(15 days)
The NICO TRIOwand is a disposable device designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of tissue.
The NICO TRIOwand is a surgeon controlled device that enables the delivery of bipolar coagulation via third-party electrosurgical generators. Coagulation occurs between two stationary insulated electrodes which are continuously drip irrigated during use. Second, the TRIOwand provides user controlled delivery of aspiration/vacuum for the evacuation of fluids from the surgical site. Third, the TRIOwand provides the user the ability to deliver irrigation for flushing the surgical field.
This submission covers a single configuration of the device:
- . NICO TRIOwand - 4mm diameter, 14cm length, pre-bent (~30°)
The direct patient contacting materials consist of PEBA and stainless steel. The indirect contacting materials are PVC, TPV, polycarbonate, ABS, PC/ABS, silicone, and glue.
This document describes the NICO TRIOwand, an electrosurgical cutting and coagulation device. The provided text is a 510(k) summary for clearance of a modified version of the device (K162075), comparing it to a previously cleared predicate device (K150993).
Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical targets for performance metrics. Instead, the approach is one of demonstrating substantial equivalence to a predicate device. The performance is assessed by repeating nonclinical tests to ensure the modified device (K162075) meets applicable design and performance requirements, as compared to the predicate (K150993).
The "acceptance criteria" are implied to be that the modified device's performance in these nonclinical tests is equivalent to or better than the predicate device and does not raise new questions of safety or effectiveness.
| Performance Characteristic Tested | Implied Acceptance Criteria (relative to Predicate K150993) | Reported Device Performance (K162075) |
|---|---|---|
| Biocompatibility | No new or increased risk (passes ISO 10993-1) | Passes Cytotoxicity, Sensitization, and Irritation tests. |
| Tensile Testing | Meets strength requirements | Results support substantial equivalence. |
| Irrigation/Flush Drip Measurement | Proper drip rate performance | Results support substantial equivalence. |
| Longevity Testing | Maintains function over expected lifetime | Results support substantial equivalence. |
| Usability/Human Factors Analysis | Safe and effective for user interactions | Results support substantial equivalence. |
| Sterility Bioburden | Meets sterility requirements | Results support substantial equivalence. |
| Shelf Life and Packaging Validation | Maintained sterility and device integrity | Results support substantial equivalence. |
| Specification Review & Dimensional Analysis | Conforms to design specifications | Results support substantial equivalence. |
| Product Stability | Maintains function and integrity over time | Results support substantial equivalence. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for the nonclinical tests.
The data provenance is not explicitly mentioned as retrospective or prospective, nor does it detail the country of origin. However, given that these are nonclinical laboratory tests conducted for a 510(k) submission, they are typically performed in a controlled laboratory environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. The tests performed are nonclinical and involve laboratory measurements and comparisons to established standards (e.g., ISO 10993-1) or predicate device performance, not human expert interpretation of data to establish a ground truth as typically seen in in vivo or clinical studies.
4. Adjudication method for the test set
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies involving human interpretation or outcome assessment. The listed studies are nonclinical performance tests.
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
There is no MRMC comparative effectiveness study mentioned. The device is an electrosurgical tool, and the studies performed are nonclinical engineering and safety tests, not related to AI or image interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical surgical instrument, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as it applies to clinical diagnosis or image interpretation is not directly applicable here. For the nonclinical tests:
- Biocompatibility: Ground truth is established by adherence to recognized international standards (ISO 10993-1) and the results of laboratory tests (e.g., observing cell viability, skin reactions).
- Tensile Testing, Irrigation/Flush Drip Measurement, Longevity Testing, Shelf Life, Product Stability, Specification Review: Ground truth is defined by engineering specifications, control samples (predicate device), and established physical/chemical testing methodologies. Performance is compared to these predetermined standards or to the predicate performance.
- Usability/Human Factors Analysis: Ground truth for usability typically involves identifying potential use errors or difficulties based on user interaction protocols and expert review, aiming to ensure safe and effective operation.
8. The sample size for the training set
This information is not applicable and not provided. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
§ 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.