(84 days)
The leak detection sensor and tray provide a means of detecting fluid leaks when used as an accessory to the NxStage System One.
The NxStage leak detection sensor and tray is designed for use with the NxStage System One. The plastic tray and leak detection sensor are external devices that are not connected to the NxStage System One. The tray fits under the door area of the NxStage System One cycler. The tray includes a molded area on the left-hand side that holds a commercially available leak detection sensor.
The provided text describes a 510(k) premarket notification for the "NxStage Medical, Inc. Leak Detection Sensor and Tray." It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report with performance metrics.
Therefore, many of the requested details, such as specific acceptance criteria, reported device performance metrics, sample sizes, expert qualifications, and ground truth establishment, are not explicitly available in the provided document.
However, I can extract and infer some information:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the document. The document states: "Performance, verification and validation testing was conducted to characterize performance of the proposed leak detection sensor and tray. Results of this testing have documented that the proposed leak detection sensor and tray is substantially equivalent to the predicate devices and is suitable for the labeled indications for use." This implies that the device met internal acceptance criteria for substantial equivalence, but the specific metrics are not detailed here.
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not provided. The document generally mentions "Performance, verification and validation testing" but does not specify the sample size for these tests.
- Data provenance: Not provided. The location or nature (retrospective/prospective) of the data collection is not mentioned. It is implied to be internal testing by NxStage Medical, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not applicable/Not provided. For a leak detection sensor, the "ground truth" would likely be objectively determined (e.g., whether a leak actually occurred and was detected) rather than requiring expert consensus interpretation. The document does not mention any expert involvement for ground truth establishment.
- Qualifications of experts: Not applicable/Not provided.
4. Adjudication method for the test set:
- Adjudication method: Not applicable/Not provided. As stated above, the ground truth for a physical leak detection system is typically objective and doesn't involve subjective adjudication by multiple experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- MRMC study: No. This type of study is relevant for diagnostic imaging or interpretation tasks where human readers make subjective judgments. A leak detection sensor is an automatic detection system, so an MRMC study is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone performance: Yes, implicitly. The device (Leak Detection Sensor and Tray) is a standalone accessory designed to detect fluid leaks automatically. The performance testing mentioned ("Performance, verification and validation testing was conducted to characterize performance") would inherently be standalone, evaluating the sensor's ability to detect leaks without human intervention in the detection process itself. Human intervention would be in responding to the alarm, not in the detection.
7. The type of ground truth used:
- Type of ground truth: Implied objective/physical ground truth. For a leak detection sensor, the ground truth would be established by physically creating leaks of specified volumes/rates and verifying if the sensor consistently detects them. This would be an objective, experimentally controlled ground truth.
8. The sample size for the training set:
- Sample size for training set: Not applicable/Not provided. This device is a sensor, likely relying on physical principles (e.g., conductivity) rather than a complex algorithm that requires a "training set" in the machine learning sense. The performance is characterized through verification and validation testing against defined specifications.
9. How the ground truth for the training set was established:
- Ground truth for training set: Not applicable/Not provided. As explained in point 8, a "training set" for an algorithm to establish ground truth is generally not relevant for a simple leak detection sensor. If there were any calibration or development, it would involve empirical testing against known leak conditions.
§ 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.