FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for a medical device. This type of regulatory submission does not contain the detailed study information, acceptance criteria, or performance data that would be found in a clinical study report or a more comprehensive premarket application (like a PMA).

Therefore, based only on the provided text, I cannot answer most of your specific questions. I can only infer very limited information.

Here's a breakdown of what can and cannot be answered from the provided text:

Information that CANNOT be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. A 510(k) clearance letter confirms substantial equivalence, but doesn't detail performance metrics or acceptance criteria unless specifically included in the "Indications for Use" which it isn't here.
2. Sample sized used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/available for this type of document.
4. Adjudication method: Not applicable/available.
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 an "Extracorporeal Blood Circuit," not an AI-powered diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm/AI device.
7. The type of ground truth used: Not applicable/available.
8. The sample size for the training set: Not applicable/available (not an AI device).
9. How the ground truth for the training set was established: Not applicable/available (not an AI device).

What can be extracted/inferred:

Device Name: Extracorporeal Blood Circuit
Intended Use: "channeling blood during Haemodialysis Treatement."
Regulatory Class: II
Product Code: 78 FJK
Submission Type: 510(k) Premarket Notification
Manufacturer: Haidylena Medical
Date Cleared: Apr 30, 1999
Substantial Equivalence: The device was found substantially equivalent to predicate devices. This implies that its performance (safety and efficacy) is considered on par with existing, legally marketed devices for the same intended use, but the specific performance data is not detailed in these documents.

Conclusion:

The provided documents are regulatory clearance letters and an "indications for use" statement. They do not contain the specific performance study details (acceptance criteria, sample sizes, ground truth methods, expert qualifications, etc.) that would typically be required to answer your questions. These details would be found in the full 510(k) submission summary or associated testing reports, which are not included here.

Summary

Regulation Number and Section

§ 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.