(88 days)
The Olympus Ultrasonic 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 thoracic 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 thoracic surgery.
The provided document is a 510(k) summary for the Olympus Ultrasonic Surgical System. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data from extensive clinical studies with acceptance criteria in the manner typically seen for novel medical devices or software.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth procedures, and MRMC studies for device performance is largely not applicable in this context.
Here's why and what information can be extracted or inferred:
- No explicit acceptance criteria for device performance are listed. The submission relies on demonstrating that the device meets existing safety standards and has technological characteristics "the same as the Predicate Devices."
- No clinical study demonstrating the device meets acceptance criteria is presented. 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 is not an AI/Software as a Medical Device (SaMD) submission. Therefore, questions related to AI performance metrics (like MRMC studies, standalone algorithm performance, training/test set details, ground truth establishment for AI) are irrelevant.
However, I can provide a table based on the safety standards the device complies with, which function as "acceptance criteria" for the device's design and manufacture.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Safety/Design Standards) | Reported Device Performance (Compliance) |
|---|---|
| IEC 60601-1 (General Requirements for Basic Safety and Essential Performance) | Device designed, manufactured, and tested in compliance. Meets requirements. |
| IEC 60601-1-1 (Collateral Standard: Safety Requirements for Medical Electrical Systems) | Device designed, manufactured, and tested in compliance. Meets requirements. |
| IEC 60601-1-2 (Collateral Standard: Electromagnetic Compatibility) | Device designed, manufactured, and tested in compliance. Meets requirements. |
2. Sample size used for the test set and the data provenance
Not applicable. This is not a study requiring a test set of data. The device's safety and efficacy are established through comparison to predicate devices and compliance with recognized consensus standards for design and manufacturing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There was no test set requiring expert ground truth for device performance evaluation in this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication was presented.
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 is not an AI/SaMD device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/SaMD device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this type of device and submission, "ground truth" relates to compliance with safety standards and functional equivalence to predicate devices, rather than diagnostic accuracy or patient outcomes.
8. The sample size for the training set
Not applicable. This is not an AI/SaMD device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/SaMD device.
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