(126 days)
The GENICON X-Surge instrumentation line is intended for use in endoscopic surgical procedures. It is a family of instruments which includes graspers, dissectors, which are intended to be used to grasp, manipulate, cut, and cauterize soft tissue.
The GENICON X-Surge monopolar laparoscopic instruments are sterile packaged Single Use Mono-Polar attachments intended for use in combination with a compatible reposable handle. It is designed to include graspers, dissectors, and scissors, intended to grasp, manipulate, cut, and cauterize soft tissue. The device diameter has a range of 3 - 5mm, and connects to a handle with the appropriate configuration. The handle has a male cautery connector that will be utilized for cauterizing soft tissue when attached to standard monopolar cautery cables and their generators.
The disposable shaft and tips are composed of an aluminum outer shaft, and a stainless steel drive rod which connects to the scissor blades and interacts with the handle activation rod. The outer insulation consists of fluorinated ethylene which is an insulation with functional material properties that are improved over Polytetrafluoroethylene PTFE, and is less rigid than Radel insulation. The disposable shafts and tips are to be supplied sterile in single unit trays with Tyvek lid, similar to the current GENICON electrosurgical instrumentation line. The Reposable handle is sterilized by the user using an autoclave process and is then connected to the sterile disposable shaft or tip. Once the procedure is completed, the instrument ends are disassembled from the handle, and are disposed of appropriately, and the handle is cleaned and sterilized for the next procedure.
The provided text describes the 510(k) submission for the GENICON X-Surge Electrosurgical Instrument, comparing it to a predicate device (GENICON Electrosurgical Instrumentation, K061417). The submission focuses on demonstrating substantial equivalence rather than proving the device meets specific acceptance criteria related to AI or diagnostic performance. Therefore, many of the requested elements for an AI/diagnostic study (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth types) are not applicable or detailed in this document.
However, I can interpret "acceptance criteria" based on the provided performance testing for a medical device and highlight what information is available. The study described focuses on non-clinical performance and safety testing to show equivalence to a predicate device.
Here's an attempt to answer the questions based only on the provided document, noting where information is not available due to the nature of the device and submission:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly list specific quantitative "acceptance criteria" in a table format for performance beyond "equivalent or better" compared to the predicate. Instead, it describes performance studies conducted to demonstrate equivalence.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Cut Performance | Equivalent or better than the predicate device. | "Testing showed the X-Surge device performed equivalent or better than the predicate Genicon product." (Regarding instances of slipping, overall cut length, scissor geometry) |
| Electrical Performance (Thermal Spread) | Equivalent or less thermal spread than the predicate device under same conditions. | "Results showed an equivalent or less area of thermal spread under the same conditions across the different tissue types and power settings." |
| Bench Testing (Visual & Operational Use, Ergonomic Forces) | Met the same requirements as the predicate product. | "Testing on performance and general ergonomic use showed that the X-Surge device met the same requirements as the predicate product in terms of closure force, opening angle, finger spacing, and rotation knob interaction." |
| Biocompatibility | Conforms to ISO10993 | "Conforms to ISO10993" |
| Sterilization | Equivalent to predicate (Irradiation or Ethylene Oxide) | "SAME" as predicate (Irradiation or Ethylene Oxide) |
| Materials | Equivalent or comparable to predicate (specific list provided). | Patient Contact: AISI Stainless Steel, FEP; Non-Patient Contact: Aluminum, Polycarbonate, Nylon, ABS, HDPE/LDPE, TPE. (Predicate used Radel instead of FEP for patient contact) |
| Diameter | SAME as predicate (3mm to 5mm) | "SAME" as predicate |
| Intended Use | SAME as predicate (General & Plastic Surgery, GEI) | "SAME" as predicate |
| Prescription Only | YES | "SAME" as predicate |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document mentions "three tissue samples of different origin" for cut performance testing and "three different tissue types" for electrical performance testing. Specific quantities beyond "three" for these tissue samples are not provided. For bench testing, no specific sample size is mentioned.
- Data Provenance: Not specified (e.g., country of origin).
- Retrospective or Prospective: The testing described appears to be prospective lab/bench testing conducted for the purpose of this submission rather than analysis of existing 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. This is not a study requiring expert ground truth for diagnostic performance like an AI algorithm. The performance evaluation is based on objective measurements (e.g., thermal spread under magnification, force measurements, visual inspection of cuts) directly from the device's function.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Not a diagnostic study with human interpretation requiring adjudication.
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 device is an electrosurgical instrument, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical electrosurgical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. Ground truth, in the sense of a diagnostic benchmark, is not relevant here. The "ground truth" for performance is the objective measurement of the device's physical and electrical properties against its intended function and comparison to the predicate device. For example:
- Cut performance: measured cut length, observation of slipping, geometry measurements.
- Electrical performance: measured area of thermal spread.
- Ergonomic forces: objective force measurements, angle measurements, finger spacing measurements.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is a physical medical device, not an AI model.
§ 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.