(35 days)
The Trigger Switch and Cord are accessories that are intended for use in monopolar laparoscopic and thoracoscopic electrosurgical procedures where handswitching of laparoscopic instruments is desired.
The Trigger Switch and Cord are an electrical connecting cord assembly, intended to provide an electrical path between an RF electrosurgery generator and an RF surgical electrode. The insulated wire of the Cord is 10ft long. The Cord is intended to be plugged into an in-line Trigger Switch which is attached to the RF electrode handle with an adhesive backing. The Trigger Switch allows hand switching of the electrical current through the Cord during surgery. These devices can be used in hospitals and are used by trained professionals only.
The Trigger Switch and Cord are compatible with the monopolar instruments with a shrouded 4mm male electrical connector and with an electrosurgical generator.
Typically, these application devices are used in place of foot switches in the flow of electrosurgical current to the target site.
These devices are sold as sterile, single-use devices.
The provided document is a 510(k) premarket notification for a medical device: the New Deantronics Trigger Switch and Cord. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets novel acceptance criteria for an AI/ML powered device.
Therefore, many of the specific questions you've asked (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set, how ground truth for training set was established, effect size of human readers improving with AI) are not applicable to this document. This document deals with electrosurgical accessories, which are hardware devices, not software or AI-driven systems.
However, I can extract information related to the acceptance criteria and study that does apply to this electrosurgical accessory, focusing on performance and safety testing against established standards and the predicate device.
Here's the information extracted from the document, tailored to the context of a hardware medical device and addressing the relevant parts of your request:
Acceptance Criteria and Device Performance for New Deantronics Trigger Switch and Cord
This document (K200455) is a 510(k) premarket notification for a traditional medical device (electrosurgical accessory), not an AI-powered one. Therefore, the "acceptance criteria" and "study" are focused on demonstrating the device's safety and effectiveness and its substantial equivalence to a predicate device through engineering and performance testing, rather than clinical efficacy studies with human readers or AI algorithm performance.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by adherence to recognized international and domestic standards for electrosurgical devices, as well as meeting predefined performance thresholds in mechanical and electrical tests. Performance is reported as "Pass" or "Fail" for each test.
| Acceptance Criteria (Specification/Test Purpose) | Standard/Method of Verification | Reported Device Performance | Comments |
|---|---|---|---|
| Minimize risks associated with mechanical failure and short circuit (Electrosurgical instruments mechanical testing) | Connector pull force | Pass | Minimizes risks by mechanical testing before and after transit. |
| 0.26kg Dynamic Strain Relief | Pass | ||
| 10 Pound Static Strain Relief | Pass | ||
| Anchorage Test | Pass | ||
| Visual Inspection | (General Requirement) | PASS | |
| Continuity test | (General Requirement) | PASS | |
| Drop Test (preconditioning) | IEC 60601-1:2005+ AM1:2012 (Clause 15.3.4.1) | PASS | |
| HF Leakage Current Test | IEC 60601-2-2:2017 (Clause 201.8.8.3.102) | PASS | |
| High Frequency Dielectric Test | IEC 60601-2-2:2017 (Clause 201.8.8.3.103) | PASS | |
| Hi-Pot Test | IEC 60601-2-2:2017 (Clause 201.8.8.3.104) | PASS | |
| Mains Frequency Dielectric Strength Test | IEC 60601-2-2:2017 | PASS | |
| Fluid Ingress Test | IEC 60601-2-2:2017 (Clause 201.11.6.5) | PASS | |
| EMC Test | IEC 60601-2-2:2017 (Clause 201.17, 202) | PASS | |
| Package and product performance criteria after ship testing | ASTM D4169 (Transit test) | Met Acceptance Criteria | Results demonstrate that the device and sterile packaging are functional after shipping transportation. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not specify exact sample sizes for each bench test conducted. The testing described is primarily bench testing (engineering and electrical safety tests), not human subject clinical trials. The data provenance is internal testing performed by New Deantronics Taiwan, Ltd. and its contractors. The studies are prospective in the sense that they were conducted for this premarket submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable in the context of an AI/ML device. For this hardware device, "ground truth" is established by adherence to recognized engineering standards (e.g., IEC, ASTM) and predefined physical and electrical specifications. The expertise would lie in the engineers and technicians performing and verifying the tests in accordance with these standards.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like "2+1" or "3+1" are relevant for clinical endpoints adjudicated by multiple experts, typically in clinical trials. For bench testing, test results are typically objective measurements against a Pass/Fail criterion.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. MRMC studies are specific to evaluating diagnostic accuracy and reader performance, commonly used for imaging AI. This device is an electrosurgical accessory, not a diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a hardware accessory and does not contain an algorithm in the sense of an AI/ML model. Its performance is evaluated through physical and electrical tests.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is the engineering specifications and safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ASTM D4169) to which the device must conform to be considered safe and effective. It's based on established physical and electrical properties, not clinical outcomes or expert consensus on a medical condition.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware accessory, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As the device is not an AI/ML model, there is no training set or ground truth associated with it in that context.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.