(106 days)
The Suction Stimulator Probe is a dedicated manual surgical instrument that allows the surgeon to clear secretions and test surgical tissue with nerve stimulation at the same time and with the same instrument. It is intended for use only by a licensed physician and in conjunction with the Neurovision SE (Nerveana) Nerve locator Monitor System.
The Suction Stimulator Probe is a disposable, single use, sterile instrument that combines concurrent suction and stimulation into one device for use during tissue dissection and nerve stimulation during surgery.
The instrument consists of a stainless steel shaft, partially insulated with biocompatible PTFE and ending with a ball-tip suction. Proximal connectors attach the instrument to a nerve stimulator. A tapered type adapter attaches the device to a standard suction catheter and a finger-hole allows for adjusting the suction strength manually by the surgeon. The insulated shaft has a 2mm diameter and 2 length options of 13 or 26 cm. The ball tip feature reduces the current density of stimulation, allows stimulation along right angles, such as drill holes, and prevents bone chip clogging of the instrument.
The Neurovision Medical Products Inc. Suction Stimulator Probe (DryTouch Suction Stimulator Probe) is a Class II medical device (Product Code ETN) that combines concurrent suction and nerve stimulation in a single, disposable, sterile instrument for use during tissue dissection and nerve stimulation in surgery. It is
intended for use by a licensed physician in conjunction with the Neurovision SE (Nerveäna) Nerve locator Monitor System.
The provided document describes both the acceptance criteria and the study conducted to demonstrate substantial equivalence for the device. However, it is important to note that this is a Traditional 510(k) submission, which primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data, rather than a standalone clinical study with extensive acceptance criteria explicitly defined in terms of clinical outcomes or diagnostic performance metrics often seen with AI/ML devices.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) submission for a surgical instrument, the "acceptance criteria" are related to mechanical, electrical, and sterility performance, as well as substantial equivalence to predicate devices, rather than AI/ML diagnostic or prognostic metrics.
| Acceptance Criteria (Bench Testing) | Device Performance |
|---|---|
| Ball tip diameter measurement | Confirmed (implicitly, as it contributed to the "quality of manufacturing" and "reliability of the surface area of the ball as indicating the current density of delivered stimulation") |
| Electrical continuity testing | Confirmed (implicitly, as it contributed to "reliability of current delivered to the tip") |
| Suction testing with applied air | Confirmed (implicitly, as it contributed to "gross delivery of air/suction as reflecting the suction power of the device") |
| Sterilization | EO validation compliant with ISO 11135-1:2007; EO residuals analysis compliant with ISO 10993-7:2008; Sterility Assurance Level 10-6 |
| Shelf Life | 1 year, confirmed by package integrity testing compliant with ISO 11607 |
Note: The document does not provide specific numerical targets or thresholds for "acceptance criteria" for the bench tests (e.g., a specific range for ball tip diameter or a minimum suction flow rate). Instead, it states that these tests were conducted to "assess performance and safety" and to "test the quality of the manufacturing, the reliability of the surface area of the ball as indicating the current density of delivered stimulation, the continuity of the device as reflecting the reliability of current delivered to the tip, and finally, the gross delivery of air/suction as reflecting the suction power of the device." The FDA's substantial equivalence determination implies that these criteria were met adequately.
2. Sample Size Used for the Test Set and Data Provenance
The study described is bench testing, not a clinical study involving a "test set" in the context of AI/ML or clinical efficacy.
- Sample Size for Test Set: Not applicable in the context of clinical data or AI/ML evaluations. The bench tests would have used an unspecified number of physical devices.
- Data Provenance: Not applicable in the context of country of origin of clinical data. The testing was likely conducted in a lab setting by the manufacturer (Neurovision Medical Products, Inc., in Ventura, CA, USA).
- Retrospective or Prospective: Not applicable as it refers to bench testing on physical devices, not data collection from subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. Ground truth for bench testing involves engineering measurements and adherence to standards, not human expert consensus for clinical image interpretation or diagnosis.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This concept primarily applies to clinical studies where multiple human readers or ground truth establishers might disagree, requiring a method to reach a definitive truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This is not mentioned. The device is a surgical instrument, and the submission focuses on its physical and functional equivalence to existing predicate devices through bench testing. It does not involve human readers evaluating cases with or without AI assistance.
- Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study Done: No. The device is a physical surgical instrument. The concept of an "algorithm only" performance study is not relevant here.
7. Type of Ground Truth Used
- Type of Ground Truth: For the bench testing, the ground truth was based on engineering measurements, established industry standards (e.g., ISO 11135-1:2007, ISO 10993-7:2008, ISO 11607), and the functional specifications of the device. This is analogous to "physical specifications" or "performance metrics" derived from controlled experimental setups.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no AI/ML component described that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable.
In summary: The provided document is a 510(k) summary for a physical surgical instrument. The "study" proving acceptance criteria involves bench testing to confirm physical characteristics, electrical continuity, suction capability, and adherence to sterilization and shelf-life standards. The concept of AI/ML-specific criteria, such as test sets, training sets, expert ground truth, or MRMC studies, is not applicable to this type of device submission. Substantial equivalence was primarily demonstrated by comparing its technological characteristics and performance to legally marketed predicate devices through engineering and laboratory evaluations.
§ 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.