(85 days)
OneView is an optional computer-based interface to be used with the NxStage System One to provide on-line instructions for use, summarized system information, and remote access.
OneView is contraindicated as the sole method of monitoring a patient during treatment.
OneView is an optional computer-based interface accessory to the NxStage System One to provide on-line instructions for use, summarized system information, and remote viewing of treatment information. OneView consists of software, a flat panel touch screen display, and a central processing unit (CPU).
The provided text is related to a 510(k) premarket notification for the NxStage OneView Interface, a hemodialysis accessory. It describes the device, its intended use, and states that performance testing was conducted to demonstrate substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or detailed results of a study that proves the device meets those criteria, nor does it provide information on reader studies, sample sizes, ground truth establishment, or expert qualifications.
The content focuses on regulatory submission details and general statements about performance testing. Therefore, based on the provided text, I cannot complete the table or answer most of the questions as the information is not present.
Here's what can be extracted from the given input:
1. A table of acceptance criteria and the reported device performance
The document states: "Performance testing was conducted to characterize performance of the proposed NxStage OneView Interface to provide a basis of comparison to the predicate devices. Results of the performance testing have documented that the proposed NxStage OneView Interface is substantially equivalent to the predicate devices and is suitable for the labeled indications for use."
However, no specific acceptance criteria or quantitative performance metrics are provided in the document. Therefore, this table cannot be filled out.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
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 information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. The device is an interface accessory, not an AI for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is an interface accessory and not an algorithm for standalone diagnostic performance. The document explicitly states: "OneView is contraindicated as the sole method of monitoring a patient during treatment." This implies it's designed to assist, not replace, human monitoring.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the document. The device is for displaying information and instructions, not making diagnostic or therapeutic decisions independently.
8. The sample size for the training set
This information is not provided in the document.
9. How the ground truth for the training set was established
This information is not provided in the document.
§ 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.