(152 days)
OLYMPUS Ultrasonic Surgical System has been designed to be used with the Olympus SonoSurg generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for laparoscopic and intrabdominal procedures in general (open) surgery. Also it has been designed to be used with them to cut and coagulate soft tissue for open and endoscopic procedures in ENT(Ears, Nose, Throat) surgery.
The Olympus Ultrasonic Surgical System is composed of three sections, (1), (2), and (3).
- (1) Olympus SonoSurg Scissors 5mm O.D. T3050" or "Olympus SonoSurg Long Hook 5mm O.D. T3060" or "Olympus SonoSurg Long Scissors 5mm O.D. T3070", or "Olympus SonoSurg Scissors 5mm O.D., HF Series.
- (2) Olympus SonoSurg Transducer SonoSurg-T2H.
- (3) Olympus SonoSurg Generator Set SonoSurg-G2 Set (SonoSurg-G2, MAJ-51).
This device is intended to cut and coagulate soft tissue for open and endoscopic procedures in ENT(Ears, Nose, Throat) surgery.
This document is a 510(k) summary for the Olympus Ultrasonic Surgical System. It's a premarket notification for a medical device seeking clearance from the FDA, asserting substantial equivalence to previously cleared devices.
Here's an analysis of the provided text in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the device's design and technological characteristics but does not explicitly state specific acceptance criteria (e.g., performance thresholds of a certain metric). Instead, it focuses on demonstrating that the device meets safety standards and operates on the same principles as its predicate devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety Standards Adherence | Designed, manufactured, and tested in compliance with Voluntary Safety Standards (IEC 60601-1, IEC60601-1-1, IEC60601-1-2). |
| Material Equivalence | No new patient-contacting materials introducing new risks. |
| Technological Equivalence (Theory of Operation) | Theory of operation (electrical energy to ultrasonic vibration for tissue cutting/coagulation) is the same as predicate devices. |
| Intended Use Equivalence | Intended use (cutting and coagulating soft tissue for open, endoscopic, laparoscopic, and intra-abdominal procedures in general and ENT surgery) is consistent with predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "When compared to the predicate devices, "Olympus Ultrasonic Surgical System" does not incorporate any significant changes that would effect safety or efficacy. Therefore clinical data is not necessary for its evaluation of safety."
This means:
- Sample size for the test set: Not applicable, as no external test set or clinical study was conducted for this 510(k) submission.
- Data provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable, as no clinical study or test set requiring expert ground truth was conducted for this 510(k) submission.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical study or test set requiring adjudication was conducted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The submission explicitly states that clinical data was not necessary due to substantial equivalence to predicate devices.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is a surgical instrument system, not an AI algorithm. Its performance is inherent to its physical design, materials, and operating principle, which are compared to existing, cleared devices.
7. Type of Ground Truth Used:
Not applicable. The "ground truth" in this context is the safety and efficacy established for the predicate devices through prior regulatory clearances and adherence to recognized safety standards. The new device demonstrates equivalence to this established performance.
8. Sample Size for the Training Set:
Not applicable, as this is a physical medical device and not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
In summary:
This 510(k) submission for the Olympus Ultrasonic Surgical System relies on demonstrating substantial equivalence to already cleared predicate devices. The core argument is that the device has the same intended use, similar technological characteristics, and adheres to the same safety standards, with no significant changes to safety or efficacy. Therefore, no new clinical studies, test sets, or ground truth establishment (as would be typical for a novel diagnostic or AI device) were deemed necessary by the submitter and subsequently agreed upon by the FDA for clearance.
N/A