(42 days)
The AUTO SUTURE* ultrasonic hand instruments have application in abdominal, pediatric, gynecologic, thoracic, urologic and general open and endoscopic procedures for the transection, dissection and coagulation of tissue(s). The instrument is available with a hook probe, with a shear and with a ball probe.
The subject instruments consists of three endoscopic hand instruments which connected by an acoustic transducer to a generator. The hand instruments consist of an ultrasonic shear, ultrasonic hook probe and ultrasonic ball probe.
The provided text is a 510(k) Premarket Notification for a medical device and therefore does not contain the detailed study information typically found in a clinical trial report or a performance study to assess acceptance criteria. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies against pre-defined acceptance criteria for a novel technology.
However, I can extract the information provided and note where details are missing based on your request.
1. A table of acceptance criteria and the reported device performance
Based on the provided 510(k) summary, explicit acceptance criteria and corresponding reported device performance against those criteria are not available. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (Ethicon Ultracision ultrasonic hand instruments, K961104). The "device description" and "intended use" sections describe the device's function, but no quantitative performance metrics or acceptance thresholds are listed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document does not describe any specific test set or data provenance from a performance study.
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 information is not provided in the 510(k) summary. Given that it's a 510(k) for an ultrasonic surgical instrument, the "ground truth" would likely relate to objective measurements of tissue transection, dissection, and coagulation capabilities, rather than expert interpretation of images. However, no such studies are detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the 510(k) summary.
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 is not mentioned and is not applicable to this type of device (an ultrasonic surgical instrument for transection, dissection, and coagulation of tissue). This type of study is typically used for diagnostic devices involving human interpretation of data, often with AI assistance, which is not the function of this surgical tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the AUTO SUTURE* Ultrasonic Hand Instrument system. This is a physical surgical tool operated by a human, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the 510(k) summary. For a surgical instrument, "ground truth" related to its performance would likely involve objective measures of tissue effect (e.g., precise cutting, effective coagulation, minimal thermal spread), which would typically be assessed in preclinical (e.g., animal or benchtop) studies. However, the details of such studies are not included in this summary.
8. The sample size for the training set
This information is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
In summary, the provided 510(k) Premarket Notification primarily serves to demonstrate substantial equivalence to a predicate device rather than detailing comprehensive performance studies with explicit acceptance criteria, sample sizes, expert involvement, or adjudication methods as requested. These types of detailed studies would likely have been performed during the development and verification/validation phases but are not included in this summary document.
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