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1. Indications for Use of SonoSurg Trocar

This instrument has been designed to be used with the SonoSurg generator (SonoSurg-G2) and is inserted into the body cavity wall by means of ultrasonic waves under endoscopic surgery in order to coagulate and cut soft tissue as well as to place a trocar tube within the body cavity wall.

2. Indications for Use of SonoSurg G-2 Set

This instrument has been designed to be used with the SonoSurg transducers and the SonoSurg ultrasonic surgical instruments for soft tissue cutting and coagulation for laparoscopic and general (open) surgery in intraabdominal and obstetric/gynecologic procedures, and endoscopic and general surgery in ENT (Ears, Nose, Throat), thoracic, and urologic procedures.

This instrument may also be combined with the SonoSurg Irrigation Unit (SonoSurg-IU). Please refer to the SonoSurg-IU instruction manual to review the intended use of this combined system.

This instrument may also be combined with the SonoSurg Trocar. Please refer to the SonoSurg Trocar instruction manual to review the intended use of this combined system.

The SonoSurg Trocar is an Ultrasonic trocar for endoscopic surgery which enable the puncture and cutting of the abdominal wall with tissue coagulation by means of ultrasonic vibration. SonoSurg Trocar is composed of two sections, the SonoSurg Trocar and the Olympus SonoSurg Generator SonoSurg-G2.

The SonoSurg Trocar is composed of a trocar transducer, dilator, valve, trocar tube, insertion sheath, probe, and Olympus SonoSurg Generator SonoSurg-G2, which provides ultrasonic vibration to the SonoSurg Trocar.

This document is a 510(k) Pre-market Notification for a medical device called the "SonoSurg Trocar." It's essentially a request to the FDA to market a new device by demonstrating its substantial equivalence to a device already legally on the market.

Crucially, this type of submission (510(k)) generally does NOT include new clinical studies or detailed performance data to establish acceptance criteria for the new device itself. Instead, it relies on demonstrating that the new device is as safe and effective as a legally marketed "predicate device."

Therefore, the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for this specific submission will be largely absent because it's inherent to the 510(k) pathway that such detailed, de novo clinical studies are typically not performed or required.

Here's how to address your request based on the provided document:

Acceptance Criteria and Study for SonoSurg Trocar (K042160)

This 510(k) submission for the SonoSurg Trocar does not present new acceptance criteria or a dedicated study to prove the device meets such criteria in the way you've outlined. Instead, the submission demonstrates "substantial equivalence" to a predicate device already on the market. The implied "acceptance criteria" here are that the new device performs comparably to the predicate device and does not raise new questions of safety or effectiveness.

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)

• Not applicable. This submission did not involve a test set for clinical performance evaluation as part of a de novo study. The FDA determined substantial equivalence based on a comparison to the predicate device's established safety and effectiveness. The biocompatibility testing likely involved standard laboratory samples, not a clinical "test set" in the context of device performance.

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. No ground truth establishment by experts for a test set was described in this 510(k) summary.

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

• Not applicable. No adjudication method for a test set was described.

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. This document describes a surgical instrument, not an AI-assisted diagnostic device. No MRMC study was performed or described.

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

• Not applicable. This device is a surgical instrument. "Standalone algorithm performance" is not relevant.

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

• Not applicable in the context of a new clinical performance study. The "ground truth" for this 510(k) submission is implicitly the established safety and effectiveness of the predicate device (SonoSurg Trocar XT3900, K000095, and Olympus SonoSurg System, K021962/K031305/K031523/K031710). The submission argues that the new device is comparable to this established safe and effective predicate.

8. The sample size for the training set

• Not applicable. This submission does not describe an AI/ML-based device requiring a training set.

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

• Not applicable. This submission does not describe an AI/ML-based device requiring a training set.

Summary of the 510(k) Approach for the SonoSurg Trocar:

The core of this submission is the claim of "substantial equivalence" to existing predicate devices.

• Rationale for not requiring clinical data: "When compared to the predicate device, the SonoSurg Trocar does not incorporate any significant change that impacts safety and efficacy in comparison to the predicate device. Therefore, clinical data is not necessary to establish the subject device."
• Demonstration of Equivalence:
  • Intended Use: The intended uses of the SonoSurg Trocar system are presented and are consistent with the predicate.
  • Technological Characteristics: The theory of operation is stated to be equivalent to the predicate device.
  • Design and Materials: Compliance with voluntary safety standards (IEC 60601 series) for the generator and biocompatibility testing for non-identical patient-contacting materials (ISO 10993-1) are referenced.
  • Predicate Device: Clearly identifies the Olympus SonoSurg Trocar XT3900 (K000095) and the Olympus SonoSurg System (multiple 510(k)s) as predicate devices.

In essence, the "study" for this device was a comparison against established, already-cleared devices, rather than a novel clinical trial with specific performance endpoints.

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