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The SmartHDM-510 system may be used by hemodialysis personnel to test the conductivity, temperature, pH and flow of the dialysate solution used with hemodialysis delivering systems.

The SmartHDM-510 system 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 intended use is limited to periodic use for installation and maintenance of hemodialysis delivering systems and does not include the daily monitoring of hemodialysis delivering systems prior to treatment.

The SmartHDM-510 System is designed for the installation and maintenance of hemodialysis delivering systems. The system consists of different sensors and sensor-modules to measure conductivity, temperature, pressure, pH and flow and an Android operating system based display module with SmartHDM-510 App.

The SmartHDM-510 system consists of:

• HDU-Sensors for Conductivity/Temperature, Pressure, pH and flow
• HDM-Sensor Modules for Conductivity/Temperature, Pressure,
• 90XL-Sensors for Conductivity/Temperature, Pressure and pH
• Android-based Display Module with SmartHDM-510 App.

The provided text describes the SmartHDM-510 System, a device used for testing hemodialysis systems. However, it does not contain specific acceptance criteria, a detailed study proving device performance against such criteria, or the requested information regarding sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed performance study with explicit acceptance criteria as typically found in clinical trials or rigorous validation studies.

Here's an analysis of what is available and what is missing based on your request:

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

• What's available: The document provides a comparative table of specifications between the SmartHDM-510 System and three predicate devices (HDM99, HDM97, and 90XL). This table lists various performance parameters such as "Conductivity Measuring Range," "Conductivity Range Accuracy," "Temperature Measuring Range," "Temperature Accuracy," "Pressure Measuring Range," "Pressure Accuracy," "Flow Measuring Range," "Flow Measuring Accuracy," "pH Measuring Range," and "pH Measuring Accuracy."
• What's missing: Explicitly defined acceptance criteria (e.g., "The device must achieve conductivity accuracy of X ± Y"). While the device's reported performance (e.g., "Conductivity Range Accuracy: 0 to 199.9 uS/cm +/- 0.6 uS/cm") is listed, the document does not state what "acceptable" performance would be for these parameters. The comparison is primarily against the performance of the predicate devices to show equivalence.

Table of Performance (extracted from the provided text, but without explicit acceptance criteria):

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

• Missing: The document states "The design of the device has been verified and validated both through testing and actual experience in international use" and "The testing and international experience provided data that demonstrated substantial equivalence to the predicate devices." However, it does not provide any specific sample sizes, details about test sets, data provenance (country of origin), or whether the data was 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)

• Missing: This information is completely absent from the document. The device measures physical parameters (conductivity, temperature, pH, flow, pressure), which are typically verified against calibrated reference standards, not established by human experts in the way clinical diagnostic devices are.

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

• Missing: As the device measures physical parameters, adjudication methods involving multiple human readers are not applicable or mentioned.

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

• Missing: No MRMC comparative effectiveness study is mentioned, nor is there any AI component described that would involve human readers improving with AI assistance. The device is a measurement instrument for hemodialysis systems, not an AI-assisted diagnostic tool.

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

• Missing (in the context of "algorithm only"): The device is a measurement system; its "performance testing" refers to the accuracy and reliability of its physical measurements. It is not an algorithm making diagnostic decisions. While it operates "standalone" in the sense that it provides measurements without human-in-the-loop diagnostic interpretation, the concept of "standalone performance" as typically applied to AI/algorithmic medical devices doesn't fit here. The performance described is inherently standalone as it's mechanical/electronic measurement.

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

• What's available (implied): The "ground truth" for the measurements would be established by calibrated reference standards and established metrology practices for conductivity, temperature, pH, pressure, and flow. The document mentions "system verification and validation testing," which would inherently involve comparison to such standards.
• What's missing: Explicit details on how the ground truth was established for each parameter (e.g., "Conductivity was verified against NIST-traceable conductivity standards").

8. The sample size for the training set

• Missing: This device is a measurement instrument, not a machine learning/AI device, so there is no "training set" in the typical sense.

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

• Missing: Not applicable for this type of device.

In summary:

This document is a regulatory submission focused on demonstrating substantial equivalence for a medical device that measures physical parameters. It provides performance specifications but lacks the detailed study information (sample sizes, ground truth establishment specifics, expert involvement, etc.) that would be expected for a complex AI/diagnostic device or a clinical trial. The "study" mentioned is a general "performance testing" and "verification and validation" against compliance standards, not a specific clinical or comparative effectiveness study as implied by many of your questions.

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This device is designed for use by hemodialysis professionals to verify the conductivity, temperature, and pH of solutions in the hemodialysis setting.

This device is a hand-held battery powered, multi-test meter designed for use by hemodialysis professionals to measure the conductivity, temperature and pH of Dialysate solutions associated with the dialysis treatment. The unit houses the conductivity cell, electronic circuitry and digital display. A syringe attaches to the unit with luer connectors. When pulled, the syringe creates a vacuum and draws solution through the conductivity cell for measurement. The conductivity cell contains the conductivity electrodes, a thermistor, and a pH electrode. A 3.6 volt battery provides power.

The provided text is a 510(k) Summary for the Phoenix XL Dialysate Meter. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and the comprehensive study results of the new device. However, it does provide some information that can be used to infer acceptance criteria and aspects of the study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The table below reconstructs the acceptance criteria based on the "Technological Characteristics" comparison with the predicate device. The "Reported Device Performance" is implied to meet these criteria, as the document states the device is "substantially equivalent" and that "the results of the validations show that the pHoenix XL Dialysate Meter is equivalent to the pHoenix Dialysate Meter for measuring Conductivity, pH, and temperature."

Note on Conductivity Accuracy: The new device (Phoenix XL Dialysate Meter) actually improves on the predicate's conductivity accuracy in the range of 120.0 to 200.0 mS/cm (±5.0 mS/cm for the new device vs. ±30.0 mS/cm for the predicate). This demonstrates it meets or exceeds the predicate's performance.

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

The document states: "Nonclinical Validation of the performance of the device was performed on units equivalent to production."

• Sample size: Not explicitly stated. The phrase "units equivalent to production" suggests more than one unit, but a specific number is not provided.
• Data provenance: Not explicitly stated. However, nonclinical validation of a device manufactured by Mesa Laboratories, Inc., located in Colorado, USA, implies the testing would have been conducted internally or by a contracted lab within the USA. The study design is a nonclinical validation, meaning it does not involve human subjects. It would be considered prospective as it's testing a new device designed for market.

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

Not applicable. This device measures physical parameters (conductivity, temperature, pH) directly, rather than interpreting images or clinical data where expert consensus would be required for ground truth. The "ground truth" would be established by reference standards or highly accurate laboratory equipment.

4. Adjudication method for the test set

Not applicable. As noted above, the measurements are direct physical parameters, not subjective assessments requiring adjudication.

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

Not applicable. This device is not an AI-assisted diagnostic or interpretation tool. It is a measurement device where human readers are not involved in interpreting its "output" in a comparative effectiveness study sense.

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

Yes, a standalone performance evaluation was conducted. The "Nonclinical Validation" specifically assesses the device's ability to measure conductivity, pH, and temperature. The device itself (the "algorithm" in this context) directly provides the measurements without human interpretation or intervention in the measurement process.

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

The ground truth for this type of device would typically be established by:

• Reference standards: Calibrated solutions with known conductivity, temperature, and pH values.
• Highly accurate laboratory equipment: Measurements taken simultaneously or sequentially by laboratory-grade instruments calibrated to primary standards.
• This is an objective physical measurement and does not rely on subjective expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This is a physical measurement device, not an AI or machine learning model 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 type of device.

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The 90XL Dialysis Meter is intended for use by hemodialysis professionals to measure the conductivity, temperature, pH, and pressure of the dialysate solution associated with hemodialysis delivery systems. Water purification specialists may also use the 90XL instrumentation system to verify proper characteristics of the water used in hemodialysis. These parameters are key indicators of system performance that require periodic monitoring and documentation for effective hemodialysis systems.

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I apologize, but the provided text only contains a 510(k) clearance letter for the "90XL Instrumentation System" and its "Indications for Use Statement."

It does NOT contain any information about acceptance criteria, device performance results, study details (sample sizes, ground truth establishment, expert qualifications, adjudication methods), or multi-reader multi-case studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

To answer your request, I would need a document that specifically details:

• The performance metrics used (e.g., accuracy, sensitivity, specificity for diagnostic devices, or specific measurement tolerances for instrumentation like the 90XL).
• The predefined acceptance thresholds for those metrics.
• The methodology and results of a study designed to demonstrate the device meets those thresholds.

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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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The NEO-2 Meter may be used by hemodialysis personnel to test conductivity, temperature, pressure, and pH of the dialysate solution used with hemodialysis delivery systems. The NEO-2 Meter may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications.

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This document is a 510(k) clearance letter from the FDA for a device called the "NEO-2 Meter". It indicates that the device has been found substantially equivalent to a predicate device. However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The text only states:

• Device Name: NEO-2 Meter
• Intended Use: To test conductivity, temperature, pressure, and pH of the dialysate solution used with hemodialysis delivery systems, and the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications.
• Regulatory Class: II (21 CFR §876.5820/Product Code: 78 FIZ)
• Date of Clearance: October 13, 1999

Therefore, I cannot provide the requested information regarding acceptance criteria and studies because it is not present in the provided text. The output will reflect this lack of information for each requested point.

Acceptance Criteria and Study Information for NEO-2 Meter

Based on the provided document, the following information regarding acceptance criteria and supporting studies for the NEO-2 Meter is not available:

1. Table of acceptance criteria and reported device performance:

   • No acceptance criteria are mentioned in the document.
   • No device performance data is reported.

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

   • No information about a test set or its sample size is provided.
   • No data provenance (country of origin, retrospective/prospective) is mentioned.

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

   • No information regarding experts or ground truth establishment is provided.

4. Adjudication method for the test set:

   • No information regarding a test set or adjudication method is provided.

5. Multi-reader multi-case (MRMC) comparative effectiveness study and effect size:

   • No MRMC study or comparative effectiveness data is mentioned.

6. Standalone (algorithm-only) performance:

   • The NEO-2 Meter is a physical measurement device, not an AI/algorithm-based device in the context typically described by "standalone performance." Therefore, this question is not applicable, and no such study is mentioned anyway.

7. Type of ground truth used:

   • No information about the type of ground truth is provided.

8. Sample size for the training set:

   • This question is typically relevant for machine learning models. As the NEO-2 Meter is a measurement device, a "training set" in this context is not applicable. No information about any training data is provided.

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

   • As with point 8, this is not applicable for this type of device, and no relevant information is provided.

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The ODYSSEY Instrumentation System is intended for use by hemodialysis professionals to measure the conductivity, temperature, pH, and pressure of the dialysate solution associated with hemodialysis delivery systems. Water purification specialists may also use the ODYSSEY Instrumentation System to verify proper characteristics of the water used in hemodialysis. These parameters are key indicators of system performance that require periodic monitoring and adjusting to maintain safe and effective hemodialysis systems.

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The provided documents (K981294) are a 510(k) clearance letter and an Indications for Use statement for the "ODYSSEY Instrumentation System." This system is intended for measuring physical parameters of dialysate solution (conductivity, temperature, pH, and pressure) and water for hemodialysis. It is not a device that processes or analyzes medical images, clinical data, or makes diagnostic/AI predictions.

Therefore, the concepts of "acceptance criteria," "study," "sample size," "ground truth," "experts," "adjudication method," "MRMC study," and "standalone performance" do not apply in the context of this device. These terms are relevant for evaluating devices that generate or interpret clinical information, especially those incorporating AI or complex algorithms for diagnosis or prediction.

The ODYSSEY Instrumentation System is a measurement device. Its "performance" would typically be established through metrology studies, calibration, and validation against known standards to ensure accuracy, precision, and reliability of its measurements (conductivity, temperature, pH, pressure). The "acceptance criteria" for such a device would relate to the maximum permissible error, stability, response time, and other metrological specifications in comparison to established industry standards or a predicate device.

To provide an answer in the requested format, but acknowledging the mismatch in the nature of the device and the questions, I will state that the information requested is not applicable given this device's function.

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

• Not Applicable. The provided documents do not contain acceptance criteria or reported device performance data in the context of a clinical study for diagnostic accuracy or algorithmic performance. As a measurement instrumentation system, its performance would be defined by metrological specifications (e.g., accuracy, precision, linearity for conductivity, temperature, pH, and pressure), which are not detailed in these regulatory documents.

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

• Not Applicable. This device is a physical measurement system, not one that processes clinical data or involves a "test set" in the sense of clinical samples or imaging data for diagnostic evaluation.

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. The device measures physical parameters. "Ground truth" for such a device would be established through calibrated standards and reference methods, not by expert consensus on clinical data.

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

• Not Applicable. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies where human interpretation is involved. This device does not generate such data.

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

• Not Applicable. This is not an AI-assisted diagnostic device, nor does it involve human readers interpreting clinical cases.

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

• Not Applicable. There is no "algorithm only" performance or human-in-the-loop component in the diagnostic sense for this device. It is a measurement instrument.

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

• Not Applicable. For a measurement instrument, "ground truth" would refer to NIST-traceable standards, certified reference materials, or highly accurate reference measurement systems for conductivity, temperature, pH, and pressure. These details are not provided in the submitted documents.

8. The sample size for the training set

• Not Applicable. This type of device does not involve a "training set" in the context of machine learning or AI.

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

• Not Applicable. As above, no training set is relevant for this device.

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