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The PowerPump is a dual arthroscopic pump system intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures.

The PowerPump provides liquid irrigation and aspiration for arthroscopic procedures in one unit through two individual roller pumps. Both roller pumps are software controlled and automatically manage fluid and joint pressure based on procedure settings chosen by the user. If needed, both flow and pressure settings can be individually adjusted. By controlling both inflow and outflow, the PowerPump accurately regulates pressure and flow in the joint. The PowerPump also provides suction when used in conjunction with a shaver. The PowerPump consists of the following articles:

1. PowerPump Unit
2. Non-sterile Foot Control
3. Non-sterile Power Cord
4. Disposable, sterile Patient Cassette
5. Disposable, sterile Day Cassette
6. Disposable, sterile PowerPump Irrigation Tubing

The provided document is a 510(k) summary for the PowerPump® Arthroscopy System. It focuses on demonstrating substantial equivalence to predicate devices for its intended use as an arthroscopic pump. The document does not contain the detailed information typically found in a study demonstrating how a device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or similar quantitative assessments.

Therefore, most of the requested information cannot be extracted from this document, as it is primarily a regulatory filing for substantial equivalence, not a performance study report.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided directly. The document states, "Summary of Testing: The PowerPump has been tested for function, performance and safety. Test results show that all specifications have been met." However, it does not list the specific acceptance criteria (e.g., pressure regulation accuracy within X%, flow rate within Y%) or the reported device performance values against those criteria. It only provides a high-level statement that specifications were met.

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. The document does not describe a clinical or performance study with a 'test set' in the context of typical AI/diagnostic device evaluation. The assessment seems to be based on engineering and safety testing.

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)

• Not applicable / Cannot be provided. This information is relevant for studies where expert consensus or interpretation is used to establish ground truth, typically in image analysis or diagnostic device assessments. This document describes an arthroscopy pump, a mechanical and fluid management device, where "ground truth" for performance is established through direct measurement against engineering specifications rather than expert interpretation of data.

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

• Not applicable / Cannot be provided. This refers to consensus methods for expert decisions in diagnostic studies. It doesn't apply to the engineering and safety testing of a fluid management system.

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 type of study (MRMC, human-AI interaction) is specific to AI-powered diagnostic or assistive devices, particularly in image interpretation. The PowerPump is an arthroscopy pump and does not involve human readers or AI assistance in this context.

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

• Not applicable. This question is also specific to AI algorithms. The PowerPump's performance is inherently its standalone mechanical/fluid management function; there isn't a separate "algorithm only" performance to evaluate in this context.

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

• Cannot be explicitly determined, but inferred. For a device like an arthroscopy pump, "ground truth" for performance would likely be established through:
  • Engineering specifications and standards: e.g., pressure gauges demonstrating actual intra-articular pressure, flow meters measuring fluid delivery/aspiration rates.
  • Bench testing: In vitro models simulating joint cavities.
  • Safety standards compliance: Electrical safety, biocompatibility, etc.
    The document doesn't detail these, but these are the typical methods for such a device.

8. The sample size for the training set

• Not applicable / Cannot be provided. This refers to machine learning models. The PowerPump is not described as an AI/ML device requiring a training set.

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

• Not applicable / Cannot be provided. Same reason as above.

In summary, the provided 510(k) document is a regulatory filing focused on establishing substantial equivalence for an arthroscopy pump. It does not provide the details of a performance study in the way one would for an AI or diagnostic device, and therefore, most of the detailed questions cannot be answered from this text.

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