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DRYalysate™ Concentrate is intended for use for patients being treated by hemodialysis. The primary patient population that will use this device are those who suffer from loss of kidney function and who are prescribed acute or chronic hemodialysis. The indications for use of this product are exactly the same as those for currently marketed dialysate concentrates.

The device consists of packaged dry chemicals which, when mixed and dissolved with AAMI quality water, according to the directions for use, makes an acid concentrate that can be used by current proportioning type hemodialysis machines to make dialysate.

DRYalysate™ Concentrate will be packaged and sold in two convenient boxed sizes; a 'single dose' package designed to make enough dialysate concentrate (5 Liters) for one patient for one treatment and a 'bulk' package which contains enough powder to make 50 liters of dialysate at a time.

Once the package of chemicals is mixed according to the instructions for use, the resulting liquid concentrate is used in the hemodialysis process in proportioning type hemodialysis machines in exactly the same way that existing concentrates are used.

The provided text describes a 510(k) submission for a medical device called DRYalysate™ Concentrate, a powdered dialysate concentrate for hemodialysis. The document focuses on demonstrating substantial equivalence to predicate devices and does not detail specific acceptance criteria, performance metrics, or study designs in the way an AI/ML device submission would.

Therefore, many of the requested details about acceptance criteria, study methodologies, and ground truth establishment (which are common for AI/ML device evaluations) are not present in the provided text. The submission for DRYalysate™ Concentrate primarily relies on chemical formulation comparison and clinical studies to demonstrate safety and effectiveness for a chemical product, not a diagnostic or AI-powered device.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative table format. Instead, it claims:

• "The three clinical studies and other testing data submitted provide the necessary and sufficient evidence to support that Advanced Renal Technologies DRYalysate™ Concentrate is cafe and effective and substantially equivalent to currently marketed products."

The "performance" is implicitly deemed equivalent to existing, legally marketed dialysate concentrates based on its chemical formulation and clinical use. The key aspect here is "substantial equivalence" to predicate devices, rather than meeting specific performance thresholds against a diagnostic gold standard.

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

The document mentions "three clinical studies" but does not provide details on:

• Sample size for any test set or clinical studies.
• Data provenance (e.g., country of origin).
• Whether the studies were retrospective or prospective.

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)

This information is not applicable and not provided. The device is a chemical concentrate, not a diagnostic tool requiring expert interpretation for ground truth establishment. Clinical studies for such a device would typically focus on patient outcomes, tolerability, and efficacy in maintaining appropriate blood chemistry during dialysis, not on diagnostic accuracy based on expert consensus.

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

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in diagnostic imaging or clinical trials where expert consensus is needed to establish a "ground truth" for a decision, which is not relevant to a dialysate concentrate.

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 and not provided. MRMC studies are used to evaluate diagnostic imaging devices, especially AI-assisted ones. This device is a chemical concentrate for hemodialysis.

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

This information is not applicable and not provided. "Standalone" performance refers to AI algorithm performance without human intervention, which does not apply to a chemical medical device.

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

The concept of "ground truth" as typically discussed for diagnostic or AI/ML devices is not directly applicable here. For a hemodialysis concentrate, the "truth" would be evaluated based on:

• Chemical composition and stability: Ensuring the concentrate, when mixed, produces the intended dialysate according to AAMI quality water standards.
• Clinical outcomes data: Demonstrating safety and effectiveness in patients undergoing hemodialysis, likely focusing on blood chemistry parameters, patient well-being, and comparison to existing products.
  The document states "The three clinical studies and other testing data submitted provide the necessary and sufficient evidence to support that... DRYalysate™ Concentrate is safe and effective." This suggests clinical outcomes data and laboratory testing of chemical properties would form the basis of the "truth."

8. The sample size for the training set

This information is not applicable and not provided. The device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable and not provided. There is no training set for this type of device.

In summary, the provided 510(k) summary is for a chemical medical device (dialysate concentrate) and therefore lacks the detailed information regarding study design, acceptance criteria based on performance metrics, and ground truth establishment that would be typically found in an FDA submission for an AI/ML powered diagnostic device. The primary claim for this device is "substantial equivalence" to existing predicate devices based on its chemical formulation and intended clinical use.

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