(192 days)
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."
| Characteristic | Acceptance Criteria (Implied from Predicate Specifications) | Reported Device Performance (Implied) |
|---|---|---|
| Conductivity Accuracy | ±0.01 mS/cm from 0.10 to 1.99 mS/cm | |
| ±0.1 mS/cm from 2.0 to 19.9 mS/cm | ||
| ±2.0 mS/cm from 20.0 to 119.9 mS/cm | ||
| Max ±30.0 mS/cm from 120.0 to 200.0 mS/cm | **±0.01 mS/cm from 0.10 to 1.99 mS/cm | |
| ±0.1 mS/cm from 2.0 to 19.9 mS/cm | ||
| ±2.0 mS/cm from 20.0 to 119.9 mS/cm | ||
| ±5.0 mS/cm from 120.0 to 200.0 mS/cm** | ||
| Conductivity Resolution | 0.01 mS/cm from 0.10 to 1.99 mS/cm | |
| 0.1 mS/cm from 2.0 to 19.9 mS/cm | ||
| 1 mS/cm from 20.0 to 200.0 mS/cm | 0.01 mS/cm from 0.10 to 1.99 mS/cm | |
| 0.1 mS/cm from 2.0 to 19.9 mS/cm | ||
| 1 mS/cm from 20.0 to 200.0 mS/cm | ||
| Conductivity Temperature Compensation | 15°C to 45°C | 15°C to 45°C |
| Temperature Range | 15°C to 90°C | 15°C to 90°C |
| Temperature Accuracy | ±1°C from 15°C to 90°C | ±1°C from 15°C to 90°C |
| Temperature Resolution | 1°C from 15°C to 90°C | 1°C from 15°C to 90°C |
| pH Range | 2.0 to 10.0 pH | 2.0 to 10.0 pH |
| pH Accuracy | ±0.1 from 2.0 to 10.0 pH | ±0.1 from 2.0 to 10.0 pH |
| pH Resolution | 0.1 from 2.0 to 10.0 pH | 0.1 from 2.0 to 10.0 pH |
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.
§ 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.