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The Rockwell Medical Technologies, Inc. CitraPure® Acid Concentrate powders/liquidsfor 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 Technologies, Inc. CitraPure® Acid Concentrate for Bicarbonate Dialysis powders and liguits contain salt, sugar, and non-sugar and powders formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and bicarbonate concentrate/powder. These solutions and powders 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 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 citric 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.

The provided 510(k) notification for the CitraPure® Dry Acid Concentrate for Bicarbonate Dialysis does not present acceptance criteria in the typical format of performance metrics with thresholds. Instead, the entire submission is focused on demonstrating substantial equivalence to predicate devices based on chemical composition and intended use.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The "in vitro testing" likely involved laboratory analysis of the chemical composition of the CitraPure® concentrate. The number of batches or samples tested is not provided.
• Data Provenance: The testing was "in vitro," implying laboratory-based testing on the manufactured product. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of clinical data, as no clinical data was collected.

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

• Experts: Not applicable. The "ground truth" for chemical composition would be established through analytical chemistry techniques and comparison to product specifications or predicate device data, not by expert interpretation in the way, for example, a radiologist interprets images.
• Qualifications: Not applicable for establishing chemical ground truth. The analyses would be performed by qualified laboratory technicians and chemists.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Given that the testing involved chemical composition analysis, there would not be an adjudication process involving multiple human reviewers like in a clinical study. The determination of "substantial equivalence" based on chemical parameters would be a direct comparison against established specifications or predicate device data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. The device is a medical concentrate, not an imaging or diagnostic device that would typically involve human readers. Clinical testing was explicitly stated as "not performed."

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

• Standalone Performance: Not applicable. This concept pertains to AI/ML devices where the algorithm performs a task independently. The CitraPure® concentrate is a chemical product, not an algorithm. The "performance" refers to its chemical properties and intended function as a component in dialysis.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the "non-clinical tests" (in vitro testing) was based on chemical composition analysis and comparison to predicate device specifications/data. This is akin to a "laboratory standard" or "established chemical profile."

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. Chemical concentrates do not have "training sets" in the context of AI/ML algorithms. The manufacturing process itself (which determines the composition) implicitly involves quality control and formulation development, but this is distinct from training a machine learning model.

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

• How Ground Truth for Training Set Was Established: Not applicable. As there is no training set in the AI/ML sense, there is no ground truth to be established for it. The formulation of the CitraPure® concentrate would have been developed and refined through standard chemical engineering and manufacturing processes to achieve the desired composition, which then aligns with the predicate devices.

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The Rockwell Medical Technologies, Inc., Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate 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 Technologies, Inc. Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acctate contain, water, salt, dextrose, and non-sugar electrolytes formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and bicarbonate concentrate solution. These concentrate solutions, when proportioned/ mixed in a threestream dialysis machine with pre-treated or purified water meeting AAMI Standards and a bicarbonate concentrate solution, may be used in conventional and commercially available hemodialysis machines or monitors as a hemodialysis solution. The Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate 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 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 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 cutoff 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 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.

This 510(k) summary describes a medical device, Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate, and its substantial equivalence to predicate devices. However, it does not contain the level of detail regarding acceptance criteria and performance studies that would typically be found for a device being evaluated for novel performance claims.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" in a quantitative, measurable sense beyond "equivalent to the proposed device for these parameters." It primarily relies on demonstrating substantial equivalence in chemical composition and range.

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

• Sample Size: Not specified. The document states "In vitro testing was performed to determine the chemical composition and range of composition." without indicating the number of batches, units, or samples tested.
• Data Provenance: Not specified, but based on the nature of in vitro testing for chemical composition, it would be laboratory-generated data from the manufacturer's testing of their product. It is inherently prospective for the device being submitted.

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

• Not Applicable. The ground truth for chemical composition is established by analytical testing and comparison to established specifications or predicate device compositions, not by expert consensus on clinical findings.

4. Adjudication Method for the Test Set

• Not Applicable. As the testing is for chemical composition, there's no "adjudication" in the clinical sense. Results would be objectively measured and compared.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This type of study is not relevant for a dialysis concentrate. MRMC studies are typically used to evaluate the diagnostic performance of imaging devices or algorithms where human interpretation is involved.

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

• Not Applicable. This device is a chemical concentrate, not an algorithm or AI. The concept of "standalone performance" in this context is not relevant.

7. The Type of Ground Truth Used

• Analytical/Chemical Specifications and Predicate Device Composition. The "ground truth" for the device's performance is its chemical composition and how it compares to established standards for safety and effectiveness in dialysis concentrates, as well as the known composition of the predicate devices.

8. The Sample Size for the Training Set

• Not Applicable / Not Provided. This device is hardware/chemical in nature, not an AI or machine learning algorithm that requires a "training set." The understanding of its function comes from chemical principles and comparison to existing, approved products.

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

• Not Applicable. As there is no training set mentioned or implied for this type of device, this question is not relevant.

Summary of Device Evaluation Approach:

The submission for Rockwell Medical Technologies, Inc. Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate relies on demonstrating substantial equivalence to existing legally marketed predicate devices. The primary evidence presented is that the proposed device:

• Has the same intended use.
• Utilizes the same range of chemical compositions, packaging, and formulations as the predicate devices.
• Underwent "in vitro testing" to confirm its chemical composition and range.
• No clinical testing was performed.

The FDA's 510(k) clearance process often allows for substantial equivalence determinations without extensive clinical trials if the new device is sufficiently similar to a predicate device in terms of technology, materials, and intended use, and if non-clinical testing can adequately demonstrate equivalence. In this case, chemical analysis was deemed sufficient.

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The Rockwell Medical Technologies' Bicarbonate Dialysate Concentrate Mixer is designed to mix the Rockwell Medical Technologies Concentrate Powders for Bicarbonate Dialysis with purified water to produce a bicarbonate concentrate solutions for hemodialysis for use in 3stream (acid concentrate, bicarbonate concentrate, and water) hemodialysis machines / monitors. The Rockwell Medical Technologies, Inc. Concentrate Powders for Bicarbonate Dialysis which are mixed with water in the Bicarbonate Dialysate Concentrate Mixer™ are indicated for use in acute and chronic hemodialysis.

The Rockwell Medical Technologies' Bicarbonate Dialysate Concentrate Mixer is designed to mix the Rockwell Medical Technologies Dri-Sate Bicarbonate Concentrate Mixes with purified water to produce a bicarbonate concentrate solution for hemodialysis for use in 3-stream (acid concentrate, bicarbonate concentrate, and water) hemodialysis machines / monitors.

Hemodialysis therapy removes blood wastes by diffusion through a dialyzer membrane into a dialysate solution flowing on the opposite side of the dialyzer membrane. Hemodialysis also involves using a differential transmembrane pressure to ultrafilter water from the blood usually resulting in a net patient weight loss during the treatment.

The Rockwell Medical Technologies' Bicarbonate Dialysate Concentrate Mixer is designed to be used with The Rockwell Medical Supply, LLC. Dri-Sate™ Bicarbonate Concentrate Hemodialysis Mixes which contain sodium bicarbonate and sodium chloride and in another formulation, only sodium bicarbonate (for Cobe Machines). These Dri-Sate™ Bicarbonate Concentrate Hemodialysis Mixes have been previously cleared by the FDA in 510(k) Number K954527 on March 18, 1996. Copies of the 510(K) clearance letter and samples of the labels/instructions for use for these powders are included in Appendix II of this Notification. These are formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and acid concentrate in a three-stream hemodialysis machine.

These powders 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. These proportioned hemodialysis solutions are 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 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 provided text describes a 510(k) summary for the Rockwell Medical Technologies, Inc. Bicarbonate Dialysate Concentrate Mixer. Based on the information presented, here's an analysis regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific, quantifiable acceptance criteria (e.g., pH range, conductivity range, concentration accuracy) for the performance of the Bicarbonate Dialysate Concentrate Mixer.

Instead, the "performance" is implicitly defined by the device's substantial equivalence to predicate devices and its ability to produce a bicarbonate concentrate solution for hemodialysis as intended.

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

• Test Set Sample Size: Not specified.

• Data Provenance: The document explicitly states:

  • "In vitro testing was not performed was not included in this 510(k) Notification." (000052, Summary of Non-Clinical Tests)
  • "Clinical testing was not performed." (K032521, Clinical Test Results)

  Therefore, there is no disclosed test set or primary data provenance in the provided document. The basis for the claims of safety, effectiveness, and substantial equivalence relies on comparison to predicate devices and the understanding of the underlying technology, rather than new empirical testing.

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

Not applicable, as no in vitro or clinical testing was performed for this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable, as no in vitro or clinical testing was performed for this 510(k) submission.

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

No, an MRMC comparative effectiveness study was not done. The device is a concentrate mixer, not an imaging or diagnostic device that would typically involve human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study was not done. This device is not an algorithm or AI system.

7. The Type of Ground Truth Used

Not applicable, as no in vitro or clinical testing was performed. The "ground truth" for the submission is based on the established safety and effectiveness of the predicate devices and the technological equivalence argument.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm.

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

Not applicable. This device is not an AI/ML algorithm.

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The Rockwell Medical Technologies, Inc., Dri-Sate Dry Acid Concentrates 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 Technologies. Inc. DRI-SATE Dry Acid Concentrates containing sodium diacetate, for bicarbonate dialysis contain salt, sugar, and non-sugar and powders formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and bicarbonate concentrate / powder. These powders when proportioned/ mixed in a three-stream dialysis machine with pre-treated or purified water meeting or exceeding AAMI Standards and a bicarbonate concentrate solution, may be used in conventional and commercially available hemodialysis machines or monitors as a The hemodialysis powders presented in this 510K Notification are intended to be hemodialysis solution. 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, is proportioned into the second stream of the hemodialysis machine, and water is proportioned into the third 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 These bicarbonate hemodialysis solutions are separated from the patient's blood by or hemodialyzers. 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 cutoff 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 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.

The provided document is a 510(k) summary for a medical device called "DRI-SATE Dry Acid Concentrate for Bicarbonate Dialysis." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study with defined metrics.

Here's a breakdown based on the sections you requested, highlighting what is (and isn't) present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the form of performance metrics (e.g., sensitivity, specificity, accuracy, chemical concentrations within a specific range). Instead, the "acceptance criteria" are implied to be substantial equivalence to legally marketed predicate devices in terms of chemical composition, intended use, and efficacy.

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

• Test Set Sample Size: Not applicable. No clinical test set with human subjects or a defined "test set" of samples undergoing performance measurement (beyond basic in-vitro compositional analysis) is described.
• Data Provenance: The in vitro testing was performed to determine chemical composition. The document does not specify the origin of any "data" in terms of retrospective/prospective studies or country of origin, as it pertains to product composition analysis rather than clinical data.

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

Not applicable. No ground truth establishment by experts for a test set is mentioned, as there was no clinical study. The equivalence is based on chemical and functional similarity to established predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a dry acid concentrate for dialysis, not an imaging diagnostic tool or a device where human interpretation of medical cases is relevant to its primary function in the same way as an MRMC study would assess.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not a software algorithm; it is a chemical product. The "performance" is its chemical composition and its ability to function correctly when mixed in a dialysis machine. The in vitro tests assessed the chemical composition, which can be considered relevant to its standalone performance, but it's not an "algorithm-only" study.

7. Type of Ground Truth Used

The "ground truth" implicitly used is the chemical specifications and verified performance of the predicate devices. The new device's chemical composition was compared against its own stated specifications and implicitly against the known composition profiles of the predicate devices.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device, so there is no "training set."

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

Not applicable. There is no training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" described is a non-clinical in vitro testing to determine the chemical composition and range of composition of the Dri-Sate Dry Acid Concentrate. The results of these tests confirmed that the proposed device is equivalent to the predicate devices for these parameters.

The core of the submission is a demonstration of substantial equivalence to legally marketed predicate devices (Rockwell Medical Dri-Sate Acid Concentrate Mixes and Fresenius USA, Inc. Granuflo Dialysate Concentrate) in terms of:

• Intended Use: "essentially the same"
• Technological Characteristics: "same range of chemical compositions, packaging and formulations. There are no significant differences."
• Safety and Effectiveness: Concluded to be "safe, effective, and performs as well as the predicate device" based on the in vitro testing and comparison.

Clinical testing was not performed for this 510(k) submission, reflecting that for this type of device (a concentrate used in an established medical procedure with predicate devices), in vitro chemical equivalence often suffices for demonstrating substantial equivalence.

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The Rockwell Medical Technologies' Dri-Sate™Mixer is designed to mix the Rockwell Medical Technologies Dri-Sate Acid Concentrate Mixes with purified water to produce an acid concentrate solution for hemodialysis for use in 3-stream (acid concentrate, bicarbonate concentrate, and water) hemodialysis machines / monitors. The Rockwell Medical Supply LLC. Dri-Sate Acid Concentrate Solutions which are mixed in the Dri-Sate Mixer™ 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 Technologies' Dri-Sate™Mixer is designed to mix the Rockwell Medical Technologies Dri-Sate Acid Concentrate Mixes with purified water to produce an acid concentrate solution for hemodialysis for use in 3-stream (acid concentrate, bicarbonate concentrate, and water) hemodialysis machines / monitors.

Hemodialysis therapy removes blood wastes by diffusion through a dialyzer membrane into a dialysate solution flowing on the opposite side of the dialyzer membrane. Hemodialysis also involves using a differential transmembrane pressure to ultrafilter water from the blood usually resulting in a net patient weight loss during the treatment.

The Rockwell Medical Technologies' Dri-Sate™ Mixer is designed to be used with the Rockwell Medical Supply, LLC. Dri-Sate™ Acid Concentrate Hemodialysis Mixes which contain salt, sugar, and non-sugar and water containing solutions and powders. These are formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and bicarbonate concentrate / powder. These solutions and powders 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 Dri-Sate™ Acid hemodialysis Mixes which have been presented in a previously cleared 510K Notification (K981003) 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 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 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.

Since different patients have different requirements for the removal rates and quantities of various molecules and toxins (i.e. blood urea nitrogen, creatinine, potassium, phosphate, magnesium, chloride, sodium calcium water, etc.) in acute and chronic renal failure, it necessitates having a variety of different bicarbonate containing hemodialysis solutions to satisfy the needs of all acute and end-stage renal failure patients. In addition, there a number of different types of hemodialysis machines which have different proportioning rates.

The provided text does not contain information about acceptance criteria or a study proving the device meets them in the context of performance metrics like accuracy, sensitivity, or specificity. Instead, the document describes a 510(k) submission for a medical device (Rockwell Medical Technologies' Dri-Sate™ Mixer) that sought to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

• Nature of the Device: The Dri-Sate™ Mixer is a device designed to mix solutions for hemodialysis. It is not a diagnostic device or an AI-powered system that would typically have performance metrics like sensitivity, specificity, or rely on expert ground truth for evaluation. It's a mechanical mixing apparatus.
• 510(k) Submission Focus: The 510(k) process primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use, technological characteristics, and raises no new safety or effectiveness questions. It doesn't typically require extensive performance studies with acceptance criteria in the way a novel therapeutic or diagnostic device might.
• Absence of Performance Data: The document explicitly states:
  • "In vitro testing was not performed was not included in this 510(k) Notification."
  • "Clinical testing was not performed."

Therefore, based on the provided text, I cannot complete the table or answer most of your detailed questions because the type of study and data you're asking about were not part of this 510(k) submission.

However, I can extract the following relevant information regarding the absence of such studies:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• No test set was used as no in vitro or clinical testing was performed for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as no test set was used and no ground truth was established by experts for performance evaluation. The device is a mixer, not a diagnostic tool requiring expert interpretation.

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

• Not applicable as no test set was used.

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

• No, a multi-reader multi-case comparative effectiveness study was not done. This device is not an AI-assisted tool for human readers.

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

• Not applicable. This device is a mechanical mixer, not an algorithm.

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

• Not applicable as no performance studies requiring ground truth were conducted.

8. The sample size for the training set

• Not applicable as no training set was used.

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

• Not applicable as no training set was used.

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