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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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The HYDRA Meter is a hand-held, multi-test instrument intended for use by water purification specialists to measure the conductivity, resistivity, total dissolved solids (TDS), pH, and temperature of water used in hemodialysis.

The HYDRA Meter may also be used to verify proper functioning of the water system's in-line conductivity, resistivity and pH meters.

The HYDRA Meter is a hand-held, multi-test instrument.

This FDA letter and associated Indications for Use statement do not contain the detailed information necessary to fully answer the request regarding acceptance criteria and a study proving device performance. This document is a 510(k) clearance letter, which means the device (HYDRA Meter) was determined to be substantially equivalent to an already marketed predicate device, rather than requiring extensive clinical trials for approval.

Therefore, the requested information, which would typically be found in a comprehensive clinical study report or a detailed 510(k) submission summary, is not available in the provided text.

Based on the provided text, here's what can be stated about the device and the lack of study information:

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

• Not available. The document does not specify any performance acceptance criteria or report specific performance metrics for the HYDRA Meter. As a 510(k) clearance, the primary focus is on substantial equivalence to a predicate device rather than presenting detailed performance data against pre-defined acceptance criteria.

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

• Not available. There is no mention of a test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective).

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

• Not applicable/Not available. Since no test set or ground truth establishment process is described, this information is not present.

4. Adjudication method for the test set

• Not applicable/Not available. No information on adjudication is provided.

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

• Not applicable. The HYDRA Meter is described as a "hand-held, multi-test instrument" for measuring water parameters (conductivity, resistivity, TDS, pH, temperature). It is not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

• Not applicable. This device is an instrumentation device, not an algorithm, so a standalone algorithm performance study is not relevant.

7. The type of ground truth used

• Not available. No ground truth for device performance is discussed in this document. For devices measuring physical parameters, the "ground truth" would typically refer to highly accurate reference measurements against which the device's accuracy is assessed, but no such assessment is detailed here.

8. The sample size for the training set

• Not applicable/Not available. This is a physical instrument, not a machine learning model, so there is no concept of a "training set."

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

• Not applicable/Not available. As above, no training set concept applies.

Summary based on available information:

The provided document is a 510(k) clearance letter for the HYDRA Meter. This type of clearance relies on demonstrating "substantial equivalence" to a predicate device already on the market, rather than requiring the extensive clinical trial data typically found in a PMA (Premarket Approval) or for a novel device. Therefore, the details requested about acceptance criteria, study design, sample sizes, expert ground truth, and specific performance metrics are not typically included in a 510(k) clearance letter itself. These details would likely be part of the full 510(k) submission, which is not provided here.

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