(92 days)
Series 3 LOTUS shear & hook are 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, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint).
The SRA Developments Series 3 LOTUS Laparoscopic Ultrasound Surgery System consists of the power module which generates the ultrasonic energy and provides overall control of the device, the reusable part of the handset; and the disposable part of the handset. The Series 3 LOTUS system employs torsional mode ultrasound at 35-40kHz to cut and coagulate soft tissue during laparoscopic or open surgery.
The provided text describes the Series 3 LOTUS Laparoscopic Ultrasound Surgery System (K063531). However, the document is a 510(k) summary and not a detailed study report. Therefore, it discusses testing performed but does not provide specific acceptance criteria or the detailed results of a study designed to prove the device meets those criteria in the format requested.
Here's a breakdown of what can be extracted and what information is missing based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The 510(k) summary states that "Performance testing was carried out for some characteristics. The data from this testing was available and was presented in this 510(k)." but it does not detail:
- Specific quantitative acceptance criteria (e.g., "device must achieve X % reduction in bleeding").
- The exact results of the performance tests against such criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions three types of testing:
- Animal study: "Performance testing was carried out in an animal study in Portugal".
- Ex-vivo testing: "Ex-vivo testing was also completed both in Portugal and the UK".
- User trials: "User trials were undertaken at a number of UK hospitals."
However, the sample sizes for any of these test sets are not specified. The data provenance states Portugal and the UK, but it does not specify if the studies were retrospective or prospective, though animal and ex-vivo studies are typically prospective. User trials would also typically be prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The document makes no mention of "ground truth" or the use of experts in establishing it for any of the performance tests.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided. Such a study would typically involve human readers interpreting images or data, which is not the primary function of this surgical instrument. The user trials might involve clinicians' feedback on device performance, but not in an MRMC comparative effectiveness study context as typically understood for diagnostic AI.
6. Standalone Performance
The device itself is a surgical instrument (ultrasound shear & hook), not primarily a diagnostic algorithm. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not directly applicable in the same way as it would be for an AI diagnostic device. The performance tests described (animal, ex-vivo, user trials) inherently test the device's function directly.
7. Type of Ground Truth Used
This information is not explicitly provided. Since it's a surgical instrument, the 'ground truth' in performance testing would likely relate to objective measures of tissue cutting, coagulation, thermal injury, and functional outcome in the animal and ex-vivo studies. For user trials, it would be subjective feedback from surgeons. The document does not specify how these outcomes were definitively assessed or by whom.
8. Sample Size for the Training Set
This device is a physical surgical instrument and not an AI algorithm that undergoes "training" in the computational sense. Therefore, the concept of a "training set" and its sample size is not applicable.
9. How the Ground Truth for the Training Set Was Established
As above, this concept is not applicable to this device.
Summary of available information regarding testing:
While specific acceptance criteria and detailed study results are absent, the document indicates that the following testing was performed to support the device's substantial equivalence:
- Electromagnetic compatibility testing: Successfully carried out to EN 60601-1-2 and FCC Part 18.
- Electrical safety testing: Carried out in-house to EN 60601-1, with plans for UL60601-1 testing before US marketing.
- Biocompatibility issues: Covered by the predicate device's application (K032424).
- Performance testing:
- Animal study in Portugal (results included in Exhibit 21 of the 510(k)).
- Ex-vivo testing in Portugal and the UK (results included in Exhibit 21).
- User trials in a number of UK hospitals (summary included as Exhibit 22).
The 510(k) concludes that based on this testing, the device demonstrates substantial equivalence to predicate devices, implying that its performance is comparable and acceptable for its intended use.
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