(207 days)
SunStim Peripheral Nerve Stimulator and SunStim Plus Peripheral Nerve Stimulator are a battery-powered device intended for monitoring the magnitude of neuromuscular block in general anesthesia, by delivering an electrical stimulus near a peripheral motor nerve.
SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator are battery powered peripheral nerve stimulators which provide low electrical direct current (DC) stimulation in order to determine the level of anesthetic nerve block. The Stimulus Amplitude control dial provides variable current control (0 to 70 mA into a 2K ohm load).
The Output Stimulus Pulse Indicator flashes each time current passes through the patient. Functions include: Double Burst (DBS), Train-of-Four, Twitch, and 100Hz Tetanus. The device offers sufficient output to ensure supramaximal stimulation: from 0 to 70 mA. SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator models have the same functions with the following exceptions: the SunStim™ Peripheral Nerve Stimulator functions do not include Double Burst and the 50 Hz Tetanus option.
The document provided is a 510(k) summary for the SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator. It describes the device, its intended use, and its substantial equivalence to a predicate device (EasyMed Instruments Co., LTD. Peripheral Nerve Stimulator, K121743).
However, the document does not contain specific acceptance criteria, reported device performance metrics, or details about a study designed to prove the device meets such criteria in the way that would typically apply to AI/ML or diagnostic devices.
The "Performance Data" section lists recognized consensus standards that the device underwent tests against, which are primarily related to electrical safety, electromagnetic compatibility, risk management, and software lifecycle processes. These are general standards for medical electrical equipment and software, not performance metrics like accuracy, sensitivity, or specificity that would be expected for an AI system or device requiring clinical performance validation.
Therefore, many of the requested details about acceptance criteria and a study proving performance cannot be extracted from this document because they are not present. This document is focused on demonstrating substantial equivalence based on technological characteristics and adherence to general safety and quality standards, not a specific clinical performance study with defined criteria and results.
Here's an attempt to answer based on the available information, with many points marked as "Not provided in the document."
Description of Acceptance Criteria and Study to Prove Device Meets Criteria
The provided document describes the SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator, highlighting its substantial equivalence to a predicate device (K121743) based on its intended use, operating principle, basic design principle, operating modes, and stimulation parameters. The "performance data" section focuses on adherence to general safety, electromagnetic compatibility, risk management, and software lifecycle process standards, rather than specific clinical performance metrics.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria (from standards) | Reported Device Performance (from document) | Notes |
|---|---|---|---|
| Electrical Safety | Adherence to AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, Mod). | "Test results show that the modification for the new device do not affect the safety and effectiveness." | This implies compliance with the standard but no specific numerical performance is given. |
| Electromagnetic Compatibility (EMC) | Adherence to AAMI / ANSI / IEC 60601-1-2:2007/(R) 2012, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests (Edition 3). | "Test results show that the modification for the new device do not affect the safety and effectiveness." | This implies compliance with the standard but no specific numerical performance is given. |
| Risk Management | Adherence to ISO 14971: Second Edition 2007-03-01 Medical devices- Application of Risk Management To Medical Devices. | "Test results show that the modification for the new device do not affect the safety and effectiveness." | This implies compliance with the standard but no specific numerical performance is given. |
| Software Life Cycle Processes | Adherence to IEC 62304 First Edition 2006-05, Medical devices software- Software life cycle processes. | "Test results show that the modification for the new device do not affect the safety and effectiveness." | This implies compliance with the standard but no specific numerical performance is given. |
| Clinical Performance | Not provided in the document. (No specific clinical performance acceptance criteria like accuracy, sensitivity, specificity, etc., are mentioned.) | Not provided in the document. | The marketing submission focuses on substantial equivalence based on technological characteristics and safety standards, not a clinical performance study with specific metrics. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in the document. The testing mentioned refers to conformance with general safety and engineering standards, not a clinical test set with patient data.
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, as no clinical ground truth or expert review process for a test-set of patient data is described. The "testing" refers to engineering and quality assurance against recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical data test set requiring adjudication is described.
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
Not applicable. The device is a peripheral nerve stimulator, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as the document describes a hardware medical device (peripheral nerve stimulator), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as the "testing" described is against engineering and safety standards, not based on clinical ground truth.
8. The sample size for the training set
Not applicable, as the document describes a hardware medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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).