Search Results

This TDS Standard Solution is indicated for verifying the accuracy (calibration) of TDS (Total Dissolved Solids) meters. This standard solution should be used immediately before conductivity meters are used to determine the conductivity of water obtained from water purification systems used in hemodialysis. This solution is prepared from a mixture of salts comprised of 40% Sodium Bicarbonate, 40% Sodium Sufate, and 20% Sodium Chloride which is intended to mimic natural water systems. These solutions are used remotely from the water purification equipment, and do not come into contact with the patient.

The device consists of salts (Sodium Chloride, Sodium Bicarbonate and Sodium Sulfate) dissolved in de-ionized water. The solution is packaged into sealed polyethylene bottles.

The document describes the acceptance criteria and supporting studies for the "TDS Standard Solution."

Here's the breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

• 15ppm TDS Solution: 15.063 ppm, 15.032 ppm, 15.007 ppm, 14.988 ppm, 14.994 ppm.
• 150ppm TDS Solution: 150.546 ppm, 150.480 ppm, 150.546 ppm, 150.876 ppm, 150.744 ppm.
• 1500ppm TDS Solution: 1508.18 ppm, 1505.99 ppm, 1505.99 ppm, 1506.72 ppm, 14.994 ppm. |
  | Open Bottle Shelf Life | Remained within specification for 60 days after the bottle was opened and tightly recapped. | The three values (23.8 µS/cm, 229 µS/cm, and 2060 µS/cm) were all found to be within tolerance after the bottle was opened for 60 days and then tightly resealed. |
  | Sealed Bottle Storage Shelf Life | Remained within specification for 18 months after the bottle was sealed. | The results for 23.8 µS/cm, 229 µS/cm, and 2060 µS/cm solutions showed that they remained in tolerance for 18 months. Multiple batches were tested, demonstrating uniform properties throughout production. The goal to produce solutions with values within the lower 10% range of specifications was met to ensure values remained within specification after 18 months. |

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

• Sample Size for performance tests (Conductivity Values): 5 bottles were tested for each TDS solution (15ppm, 150ppm, 1500ppm).
• Sample Size for Open Bottle Shelf Life: The number of bottles tested is not explicitly stated, but it refers to "the new device" in general terms for the three specified conductivity values, suggesting at least one for each value.
• Sample Size for Sealed Bottle Storage Shelf Life: For each of the three conductivity values (23.8 µS/cm, 229 µS/cm, and 2060 µS/cm), five different batches were manufactured. For each batch, 5 bottles were measured at specified intervals over 18 months.
• Data Provenance: The document does not specify the country of origin of the data. The studies appear to be prospective, as they involve manufacturing and then testing the new device over time for shelf life and immediate performance.

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)

• The ground truth for the test set (conductivity values) was established using a Reference Conductivity meter calibrated with Standard Reference Materials purchased from Cole-Palmer. The document does not mention the use of human experts to establish ground truth or their qualifications. The ground truth is based on the calibrated instrumentation and reference materials.

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

• Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or subjective assessment. This device's performance testing is objective (measurement of conductivity), and thus no adjudication method was used or needed. The results were directly measured by a calibrated instrument.

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 MRMC comparative effectiveness study was done. This device is a standard solution for calibrating meters, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

• Yes, a standalone performance assessment was done. The performance of the "TDS Standard Solution" (the device itself) was evaluated by measuring its conductivity properties directly using a calibrated Reference Conductivity meter. This assessment did not involve a human-in-the-loop for the primary measurement of the solution's properties.

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

• The ground truth used was based on objective measurement against Standard Reference Materials using a calibrated Reference Conductivity meter. This is a form of instrumental ground truth, rather than expert consensus, pathology, or outcomes data, which are typically found in diagnostic applications.

8. The sample size for the training set

• This device is a physical standard solution, not a machine learning model. Therefore, there is no training set in the context of algorithm development.

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

• Since there is no training set for an algorithm, this question is not applicable.

Ask a specific question about this device

Conductivity/pH Calibrator Solutions are a secondary standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS and pH measurement instruments. The conductivity /TDS cells and instruments may be indicated for calibrating the conductivity and pH measurement function of hemodialysis machines and water purification equipment for hemodialysis, or for verifying proper function of hemodialysis machine or water purification equipment measurement functions. These solutions are used remotely from the hemodialysis machine or water purification equipment, and does not come into contact with the patient.

The device consists of salts (Sodium Chloride, Sodium Phosphate Dibasic, and Potassium Phosphate Monobasic) dissolved in de-ionized water. The proportion of total salt determines the solution's conductivity. The proportions of Sodium Phosphate Dibasic and Potassium Phosphate Monobasic determine the solution's pH. The solution is packaged into sealed polyethylene bottles. The performance specifications of the device are a pH value of pH 7.0 ± 0.03 pH units and a conductivity value of 14.00 mS/cm ± 0.03 mS/cm. The solution should maintain these values for 18 months stored in a sealed bottle. The solution should also maintain these values for 30 days within an opened but recapped bottle. There will be two bottle sizes of this solution, a 32-oz bottle and a 16-oz bottle.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Conductivity/pH Calibrator Solution

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state specific sample sizes (number of bottles, measurements, etc.) for each validation test (PQ-RM017, PQ-RM018, PQ-RM019, PQ-RM020). It refers to "production lots" for the initial manufacturing process validation.

The data provenance is retrospective, as the studies were performed on "production lots" and involved testing for stability over time. The country of origin of the data is Mesa Laboratories, Inc., located in Lakewood, CO, USA.

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

This information is not applicable to this type of device. The ground truth for calibrator solutions is established through comparison to N.I.S.T. (National Institute of Standards and Technology) SRM's (Standard Reference Materials), which are highly precise and certified standards. It does not involve human expert interpretation or consensus.

4. Adjudication Method for the Test Set

This information is not applicable. As discussed above, the validation involves objective measurement against NIST standards, not human interpretation that would require adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks where human readers' performance is evaluated and compared with and without AI assistance. This device is a calibrator solution, not an interpretive medical device.

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

This concept is not directly applicable in the traditional sense of an "algorithm only" performance for an AI/ML device. However, the performance of the calibrator solution itself, independent of the user, is assessed in the various validation studies (e.g., manufacturing process, storage stability, open bottle stability, instrument independence). The device's performance characteristics (pH, conductivity) are measured directly using instrumentation.

7. The Type of Ground Truth Used

The ground truth used for these studies is N.I.S.T. SRM's (Standard Reference Materials). These are primary calibration standards produced in accordance with NIST instructions, providing highly accurate and traceable reference values.

8. The Sample Size for the Training Set

This information is not applicable. This device is a chemical calibrator solution, 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, as there is no "training set" for this device.

Ask a specific question about this device

"H&S - Conductivity Standard Solutions" are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters; which may include the odilibrator of conduction to verify or calibrate conductivity or calibrate conductivity functions of dialysis related equipment.

These solutions are used remotely from the hemodialysis machine or water purification equipment and do not come in contact with the patient. Conductivity Standard Solution is for In-Vitro Use Only.

H&S - Conductivity Standard Solution is salt-based liquid produced by dissolving reagent grade salt in treated water and equilibrated to atmospheric CO2. The salt concentration determines the conductivity value. The solution is packaged in various size polyethylene bottles and sealed with a taper indicator seal and cap. The product label is added, and the device is placed in a clear plastic bag The product label contains instructions for use, warnings, and other safety information. H&S - Conductivity Standard Solution is available in of a range sizes, values and accuracies.

No acceptance criteria or study information is available in the provided document for the "H&S - Conductivity Standard Solution". The document describes the device, its intended use, and states that verification and validation were performed, but it lacks specific details on quantitative acceptance criteria or the study methodology and results.

Therefore, I cannot populate the table or answer the specific questions about sample size, ground truth, expert involvement, or comparative effectiveness studies.

Here's the table of acceptance criteria and reported device performance, however, it will be empty as the information is not present:

Acceptance Criteria and Reported Device Performance

Based on the provided document, the following information is not available:

• Sample size used for the test set and the data provenance: Not mentioned. The document states "Verification and validation of the performance specifications of the device was performed on production lots and samples of the two predicate devices," but no sample sizes or data provenance (e.g., country of origin, retrospective/prospective) are provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a conductivity standard solution, not an AI-assisted diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a conductivity standard solution, not an algorithm.
• The type of ground truth used: Not explicitly stated as "ground truth." The document mentions that the device is "traceable to NIST (National Institute of Standards and Technology)," implying that NIST standards serve as the reference for accuracy.
• The sample size for the training set: Not applicable as this is not an AI/ML device requiring a training set.
• How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

Conductivity/TDS Calibrator Solutions are a secondary standard solution used for the calibration of conductivity/TDS cells and instruments. The Conductivity/TDS Calibrator Solutions may be indicated for calibrating the conductivity measurement function of hemodialysis machines and water purification equipment for hemodialysis, or for verifying proper function of hemodialysis machine or water purification equipment measurement functions. These solutions are used remotely from the equipment, and do not come into contact with the patient.

The device consists of salt dissolved in purified water. The proportion of salt determines the solution's conductivity. The solution is packaged into sealed polyethylene bottles.

The provided text describes the 510(k) summary for the "Conductivity/TDS Calibrator Solution." Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document mentions "production lots" were used for validation.
• Data Provenance: The validation was performed by the "Danish Institute of Fundamental Metrology." This indicates an international (Denmark) origin for the testing. The study was likely prospective as it was performed on "production lots" to validate the device.

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

• This information is not provided in the document. The validation was performed by an institute, not explicitly by individual experts establishing ground truth in a clinical context.

4. Adjudication Method for the Test Set

• This information is not provided in the document. The study does not appear to involve human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This device is a calibrator solution for instruments, not an AI-based diagnostic tool that assists human readers.

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

• Yes, a standalone performance study was done. The device itself is the "algorithm" (in the sense of a physical reference standard) and its performance was evaluated independently by the Danish Institute of Fundamental Metrology. There is no human-in-the-loop component for this type of device's primary function.

7. The Type of Ground Truth Used

• The ground truth for the performance validation was established by the "Danish Institute of Fundamental Metrology." This implies a metrological standard or reference measurement as the ground truth. They are an institute specializing in fundamental metrology, which concerns the scientific study of measurement.

8. The Sample Size for the Training Set

• This information is not applicable/not provided. The device is a calibrator solution, not a machine learning algorithm that requires a training set.

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

• This information is not applicable/not provided. As mentioned above, there is no training set for this type of device.

Ask a specific question about this device

The "Conductivity Standard Solution - MeterCare" may be used to calibrate conductivity reference meters used to test the dialysate, dialysate concentrate and water treatment systems used with dialysate delivering systems. MeterCare is an Over-the-Counter product and needs no prescription. The product is for In Vitro use only.

The "Conductivity Standard Solution – MeterCare" is a range of high accuracy conductivity standard solutions to calibrate conductivity meters used in dialysis to test the conductivity of dialysate of dialysis machines and water used in hemodialysis applications.

The information provided focuses on the regulatory submission for a medical device (a conductivity standard solution) and its substantial equivalence to a predicate device, rather than a clinical study evaluating its performance against specific acceptance criteria in a typical medical diagnostic or treatment context.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable or cannot be extracted from the provided text for this type of device.

However, I can extract the relevant information regarding the acceptance criteria and the methods used to demonstrate the device's characteristics.

Here is the breakdown of the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are implied by the stated uncertainties for the solutions. The primary method of demonstrating performance is through adherence to established standards and substantial equivalence to a predicate device, as opposed to a direct measure against a performance goal in a clinical trial.

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable. The "test set" in this context refers to the batches of the Conductivity Standard Solution - MeterCare that were manufactured and tested according to various standards, not a patient cohort or a set of clinical cases. The document does not specify the number of batches or individual samples tested.
• Data Provenance: Not applicable in the context of clinical data. The device itself is a standard solution, and its performance is validated through metrological testing against recognized standards.

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

• Number of Experts: Not applicable. The "ground truth" for a conductivity standard solution is established by its chemical composition and precise manufacturing processes, which are then verified against metrological standards. There are no "experts" in the sense of clinical reviewers establishing a ground truth for diagnostic accuracy.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. The performance is determined through standardized laboratory measurements and comparison to metrological standards, not through expert adjudication of ambiguous cases.

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

• MRMC Study: Not applicable. This device is a calibration standard, not an AI-powered diagnostic tool. There are no "human readers" in the context of interpreting results derived from this product in a diagnostic setting.

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

• Standalone Performance: Not applicable. This is a physical chemical standard, not an algorithm or software device.

7. The type of ground truth used

• Type of Ground Truth: The ground truth for the "Conductivity Standard Solution - MeterCare" is based on:
  • Metrological Standards: Adherence to established scientific and industry standards for conductivity and calibration, such as NIST Special Publication 260-142, IUPAC Standards for Conductivity, OIML Standards for Conductivity, ASTM D 1125-91, and ISO 7888.
  • Chemical Composition and Manufacturing Process: The precise formulation of the solutions (e.g., KCl, NaCl, 442 Natural Water composition) and their accurate preparation to yield specific conductivity values with defined uncertainties.

8. The sample size for the training set

• Sample Size: Not applicable. This is a manufactured product, not a machine learning algorithm.

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

• Ground Truth Establishment: Not applicable.

Ask a specific question about this device