Search Results

The HydraSolve™ Lipoplasty System is intended to be used for liquefaction and aspiration of localized subcutaneous fatty deposits for the purpose of aesthetic body contouring. The HydraSolve™ Lipoplasty System is Indicated for use in aesthetic body contouring.

The Andrew Technologies HydraSolve™ Lipoplasty System is a liposuction system used to perform body contouring. It is designed to perform selective tissue extraction through a cannula that utilizes pressurized, heated, and pulsed saline solution in addition to suction.

The device includes the HydraSolve™ Console which contains within its durable case. a user interface, controller, power supply, and Phaser™ energy transfer systems (both heat and pressure). The system also includes a tumescent infusion component which is compatible with commercial off-the-shelf (COTS) tumescent cannulae and tubing. The device also includes the Sterile Treatment Kit consisting of a pumping mechanism, heat exchanger and tubing and a reusable limited-use handpiece with integral cannula. The device interfaces with COTS waste canisters and suction tubing.

The provided text is a 510(k) summary for the Andrew Technologies HydraSolve™ Lipoplasty System. It is focused on demonstrating substantial equivalence to a predicate device based on non-clinical testing. Therefore, it does not contain the detailed information required to answer all parts of your request regarding acceptance criteria and a study proving device performance in the context of an AI/ML device.

Specifically, the document states: "Non-clinical test data was used to support the decision of safety and effectiveness. Clinical testing was not necessary. Non-clinical testing consisted of performance testing of the new cannulae design." This indicates that the evaluation was for a physical medical device (a lipoplasty system and its cannulae), not an AI/ML device.

However, I can extract the information that is present and explain why other requested information is not available in this document.

Here's what can be addressed based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with specific metrics or reported device performance in a quantitative manner. It generally states that "Non-clinical test data was used to support the decision of safety and effectiveness. Non-clinical testing consisted of performance testing of the new cannulae design." Without specific performance metrics or criteria, a table cannot be constructed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "non-clinical test data" and "performance testing of the new cannulae design," but it does not specify sample sizes for these tests, nor the origin or nature (retrospective/prospective) of any data.

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)

This information is not applicable and not provided. The testing described is "non-clinical performance testing of the new cannulae design," which would typically involve engineering or laboratory tests, not expert interpretation or ground truth establishment in the context of diagnostic or prescriptive AI/ML.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. As mentioned above, the testing is non-clinical performance testing, not a study involving human adjudication of results.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically relevant for AI/ML devices where human readers (e.g., radiologists) interact with the AI. The HydraSolve™ Lipoplasty System is a physical medical device.

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

No, a standalone algorithm performance study was not done. The device is a physical lipoplasty system, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not applicable and not provided. "Ground truth" in this context usually refers to a confirmed diagnosis or condition used to evaluate an AI's accuracy. For performance testing of a physical device like a cannula, ground truth would relate to physical specifications (e.g., cannula bore diameter, material strength, fluid flow rates), which are not detailed here.

8. The sample size for the training set

This information is not applicable and not provided. There is no mention of a "training set" as the device is not an AI/ML system that requires training data.

9. How the ground truth for the training set was established

This information is not applicable and not provided for the same reasons as above.

In summary:

The provided 510(k) summary is for a physical medical device (HydraSolve™ Lipoplasty System) and discusses "non-clinical performance testing of the new cannulae design" to demonstrate substantial equivalence to a predicate device. It does not contain any information related to AI/ML device performance, acceptance criteria for AI algorithms, expert consensus, ground truth establishment, or human-in-the-loop studies that would be relevant to an AI/ML product. The request's questions are tailored for AI/ML device evaluations, which are not detailed in this document.

Ask a specific question about this device

The Dyonics InteliJET Reusable Cannulas are indicated for use with the InteliJET Fluid Management System during arthroscopic surgical procedures of the knee, shoulder and small joints to regulate flow of irrigation fluids through the joint to maintain intra-articular pressure for uniform distention and clear visualization of the surgical site.

The Dyonics InteliJET Reusable Cannulas are used to establish portals to the surgical site during arthroscopic surgical procedures. The Dyonics InteliJET Reusable Cannulas are designed to work in conjunction with the InteliJET Fluid Management System to maintain intra-articular pressure for uniform distention and clear visualization of the surgical site.

This document (K020947) is a 510(k) premarket notification for a medical device called the Dyonics InteliJET™ Reusable Cannulas. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical trial data with detailed acceptance criteria and performance metrics typically found in novel device approvals.

Based on the provided text, here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The submission does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., flow rate, pressure regulation with specific tolerances). Instead, the key "acceptance criterion" for this 510(k) appears to be demonstrating that a material modification to the existing Dyonics InteliJET Reusable Cannulas does not raise new issues of safety and effectiveness.

2. Sample size used for the test set and the data provenance

The document does not detail specific "test set" sample sizes or data provenance in the context of clinical studies. The assessment focuses on the material change.

• Sample Size: Not applicable in the context of clinical studies or test sets as described in the prompt. The assessment pertains to material properties and functional equivalence, likely involving laboratory testing of material samples.
• Data Provenance: Not applicable in the context of clinical studies. The biocompatibility standard (ISO 10993-1: 1997) is an international standard, indicating the testing methodologies would conform to these globally recognized guidelines.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. Expert review for clinical ground truth is not typically a requirement or component of a 510(k) submission for a material modification of an existing device. The "ground truth" here is compliance with material standards and functional equivalence, which would be assessed by engineers and toxicologists.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used in clinical trials where multiple readers interpret clinical data. This submission focuses on material and engineering equivalency.

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 is not an AI-assisted device, nor is it a comparative effectiveness study involving human readers. It is a re-submission for a material change to an existing cannula.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission revolves around:

• Biocompatibility Standards: Compliance with ISO 10993-1: 1997 for the new material. This standard itself defines the acceptable biological response of medical devices.
• Functional Equivalence: Engineering assessment and comparison to the predicate device's design and intended function.

There is no mention of clinical ground truth established by expert consensus, pathology, or outcomes data, as this is a material modification rather than a novel device requiring new clinical validation.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. There is no training set.

Ask a specific question about this device

Ask a specific question about this device

The Dyonics InteliJet Reusable Cannulas are indicated for use with the Dyonics InteliJet Fluid Management System during arthroscopic surgical procedures of the knee, shoulder and small joints to regulate flow of irrigation fluids through the joint to maintain intra-articular pressure for uniform distention and clear visualization of the surgical site.

The Dyonics InteliJet Reusable Cannulas are used to establish portals to the surgical site during arthroscopic surgical procedures. The Dyonics InteliJet Reusable Cannulas are designed to work in conjunction with the InteliJet Fluid Management System to maintain intra-articular pressure for uniform distention and clear visualization of the surgical site.

This submission is for a material change to an existing device, the Dyonics InteliJet Reusable Cannula. The 510(k) summary indicates that the change "has no impact on the designed safety and efficacy" of the device.

Here's an analysis of the provided information, noting what can be extracted and what is not available due to the nature of this particular 510(k) summary (which focuses on a material change to an already approved device rather than a de novo submission):

1. Table of Acceptance Criteria and Reported Device Performance

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

Specific sample sizes for the "biocompatibility and flow curve analysis" are not provided in this summary. The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this type of 510(k) submission. A material change primarily relies on engineering and scientific testing (biocompatibility, flow analysis) rather than clinical expert ground truth for medical image analysis or diagnostic performance. No experts were used in this context.

4. Adjudication Method

This information is not applicable. No expert adjudication was performed for this type of testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the focus of a material change submission for a cannula.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not done. This device is a mechanical cannula, not an algorithm, so this type of study isn't relevant.

7. Type of Ground Truth Used

The "ground truth" for this material change involved engineering and scientific measurements corresponding to the device's functional and safety characteristics. Specifically:

• Biocompatibility: Likely involved testing against relevant ISO standards to ensure the new material is not toxic or reactive.
• Flow Curve Analysis: Involved measuring fluid flow properties through the cannula to ensure it meets the original design specifications for maintaining intra-articular pressure and fluid delivery.

8. Sample Size for the Training Set

This information is not applicable. This is a hardware device, not an AI or machine learning algorithm, so there is no "training set."

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

This information is not applicable for the same reason as above.

Ask a specific question about this device