(135 days)
NeuroMetrix ASCEND is a peripheral nerve stimulator used for localization and verification of needle placement for perineural application of pharmacological agents.
ASCEND is a battery powered peripheral nerve stimulator. This device is intended for localization and verification of needle placement for perineural application of pharmacological agents. ASCEND consists of the following components: Stimulator, Battery, Bluetooth, Charging Station.
This is a 510(k) premarket notification for the NeuroMetrix ASCEND, a peripheral nerve stimulator. 510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria and performance metrics described in your request for new devices.
Based on the provided text, the following information can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not contain a table of explicit acceptance criteria with quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for the device's function. The submission focuses on demonstrating substantial equivalence to a predicate device based on similar intended use and technological characteristics.
2. Sample Size Used for the Test Set and Data Provenance:
No information regarding a "test set" with a specific sample size or data provenance (country of origin, retrospective/prospective) is provided. This type of data is usually part of clinical studies, which are not typically required for a 510(k) submission seeking substantial equivalence for this class of device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
No information regarding experts establishing ground truth is provided. This is generally associated with performance evaluations that are not part of this 510(k) submission.
4. Adjudication Method:
No adjudication method is mentioned as there is no described test set or performance evaluation requiring such a method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study is mentioned. This type of study would compare human reader performance with and without AI assistance, which is not relevant for a peripheral nerve stimulator that is not an AI-driven image analysis tool.
6. Standalone (Algorithm Only) Performance Study:
No standalone performance study is mentioned. The device is a stimulator, not an algorithm that performs analysis independently. Its function is to provide electrical stimulation for nerve localization.
7. Type of Ground Truth Used:
No specific "ground truth" (e.g., pathology, outcomes data) is mentioned in the context of a performance study. The substantial equivalence relies on the established efficacy and safety of the predicate device and the similar design and intended use of the new device.
8. Sample Size for the Training Set:
No training set or sample size for a training set is mentioned. This is applicable to machine learning or AI-based devices, which this stimulator is not.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set is mentioned.
Summary of Device Acceptance and Study as Per 510(k) Submission:
The NeuroMetrix ASCEND device gained market clearance through a 510(k) Premarket Notification (K091155) by demonstrating substantial equivalence to a legally marketed predicate device, the Stockert GmbH Stimuplex HNS 12 (K052313).
The basis for acceptance was primarily the comparison of intended use, technological characteristics, and verification and validation testing.
- Intended Use: Both devices are used for "localization and verification of needle placement for perineural application of pharmacological agents."
- Technological Characteristics: The submission states that the "technological characteristics of the stimulator in ASCEND and the Stockert GmbH Stimuplex HNS 12 are the same or similar in specification."
- Verification and Validation Testing: The document mentions that "Based on the verification and validation testing presented, the comparison of ASCEND to the predicate supports a finding of substantial equivalence." (However, the details of this testing, specific metrics, or acceptance criteria within that testing are not elaborated in the provided text).
In essence, the "study" proving the device meets acceptance criteria is the comparison to the predicate device and the underlying engineering verification and validation testing to confirm that the new device functions as intended and safely, similar to the predicate. The FDA's decision to clear the device indicates that they found sufficient evidence of substantial equivalence to the predicate.
§ 868.2775 Electrical peripheral nerve stimulator.
(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).