(46 days)
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.
§ 876.5665 Water purification system for hemodialysis.
(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.