(62 days)
The NxStage Connected Health System is for use by chronic hemodialysis patients remotely in combination with the NxStage System One and a variety of devices such as blood pressure monitor and weight scale upon the prescription of a licensed physician or healthcare practitioner. The Connected Health System serves as the data repository and communication link to the server software which is utilized by the healthcare facility. The healthcare facility may include the physician or licensed healthcare practitioner, other clinicians, or a disease management center.
The purpose of the system is to collect, accumulate, store and transmit medical information such as flowsheet data, vital signs, blood pressure, weight and dialysis data from the patient and transmit these results to their healthcare practitioner at another facility. The system also provides online labeling, treatment status, trending and supports education and messaging.
The device is not intended to provide time sensitive data or alarms and does not control the System One Cycler. This system may not be used as a substitute for direct medical intervention or emergency care.
Interpretation of the information collected and transmitted requires clinical judgment by an experienced medical professional.
The NxStage Connected Health system collects, stores, and transmits medical information such as flowsheet data, vital signs, blood pressure, weight, and dialysis treatment data from the patient and transmits these results to their healthcare practitioner at another facility. The system also provides online labeling, treatment status, trending and supports education, has the ability to add picture attachments through the notes in a flowsheet, and the ability for the Clinician to remotely access snapshots of patient's treatment data while the treatment is taking place.
The internet server receives the patient data from the home setting or remote location where it is made available to the healthcare facility to track, graph, trend, note variances, set alert criteria, and receive alerts when parameters are outside the criteria set.
The provided documentation is a 510(k) Premarket Notification for the NxStage Connected Health System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results often seen in PMA (Premarket Approval) submissions. Therefore, the information regarding acceptance criteria and performance studies is primarily related to non-clinical verification and validation testing, and does not involve AI or human reader studies.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Verification Testing | Performed by Software Quality Engineering personnel not involved in design. All tests performed according to approved protocols with pass/fail criteria. All predetermined acceptance criteria were met. |
| Simulated Use Testing | Approved protocol executed to validate end-to-end system (Nx2me App - Nx2me Clinician Portal), GUI functionality, general use, and customer use scenarios. All predetermined acceptance criteria were met. |
| Design Validation Testing | Performed on new functional areas ("Link" and "Remote View") by Clinicians at Dialysis Clinics and NxStage Technical Support personnel. All predetermined acceptance criteria were met. |
| Overall Conclusion | The system performs as intended, is safe and effective for its intended use, and has been successfully validated. All predetermined acceptance criteria were met. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document describes non-clinical verification and validation testing, not a clinical study involving a "test set" of patient data in the sense of a dataset for AI evaluation.
- Sample size: Not applicable in the context of a "test set" of patient data for AI. The testing involved various software verification tests, simulated use scenarios, and design validation activities rather than a sample of patient data.
- Data provenance: Not applicable. The testing is described as internal verification and validation of software and system functionalities by the manufacturer.
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)
This is not applicable as the document describes non-clinical software and system validation, not a study requiring expert-established ground truth for a diagnostic AI.
- Design Validation Testing (for "Link" and "Remote View" functionalities) involved "Clinicians at Dialysis Clinics and NxStage Technical Support personnel." Specific numbers or detailed qualifications are not provided beyond "Clinicians" and "Technical Support personnel."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. The description refers to internal verification and validation testing with predetermined pass/fail criteria, not a clinical study with an adjudication process for ground truth establishment.
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
No MRMC study was done. This submission is for a data collection and communication system, not an AI-powered diagnostic device. The device does not involve "human readers" or "AI assistance" in the diagnostic context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a system for collecting, storing, and transmitting medical information, not a standalone diagnostic algorithm. It explicitly states it is "not intended to provide time sensitive data or alarms and does not control the System One Cycler" and "Interpretation of the information collected and transmitted requires clinical judgment by an experienced medical professional."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of diagnostic ground truth. The "ground truth" for the verification and validation described here would be the pre-defined product specifications and requirements that the system was tested against. The software functionality was verified to meet these specifications.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a "training set." It is a data collection and communication system.
9. How the ground truth for the training set was established
Not applicable. As noted above, 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.