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The Ultrasonic Generator (USG-400) is intended to be used with the Electrosurgical Generator (ESG-400), the THUNDERBEAT Transducer (TD-TB400), the SONICBEAT Transducer (TD-SB400), the THUNDERBEAT, and / or the SONICBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.

The Ultrasonic Generator USG-400 Ver 2 is intended to be used with the Electrosurgical Generator ESG-400, the THUNDERBEAT Transducer TD-TB400, the SONICBEAT Transducer TD-SB400, the THUNDERBEAT hand instruments, and / or the SONICBEAT hand instruments.

It is an ultrasonic generator capable of vessel sealing & cutting, tissue coagulating & cutting, grasping, and dissecting.

The provided text describes the regulatory clearance (K172691) for the Olympus Medical Systems Corp. Ultrasonic Generator USG-400 (Ver 2). However, it does not contain acceptance criteria for device performance or a study that proves the device meets specific performance criteria related to diagnostic accuracy or clinical outcomes.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (USG-400 Ver 1) based on similar technological characteristics and non-clinical testing.

Here's an analysis of the requested information based on the provided text, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not specified for ex-vivo or animal testing. The text only mentions "porcine blood vessels" and "porcine mesentery" for ex-vivo tests, and "porcine animal models" for the acute animal study, without quantitative sample sizes.
• Data provenance: For ex-vivo and animal testing, the data origin is implied to be laboratory/animal study data, not human clinical data. The country of origin for the studies is not explicitly stated, but the manufacturer (Olympus Medical Systems Corp.) and the testing sites might be in Japan (where the manufacturer is located) or elsewhere. The studies are prospective in nature as they involve controlled experiments.

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)

• Not applicable. The "ground truth" here refers to objective measurements in in-vitro and animal models (e.g., burst pressure, cutting time, thermal spread). These are assessed directly through experimental methods, not by expert interpretation like in diagnostic accuracy studies. Therefore, no experts were used to establish ground truth in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. As noted above, the testing involves objective measurements in laboratory and animal settings, not subjective human assessment requiring adjudication.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an ultrasonic generator, not an AI-powered diagnostic or assistive tool for human readers.
• The document explicitly states: "Clinical testing using the proposed device was not conducted."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable in the context of an AI algorithm. The device itself is an "Ultrasonic Generator" for surgical procedures. The performance evaluated was the direct performance of the device's functional outputs (sealing, cutting, safety) using its hardware and embedded software. This is inherently a "standalone" or "algorithm only" performance for the device's operational capabilities, but not in the sense of a standalone AI algorithm interpreting data.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The ground truth for the non-clinical tests was established through direct objective measurement in controlled laboratory (ex-vivo) and animal (in-vivo acute) settings. Examples include:
  • Ex-vivo Vessel Burst Pressure: Direct measurement of the pressure required to burst a sealed vessel.
  • Ex-vivo Cutting Performance: Direct measurement of cutting time.
  • Acute Animal Study: Direct observation and measurement of seal maintenance rates, thermal spread, and degree of degeneration in animal tissues.

8. The sample size for the training set

• Not applicable. The document describes a medical device (ultrasonic generator), not a machine learning model that requires a "training set" of data for algorithm development. Any internal development and testing would have used engineering and performance data, but it's not referred to as a "training set" in a machine learning sense.

9. How the ground truth for the training set was established

• Not applicable, as there is no "training set" in the machine learning context.

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