(65 days)
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):
| Specification | Reported SmartHDM-510 System Performance |
|---|---|
| Conductivity Measuring Range | 0 to 200 mS/cm |
| Conductivity Range Accuracy | 0 to 199.9 uS/cm ± 0.6 uS/cm |
| 200 to 1999 uS/cm ± 6 uS/cm | |
| 2 to 11.99 mS/cm ± 0.06 mS /cm | |
| 12 to 19.99 mS/cm ± 0.03 mS/cm | |
| 20 to 200 mS/cm ± 0.60% of reading | |
| Temperature Measuring Range | 0 to 100 °C |
| Temperature Accuracy | ± 0.1°C |
| Pressure Measuring Range | -672 to +1551 mmHg |
| Pressure Accuracy | 0 to 300 mmHg ± 1 mmHg, otherwise ± 2 mmHg |
| Flow Measuring Range | 100 to 2000 ml/min |
| Flow Measuring Accuracy | ± 2.0 % of reading |
| pH Measuring Range | 0...14 pH |
| pH Measuring Accuracy | ± 0.02 pH |
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.
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.