(42 days)
The GENICON Aquas Probes are instruments insulated for optional monopolar coagulation which enable a surgeon to manipulate, cut, or coagulate internal tissue or organs while performing laparoscopic procedures.
The GENICON Aquas Probes product line are multiple-use provided nor-sterile. The probes are insulated for optional monopolar coagulation which enables a surgeon to manipulate, cut, or coagulate soft tissue or organs while performing laparoscopic procedures. The GENICON Aquas Probes have an outside diameter of 5 mm and are provided in varying lengths and tip configurations. Working lengths range from 20 to up to 45 cm. Common tip configurations include L-Hook (Right Angle), J-Hook, Spatula, 45 Deg, Knife, Ball, Needle, and Spoon. Devices may also include a channel for suction and irrigation of sterile irrigant solution when attached to a compatible lavage device. Devices may also include retractable insulation and insulation at the digression of the user. Device are intended to be reused up to 50 times, and may be sterilized by high-pressure steam autoclave.
The provided text is a 510(k) Summary for the GENICON Aquas Probes. It focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and non-clinical performance data. Since this is a submission for an electrosurgical device for general surgery, it does not involve AI/ML technology or studies typically associated with AI device performance such as those listed in your prompt.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance cannot be extracted from this document as these types of studies were not conducted or described.
Here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document mentions that "Non-clinical tests were conducted to verify that the GENICON Reusable Electrosurgical Probe product line met all acceptance criteria and specifications as the substantially equivalent predicate device and any additional test that were required." The specific acceptance criteria are not explicitly detailed as numerical targets but are implied through equivalence to predicate devices and compliance with international standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent overall use/performance to predicate devices (Stryker Stiletto Electrosurgical Probe K052141 and Pajunks HF Electrodes K062047) | "Performance of the GENICON Reusable Electrosurgical Probe product showed that the device performed equivalent or better and is therefore substantially equivalent in performance to the predicate devices." |
| Electrical safety and effectiveness compliant with standards | "Electrical safety complies with IEC 60601." (Referring to predicate, and then implies the same for GENICON)"Electrical performance of the device was completed following FDA guidance 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery' issued August 15, 2016. This requires testing on three different tissue types. The spread is then measured under magnification, and TCO (thermal coagulation) is compared using different tissue types and maximum generator power in order to simulate thermal spread with the predicate product. Results showed an equivalent." |
| Mechanical performance, ergonomic forces | The GENICON Aquas Probes product line was also compared to the predicate device through bench testing which included visual & operational use, ergonomic forces, and electrical safety. Testing demonstrated that the devices met the same requirements as the predicate product. |
| Autoclave sterilization validation (for reusability) | "Autoclave Sterilization Validation" (Listed as a non-clinical test conducted). Device is intended to be reused up to 50 times and sterilized by high-pressure steam autoclave. |
| Biocompatibility | "Conforms to ISO 10993" |
| Cycle Count Testing | "Cycle Count Testing" (Listed as a non-clinical test conducted) |
| Compliance with specific IEC standards | IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007), IEC 60601-2-2:2009, IEC 60601-2-18:2009, ISO 17655-1:2006 (Are listed as standards applied in testing) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes non-clinical bench testing, not human subject testing with a "test set" in the context of an AI/ML algorithm. The testing involved "three different tissue types" for electrical performance evaluation, but no further details on sample size or provenance for this non-human tissue testing are provided.
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. This information pertains to studies with human expert interpretation (e.g., for medical imaging or diagnostics), which is not relevant to this electrosurgical probe submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is relevant for studies involving human expert assessment, not for the technical bench testing 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. This type of study is for evaluating AI-assisted human performance, which is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device. The "performance" described refers to the physical and electrical characteristics of the electrosurgical probe.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's performance would be the experimentally measured physical and electrical characteristics as compared to predefined specifications and predicate device performance. It doesn't involve clinical "ground truth" derived from patient data.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML algorithm, this information is not relevant.
§ 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.