Search Results

The Rockwell Medical Supply LLC. Dri-Sate Acid Concentrate Solutions and powders for Bicarbonate Dialysate are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor and bicarbonate concentrate.

The Rockwell Medical Supply, LLC. Dri-Sate Acid Concentrate Mixes / hemodialysis concentrate solutions and powders contain salt, sugar, and non-sugar and water containing solutions and powders are formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and bicarbonate solution/powder. These solutions and powders when proportioned/ mixed with pretreated or purified water meeting or exceeding AAMI Standards, may be used in conventional and commercially available hemodialysis machines or monitors as a hemodialysis solution. The hemodialysis concentrate solutions and powders presented in this 510K Notification are intended to be used in three stream hemodialysis machines in which an acidified concentrate is proportioned into one stream, a bicarbonate, chloride and sodium concentrate solution which has been prepared by mixing the powder with a specified volume of water and glacial acetic acid is proportioned into the second stream of the hemodialysis machine, and water is proportioned into the third stream. These three streams are then mixed to prepare a final proportioned hemodialysis solution. These types of a final hemodialysis solutions are commonly referred to as "Bicarbonate Hemodialysis Solutions." These proportioned hemodialysis solutions are then heated to body temperature and then perfused through the dialysis fluid compartment of artificial kidneys or hemodialyzers. These bicarbonate hemodialysis solutions are separated from the patient's blood by means of a semi-permeable cellulosic or non-cellulosic membrane which serves as a molecular weight selective barrier to the passage of molecules beyond a certain molecular weight. The molecular weigh cut-off of each type of membrane may vary depending on the membrane type, manufacturing process, etc. The semi-permeable membrane in a hemodialyzer permits the passage of smaller molecular weight (less than 5,000 daltons for conventional cellulosic membranes), ionized and non-ionized molecules, waste products and toxins (i.e. blood urea nitrogen, creatinine, potassium, etc.) contained in the patient's blood circulating through the dialyzer, to pass through the semi-permeable membrane into the bicarbonate hemodialysis solutions, exit the hemodialyzer, enter the hemodialysis monitor and exit the monitor and are ultimately discarded. The ionic and molecular composition of the hemodialysis solution establishes the concentration gradient between the blood and the hemodialysis solution passing through the hemodialyzer which permits the effective removal of waste products and toxins found in excess in the patient's blood during acute and end-stage renal failure.

Here's an analysis of the provided text regarding acceptance criteria and the study conducted for the Rockwell Medical Supply, LLC. Dri-Sate Acid Concentrate Mixes:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state defined acceptance criteria with numerical targets. Instead, the basis for approval is "substantial equivalence" to a predicate device. The performance is reported in terms of chemical composition and functionality.

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

• Sample Size for Test Set: The document does not specify a quantitative sample size for the "in vitro testing." It only generally mentions "testing was performed."
• Data Provenance: The testing was "in vitro testing." The country of origin is not explicitly stated, but given the submission to the FDA, it is presumed to be relevant to the US market or conducted according to US regulatory standards. The testing appears to be retrospective in the sense that it's comparing a new product to an existing predicate.

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

This information is not applicable as the study described is a non-clinical, in vitro chemical comparison study, not one requiring expert human interpretation of medical data. There is no "ground truth" established by experts in the context of diagnostic or interventional performance.

4. Adjudication Method for the Test Set

This is not applicable for an in vitro chemical comparison. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not performed."

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

This question is not applicable as the device is a medical concentrate solution, not an algorithm or AI-driven system. The "standalone" performance here would refer to the chemical properties of the concentrate itself, which was assessed through in vitro testing.

7. The Type of Ground Truth Used

For this specific device, the "ground truth" used for comparison was the chemical composition and performance characteristics of the predicate device (Renal Systems Hemodialysis Concentrate Solutions / Renal Systems Sta-Pak Bicarbonate Hemodialysis Bath Concentrate Solutions & Powders), as determined by testing. There was no pathology, expert consensus on clinical findings, or outcomes data used as the ground truth.

8. The Sample Size for the Training Set

This information is not applicable. The device is a chemical concentrate, not a machine learning model. Therefore, there is no "training set" in the context of an AI algorithm.

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

This information is not applicable for the reasons stated in point 8.

Ask a specific question about this device

The Rockwell Medical Supply LLC. Concentrate Solutions for Acetate Dialysate are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor.

The Rockwell Medical Supply, LLC. Hemodialysis concentrate solutions and for acetate dialysate contain salt (acetate, sodium, calcium, potassium and chloride), sugar (dextrose), and water containing solutions formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water. These solutions when proportioned/ mixed with pre-treated or purified water meeting or exceeding AAMI Standards, may be used in conventional and commercially available hemodialysis machines or monitors as a hemodialysis solution. The hemodialysis concentrate solutions presented in this 510K Notification are intended to be used in two stream hemodialysis machines in which an acetate concentrate is proportioned into one stream, and a specified volume of water is proportioned into the second stream of the hemodialysis machine proportioning system. These two streams are then mixed to prepare a final proportioned hemodialysis solution. These types of a final hemodialysis solutions are commonly referred to as "Acetate Hemodialysis Solutions." These proportioned hemodialysis solutions are then heated to body temperature and then perfused through the dialysis fluid compartment of artificial kidneys or hemodialyzers. These acetate hemodialysis solutions are separated from the patient's blood by means of a semipermeable cellulosic or non-cellulosic membrane which serves as a molecular weight selective barrier to the passage of molecules beyond a certain molecular weight. The molecular weigh cut-off of each type of membrane may vary depending on the membrane type, manufacturing process, etc. The semi-permeable membrane in a hemodialyzer permits the passage of smaller molecular weight (less than 5,000 daltons for conventional cellulosic membranes), ionized and non-ionized molecules, waste products and toxins (i.e. blood urea nitrogen, creatinine, potassium, etc.) contained in the patient's blood circulating through the cialyzer, to pass through the semi-permeable membrane into the acetate containing hemodialysis solutions, exit the hemodialyzer, enter the hemodialysis monitor and exit the monitor and are ultimately discarded. The ionic and molecular composition of the hemodialysis solution establishes the concentration gradient between the blood and the hemodialysis solution passing through the hemodialyzer which permits the effective removal of waste products and toxins found in excess in the patient's blood during acute and end-stage renal failure.

The provided text is a 510(K) summary for a medical device: "Concentrate Solutions for Acetate Dialysate" by Rockwell Medical, LLC. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a detailed study.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not applicable or not provided in this type of regulatory submission. The document explicitly states: "Clinical testing was not performed."

Here's a breakdown of the information that can be extracted or inferred based on the supplied text:

Acceptance Criteria and Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly met if the proposed device is found to be substantially equivalent to the predicate device. The primary "performance" demonstrated is that the device has the same chemical composition and intended use as the legally marketed predicate device.

Study Details Based on the Provided 510(K) Summary:

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

   • Test Set Sample Size: Not applicable. There was no specific "test set" in the context of clinical performance evaluation. The "testing" referred to appears to be analytical/bench testing to confirm chemical composition.
   • Data Provenance: The "in vitro testing" was performed by the submitter (Rockwell Medical, LLC). Specific details about the data's origin (e.g., country) are not provided, but it would have been conducted internally by Rockwell Medical. The study is akin to retrospective analytical comparison to the predicate device's established characteristics.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. There was no clinical test set requiring expert ground truth. Ground truth for the chemical composition would be established through laboratory analysis following recognized standards/methods, not expert consensus in the clinical sense.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. As no clinical test set requiring human adjudication was involved.

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 solution for hemodialysis, not an AI-assisted diagnostic or therapeutic device that would involve human "readers" or an MRMC study.

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

   • Not applicable. This is not an algorithm or AI device.

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

   • The "ground truth" for this submission is the established chemical composition and operational characteristics of the predicate device. The proposed device's chemical parameters were compared against these established ranges via in vitro chemical analysis.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that would require a "training set."

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

   • Not applicable. No training set was used.

Ask a specific question about this device

The research indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine / monitor.

Bicarbonate Solution Concentrates for Bicarbonate Dialysis

I am sorry, but based on the provided text, there is no information about acceptance criteria for a device, nor a study proving a device meets such criteria.

The text is a 510(k) clearance letter from the FDA to Rockwell Medical Supply, LLC regarding "Bicarbonate Solution Concentrates for Bicarbonate Dialysis." This letter grants clearance for the device to be marketed based on its substantial equivalence to existing devices, meaning it doesn't require a new premarket approval process.

The document does not contain any data, study descriptions, or performance metrics that would allow me to answer the questions you've posed. It is purely an administrative document affirming regulatory clearance.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance.
3. Number and qualifications of experts.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Training set sample size.
9. How ground truth for the training set was established.

Ask a specific question about this device