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CitriSol acid concentrate dry powder or liquid is indicated for use in the acute and chronic Hemodialysis. It is an accessory to be used with the appropriate Hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO standard water for hemodialysis and Sodium Bicarbonate Mix.

CitriSol is manufactured following strict cGMP's and in accordance with the AAMI/ANSI/ISO 13958:2009 concentrates for hemodialysis and AAMI/ISCHANSI 13959:2009 Water for Hemodialysis. Our product codes are easy to understand. The electrolytes present in each solution. Preceded by CS representing the Citric Acid part. In the 45x proportioning formulations the first three numbers -100 stand for the Na. followed by K (ex 2). Ca (25). -Mg (75). This example stands for CS 100225-75 a 2K 2.5 Ca product. CitriSol acid concentrate comes in liquid and dry powder form. The product is available in all 3 different proportioning, as shown in the table below: 45X LIQUID, 36.83X LIQUID, 35X LIQUID, POWDER. CitriSol, contains all the same electrolytes as Diasol Concentrate and 2.4mEq of Citric Acid. CitriSol, when mixed with ANSI/AAMI/ISO standard water for hemodialysis, has the same chemical equivalence as the predicates.

While the provided text mentions "Citrisol acid concentrates" and its intended use in hemodialysis, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

This document is a 510(k) summary for a medical device called "CitriSol acid concentrate." It primarily focuses on demonstrating substantial equivalence to predicate devices, outlining the product's formulations, and stating its indications for use.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and the study proving the device meets them based on the provided text. The document does not describe such a study or its results.

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Diasol -- Additives are used in conjunction with Diasol acid concentrate, AAMI standard water and Sodium Bicarbonate as Dialysate solution for concentralia, 2011 homodialysis in 3 stream homodialysis machines allowing the physician to customize the dialysate to meet the patient's needs .

puysesan additives, Infusates and Infusate additives are for use with sorbent regenerated Dulysis and allows physicians to customize the dialysate to meet the patient's needs.

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This is a response to the prompt based on the provided text, however, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically understood in the context of AI/ML-powered medical devices (performance metrics, test sets, ground truth establishment, etc.) does not apply to this document.

The document is a 510(k) clearance letter from the FDA for a conventional medical device, "Diasol - Additives," which are used in hemodialysis. The FDA's review for such devices primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than performance against predefined acceptance criteria for an AI algorithm.

Therefore, the requested information cannot be extracted from this document in its current form. The document does not describe any acceptance criteria, device performance metrics, study design, sample sizes, expert involvement, or ground truth for an AI/ML device.

However, if we were to interpret "acceptance criteria" and "device performance" in the context of a conventional medical device clearance (even though it's not explicitly about AI/ML), it would be related to meeting the standards of the predicate device and the safety and effectiveness for its intended use.

Given this limitation, I will respond by stating that the information requested for AI/ML device performance is not present in the provided document.

Analysis of the Provided Document Regarding AI/ML Device Performance:

The provided document is a 510(k) clearance letter from the FDA for a device named "Diasol - Additives," referenced under K020231. This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

The "Statement of Intended Use" describes "Diasol - Additives" as components used in conjunction with other materials (Diasol acid concentrate, AAMI standard water, and Sodium Bicarbonate) to form a dialysate solution for hemodialysis machines. It also mentions their use with sorbent regenerated dialysis to customize dialysate for patient needs.

Crucially, there is NO mention of any AI or Machine Learning component, algorithm, or software in this document. The device appears to be a chemical additive product used in a medical procedure, not an AI/ML powered diagnostic or therapeutic device.

Therefore, the questions regarding acceptance criteria, study data, sample sizes, ground truth, expert opinions, and MRMC studies, which are pertinent to the evaluation of AI/ML medical devices, are not applicable to the information contained in this FDA clearance letter.

Conclusion:

The provided document does not contain the information requested regarding acceptance criteria and performance studies for an AI/ML powered medical device. The device described, "Diasol - Additives," is a conventional medical product used in hemodialysis, and its clearance process, as reflected in this 510(k) letter, does not involve the type of AI/ML specific evaluations outlined in your prompt.

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Diasol-BiCarb Schutions are indicated for use in acute and chronic hemodialysis and have to be used in conjunction with Diasol acid concentrate or any other commercially available concentrate in the correct proportioning and AAMI standard water as Dialysate solution for hemodialysis .For use in 3 stream dialysis machines calibrated for use with acid and bicarbonate concentrate.

Sodium Bicarbonate is part of the dialysate concentrate for hemodialysis. When mixed with AAM standard water and Acid Concentrate, it creates a dialysate solution for use in renal dialysis therapy. read diarysis therepy . Diasol-BiCarb solution is in a ready to use form that is convenient for use in chronic care dialysis unit as well as acute care, dialysis thin as well as noter care. Sodium bicarbonate Hemodialysis grade, a white, water soluble powder is mixed with South block one of the case your Chloride USP (for 36.83 proportioning) in adequate proportions to provide the bicarbonate part of the dialysate. proportions to provide the breat benefits plastic container (HDPE) similar to the predicate. The solution is non-sterile, non-pyrogenic. Finished product is gamma radiated. The southout is non-centions have been taken to assure that the finished product does not promote bacterial growth.

This document describes a 510(k) premarket notification for the DIASOL-BiCarb, a liquid sodium bicarbonate solution for hemodialysis. As such, the submission focuses on demonstrating "substantial equivalence" to a predicate device rather than conducting a full clinical study with acceptance criteria and a detailed study report as would be typical for novel devices.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit "acceptance criteria" for performance metrics are provided in the document in the way one would see for a diagnostic or therapeutic device with measurable outcomes (e.g., sensitivity, specificity, accuracy). The acceptance criteria for this 510(k) submission are implicit in demonstrating substantial equivalence to predicate devices. This means proving that the new device is as safe and effective as a legally marketed device.

The "reported device performance" is essentially that the DIASOL-BiCarb is substantially equivalent to the predicate devices (RENOSOL K792213 and K781967, and STERILYTE K971053) based on its intended use, composition, raw materials, manufacturing processes, and packaging.

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

This is not a clinical study involving a "test set" of patients or biological samples in the traditional sense. The "test set" here refers to the manufacturing and quality control data of the DIASOL-BiCarb product itself, compared against the known characteristics and standards of the predicate devices.

• Sample Size: Not specified as a number of "cases." Instead, it refers to "all batches" of the manufactured product on which LAL and microbiological cultures are performed.
• Data Provenance: The data comes from the manufacturing and quality control processes of Diasol Inc. for the DIASOL-BiCarb. There is no information about country of origin of patient data or whether it's retrospective/prospective, as this is a materials/process equivalence submission, not a patient outcome study.

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

This type of submission typically does not involve medical experts establishing "ground truth" derived from patient data. The "ground truth" for chemical composition, sterility, and adherence to AAMI standards would be established by:

• Internal experts within Diasol Inc.: Quality control specialists, chemists, microbiologists, and manufacturing engineers who ensure compliance with specified formulations, raw material quality, and AAMI standards. Their qualifications would include relevant scientific degrees and experience in pharmaceutical/medical device manufacturing and quality control.
• Regulatory Experts at FDA: The FDA reviewers who assess the 510(k) submission act as experts in determining if the provided data is sufficient to establish substantial equivalence.

No specific number of experts or detailed qualifications are provided in the public summary.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" needing expert adjudication in the context of clinical outcomes. Quality control tests (like LAL, microbiological cultures) have predefined pass/fail criteria.

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

Not applicable. This is not a diagnostic imaging or human-in-the-loop AI device, so MRMC studies are not relevant.

6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance)

Not applicable. This device is a chemical solution used in a hemodialysis system, not a software algorithm or AI.

7. Type of Ground Truth Used

The "ground truth" employed for this device is based on:

• Chemical composition and purity standards: Ensuring the ingredients (Sodium Bicarbonate, Sodium Chloride USP, water) meet required grades and proportions.
• Microbiological standards: Adherence to AAMI microbiological standards, confirmed through LAL and microbiological cultures.
• Manufacturing process controls: Ensuring the production methods consistently yield a product meeting specifications.
• Predicate device characteristics: The known specifications, safety profile, and effectiveness of the legally marketed predicate devices (RENOSOL and STERILYTE) serve as the benchmark for "ground truth" in demonstrating equivalence.

8. Sample Size for the Training Set

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

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

Not applicable, as there is no training set for this device.

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Provides access to patients vascular system to administer IV fluids Is used in blood drawing Aid in prevention of needlestick injury.

Daisy Protected Scalp Vein Set

This document is a 510(k) clearance letter from the FDA for a medical device called the "Daisy Protected Scalp Vein Set." It confirms that the device is substantially equivalent to a predicate device already on the market.

However, the provided text does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria. The letter is a regulatory approval, not a scientific study report. It mentions the "indications for use" for the device, which are:

• Provides access to patients vascular system to administer IV fluids
• Is used in blood drawing
• Aid in prevention of needlestick injury.

Without the actual 510(k) submission document or a separate study report, I cannot provide the requested details about acceptance criteria, device performance, study design, sample sizes, ground truth establishment, or expert involvement. The letter itself does not include this information.

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Shelly Protected Fistula Needle is part of the hemodialysis system that connects patients to the machine and provides access to patient's blood, It is also used in plasmapheresis for the same purpose. Shelly Protected Fistula Needle has a shield that when activated enclose the needle. This mechanism is intended to reduce the incidence of accidental needlesticks.

Shelly Protected Fistula Needle has a shield that when activated enclose the needle.

This document is a 510(k) clearance letter from the FDA for a medical device called the "Shelly Protected AV Fistula Needle Set." It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML or diagnostic device. The letter is a regulatory approval, not a scientific or clinical study report. Therefore, I cannot extract the requested information.

The document primarily focuses on:

• Device Identification: Shelly Protected AV Fistula Needle Set
• Regulatory Clearance: 510(k) clearance, indicating substantial equivalence to a predicate device.
• Indications for Use: Describing the device's purpose in hemodialysis and plasmapheresis, and its safety mechanism for preventing needlesticks.
• Regulatory Compliance: Mentioning general controls and good manufacturing practices.

There is no mention of:

• Acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy).
• Any performance study results (e.g., test set sample size, data provenance, expert ground truth, adjudication methods).
• AI/ML components or comparative effectiveness studies with human readers.
• Training set details.

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Fistula needle is part of the Hemodialysis system that provides access to the patient's blood. It is also used in plasmapheresis for the same purpose.

Shelly AV Fistula Needle

I apologize, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Shelly AV Fistula Needle) and an "Indications for Use" statement.

This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific study details you've requested.

The letter is a regulatory document indicating that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not include the technical study data you're looking for.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or any of the other study-related information based on the text provided.

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Dryasol Acid Concentrate mix is indicated for use in acute and chronic hemodialysis. It is an accessory to be used with the appropriate hemodialysis machine in the exact prescribed proportion with RO water and Sodium Bicarbonate Mix.

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This is a PMA for a device called "Dryasol Acid Concentrate Mix". This document is a 510(k) clearance letter, not a PMA. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. The information provided in the prompt is a 510(k) clearance letter and an Indications for Use statement. These documents do not contain the detailed study information required to answer your request.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The provided documents only state that the Dryasol Acid Concentrate Mix is indicated for use in acute and chronic hemodialysis and is substantially equivalent to a legally marketed predicate device. This substantial equivalence is typically based on comparing technological characteristics and, in some cases, performance data, but the details of such comparisons are not in these specific FDA letters.

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