(122 days)
The intended use of the Olympus USU is identical to the currently marketed CUSA® system 200 which was cleared for marketing in 510(k)#s K#910696 and K#921251.
Both systems are used for smashing and aspirating disease tissues in the Neuro surgery field.
The Olympus Ultrasonic System is indicated for use in the fragmentation, emulsification, and aspiration of soft tissue in the neurosurgery field.
The Olympus USU is specially designed for open procedure in the Neurosurgery field, in order to smash and aspirate disease tissue such as cerebral tumor, cerebral hematoma, cerebral aneurysm/varicosity.
Actuation mechanisms of the above systems is the same as the USU based as the following:
The small ultrasound vibration which is generated by the ultrasound actuator built-in hand piece, is transferred to the probe which is mounted on the edge of hand piece. The tissue is smashed by the shock force exchanged from the vibration on the probe with pushing to the tissue.
The smashed tissue is taken out by the suction space between the probe and sheath of hand piece.
The Olympus USU mainly is used in microscopic surgery.
This document is a 510(k) summary for the Olympus Ultrasonic Surgical System (USU) submitted in 1996. The device is for smashing and aspirating diseased tissues in neurosurgery.
Based on the provided text, a conventional acceptance criteria and study to prove the device meets these criteria as would be expected for a diagnostic AI device or similar classification, is not detailed. The document focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway.
Here's an analysis based on the information provided, highlighting the absence of typical acceptance criteria and study details for an AI-like device:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified directly in terms of performance metrics like sensitivity, specificity, accuracy, or F1-score. | The device's "performance" is implicitly tied to its substantial equivalence to predicate devices for its intended use of "fragmentation, emulsification, and aspiration of soft tissue in the neurosurgery field." |
Explanation: The 510(k) summary does not set forth specific performance metrics or thresholds that the Olympus USU must achieve. Instead, it argues that the device is "substantially equivalent" to already-marketed predicate devices. This means its safety and effectiveness are established by demonstrating that it has the same intended use and similar technological characteristics as a legally marketed device, or, if there are differences, that those differences do not raise new questions of safety and effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable/Not specified.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable/Not specified.
Explanation: The document does not describe a performance study with a test set of data (e.g., patient cases, images) to evaluate the device's accuracy or efficacy. The "study" described is a comparison against predicate devices, not an independent clinical trial using a defined test population.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Number of Experts: Not applicable/Not specified.
- Qualifications of Experts: Not applicable/Not specified.
Explanation: Since there isn't a stated test set or a process for establishing ground truth for performance evaluation in the typical sense, there's no mention of experts being used for this purpose.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
- Adjudication Method: Not applicable/Not specified.
Explanation: As there's no test set described for performance evaluation, adjudication methods are not relevant to this submission.
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:
- MRMC Study: No.
- Effect Size: Not applicable.
Explanation: This device is an ultrasonic surgical system, not an AI diagnostic tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Standalone Performance Study: No.
- Explanation: This device is a surgical instrument operated by a human, not an autonomous algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not applicable/Not specified.
- Explanation: The concept of "ground truth" for evaluating performance metrics of a diagnostic or AI device is not applied in this submission. The "truth" here relates to the established safety and effectiveness of the predicate devices based on their prior clearance and historical use.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable/Not specified.
Explanation: This device is not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Method for Establishing Ground Truth: Not applicable/Not specified.
Explanation: As there is no training set, this question is not relevant.
Summary of the Study that Proves the Device Meets Acceptance Criteria (based on the provided text):
The acceptance criteria for the Olympus USU, as presented in this 510(k) summary, are implicitly tied to demonstrating substantial equivalence to predicate devices. The "study" (or rather, the regulatory argument) is a comparison to existing, legally marketed ultrasonic surgical aspirators.
The document asserts that:
- The intended use of the Olympus USU is identical to the currently marketed CUSA® system 200 (Predicate K#910696 and K#921251). Both are used for "smashing and aspirating disease tissues in the Neuro surgery field."
- The actuation mechanisms of the Olympus USU and the predicate devices are the same, involving "small ultrasound vibration which is generated by the ultrasound actuator built-in hand piece, is transferred to the probe... The tissue is smashed by the shock force... The smashed tissue is taken out by the suction space..."
- The Olympus USU is designed, manufactured, and tested in compliance with Voluntary Safety Standards (IEC 601-1, 601-1-2, and CISPR 11).
- Compared to the predicate devices, the Olympus USU "does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness."
Therefore, the proof that the device meets its "acceptance criteria" (i.e., is safe and effective) is established by asserting its fundamental technological and intended use equivalence to devices already cleared by the FDA, combined with adherence to relevant safety standards. No new clinical performance data from a specific study is presented to establish novel performance metrics.
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