(92 days)
The Olympus SonoSurg System consists of the SonoSurg Generator (SonoSurg-G2 Set), SonoSurg Irrigation Unit (SonoSurg-IU), SonoSurg Transducers (SonoSurg-T2L-GE, SonoSurg-T2L-GE-C), and SonoSurg ultrasonic surgical instruments and surgical suction devices (T3000 Series). This system is intended to dissect, fragment, emulsify, and aspirate tissue for General Surgery, Laparoscopic Surgery, Plastic and Reconstructive Surgery, and Urological Surgery. This system may also be combined with electrosurgery using Olympus Model UES-20 or UES-30 Electrosurgical Units.
The Olympus SonoSurg System consists of the SonoSurg Generator (SonoSurg-G2 Set), SonoSurg Irrigation Unit (SonoSurg-IU), SonoSurg Transducers (SonoSurg-T2L-GE, SonoSurg-T2L-GE-C), and SonoSurg ultrasonic surgical instruments and surgical suction devices (T3000 Series). This system is intended to dissect, fragment, emulsify, and aspirate tissue for General Surgery, Laparoscopic Surgery, Plastic and Reconstructive Surgery, and Urological Surgery. This system may also be combined with electrosurgery using Olympus Model UES-20 or UES-30 Electrosurgical Units.
The provided text is a 510(k) summary for the Olympus SonoSurg System. It focuses on demonstrating substantial equivalence to predicate devices and does not describe a study with acceptance criteria and a detailed performance evaluation in the way a clinical trial or algorithm validation study would.
Instead, the document explicitly states:
"Therefore clinical data is not necessary for its evaluation of safety and efficacy."
This means that the manufacturer did not conduct a new study to prove the device meets specific acceptance criteria through performance metrics. The basis for acceptance is stated as substantial equivalence to legally marketed predicate devices, implying that if the new device is sufficiently similar to devices already deemed safe and effective, it can also be considered safe and effective.
Therefore, many of the requested details about acceptance criteria and study parameters cannot be extracted from this document, as such a study was not performed.
Here's what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as performance metrics. The implicit acceptance criterion is "substantial equivalence" to predicate devices. This is demonstrated by showing the device does not incorporate "any significant changes in the intended use, method of operation, material, or design that could affect safety and effectiveness."
- Reported Device Performance: Not reported in terms of specific clinical or technical performance metrics against a defined criterion. The document states that the device "has been designed and tested in compliance with voluntary safety standards," specifically IEC 60601-1, IEC 60601-1-1, and IEC 60601-2-2, and that patient-contacting materials conform to ISO 10993-1. These are compliance reports, not performance results in the context of diagnostic accuracy or clinical outcomes.
2. Sample size used for the test set and the data provenance: Not applicable. No test set or clinical study was performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth was established through expert review.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 device is a surgical system, not an AI-assisted diagnostic or interpretative tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth was established as no clinical study was performed.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
Summary of what is available from the document:
- Basis for Acceptance: Substantial Equivalence to predicate devices (Olympus Ultrasonic Surgical System #K021962, CUSA Excel Ultrasonic Surgical Aspirator System #K981262, SONOPET UST-2001 Ultra Surgical Aspirator #K010309, and Ultrasonic Surgical System #K962952).
- Proof of Equivalence: The device's design, intended use, method of operation, and materials were compared to these predicate devices.
- Safety and Effectiveness Justification: The manufacturer asserts that there are no significant changes in the new device compared to predicate devices that would affect safety and effectiveness, and therefore, clinical data is not necessary. The device also complies with voluntary safety standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-2-2) and material standards (ISO 10993-1).
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