(471 days)
Micro-X Potency Test Strips are intended for use as a semi-quantitative test of the presence of peracetic acid in dialyzers after reprocessing. This device may be used with all peroxyacetic/peracetic acid germicides used in the reprocessing of dialyzers as part of an established quality assurance program.
Micro X Potency Test Strips are approximately 0.25" x 2.0" packaged 100strips /container. The strips are labeled for use in Reprocessing Hemodialyzers. Micro Xen Potency Test Strips are impregnated with an indicator solution which is activated by the presence of peracetic acid. The reaction results in a color change of the indicator which provides visual confirmation of the presence of peracetic acid.
The provided text describes a medical device called "Micro X Potency Test Strips" and its 510(k) submission. However, the document does not contain explicit "acceptance criteria" in a tabulated format or a detailed description of a "study that proves the device meets the acceptance criteria" in the way one would expect for a quantitative performance study involving AI or complex diagnostics.
The core of the submission is a demonstration of substantial equivalence to a predicate device, not necessarily a demonstration of meeting predefined numerical performance targets in a standalone study.
Here's an attempt to extract and infer the requested information based on the provided text, while acknowledging the limitations of what's available:
1. A table of acceptance criteria and the reported device performance
Based on the document, the primary "acceptance criterion" is the demonstration of "identical performance" to the predicate device. The device's fundamental characteristic is a binary output (YES/NO) for the presence of peracetic acid above a minimum level.
| Acceptance Criteria (Inferred from function) | Reported Device Performance |
|---|---|
| Visual confirmation of peracetic acid presence upon activation above a minimum level. (YES/NO indication) | Identical performance to Renalin Indicator Test Strips |
| Activates only in the presence of peracetic acid. | Identical performance to Renalin Indicator Test Strips |
| Does not provide a measure of concentration (i.e., not quantitative). | The test is not quantitative. |
2. Sample size used for the test set and the data provenance
The document states: "Comparative testing between Micro X Potency Strips, Renalin Indicator Test Strips indicate identical performance among the test strips."
- Sample Size for Test Set: Not specified. The phrase "among the test strips" suggests multiple strips were tested, but no specific number is provided.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It appears to be a laboratory comparison performed by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The "ground truth" for this type of chemical indicator would typically be established by known concentrations of peracetic acid solutions, rather than expert interpretation of a complex image or signal.
4. Adjudication method for the test set
Not applicable/Not specified. Given the nature of a chemical indicator changing color, visual observation is the method. There's no indication of multiple readers adjudicating results or complex decision-making.
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
- MRMC Study: No.
- Effect Size: Not applicable. This device is a simple chemical indicator, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This is a manual chemical indicator, requiring human visual interpretation of a color change. It is not an algorithm or an AI device.
7. The type of ground truth used
The implicit ground truth is the known presence/absence and concentration of peracetic acid solutions. The device is activated by the presence of a minimum level of peracetic acid.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this 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.