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The LySonix Suction Lipoplasty System is intended for use in aesthetic body contouring.

The LySonix Suction Lipoplasty System consists of an Aspiration Pump, Aspiration Cannulas, Sterile Tubing Set, Microbial Filter, Collection Canisters, and Canister Liners.

The provided text is a 510(k) summary for the LySonix Suction Lipoplasty System, indicating FDA clearance based on substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance, device description, and indications for use, without detailing specific performance metrics, clinical study designs, or acceptance criteria.

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The LySonix Lipoplasty Access Port is indicated for use as an access portal to the surgical site and to reduce trauma to the incision site caused by removal and re-entry of cannulas during lipoplasty procedures during aesthetic body contouring.

The LySonix Lipoplasty Access Port is an instrument access portal designed for use during lipoplasty procedures for aesthetic body contouring. The device is inserted into the incision site and threaded into place. Once in place, the device threads retain the device in place and allow for the insertion of the lipoplasty cannula. The Lipoplasty Access Portal is designed to be substantially equivalent to Endoscopic Access Devices intended to provide access for surgical instruments and to protect the incision site from trauma during repeated insertion of the cannula during surgical procedures.

The provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document is an FDA 510(k) clearance letter for the Lysonix Lipoplasty Access Port, indicating that the device is substantially equivalent to a predicate device already on the market. This type of clearance typically relies on demonstrating similarity to an existing device rather than presenting new clinical study data with specific performance metrics and acceptance criteria.

Therefore, I cannot provide the requested information based on the provided text.

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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.

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The LySonix Irrigation System is intended for delivery of fluids during general surgical procedures. The device is designed to operate with the LySonix 2000 Ultrasonic Surgical System or as a stand-alone irrigation system. The LySonix Irrigation System is not indicated for the administration of parenteral fluids, infusion of drugs or for any life sustaining purposes.

The LySonix Irrigation System is a stand-alone version of the irrigation 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 documents are a 510(k) summary and the FDA's clearance letter for the LySonix Irrigation System. These documents confirm that the device is substantially equivalent to a predicate device, but they do not contain the specific details required to answer your request about acceptance criteria and a study proving device performance.

Here's why and what information is missing:

• 510(k) Summary Purpose: A 510(k) summary primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This often involves comparing intended use, technological characteristics, and performance data from studies (if applicable) to show that the new device is as safe and effective as the predicate. It does not typically include detailed reports of individual studies, their methodologies, acceptance criteria, or ground truth establishment.
• Missing Information: The documents do not include:
  • A table of acceptance criteria.
  • Specific reported device performance against such criteria.
  • Details about a study's sample size for a test set, data provenance, number or qualifications of experts, adjudication methods.
  • Information about MRMC comparative effectiveness studies or standalone algorithm performance.
  • The type of ground truth used, training set size, or how ground truth for the training set was established.

What the document does state regarding performance, but without the requested detail:

• Substantial Equivalence: The key "proof" in a 510(k) submission like this is the demonstration of substantial equivalence. The document states: "The LySonix Irrigation System is equivalent to the irrigation component of the LySonix Ultrasonic Surgical System in terms of intended use, design, operating principles, materials and performance." (Page 0)
• This statement implies that the performance of the LySonix Irrigation System was assessed and found to be on par with its predicate, but it doesn't describe how that performance was assessed, what specific metrics were used, or what acceptance criteria were applied in any study.

To answer your request comprehensively, one would need access to the full 510(k) submission, which would contain detailed testing protocols, results, and analyses. The summary provided here is a high-level overview for public disclosure, not the full technical report.

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The LySonix Cannulas are instruments used for suction of fluids and tissue and for infusion of fluids during a variety of surgical procedures.

The LySonix Suction/Aspiration and Infusion Cannulas are hollow stainless steel tubes, with a blunt, bullet, or spatula-shaped tip. The cannulas are provided with an attached handle. The Suction and Infusion Cannulas are each available in three cannula lengths and four diameters. The LySonix Suction/Aspiration and Infusion Cannulas will be provided non-sterile.

The provided document is a 510(k) summary for the LySonix Suction/Aspiration and Infusion Cannulas. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance data for the device itself.

Therefore, many of the requested sections (e.g., acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission.

The core of this 510(k) is to show that the new device has the same technological characteristics and intended use as legally marketed predicate devices, implying that it would perform similarly and thus be as safe and effective. It does not contain a study designed to quantify the performance of the device against predefined acceptance criteria in the way one might find for a diagnostic or AI device.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The 510(k) process for this type of device relies heavily on substantial equivalence to existing devices, rather than establishing new performance metrics. Performance is assumed to be acceptable if it matches that of the legally marketed predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

• Not Applicable / Not Provided: This 510(k) summary does not describe a performance study with a test set of data in the context of diagnostic or AI device evaluation. The assessment is based on a comparison of design, materials, and intended use to predicate devices. There is no "test set" of patient data in this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not Applicable / Not Provided: There was no "ground truth" derived from expert review of a test set, as this device submission does not involve a diagnostic or AI algorithm requiring such validation.

4. Adjudication Method for the Test Set

• Not Applicable / Not Provided: No test set or expert adjudication was performed for this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No: This document does not describe an MRMC study. This type of study is typically conducted for diagnostic devices (especially imaging-based AI) to assess the impact of the device on human reader performance. This product is a surgical tool, not a diagnostic device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable: This product is a physical surgical instrument (cannulas), not an algorithm or AI. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

• Not Applicable: For this type of medical tool that is claiming substantial equivalence, the "ground truth" is effectively the established safety and effectiveness profile of the predicate devices. There is no specific outcome data, pathology, or expert consensus used as ground truth for a new performance claim, as no new performance claim is being made.

8. The Sample Size for the Training Set

• Not Applicable / Not Provided: This submission does not involve a machine learning or AI model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

• Not Applicable / Not Provided: As there is no training set, this question is not relevant.

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