(68 days)
The Hemocor HPH Mini Hemoconcentrator is intended for the relief or mitigation of overhydration, reduction of lower molecular weight constituents and to increase formed cellular elements and protein levels in the blood of patients during and/or after cardiopulmonary procedures.
The Minntech Hemocor HPH® Mini Hemoconcentrator is made of glycerin-free polysulphone membrane. Barbed luer adaptors of 3/16" and 1/4" for blood path connection and a no-rinse feature provide versatility for insertion of the device into the extracorporeal circuit.
This document describes a 510(k) premarket notification for a medical device, the Minntech Hemocor HPH® Mini Hemoconcentrator. The information provided focuses on demonstrating substantial equivalence to a predicate device through technological characteristics and performance testing. It does not contain information about the acceptance criteria and study design you've requested for typical AI/algorithm-based device evaluations.
Here's a breakdown of why this document doesn't fit your requested format and what information is missing:
Why this document doesn't fit your request:
- Device Type: This is a physical medical device (a hemoconcentrator), not a software/AI algorithm. Therefore, the concepts of "test set," "training set," "ground truth," "experts," "adjudication," "MRMC study," and "standalone performance" as they relate to AI/HIL performance are not applicable.
- Regulatory Pathway: This is a 510(k) submission, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves comparing device specifications and performance data, not clinical studies with "ground truth" and reader performance metrics in the way your questions imply for AI.
- Data Provided: The document details the device's physical characteristics, materials, and generic performance tests (e.g., Ultrafiltration Rate, Pressure Drop). It does not provide detailed information on clinical study design or outcomes related to diagnostic accuracy or human reader improvement.
Attempting to answer your questions based only on the provided text, while acknowledging the mismatch:
Given the nature of the device (a hemoconcentrator) and the provided 510(k) summary, the concepts of "acceptance criteria" and "study" in the context of an AI/algorithm-driven device are not directly applicable. The "acceptance criteria" here would be demonstrating that the device performs as intended and is substantially equivalent to the predicate, and the "study" is the performance testing described.
1. A table of acceptance criteria and the reported device performance
| Characteristic | Acceptance Criteria (Implied: Substantially Equivalent to Predicate) | Reported Device Performance (Minntech Hemocor HPH® Mini Hemoconcentrator) |
|---|---|---|
| Housing | Same as predicate | Polycarbonate |
| Potting Material | Same as predicate | Polyurethane |
| Membrane | Same as predicate | Polysulphone |
| Membrane Surface Area | Different from predicate (smaller area) – justified by intended use | 0.07 m² |
| Effective Fiber Length (cm) | Same as predicate | 9.4 |
| Maximum Transmembrane Pressure (mmHg) | Same as predicate | 500 |
| Max. Blood Flow rate (ml/min) | Same as predicate | 500 |
| Min. Blood Flow rate (ml/min) | Different from predicate (lower min flow rate) | 50 |
| Priming volume (ml) | Different from predicate (smaller volume) | 14 |
| Molecular weight cut-off (daltons) | Same as predicate | 65000 |
| Device Effectiveness as Hemoconcentrator | Device performs as intended for "relief or mitigation of overhydration and reduction of lower molecular weight constituents" and passes specified functional tests. | Ultrafiltration Rate vs. Transmembrane Pressure studies conducted. |
| Pressure Drop vs. Blood Flow Rate studies conducted. | ||
| Protein Rejection studies conducted. | ||
| Minimum Blood Flow Rate & Blood Path Integrity studies conducted. |
Note: The "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device. The performance characteristics for the new device are directly compared to the predicate, and functional tests are listed as having been conducted to ensure effectiveness.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. For a physical device like this, "test set" and "data provenance" in the context of diagnostic accuracy are not relevant. The "testing" refers to benchtop or in-vitro performance evaluations of the device's physical functions. The document does not specify the number of units tested, the origin of test data, or if it was retrospective/prospective.
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. Ground truth, in the sense of expert consensus for diagnostic cases, is not relevant for this physical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication is not relevant for this physical device.
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
- No. An MRMC study is not applicable to a physical hemoconcentrator.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. "Ground truth" as defined for AI/diagnostic algorithms is not relevant here. The "truth" is the device's physical and functional performance against established engineering and medical standards for hemoconcentrators.
8. The sample size for the training set
- Not Applicable. This is a physical device, not an AI algorithm. There is no training set.
9. How the ground truth for the training set was established
- Not Applicable. This is a physical device, not an AI algorithm. There is no training set or associated ground truth.
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”