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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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This system is designed to incise and coagulate soft tissue for laparoscopic and intraabdominal procedures in general surgery

The major components of this system are Generator, Handpiece, and accessories. This SonoSurg generator is supplied the electrical energy to transducer built-in handpiece. The electrical energy is exchanged mechanical energy by ultrasonic vibration at the transducer. The ultrasonic vibration is transferred to the tip of probe. In conjunction with the Generator, the body tissue is incised and coagulated with handpiece.

The provided text "K972114 Olympus SonoSurg System" is a 510(k) summary for a medical device and does not contain information about a study proving the device meets specific acceptance criteria in the way described in the prompt.

A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to prove device performance against predefined acceptance criteria. The document highlights the device's technical specifications and how it compares to existing devices, along with its compliance with voluntary safety standards.

Therefore, most of the information requested in your prompt is not available in this document.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly stated in the document. The submission focuses on demonstrating substantial equivalence to predicate devices, not on meeting specific, quantified performance acceptance criteria through a study.

2. Sample size used for the test set and the data provenance: Not applicable or not provided. This document does not describe a clinical study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not provided. This document does not describe a clinical study requiring expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not provided.

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. The Olympus SonoSurg System is an ultrasonic surgical system, not an AI diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable or not provided.

8. The sample size for the training set: Not applicable or not provided. This document does not suggest an AI or machine learning model that would require a training set.

9. How the ground truth for the training set was established: Not applicable or not provided.

Summary of what is available from the document regarding "acceptance" (in the context of a 510(k)):

The document states that the Olympus SonoSurg System is designed, manufactured, and tested in compliance with Voluntary Safety Standards (IEC 601-1 and IEC 601-1-2, as well as CISPR 11). This compliance, along with demonstrating substantial equivalence to predicate devices, is the primary "acceptance criteria" for a 510(k) submission rather than a performance study.

Conclusion:

The provided 510(k) summary for the Olympus SonoSurg System is a regulatory document focused on substantial equivalence. It does not contain the details of a performance study with acceptance criteria as envisioned in your prompt.

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