(166 days)
The ALARA Neuro Access Kit is indicated for pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback.
The ALARA Neuro Access Kit with Access Needle, Sheath and Extension Handle is a single use: sterile stimulating electrode is manufactured with the following materials: 316 and LVM Stainless Steel, IXEF 1022/9008 and Lustram ABS. The disposable ALARA Neuro Access Kit is an Access Needle insulated with a sheath (see figure 1). The sheath is full length except for the distal tip (either a diamond or bevel tip) which provides tissue stimulation. The needle utilizes an extension handle as an accessory (see figure 2) to provide the surgeon stability in placement of the access needle and by providing support by allowing for more working space during a surgical procedure. The device is kitted with a set of individually packaged and (single use) disposable Alligator Clips (Rhythmlink International Alligator Clip RLSP487) see figure 3.
The provided document is a 510(k) summary for the ALARA Neuro Access Kit, which is a medical device for pedicle pilot hole preparation, locating, and identifying spinal roots/nerves by providing proximity feedback. The summary details performance testing conducted to demonstrate the device meets acceptance criteria.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ALARA Cannula Handle Torque Test | The cannula handle meets all acceptance criteria since the torque required to cause the cannula to fail was over twice the required torque of 25 in-lbs. |
| ALARA Cannula Handle Pull Test | The cannula handle meets all acceptance criteria since the force required to cause the cannula to fail was over the required force of 60 lbf. |
| ALARA Stylet Handle Pull Test | The stylet handle meets all acceptance criteria since the force required to cause the stylet to fail was over the required force of 60 lbf. |
| ALARA Bevel Sheath Needle Functionality Test | The bevel sheath needle and extension handle meets all acceptance criteria since the samples were able to functionally perform the test without failure. |
| ALARA Diamond Sheath Needle Functionality Test | The diamond sheath needle and extension handle meets all acceptance criteria since the samples were able to functionally perform the test without failure. |
| Electrical Safety IEC 60601-1 Edition 3.1 | The limited evaluation and testing of the ALARA 11 Gauge Access Needle with Sheath found the sample(s) to be in compliance with the specified standards for: Leakage Current, Dielectric Voltage Withstand, Humidity Preconditioning, Enclosure Mechanical Strength, Drop Test, Ball Pressure, and Patient Leads and Cables. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific number of samples used for each bench test. It uses phrases like "the samples were able to functionally perform the test" or "the sample(s) to be in compliance," which implies that a sample size was used but not quantified.
The testing was retrospective bench testing performed on the device itself, simulating use cases in laboratory conditions. There is no information provided about the data provenance in terms of country of origin, as it is device bench testing rather than clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the studies described are bench tests to assess physical and electrical properties of the device, not clinical performance studies requiring expert-established ground truth.
4. Adjudication Method for the Test Set
This section is not applicable as the studies described are bench tests and do not involve human interpretation or adjudication. The "ground truth" for these tests comes from engineering specifications and objective measurements (e.g., torque, force, electrical properties).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not performed. The provided document details bench testing for physical and electrical performance, not a clinical study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The ALARA Neuro Access Kit is a physical medical device, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for the bench tests is based on engineering specifications and established safety standards. For example, the torque required to cause failure must exceed 25 in-lbs, and the force required to cause failure must exceed 60 lbf. Electrical safety is verified against IEC 60601-1 Edition 3.1. These are objective, measurable criteria.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML product, so there is no "training set." The testing performed is to validate the physical device's performance against pre-defined specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML product, there is no ground truth to establish for such a set.
§ 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.