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The ARTHRO-Pump PA304 is an arthroscopic pump intended to provide fluid distension of knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid aspiration during diagnostic and operative arthroscopic procedures.

The ARTHRO-Pump PA304 is a microprocessor controlled single roller pump that functions according to the peristaltic principle. It transports sterile irrigation fluid to distend cavities and provides fluid aspiration for arthroscopic procedures. The pump consists of the following main components: a power supply, a power switch, a touch display, a connection for the suction function, a roller wheel, a pump head and a casing. The pump has to be used with the following tube sets:

• . Standard Irrigation Tube Set (also referred to as "ST261")
• . Suction Tube Set (one connection, "I"-shape; also referred to as "ST287")
• Suction Tube Set (two connections, "Y"-shape; also referred to as "ST282") .
• Vacuum Tube Set (also referred to as "ST291"). .

The provided text describes the 510(k) premarket notification for the ARTHRO-Pump PA304. This device is an arthroscopic pump, and the documentation focuses on demonstrating its substantial equivalence to a predicate device (Arthroscopy Pump A107) rather than providing detailed acceptance criteria and a study specifically designed to prove all aspects of its performance against those criteria in a typical clinical study format.

However, based on the provided information, I can infer the acceptance criteria and summarize the studies performed to demonstrate the device's safety and effectiveness for its intended use, focusing on the available performance data.

Here's an interpretation and structured presentation of the information:

Acceptance Criteria and Device Performance for ARTHRO-Pump PA304

The ARTHRO-Pump PA304 is an arthroscopic pump. The primary goal of the 510(k) submission is to demonstrate its substantial equivalence to a predicate device (Arthroscopy Pump A107) by showing that its performance does not raise new questions of safety and effectiveness. Therefore, the "acceptance criteria" are implicitly tied to meeting established safety and performance standards for arthroscopic pumps and showing comparable or superior performance to the predicate device where applicable.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Software Design Verification: Not explicitly stated, but implies comprehensive testing according to standards.
• Electrical Safety & EMC Testing: Not explicitly stated, typically involves testing representative units.
• Biocompatibility Testing: Performed on "the tube sets of both the proposed device and predicate device." Specific number of samples not given, but standard practice involves multiple samples per test (e.g., cytotoxicity, irritation, sensitization, systemic toxicity).
• Sterilization Validation: Performed on "the tube sets of both devices." Specific sample size not given, but validation processes typically involve statistically significant numbers of products run through the sterilization cycle to establish SAL and residual levels.
• Bench Performance Testing: 36 test runs were conducted.
• Data Provenance: The document refers to "The ARTHRO-Pump PA304 is designed, developed and manufactured by W.O.M. WORLD of MEDICINE GmbH" in Berlin, Germany. Therefore, the data would originate from their internal testing and validation processes. All testing appears to be retrospective bench-top and lab-based testing, performed to support the 510(k) submission, rather than prospective clinical trials.

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

• This information is not applicable in the context of this 510(k) summary. The "ground truth" here is compliance with engineering standards and specific performance metrics (e.g., pressure stability, sterilization levels, biocompatibility). These are established through validated testing methodologies and adherence to international standards, not through expert clinical consensus on a test set of patient data.

4. Adjudication Method for the Test Set:

• Not applicable. This pertains to clinical studies using human observers/experts. The tests described are laboratory-based engineering and safety validations.

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, an MRMC study was not done. This type of study is relevant for imaging devices or AI-assisted diagnostic tools where human interpretation of medical images is involved. The ARTHRO-Pump PA304 is a surgical pump; its performance is assessed through its physical characteristics, fluid dynamics, safety, and compatibility, not human interpretation of data.

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

• This question is phrased for AI/software algorithms. While the device does contain software, the "standalone" performance here refers to the pump's mechanical and fluidic operation and the correct execution of its programmed functions, which were evaluated through design verification and bench testing. The software itself was tested for compliance withIEC62304:2006. The pump's operation without human intervention (e.g., maintaining a set pressure) would be considered part of its standalone performance.

7. The type of ground truth used:

• For this device, the "ground truth" is defined by:
  • Engineering Specifications: The design parameters for pressure range, stability, fluid flow.
  • International Standards: Compliance with ISO (e.g., 10993, 11135, 11607, 14937) and IEC (e.g., 60601) standards for medical devices, electrical safety, biocompatibility, and sterilization.
  • Regulatory Guidance: Adherence to FDA guidance for software in medical devices.
  • Predicate Device Performance: Implicitly, the performance of the legally marketed predicate device (Arthroscopy Pump A107) serves as a benchmark for comparison when demonstrating substantial equivalence.

8. The sample size for the training set:

• Not applicable. This device is an arthroscopic surgical pump, not an AI/machine learning model that requires a training set. The software mentioned is likely control software for the physical pump functions, developed using standard software engineering practices rather than machine learning.

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

• Not applicable. As stated above, there is no "training set" in the context of an AI/ML system for this device. The software was developed and verified against predefined functional requirements and engineering specifications to control the pump's operations.

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