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The proposed Dialysis Priming Sets are indicated for use to provide a means to deliver rie proposed promote from a collapsible container or vented bottle into a patient's. vascular system during dialysis procedures.

The Medisystems Dialysis Priming Sets provide a means of delivering fluids and medicaments from a collapsible container or vented bottle into a patient's vascular system during dialysis procedures. The set consists of a flexible drip chamber with a spike for attachment to the solution container, an adjustable clamp that regulates flow, a flexible delivery tube with a two port connector. This connector will allow connection of the set to devices with compatible female luer connectors. The set will also allow connection of a separate device with compatible male luer to the set's female luer connector.

This document describes a 510(k) submission for Medisystems Dialysis Priming Sets, which are accessories for hemodialysis. The focus of the submission is on demonstrating substantive equivalence to previously cleared devices, rather than a novel device requiring a de novo clinical study for performance metrics. Therefore, many of the typical acceptance criteria and study details requested are not present in this type of submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific sample size for a "test set" related to clinical performance or a comparative study against a human baseline. The testing described is primarily for manufacturing quality control and material biocompatibility.

The data provenance is for manufacturing quality control and biocompatibility testing of the device itself. It doesn't appear to involve patient data or a clinical study in the typical sense for demonstrating diagnostic or treatment efficacy. The context is a device accessory, not a diagnostic algorithm or a therapeutic drug.

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 to this 510(k) submission. The "ground truth" here is adherence to manufacturing specifications, biocompatibility standards, and functional equivalence to predicate devices, which are typically assessed through laboratory testing and regulatory compliance, not expert consensus on clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a human expert-based test set adjudication process. The testing described is laboratory and manufacturing process-based.

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 applicable. This is a submission for a physical medical device accessory (dialysis priming set), not an AI/software as a medical device (SaMD) 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. This is a physical medical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's safety and effectiveness relies on:

• Predicate Device Equivalence: The primary "ground truth" for regulatory clearance is that the device is "substantially equivalent" to legally marketed predicate devices in terms of intended use and technological characteristics.
• Manufacturing Specifications: "The required testing is defined by written and approved procedures that conform to the product design specifications."
• Biocompatibility Standards: The biocompatibility testing implies adherence to recognized standards.
• Sterility and Pyrogenicity Standards: These are objective laboratory tests.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not a machine learning algorithm.

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

This information is not applicable. This is a physical medical device, not a machine learning algorithm.

Summary of the Study/Evidence Provided for Meeting Acceptance Criteria:

The "study" presented is the collection of evidence for a 510(k) premarket notification, aiming to demonstrate substantial equivalence to already marketed predicate devices. The primary evidence consists of:

• Comparison of Intended Use: Demonstrated identical intended use to predicate devices.
• Comparison of Technological Characteristics: Demonstrated identical technological characteristics (spike connector, tubing, drip chamber, adjustable clamp, connection means) to predicate devices.
• Verification and Validation Testing (Manufacturing & Materials):
  • Biocompatibility Testing: Conducted where materials differed from the predicate, showing no effect on safety and effectiveness.
  • Performance Testing: Implied comprehensive "physical testing" as part of the release specifications, ensuring the device functions as designed.
  • Sterility Testing: Performed on all finished products as a release specification.
  • Pyrogenicity Testing: Performed on all finished products as a release specification.
  • Visual Examination: Conducted on in-process and finished products.
• Adherence to "Device Master Records": Indicating that all required testing and specifications are documented and followed according to established procedures.

The ultimate "proof" of meeting acceptance criteria for this type of submission is the FDA's determination of substantial equivalence, which was granted for K971860 on August 8, 1997. This clearance is based on the submission demonstrating that the device is as safe and effective as a legally marketed predicate device.

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