(133 days)
The LOTUS Laproscopic Ultrasound Surgery System is indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important, LOTUS may be used as an adjunct to or substitute for electrosurgery, laser surgery, and traditional scalpels in general, gynecologic, and thoracic surgery.
The LOTUS (Laparosopic Operation by Torsional UltraSound) system consists of the power module, the reusable part of the handset, and the disposable part of the handset. The Lotus system employs torsional mode ultrasound at 36 kHz to cut and coagulate soft tissue during laparoscopic or open surgery.
Here's an analysis of the provided text regarding the LOTUS Laparoscopic Ultrasound Surgery System (K032424) and the requested information about its acceptance criteria and supporting studies.
Based on the provided documents, comprehensive details about specific acceptance criteria and a structured study proving it are largely absent. The submission primarily focuses on demonstrating substantial equivalence to predicate devices through general performance testing rather than against pre-defined quantitative acceptance criteria.
However, I will extract what can be inferred and explicitly stated from the text.
1. Table of Acceptance Criteria and Reported Device Performance
As specific quantitative acceptance criteria are not explicitly stated, this table will reflect the general areas of performance testing mentioned and the outcome reported.
| Acceptance Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|
| Electrical Safety Standard Compliance | Successfully carried out |
| Electromagnetic Compatibility Standard Compliance | Successfully carried out |
| Biocompatibility | Conducted on some patient-contacting parts of the system; results not detailed but implied to meet requirements. |
| Performance in Animal Model | Confirmed |
| Performance in Experiential Clinical Study | Confirmed |
| Ability to cut and coagulate soft tissue (functional equivalence) | Demonstrated equivalence to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided documents. The text mentions "an animal model" and "an experiential clinical study" and "performance testing," but no numbers are given for the number of animals or human subjects, nor the number of cases or procedures performed.
- Data Provenance:
- Country of Origin: Not explicitly stated, but the company (SRA Developments Ltd) is located in Ashburton, Devon, UK, suggesting the studies could have taken place there or in another undisclosed location.
- Retrospective or Prospective: Not specified. Animal studies are typically prospective, and "experiential clinical study" could be prospective, but no details are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The nature of the device (surgical tool) implies evaluation by surgeons or clinical specialists, but this is an inference, not an explicit statement.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. Given the type of device and testing (surgical performance), it's highly likely that direct observation and assessment by the surgical team or researchers were used, but no formal adjudication process like 2+1 or 3+1 is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted or reported. This type of study is more common for diagnostic imaging devices where multiple readers interpret cases. The LOTUS device is a surgical instrument.
- Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as this is not an AI-assisted diagnostic device, and no MRMC study was performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. The LOTUS device is a physical surgical tool that requires human operation. It does not have a standalone algorithmic component that can be evaluated without human interaction.
7. The Type of Ground Truth Used
- Ground Truth: The "ground truth" for performance seems to be based on direct observation of surgical outcomes in animal models and experiential clinical studies. This would likely include:
- Assessment of tissue cutting efficacy.
- Assessment of coagulation effectiveness (hemostasis).
- Evaluation of minimal thermal injury.
- Comparison of these outcomes with predicate devices.
- Biocompatibility testing provided "ground truth" on material safety.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The LOTUS device is a physical surgical instrument, not an AI/ML algorithm that requires a training set. There is no mention of any AI or machine learning components.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this device.
Summary of Device Performance as Reported in the Study
The provided 510(k) summary (K032424) indicates that the LOTUS Laparoscopic Ultrasound Surgery System underwent several types of testing to demonstrate its substantial equivalence to predicate devices:
- Electrical Safety and Electromagnetic Compatibility: "Successfully carried out." This implies compliance with relevant standards.
- Biocompatibility: "Conducted on some patient-contacting parts of the system." The conclusion of substantial equivalence implies these tests were successful.
- Performance Testing:
- "Performance testing in an animal model was conducted."
- "Performance was confirmed in an experiential clinical study."
- The combined results from this performance testing "demonstrate equivalence" to the predicate devices in terms of its ability to cut and coagulate soft tissue, with considerations for bleeding control and minimal thermal injury. The key difference noted is its torsional mode of operation compared to the predicate's longitudinal mode, but this difference was shown not to impact equivalence negatively.
The overall conclusion is that "The data do, in fact, demonstrate equivalence," supporting the substantial equivalence claim.
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