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The Baxter Meridian Hemodialysis Machine is part of a high permeability hemodialysis system, which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood, an extracorporeal blood set and a high permeability dialyzer. The standard features of the Meridian machine include high blood flow rate capacity (for shortened hemodialysis treatment time), automatic ultrafiltration control, standard and variable bicarbonate and sodium capabilities and automated chemical disinfection. The Meridian machine will operate in either the bicarbonate or acetate mode for concentrates. The Meridian machine is designed to operate in the chronic and acute dialysis environment.

The Baxter Meridian is a single patient hemodialysis instrument that prepares dialysis solution, circulates blood through an extracorporeal circuit of blood tubing and hemodialyzer, and monitors the system for safe operating conditions. Its features include high blood flow rates, automatic ultrafiltration control, variable sodium and bicarbonate dialysis capabilities, and patient prescription entry through a patient data card. Optional features include automated patient blood pressure monitoring, a heparin pump and a sodium administration button.

The provided document is a 510(k) summary for the Baxter Meridian Hemodialysis Machine, which is a medical device. This type of regulatory submission establishes substantial equivalence to a predicate device and does not typically include detailed studies proving performance against acceptance criteria in the manner of an AI/ML medical device or diagnostic test.

The core of a 510(k) for a device like a hemodialysis machine relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily done through comparison of technological characteristics, rather than extensive clinical performance studies with specific statistical metrics.

Therefore, the requested information elements related to AI/ML performance studies, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies are not applicable to this type of device and submission.

Here's a breakdown based on the provided text, highlighting what is available and explaining why other elements are not:

Acceptance Criteria and Device Performance

Non-Applicable Information for this 510(k) Submission:

The following information points are typically associated with performance studies for software/AI devices or clinical trials, which are not detailed in this 510(k) summary for a hemodialysis machine where substantial equivalence is based on technological characteristics.

1. Sample size used for the test set and the data provenance: Not applicable. Performance is demonstrated through comparison of engineering and functional specifications to the predicate, rather than a clinical "test set" in the diagnostic sense.
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 ground truth for diagnostic accuracy, which is not the focus here.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 a treatment machine, not an interpretive diagnostic tool that assists human readers.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device would relate to engineering validation and verification that the machine performs its mechanical and electronic functions correctly and safely, rather than a diagnostic 'truth'.
7. The sample size for the training set: Not applicable. There is no mention of an "algorithm" or "training set" in the context of this device.
8. How the ground truth for the training set was established: Not applicable.

Summary Rationale:

The provided document is a 510(k) summary for a hemodialysis machine. This type of device is classified as a physical medical device (Class II) that performs a therapeutic function. The regulatory pathway for such a device, a 510(k), focuses heavily on demonstrating substantial equivalence to an already legally marketed predicate device. In this case, the Baxter Meridian Hemodialysis Machine is stated to be "technologically the same" as its predicate (K992894).

This means the submission relies on comparing design specifications, materials, operational principles, and intended use to the predicate. It is not an AI/ML-driven diagnostic device that would require extensive performance studies involving test sets, training sets, ground truth established by experts, or MRMC studies to evaluate algorithmic performance or human-AI interaction. The "acceptance criteria" are implicitly met by demonstrating that the device functions as intended and is as safe and effective as the predicate device.

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The Baxter Meridian machine is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafitration controller to prevent excessive loss of water from the patient's blood, an extracomoreal blood set and a high permeability dialyzer. The standard features of the Meridian machine include high blood flow rate capacity (for shortened hemodialysis treatment time), automatic ultrafiltration control, standard nearchardialysis treatment capabilities and automated chemical disinfection. The Meridian machine will operate in either the bicarbonate or acctate mode for concentrates .

The Meridian Hemodialysis Machine is designed to operate in the chronic and acute dialysis environment.

The Baxter Meridian is a single patient hemodialysis instrument that prepares dialysis solution, circulates blood through an extracorporeal circuit of blood tubing and hemodialyzer, and monitors the system for safe operating conditions. Its features include high blood flow rates, automatic ultrafiltration control, variable sodium and bicarbonate dialysis capabilities, and patient prescription entry through a patient data card. Optional features include automated patient blood pressure monitoring, a heparin pump and a sodium administration button.

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. It is a 510(k) summary for the Baxter Meridian Hemodialysis Machine, which focuses on the device's description, intended use, and substantial equivalence to predicate devices, rather than detailed performance study results against specific acceptance criteria.

No information is available regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, or effect size of AI improvement.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size.
9. Ground truth establishment for the training set.

Ask a specific question about this device