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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.

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The HDM97 may be used by hemodialysis personnel to test the conductivity, temperature, pressure and pH of the dialysate solution used with hemodialysis delivering systems. The HDM97 may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications.

The HDM97 was developed in 1997 to test conductivity/temperature, pressure and pH in hemodialysis applications. The HDM97 has a large, easy readable 3½ Digital Liquid Crystal Display. It comes with a waterproof key membrane. All selections are done with 9 key's including On and Off. The software is designed to be logical and easy to use for the user either safe and precise in measurement.

Here's an analysis of the provided text regarding the HDM97 Dialysis Meter, focusing on acceptance criteria and supporting studies:

Based on the provided document, the HDM97 Dialysis Meter’s acceptance criteria and studies are primarily focused on substantial equivalence to a predicate device, rather than explicit performance metrics or clinical efficacy studies with human subjects or pathology.

Acceptance Criteria and Device Performance

The document does not explicitly list numerical acceptance criteria for the HDM97. Instead, the acceptance is based on achieving "substantial equivalence" to a predicate device, the Neo2 meter (510(k) Number: K992431). The study proving this substantial equivalence is a comparison of technological characteristics.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The technological characteristics of the HDM97 and the predicate device are completely identical." This statement considers the RS232-Interface and Rechargeable Battery as enhancements that do not alter the fundamental safety or effectiveness sufficiently to negate substantial equivalence.

Study Proving Device Meets Acceptance Criteria

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

• Test Set Sample Size: Not applicable in the context of this 510(k) submission. The "test set" in this case refers to the characteristics of the device itself rather than data from patient samples or clinical trials. The comparison is between the specifications and design of the HDM97 and the predicate device.
• Data Provenance: The data provenance is the design and manufacturing specifications of the HDM97 device, compared against the known specifications of the Neo2 meter. This is not retrospective or prospective in the sense of clinical data but rather a comparative analysis of device features. The manufacturer is IBP Instruments GmbH, Germany.

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

• Number of Experts: Not explicitly stated for establishing a "ground truth" for a test set. The review and determination of substantial equivalence are performed by the FDA (specifically, the Division of Reproductive, Abdominal, and Radiological Devices, Office of Device Evaluation), who act as the regulators evaluating the submitted comparison.
• Qualifications of Experts: The FDA personnel, such as Nancy C. Brogdon (Director of the relevant division), are experts in medical device regulation and evaluation, but they are not "experts establishing ground truth" in the sense of clinical or pathology review. The "ground truth" for the comparison is the established specifications of the predicate device and the submitted specifications of the HDM97.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. There is no "test set" in the traditional sense requiring adjudication by multiple readers or experts. The assessment is a regulatory review process comparing device specifications.

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: No, an MRMC comparative effectiveness study was not done. The HDM97 is a diagnostic/metering device, not an AI-powered diagnostic imaging tool that would typically involve human readers interpreting cases.

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

• Standalone Performance: Not applicable. The HDM97 is a physical meter with internal software for its functions (conductivity, temperature, pressure, pH measurement). It is not an algorithm performing a diagnostic task in isolation. Its "standalone performance" is its accuracy and reliability in measuring the specified parameters, which is implicitly accepted by the FDA's clearance based on substantial equivalence. Further details on the accuracy of these measurements are not provided in this summary.

7. The type of ground truth used:

• Type of Ground Truth: The "ground truth" for the substantial equivalence determination is the specifications and functional capabilities of the legally marketed predicate device (Neo2 meter). The HDM97's performance is accepted as equivalent if its specifications, intended use, and technological characteristics are deemed sufficiently similar to the predicate device, or if any differences do not raise new questions of safety or effectiveness.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This is not an AI/machine learning device that would have a "training set."

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

• Training Set Ground Truth: Not applicable.

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The HDM99 may be used by hemodialysis personnel to test the conductivity, temperature, pressure, pH and flow of the dialysate solution used with hemodialysis delivering systems.

The HDM99 may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications.

The HDM99 may also be used to test the voltage and alternating signals in hemodialysis delivering systems.

The HDM99 was developed in 1990. The first version was called HDM90. 1996 we added the Flow measurement. From this time on the device was called HDM96.

1999 we increased accuracy and software functionality. The device was renamed to HDM99.

The HDM99 has a large, easy readable Graphic Liquid Crystal Display. It comes with a waterproof key membrane. All selections are done with 22 key's including On and Off.

The software is designed to be logical and easy to use for the user either safe and precise in measurement.

The HDM99 has a RS232-Interface for the possibility to collect and visualize data on a PC.

The software is designed to be logical and easy to use for the user either safe and precise in measurement.

The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary and FDA clearance letter for the HDM99 device, focusing on its substantial equivalence to a predicate device based on general safety and effectiveness standards, not specific performance criteria from a dedicated study.

Therefore, I cannot provide the requested information.

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