMI TIR 12, ISO 17665-1). The device's performance is measured against these objective, verifiable standards.
8. The sample size for the training set
- Not applicable/Not mentioned. This device does not involve a "training set" in the context of machine learning or AI algorithms.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).