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The DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets represents an arthroscopy system using fluid from saline bags (0.9% NaCl). This arthroscopy system is intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities, and fluid suction during arthroscopy procedures.

The DOUBLEFLO INFLOW/OUTFLOW PUMP is a micro-processor controlled 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 connects via cable to various interfaces. The pump can be connected to various accessories / shaver systems. The pump has to be used with the following tube sets: DOUBLEFLO DAY TUBE SET, DOUBLEFLO PATIENT TUBE SET, DOUBLEFLO INFLOW TUBE SET, DOUBLEFLO OUTFLOW TUBE SET.

This document is a 510(k) Premarket Notification for a medical device called the "DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets." It concerns a pump used in arthroscopic procedures.

It is crucial to understand that this document does NOT describe the acceptance criteria and study proving a device meets those criteria for an AI/ML-driven medical device.

Instead, this is a traditional 510(k) summary for a physical medical device (a pump). The "software" mentioned refers to the embedded software controlling the pump's mechanical functions, not an AI/ML algorithm that interprets medical data (like images) or assists in diagnosis/treatment decisions.

Therefore, the requested information about acceptance criteria for an AI/ML device, sample sizes for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, training sets, and ground truth establishment for AI/ML is not applicable to this document.

The document discusses performance in terms of safety and effectiveness of the traditional medical device (the pump and its accessories/tubing sets), primarily through:

• Software verification and validation: Ensuring the pump's control software functions correctly and safely.
  • Acceptance Criteria (Implied for Software): Software performs as intended, no anomalies, compliant with relevant standards (IEC 62304, FDA guidance for software in medical devices).
  • Reported Performance (Software): Unit, integration, system, and validation tests performed; successfully covers RFID-related requirements; software considered "moderate" level of concern.
• Electrical safety and electromagnetic compatibility (EMC): Ensuring the device operates safely in its electromagnetic environment.
  • Acceptance Criteria: Compliance with IEC 60601-1 and IEC 60601-1-2 standards.
  • Reported Performance: Complies with recognized standards, demonstrated substantial equivalence.
• Biocompatibility testing: Ensuring the tubing sets are safe for contact with the body.
  • Acceptance Criteria: Compliance with ISO 10993 series standards and FDA guidance.
  • Reported Performance: Tests performed (Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Pyrogenicity), met requirements, demonstrated substantial equivalence.
• Sterilization validation: Ensuring the tubing sets can be effectively sterilized.
  • Acceptance Criteria: Compliance with ISO 11135, ISO 14937, ISO 10993-7. Residual EO/ECH limits met. SAL of 10^-6. Package integrity confirmed.
  • Reported Performance: Validation performed, met requirements, demonstrated substantial equivalence.
• Bench Performance Testing: Functional and usability tests of the pump and tubing sets (e.g., leak, tensile strength, accelerated aging).
  • Acceptance Criteria (Implied): Device performs as intended for fluid distension, irrigation, and suction; tubing sets maintain integrity over shelf life.
  • Reported Performance: Tests performed, demonstrated substantial equivalence.

In summary, this document is not about an AI/ML device, and thus cannot provide the specific details requested for such a system. The performance data provided relates to the physical and software functionalities of a medical pump, not an AI's analytical or diagnostic capabilities.

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The DOUBLEFLO system represents an arthroscopy system using fluid from saline bags (0.9% NaCl). This arthroscopy system is intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities, and fluid suction during arthroscopy procedures.

The DOUBLEFLO system (pump) contains as a main component a microprocessor-controlled 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 connects via cable to various interfaces. The pump can be connected to various shaver systems. The pump has to be used with the following tube sets: DAY TUBE Set, Patient Tube Set, Inflow Tube Set, Outflow Tube Set.

The provided text is a 510(k) summary for the DOUBLEFLO system, an arthroscopy system. It describes the device, its intended use, a comparison with a predicate device, and performance data used to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study information based only on the provided text. Many of the requested fields are not applicable or not explicitly stated in this type of FDA submission.

Acceptance Criteria and Device Performance

The provided document describes various performance tests rather than specific acceptance criteria with numerical targets. The "Results" column largely states that the device "demonstrated to be substantially equivalent to the predicate device." Therefore, numerical acceptance criteria are inferred from the predicate device's performance or general safety/effectiveness standards.

Study Details

1. Sample size used for the test set and the data provenance:

   • Software, Biocompatibility, Sterilization, Electrical Safety/EMC: Not explicitly mentioned as a "test set" in the context of clinical or image data. The tests were performed on the device and its components (tubing sets). The provenance of these components is not stated.
   • Bench Tests: The functional tests, usability tests, and strength/leak/tensile tests were conducted on the DOUBLEFLO system and its tubing sets. The number of samples for these tests is not specified in the document.
   • Data Provenance: The document does not describe the origin of data in terms of retrospective/prospective or country of origin, as these were non-clinical bench and lab studies.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This refers to non-clinical, performance-based testing in a laboratory setting, not studies requiring expert interpretation for ground truth.

3. Adjudication method for the test set: Not applicable. This refers to non-clinical, performance-based testing.

4. 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 device is an arthroscopy fluid management system, not an AI-powered diagnostic tool for interpretation by human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes standalone performance testing of the device itself (pump, tubing sets), without a human-in-the-loop, for aspects like fluid flow, pressure, electrical safety, etc. There is no "algorithm only" performance study in the context of AI, as this is a physical medical device.

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

   • For Software, the ground truth was the defined software requirements and intended functionality, validated against user needs.
   • For Electrical Safety, EMC, Biocompatibility, Sterilization, and Bench Tests, the ground truth was adherence to established international standards (IEC, ISO, ASTM) and the specified performance parameters (e.g., pressure, flow rates, material properties, sterility levels).

7. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning.

8. How the ground truth for the training set was established: Not applicable.

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The ZEOS AQUA VISION Pump is an arthroscopy pump system intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during arthroscopy procedures.

The ZEOS AQUA VISION pump is a micro-processor controlled 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 connects via cable to various interfaces. The pump can be connected to various shaver systems.

The provided text describes the 510(k) premarket notification for the ZEOS AQUA VISION PUMP and tube, which is an arthroscopy pump system. The document focuses on demonstrating substantial equivalence to a predicate device (FMS VUE Fluid Management & Tissue Debridement System) through various non-clinical performance tests.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the format of a typical performance study. Instead, it states compliance with recognized standards and guidelines as the acceptance criteria for each test category. The reported device performance is that the device meets these standards and demonstrated substantial equivalence to the predicate device.

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

The document does not specify the exact sample sizes for the test sets in any of the mentioned tests (Electrical Safety, EMC, Biocompatibility, Software, Sterilization, Bench Tests). It refers to "evaluation and testing were performed on the subject device" or "on equivalent device" and "the tubing sets."

The data provenance is from non-clinical performance tests conducted by the manufacturer (Hemodia SAS) in support of the 510(k) submission. No country of origin for the data is explicitly stated, other than the manufacturer being based in France and the correspondent in Germany, implying these are likely the origins of the testing. The studies are by nature retrospective for the purpose of this submission, as they were conducted to support a premarket notification.

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 in the document. The studies performed are non-clinical, primarily engineering and laboratory-based tests comparing the device to standards and a predicate. Expert consensus for ground truth is typically relevant for clinical studies, which were not required or performed for this device.

4. Adjudication method for the test set

This information is not applicable as the studies are non-clinical performance tests against established standards and predicate device characteristics, not clinical studies requiring human adjudication of outcomes.

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

This information is not provided and is not applicable. This device is an arthroscopy pump system, which assists in surgery by providing fluid management, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

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

This information is not applicable. The ZEOS AQUA VISION PUMP is a medical device, not an algorithm, and is intended for human-in-the-loop use during arthroscopic procedures.

7. The type of ground truth used

For the non-clinical tests:

• Electrical Safety and EMC: Ground truth is defined by the requirements of IEC 60601-1 and IEC 60601-1-2 standards.
• Biocompatibility: Ground truth is defined by the requirements of ISO 10993 series standards.
• Software Verification and Validation: Ground truth is defined by the software requirements, FDA guidance "General Principles of Software Validation," and IEC 62304 standard.
• Sterilization Validation: Ground truth is defined by the requirements of ISO 11135, ISO 14937, ISO 10993-7, ISO11607-1, and ASTM-F-1980:2002 standards.
• Bench Tests (Functional and Usability): Ground truth is defined by the functional specifications of the device, usability principles (IEC 62366-1), and the performance characteristics of the predicate device.

8. The sample size for the training set

This information is not applicable. The ZEOS AQUA VISION PUMP is a hardware medical device; it does not involve machine learning or AI models that require training sets. The software mentioned (IEC 62304) focuses on software life cycle processes and validation, not on training data for an algorithm.

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

This information is not applicable as there is no training set for a machine learning model.

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