(283 days)
The HPA Portable Kidney Transport System is intended for preserving and transporting kidneys for transplant.
The HPA Portable Kidney Preservation System, Model J-1000-1 is to be used when prescribed by a physician for the use of storing and preserving a human kidney
The HPA Portable Kidney Transport System is a patented, self contained renal preservation system that provides the benefits of machine perfusion with a simplified perfusion circuit. The device provides low flow pulsatile perfusion with regulated arterial pressure limits. Audio and visual alarms are provided for over pressure, over temperature, pump failure, tubing failure, and battery failure conditions.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a medical device, not an AI/ML diagnostic tool, therefore standard performance metrics like sensitivity, specificity, or AUC are not applicable here. Instead, the "acceptance criteria" are implied by the comparison to the predicate device and the demonstration of equivalent, or superior, preservation of kidney function.
| Acceptance Criteria (Implied) | Reported Device Performance (HPA) |
|---|---|
| Preserve canine kidneys as well as the MOX-100 for 24-72 hours. | The HPA preserves canine kidneys as well as the MOX-100 for preservation lasting between 24 and 72 hours. |
| Preserve canine kidneys for 120 hours. | For preservation lasting 120 hours, the HPA protects the microcirculation better than the MOX-100. |
| Maintain kidney viability and function post-preservation (evaluated by blood flow, urine output, creatinine levels, and microscopic examination). | The studies demonstrate positive outcomes across these metrics following re-perfusion and sacrifice of test animals. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of kidneys or observations, but "three studies were performed on mongrel dogs." Each study likely involved multiple kidneys.
- Data Provenance: Prospective animal study (mongrel dogs). The country of origin is not specified but implicitly assumed to be the location of Justec Medical Products, Inc. (Holbrook, NY, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not mention "experts" in the context of establishing ground truth in the way one would for diagnostic imaging. Instead, the assessment relied on objective physiological and anatomical measures in the dogs:
- Blood flow
- Urine output
- Creatinine levels
- Subsequent microscopic examination (presumably by a veterinary pathologist or histologist, but qualifications are not provided).
4. Adjudication Method for the Test Set
- Not applicable as this is not a diagnostic imaging study requiring expert adjudication of reader interpretations. The evaluation metrics are objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was not done. This is a device for organ preservation, not a diagnostic imaging tool for human-in-the-loop performance measurement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, in a way. The "performance" of the HPA device itself was evaluated in a standalone manner, meaning its ability to preserve kidneys was assessed objectively without human intervention during the preservation phase, beyond setting up and monitoring the device. There isn't an "algorithm" in the typical AI/ML sense.
7. The Type of Ground Truth Used
- The ground truth was established through a combination of physiological measurements (blood flow, urine output, creatinine levels) and histopathological examination (microscopic examination) of the preserved kidneys after re-perfusion and sacrifice. This constitutes direct evidence of organ viability and damage.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set. The "development" would have involved engineering and biological testing, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
§ 876.5880 Isolated kidney perfusion and transport system and accessories.
(a)
Identification. An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.(b)
Classification. Class II (performance standards).