(246 days)
SteriChek® Bicarb pH Reagent Strips provide a quick convenient means of checking the pH of bicarbonate solution used to prepare dialysate and concentrated bicarbonate solutions used in the preparation of dialysate.
The device is made up of a 0.20 inch square off-white reagent pad that has been chemically treated and affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip. The reagent pad is activated by exposing it to the sample. The color of the pad is visually compared to a color chart to determine the pH of the bicarbonate solution.
I am sorry, but the provided text does not contain a detailed study proving the device meets acceptance criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive study with specific acceptance criteria and detailed performance metrics.
However, based on the information provided, here's what I can extract and infer:
1. A table of acceptance criteria and the reported device performance
The document implicitly uses performance equivalence to the predicate device as its acceptance criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance equivalent to predicate device (Serim™ Bicarb pH II Test Strips) in measuring pH of acid/bicarbonate solutions and concentrated bicarbonate solutions. | "The performance was equivalent." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated. The document mentions "acid/bicarbonate solutions" and "concentrated bicarbonate solutions" were "prepared," implying a laboratory setting, but the number of samples or data points is not provided.
- Data Provenance: Not explicitly stated. It's safe to assume a laboratory setting for the preparation of solutions, likely within the United States given the submitter's address, but this is an inference. The study appears to be prospective as it involves preparing specific solutions for testing.
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)
Not applicable. The ground truth was established by instrumental measurement.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The ground truth was established by instrumental measurement rather than expert 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 a reagent strip for visual comparison, not an AI or imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not directly applicable to a reagent strip. The "performance" of the device is its ability to produce a color change accurately reflecting pH, which is then visually interpreted by a human against a color chart. The "algorithm" here is the chemical reaction on the strip. The testing was of this chemical reaction's accuracy against a standard reference method.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth was established using a "standard reference method with calibration based on NIST traceable standard reference material" to determine reference pH values. This is an objective instrumental ground truth.
8. The sample size for the training set
Not applicable. This device is a chemical reagent strip, not a 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.