(243 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 open and endoscopic procedures in general surgery. Also it has been designed to be used with them to cut and coagulate soft tissue for obstetric/gynecologic surgery, and for open and laparoscopic 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 obstetric/ gynecologic surgery, and for open and laparoscopic surgery.
This 510(k) summary for the Olympus Ultrasonic Surgical System (K021962) explicitly states that clinical data was not required for its evaluation of safety and efficacy.
Therefore, the study that proves the device meets acceptance criteria, and many of the associated details you requested, are not provided in this document. The decision was based on a finding of "substantial equivalence" to predicate devices, implying that the new device does not incorporate any significant changes that would affect safety or efficacy when compared to existing, legally marketed devices.
Here's a breakdown of what can be extracted from the provided text according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable/Not provided. The document 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."
The "acceptance criteria" are implied to be the standards met by the predicate devices and the voluntary safety standards the new device complies with.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meets requirements of IEC 60601-1, IEC60601-1-1, IEC60601-1-2. | Designed, manufactured, and tested in compliance. Meets requirements. |
| Substantially equivalent to predicate devices (#K002981, #K972114, #K990430, #K000095) in terms of safety and efficacy. | Demonstrated substantial equivalence through comparison. Does not incorporate significant changes affecting safety or efficacy. |
| No new patient-contacting materials. | Confirmed. |
| Functions to cut and coagulate soft tissue by ultrasonic vibration. | Theory of operation is consistent with predicate devices. Functions as intended. |
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. No clinical test set was used. The substantial equivalence determination was based on design, materials, and functional characteristics compared to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No clinical test set or ground truth established by experts was used.
4. Adjudication method for the test set
Not applicable/Not provided. No clinical test set.
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/Not provided. This device is an ultrasonic surgical system, not an AI-assisted diagnostic or interpretative tool that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. This is a surgical device, not an algorithm.
7. The type of ground truth used
Not applicable/Not provided. No clinical ground truth was established as no clinical study was performed. The "ground truth" for the device's acceptable performance is its substantial equivalence to previously cleared devices and compliance with relevant safety standards.
8. The sample size for the training set
Not applicable/Not provided. No AI/machine learning model, therefore no training set.
9. How the ground truth for the training set was established
Not applicable/Not provided. No AI/machine learning model, therefore no training set or ground truth for it.
In summary: The Olympus Ultrasonic Surgical System (K021962) received 510(k) clearance based on its substantial equivalence to existing predicate devices and adherence to recognized safety standards (IEC 60601 series). No specific clinical study or data related to acceptance criteria, test sets, or expert-established ground truth was required or performed for this premarket notification.
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