(186 days)
The Ultravision2™ System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.
The Ultravision2™ 5mm Trocar component establishes a path of entry for instruments used in laparoscopic surgery.
The Ultravision2™ Generator interfaces directly with the electrosurgical generator and serves as a pass-through for RF energy to RF electrosurgical instruments.
The Ultravision2™ System is a multifunctional system that synchronizes visual field clearing with the activation of smoke-producing electrosurgical devices. The system interfaces with commercially available electrosurgical instruments. The Ultravision2™ Generator connects directly to a commercially available electrosurgical generator (ESU) and passes the RF energy through to the desired electrosurgical instrument connected to the Utravision2™ Generator. The Ultravison2™ System is able to automate the activation of the Ionwand for visual field clearing to the activation of the electrosurgical device to synchronize visual field clearing with the generation of smoke. The Ionwand™ pack comprises a dedicated percutaneous 3mm trocar/catheter which accommodates the Ionwand™ cable that delivers low energy from the generator to the patient. The Ultravision™ 5mm Trocar includes a dedicated Ionwand™ cable. This device is for prescription use only.
The information provided does not contain a study that proves the device meets the acceptance criteria. It presents a summary of non-clinical testing performed, including acceptance criteria and results (all "Pass"), but does not detail the methodology, sample sizes, or ground truth establishment for these tests in a way that aligns with a typical performance study.
Based on the provided text, here's what can be extracted:
1. Table of acceptance criteria and the reported device performance:
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Shelf life | Product and package must demonstrate stability for the claimed shelf life of 5 years. | Pass |
| Software verification and validation | Device functions controlled by software must perform as intended | Pass |
| Electrical safety and electromagnetic compatibility | Device must meet the requirements of the applicable clauses in the standards (IEC 60601-1, IEC 60601-2-2, EN 60601-1-2) | Pass |
| Dimensional and physical verification of unit | Device must meet dimensional specification and physical specifications as per internal standards. | Pass |
| High voltage output | Device must deliver specified output, into required loads, at given temperatures and humidities, and for the specified product lifetime as per internal standards. | Pass |
| Generator basic function including: | Device must meet specifications for connections and functionality as per internal standards. | Pass |
| Generator safety measures including: | Must meet specifications for device function independent of software, extreme misuse, or single fault conditions as per internal standards. | Pass |
| Generator user interface hardware control | Must meet specifications for device function independent of software, extreme misuse, or single fault conditions as per internal standards. (Note: Same criterion as "Generator safety measures including:") | Pass |
| Generator high voltage power management | Must meet specifications for DC output under proximity and HVDC limit protection measure as per internal standards. | Pass |
| Generator surgical energy detection | Device must demonstrate energy detection for external ultrasonic energy as per internal standards. | Pass |
| Mechanical connections and controls | Device must demonstrate acceptable durability of link cables, fascia connections, and cable retention as per internal standards. | Pass |
| Surgical generator compatibility | Device must demonstrate compatibility with applicable generators in terms of load curve characterization, CQM performance, HF leakage, and RF detection. as per internal standards. | Pass |
| Design validation under simulated use conditions | Must demonstrate that the device can achieve its intended use when used by end users as per internal standards. | Pass |
2. Sample sized used for the test set and the data provenance:
The document summarizes "non-clinical testing" and lists various tests, but it does not specify sample sizes for any of these tests. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective nature) as these are non-clinical engineering and performance characterization tests, not studies involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided as the disclosed tests appear to be engineering and design validation tests rather than clinical studies requiring expert ground truth for interpretation (e.g., image analysis by radiologists).
4. Adjudication method for the test set:
This information is not provided for the same reasons as above. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple expert readers.
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:
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in the provided text. The device is a "Surgical Smoke Precipitator" and an "Ultravision2™ System" which focuses on clearing smoke during laparoscopic surgery, not an AI diagnostic or assistive device for human readers. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The Ultravision2™ System is a medical device for surgical smoke clearance, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable. The device's function is physical and mechanical/electrical in nature for smoke precipitation synchronization.
7. The type of ground truth used:
The "ground truth" for the reported tests appears to be engineering specifications and established standards (e.g., ASTM, IEC, internal standards). For example, for "Dimensional and physical verification," the ground truth is "dimensional specification and physical specifications as per internal standards." For "Electrical safety," it's "the requirements of the applicable clauses in the standards."
8. The sample size for the training set:
This information is not applicable as the device is not an AI/machine learning system that requires a training set in the typical sense.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above.
§ 878.5050 Surgical smoke precipitator.
(a)
Identification. A surgical smoke precipitator is a prescription device intended for clearance of the visual field by precipitation of surgical smoke and other aerosolized particulate matter created during laparoscopic surgery.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Adverse tissue reaction must be mitigated through the following:
(i) Chemical characterization and toxicological risk assessment of the treated surgical smoke.
(ii) Demonstration that the elements of the device that may contact the patient are biocompatible.
(2) Electrical safety and electromagnetic compatibility testing must demonstrate that the device performs as intended.
(3) Software verification, validation, and hazard analysis must be performed.
(4) Performance data must demonstrate the sterility of the patient contacting components of the device.
(5) Performance data must support the shelf life of the sterile components of the device by demonstrating continued functionality, sterility, and package integrity over the identified shelf life.
(6) Animal simulated-use testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Device must be demonstrated to be effectively inserted, positioned, and removed from the site of use.
(ii) Device must be demonstrated to precipitate surgical smoke particulates to clear the visual field for laparoscopic surgeries.
(iii) Device must be demonstrated to be non-damaging to the site of use and animal subject.
(7) Labeling must identify the following:
(i) Detailed instructions for use.
(ii) Electrical safety and electromagnetic compatibility information.
(iii) A shelf life.