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Medisystems Blood Tubing Set Accessories are indicated for use as a part of an extracorporeal blood circuit for hemodialysis. The specific indications for use each accessory are as follows:
a. The Reverso™ is indicated for use as an access flow reversing valve to reverse the blood flow to and from the arterial and venous access devices during hemodialysis procedures without the need to clamp and disconnect bloodlines.
b. The Recirculation Connector is indicated for use as a male to male Luer adaptor.
c. The Parallel Dialyzer Connector is indicated for use to interconnect two hemodialyzers in parallel as prescribed by the physician as part of the extracorporeal blood system.
d. The Series Dialyzer Connector is indicated for use to interconnect two hemodialyzers in series as prescribed by the physician as part of the extracorporeal blood system.

A series of blood tubing set accessories to be used as part of the extracorporeal circuit.
A. Medisystems Blood Tubing Set Accessory, Access Flow Reversing Valve, (Reverso): The technical characteristics of the device consist of a manually operated valve with a gasket to prevent leakage. The device is also equipped with tubing and Luer connectors to allow it to interconnect between the blood tubing set and the blood access devices. The device allows reversal to the arterial and venous blood access without the need to disconnect the blood tubing set from the access devices. The reversal of the arterial and venous accesses is necessary to facilitate certain common diagnostic procedures and can be used to reverse flow in central venous or femoral catheters that have patency problems.
B. Medisystems Blood Tubing Set Accessory, Recirculation Connector: The device is a singly packed recirculation connector (male-to male Luer adaptor) used to interconnect the arterial and venous bloodlines.
C. Medisystems Blood Tubing Set Accessory, Parallel Dialyzer Interconnector: The device is used with a standard blood tubing set to provide a means to connect two dialyzers in parallel into the extracorporeal circuit.
D. Medisystems Blood Tubing Set Accessory, Series Dialyzer Interconnector: The device is used with a standard blood tubing set to provide a means to connect two dialyzers in series into the extracorporeal circuit.

The provided text describes a 510(k) submission for "Blood Tubing Set Accessories" by Medisystems Corporation. The document outlines the device's intended use and technological characteristics but does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or similar measures typically found in AI/ML device submissions.

Instead, the submission focuses on establishing substantial equivalence to a legally marketed predicate device (Medisystems' Blood Tubing Sets described in K953823) and details the safety and effectiveness measures in terms of manufacturing processes and quality control.

Here's a breakdown of the requested information based on the provided text, highlighting what is missing:

Acceptance Criteria and Device Performance Study for K994306 (Medisystems Blood Tubing Set Accessories)

Given the nature of the device (blood tubing set accessories for hemodialysis) and the regulatory context (510(k) submission from 2000), the testing described is primarily for manufacturing quality assurance and functional integrity rather than AI/ML performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not specify quantitative acceptance criteria for device performance (e.g., "leakage rate must be < X%," or "reversal mechanism must operate smoothly for Y cycles"). The "acceptance criteria" are implied by the necessity to conform to "product design specifications" and "required release specifications" through general quality control tests.

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

• Sample Size: Not specified. The document states "all finished products are tested," which implies 100% inspection or batch testing based on internal procedures, but no specific sample size for a "test set" in a clinical/performance study context is mentioned.
• Data Provenance: Not applicable in the context of clinical/performance data. The testing described is part of the manufacturing process and quality control, not from patient data.

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

• Not Applicable. This device is a mechanical accessory, not an AI/ML diagnostic or prognostic device that requires expert-established ground truth from images or clinical data. The "ground truth" for this device's safety and effectiveness relies on meeting engineering specifications and quality control parameters.

4. Adjudication Method for the Test Set

• Not Applicable. There is no "adjudication method" described as it relates to expert review of output or clinical outcomes. Testing is physical and functional.

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 device is a mechanical medical accessory, not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used

• The "ground truth" for this device's safety and effectiveness is based on engineering specifications, manufacturing standards, and quality control procedures (e.g., demonstration of sterility, lack of pyrogens, physical integrity, and functional performance as designed). There is no "expert consensus," "pathology," or "outcomes data" ground truth described for its basic functional performance.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. This is not an AI/ML device that requires a training set and associated ground truth.

Summary Conclusion:

The K994306 submission describes a mechanical medical device designed to facilitate hemodialysis. The "safety and effectiveness" section focuses entirely on standard manufacturing quality control and adherence to design specifications (sterility, pyrogenicity, physical testing, visual examination). It establishes substantial equivalence based on its intended use and technological characteristics being comparable to previously cleared predicate devices, rather than through performance metrics derived from clinical studies or AI/ML evaluation. Therefore, most of the requested information (related to AI/ML device evaluation) is not present in this document.

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