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The Hemocor HPH® Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed.

Device Description

The Minntech I lemocor HPI 700 Hemoconcentrator is made of glycerin-free, microporous, hollow fiber, polysulfone membrane encased in a polycarbonate chamber meroporous, notiow troot, porty and polycarbonate blood port header caps. The FIPE 700 TS device has attached PVC 1/4" tubing and accessory polycarbonate adapters for blood path connection. The no-rinse device feature provides versatility for inscrtion of the hemococentrator into the extracorporeal circuit.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Minntech Hemocor HPH® 700 Hemoconcentrator and Tubing Set, based on the provided 510(k) summary:

This device is not an AI/ML device, so many of the requested fields are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the Minntech Hemocor HPH® 700 Hemoconcentrator does not explicitly list "acceptance criteria" in the traditional sense of a pass/fail threshold for a performance metric. Instead, it presents a comparison of technological characteristics with a predicate device and outlines performance testing that was conducted to demonstrate device effectiveness and substantial equivalence.

Characteristic / Test	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (HPH® 700)
Technological Characteristics
Housing	Polycarbonate	Polycarbonate
Potting Material	Polyurethane	Polyurethane
Membrane	Polysulfone	Polysulfone
Membrane Surface Area	(Comparable to predicate, though smaller)	0.7 m²
Max Transmembrane Pressure (mmHg)	500 mmHg	500 mmHg
Max. Blood Flow Rate (ml/min)	500 ml/min	500 ml/min
Min. Blood Flow Rate (ml/min)	100 ml/min	50 ml/min
Priming Volume (ml)	70 ml	58 ml
Molecular Weight Cut-off (daltons)	65000 daltons	65000 daltons
Performance Testing	(Demonstrates effectiveness as a hemoconcentrator comparable to predicate)	(Testing conducted to determine effectiveness)
Ultrafiltration Rate vs. Transmembrane Pressure	(Sufficient ultrafiltration for intended use)	Testing conducted
Pressure Drop vs. Blood Flow Rate	(Acceptable pressure drop for intended use)	Testing conducted
Protein Rejection	(Adequate protein rejection)	Testing conducted
Minimum Blood Flow Rate & Blood Path Integrity	(Maintains integrity and function at minimum flow)	Testing conducted

Note on Acceptance Criteria: For legacy medical devices like this, especially for 510(k) submissions, "acceptance criteria" are often implicitly demonstrated by showing substantial equivalence to a legally marketed predicate device. The goal is to show the new device is as safe and effective as the predicate, not necessarily meet pre-defined numerical thresholds beyond what is necessary to support the same indications for use. The technological characteristics table serves as a primary source of this comparison. The performance testing further supports that the device performs as expected for a hemoconcentrator.

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not specify sample sizes for the performance testing conducted. It only states that testing was conducted. This is typical for 510(k) summaries where detailed pre-clinical test results are often kept in the full submission, not in the publicly available summary.

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Given this is a device performance test, it likely refers to in vitro or ex vivo lab testing, rather than human clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This question is not applicable as the ground truth for mechanical device performance (like a hemoconcentrator) is established through technical testing and measurement against engineering specifications and industry standards, not expert clinical consensus.

4. Adjudication Method for the Test Set

This question is not applicable as the ground truth for mechanical device performance is established through technical testing and measurement, not consensus among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or clinical interpretation where human readers are involved. This submission is for a medical device (hemoconcentrator) and its physical performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The concept of "standalone performance" for an algorithm or AI is not applicable here. This is a physical medical device, not a software algorithm. The "performance testing" described (Ultrafiltration Rate, Pressure Drop, Protein Rejection, Blood Path Integrity) represents the "standalone" performance of the device in a laboratory setting.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established through:

Bench testing/Laboratory Measurements: Based on established engineering principles, fluid dynamics, membrane science, and medical device performance standards.
Comparison to Predicate Device: The performance of the new device is compared to the known and accepted performance of the legally marketed predicate device (Hemocor HPH® 1000 Hemoconcentrator). Substantial equivalence means the new device performs at least as safely and effectively.

8. The Sample Size for the Training Set

This question is not applicable. This device is not an AI/ML system, so there is no concept of a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable. As there is no AI/ML component, there is no "training set" or ground truth for such a set.

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