(79 days)
The SoundVASER System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired: Neurosurgery, Gastrointestinal and Affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, and Laparoscopic Surgery.
The SoundVASER System is comprised of an ultrasonic generator (110/120 and 220/240 VAC, 50 & 60 Hz), an ultrasonic surgical handpiece with an ultrasonic surgical probe, and a suction/irrigation subsystem. The ultrasonic surgical handpiece converts electrical energy supplied by the ultrasonic generator into vibratory motion. The vibratory motion is applied to the ultrasonic surgical probe that is attached to the ultrasonic surgical handpiece. The vibratory motion at the tip of the ultrasonic surgical probe fragments and emulsifies contacted soft tissues. The suction/irrigation subsystem is used to remove the fragmented tissues. The suction and irrigation functions may be performed simultaneously or independently.
The provided document is a 510(k) summary for the SoundVASER System, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a detailed study. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth is not present in this document.
Here's an analysis based on the information available in the provided text:
Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Explanation: This 510(k) summary does not define specific performance acceptance criteria for the SoundVASER System. The focus of the submission is to demonstrate "substantial equivalence" to existing predicate devices, implying that if it is equivalent, it implicitly meets the safety and effectiveness standards of those devices. No quantitative performance metrics are provided.
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No specific test set or study data is presented for performance evaluation.
- Data Provenance: Not applicable. No study data is provided.
3. Number of Experts and Qualifications for Establishing Ground Truth (Test Set)
- Number of Experts: Not applicable. No test set requiring expert ground truth is mentioned.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable. No test set or expert evaluation requiring adjudication is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done?: No. This document does not describe an MRMC study.
- Effect Size: Not applicable.
6. Standalone Performance Study (Algorithm Only)
- Standalone Study Done?: No. The SoundVASER System is a surgical instrument, not an AI algorithm. Its performance is related to its mechanical and ultrasonic properties, not an algorithm's standalone accuracy.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable. The document does not describe a study involving ground truth. The substantial equivalence argument relies on the inherent characteristics of the device and its similarity to already-approved devices, rather than a comparison to a "ground truth" derived from patient data or expert consensus.
8. Sample Size for Training Set
- Sample Size for Training Set: Not applicable. The SoundVASER System is a physical medical device, not an AI model that requires a training set.
9. How Ground Truth for Training Set Was Established
- How Established: Not applicable.
Summary from the Document:
The 510(k) summary for the SoundVASER System primarily aims to demonstrate substantial equivalence to predicate devices (Valleylab Inc., CUSA Excel Ultrasonic Surgical Aspirator System and CUSA Lap Accessory). It achieves this by highlighting:
- Similar Technical Design and Operation: The device is described as an ultrasonic generator, surgical handpiece with a probe, and a suction/irrigation subsystem, similar to existing devices.
- Similar Intended Use: Fragmentation, emulsification, and aspiration of soft tissue in various surgical specialties (Neurosurgery, Gastrointestinal, Urological, Plastic/Reconstructive, General, Orthopedic, Gynecological, Thoracic, and Laparoscopic Surgery).
- Similar Technological Characteristics: Design, operation, materials, methods of sterilization, and intended use are stated to be similar, leading to the conclusion that "no new safety or efficacy issues are created."
Conclusion:
This 510(k) submission is a regulatory document focused on proving equivalence rather than a detailed scientific study with defined acceptance criteria and performance metrics. It does not contain the information required to populate the requested table or answer most of the detailed questions about study design, sample sizes, expert involvement, or ground truth.
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