(41 days)
The LySonix Aspiration Pump System is for the suction or aspiration of fluids and tissue during surgical procedures. The device is designed to operate with the LySonix 2000 Ultrasonic Surgical System or as a stand-alone aspiration system.
The LySonix Aspiration Pump System is a stand-alone version of the aspiration component of the LySonix Ultrasonic Surgical System. The system is available as a tabletop unit or as part of an integrated Operative Workstation.
The provided text is a 510(k) summary for the LySonix Aspiration Pump System (K980454). This document primarily focuses on demonstrating substantial equivalence to a predicate device and outlines the intended use. It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical performance study for an AI/ML medical device would.
Therefore, many of the requested sections regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document, as they are not present.
Here's a breakdown of what can be inferred or directly stated from the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. This document does not detail specific acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy, precision) in the context of a performance study for the LySonix Aspiration Pump System. The primary "performance" discussed is its functional equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. No test set or data provenance is mentioned as there is no performance study described in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Cannot be provided. No ground truth establishment is mentioned as there is no performance study described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. No adjudication method is mentioned as there is no performance study described.
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
- Cannot be provided. This is a physical medical device (aspiration pump), not an AI/ML software device. Therefore, an MRMC study with human readers would not be applicable or expected.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm. However, the device can operate as a "stand-alone aspiration system" or with the LySonix 2000 Ultrasonic Surgical System, implying its functional independence. This is not "standalone performance" in the context of an AI algorithm evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No ground truth is mentioned as there is no performance study described.
8. The sample size for the training set
- Cannot be provided. No training set is mentioned as there is no AI/ML component or performance study described in this 510(k) summary.
9. How the ground truth for the training set was established
- Cannot be provided. No training set ground truth is mentioned.
Summary of what is present in the document:
This 510(k) summary focuses on demonstrating substantial equivalence to an existing predicate device rather than providing a detailed performance study with acceptance criteria and results.
- Device Name: LySonix Aspiration Pump System
- Intended Use: For the suction or aspiration of fluids and tissue during surgical procedures. It can operate with the LySonix 2000 Ultrasonic Surgical System or as a stand-alone aspiration system.
- Substantial Equivalence Claim: The LySonix Aspiration Pump System is equivalent to the aspiration component of the LySonix Ultrasonic Surgical System in terms of intended use, design, operating principles, materials, and performance.
- Regulatory Class: Class II
- Product Code: BTA and JCX
The document indicates that the FDA reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. This means that, for a device of this type (an aspiration pump), the performance demonstration relied on showing it functions comparably to an already approved device, rather than requiring a detailed clinical performance study with specific acceptance criteria as you might see for a diagnostic device or AI software.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.