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510(k) Data Aggregation
(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.
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(180 days)
The Ultravision 2™ Integrated Monopolar L-Hook (H/S)™ is intended to be used with applications in surgical procedures to facilitate cutting, coagulating of tissue, in combination with the clearance of smoke and other particulate matter that is created during laparoscopic surgery.
The Integrated Monopolar L-Hook (H/S)™ is a bifunctional device that combines proprietary visual field clearing and monopolar HF tissue and coagulation in a single device. The Integrated Monopolar L-Hook (H/S)™ can only interface with the Ultravision2 generator which connects directly to a commercially available electrosurgical generator (ESU) for its HF monopolar energy source. The Integrated Monopolar L-Hook (H/S)™ provides two recessed smoke clearing emitters that are automatically activated to clear the visual field when the device cutting function (HF) is activated. The mode of action of visual field clearing is electrostation as per the predicate Ultravision system. When the tissue cutting is ceased, the visual field clearing signal is automatically switched off after a short delay period that is settable on the Ultravision 2 generator user interface. Activation of the HF function of the Integrated Monopolar L-Hook (H/S)™ is via a yellow (Cut) or blue (Coag) button located on the handpiece, or via a footswitch if this connected to the parent electrosurgical generator which is connected to the Ultravision 2 system. The Integrated Monopolar L-Hook (H/S)™ itself is incompatible with the connectors of third party electrosurgical generators. On demand visual field clearing only can also be applied by activation of a third grey button on the handle. This clearing field action is stopped immediately after release of the grey button. The Integrated Monopolar L-Hook (H/S)™ is available with of 32cm. It is intended to be introduced via standard 5mm surgical trocars as long as their internal diameter is 5.70mm or greater. The device is for prescription use only.
The provided text is a 510(k) summary for the Ultravision2™ System Integrated Monopolar L-Hook (H/S)™. It details the device's characteristics, comparison to predicate devices, and a summary of non-clinical testing.
However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of a software-driven AI device. The device described is a surgical instrument that combines visual field clearing and monopolar HF tissue cutting/coagulation. The "visual field clearing" mechanism is stated as "electrostatic precipitation," which is a physical principle, not an AI algorithm.
Therefore, many parts of your request, specifically those related to AI/software performance, ground truth establishment, expert adjudication, MRMC studies, or training sets, cannot be answered from the provided text.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics comparison and non-clinical bench testing for safety and performance of the surgical instrument itself.
Here is what can be extracted from the provided text regarding device acceptance and performance through non-AI related testing:
1. A table of acceptance criteria and the reported device performance
| Test Performed | Standard Followed | Acceptance Criteria | Result |
|---|---|---|---|
| Electrical safety and electromagnetic compatibility | IEC 60601-1 Medical Electrical Equipment, Edition 3.1; IEC 60601-2-2 High Frequency Surgical Equipment (2017-03); EN 60601-1-2:2015 + A1:2021 Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic disturbances | Device must meet the requirements of the applicable clauses in the standards | Pass |
| Shelf Life | ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Medical Device Packages; ASTM 2096 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization; ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials | Product and package must demonstrate stability for the claimed shelf life of six months. | Pass |
| Mechanical robustness of device | NA (Internal standards) | Device must meet mechanical specification per internal standards. | Pass |
| General, visual, dimensional and electrical verification of instrument | NA (Internal standards) | Device must meet dimensional, electrical, and physical specifications per internal standards. | Pass |
| Visual field clearing (surgical smoke removal) | NA (Internal standards) | Device must meet performance specifications per the internal standards. | Pass |
| Electrical bench tests | NA (Internal standards) | Device must meet electrical performance and safety specifications per the internal standards. | Pass |
| Assessment of thermal depth of margin | NA | The thermal margin must be substantially equivalent to the predicate device in terms of its potential for tissue damage | Pass |
| Design validation under simulated use conditions | NA | Device must achieve its intended use when used by end users and that performance is at least equivalent to the predicate device | Pass |
| Cytotoxicity | ISO 10993-5: 2009 | Under the condition of the test, the test article must be non-cytotoxic | Pass |
| Skin Irritation Study in Rabbits | ISO 10993-11: 2017 | Under the condition of the test, the test article must be non-irritating. | Pass |
| Systemic Toxicity in Mice | ISO 10993-10: 2021 | Under the condition of the test, the test article must not elicit evidence of systemic toxicity. | Pass |
| Guinea Pig Maximization Sensitization Test | ISO 10993-10: 2021 | Under the condition of the test, the test article must be non-sensitizing. | Pass |
| Hemolysis | ISO 10993-4: 2017 | Under the condition of the test, the test article must be non-hemolytic. | Pass |
| Material Mediated Pyrogens | USP General Chapter | Under the condition of the test, the test article must be non-pyrogenic | Pass |
2. Sample sized used for the test set and the data provenance:
- The document does not specify sample sizes for the various tests.
- Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned as the testing relates to the physical device and its biocompatibility/electrical safety, not clinical study data for AI.
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):
- This is not applicable as the device is not an AI/software device requiring expert interpretation of medical images or data. Ground truth for the described tests would be established by validated measurement techniques and laboratory protocols based on the specified ISO and ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for the type of testing described (bench testing, biocompatibility).
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. The device is a surgical instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biocompatibility tests, ground truth is established by the specific chemical and biological reactions/observations as defined by the ISO and USP standards (e.g., cell viability for cytotoxicity, skin reaction for irritation, hemolysis levels).
- For electrical safety and mechanical tests, ground truth is established by direct physical measurements against engineering specifications and international standards (IEC, EN, ASTM).
- For "Visual field clearing" and "Design validation under simulated use conditions," the ground truth is against internal performance specifications, aiming for equivalence to predicate devices, implying practical demonstration of effectiveness.
8. The sample size for the training set:
- Not applicable as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/machine learning device.
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