(103 days)
The Sherpa Pak Cardiac Transport System is intended to be used for the static hypothermic preservation of hearts, up to 4 hours, during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with the heart.
The Paragonix Sherpa Pak Cardiac Transport System is a device intended to provide a safe, consistent method for cold ischemic storage and transport of donor hearts to recipients for transplantation. The Sherpa Pak System consists of 1) an outer shipper which contains various non-ice based temperature controlled packaging elements, 2) an inner and outer hard shell container (i.e. Sherpa Pak/Sherpa Pak Shell) which provides a double, rigid barrier container in which the heart is immersed and suspended in a Cold Storage Fluid cleared for use in storing and transporting donor hearts and 3) a temperature display and timer to monitor temperature and elapsed time of transport, respectively.
Here's a breakdown of the acceptance criteria and study information for the Paragonix Sherpa Pak Cardiac Transport System based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative "acceptance criteria" for the device's performance in a table format. Instead, it describes general design specifications and functional testing outcomes.
| Characteristic | Acceptance Criteria (Implied / Desired Outcome) | Reported Device Performance |
|---|---|---|
| Protection during Transport (Robustness) | Device should be robust enough to protect the heart during transport. | Testing demonstrated the Sherpa Pak System provided a transport system robust enough to protect the heart during transport. |
| Temperature Maintenance | Device should maintain temperature throughout the duration of transport. | Testing demonstrated the Sherpa Pak System maintained temperature throughout the duration of transport. |
| Biocompatibility | Direct and indirect heart contact materials must be biocompatible (non-toxic, non-sensitizing, etc.). | Biocompatibility testing including cytotoxicity, systemic toxicity, genotoxicity, sensitization, and intracutaneous testing was performed. Direct and indirect heart contact materials have been tested for biocompatibility. (Implied: results were acceptable, as the device was cleared). |
| Intended Use Period | Static hypothermic preservation of hearts up to 4 hours. | The Sherpa Pak Cardiac Transport System is intended to be used for static hypothermic preservation of hearts, up to 4 hours. The marketing clearance implies that the device demonstrated it can achieve this. |
| UNOS Policy 5 Compliance | Conformity to UNOS Policy 5 for organ storage and preservation. | The device's "Meets UNOS Policy 5" characteristic is listed as "Yes" in the comparison table. |
| Sterilization | Specific components (Sherpa Pak, Sherpa Pak Shell, Heart connector) should be sterilized. Other parts non-sterile. | Sherpa Pak, Sherpa Pak Shell, and Heart connector are sterilized by gamma irradiation. All other components are non-sterile. (This is a design characteristic that was met, rather than a performance outcome in the same way as temperature). |
| Single Use/Reuse | Entire system is single use/patient only. | The entire system is single use/patient only. (This is a design characteristic that was met, rather than a performance outcome in the same way as temperature). |
| Overall Performance | Performs as intended and is safe for its intended use, substantially equivalent to predicate devices. | The testing conducted demonstrated that the subject device performs as intended and is substantially equivalent to the predicate devices in terms of its ability to safely store and transport a donor heart at a clinically acceptable temperature range to a recipient for transplantation. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states: "Descriptive information, laboratory bench testing, and biocompatibility testing were provided to demonstrate the device meets its design specifications, performs as intended, and is safe for its intended use."
- Sample Size: The document does not specify any sample sizes for the functional or biocompatibility testing conducted. It refers to "testing" generically.
- Data Provenance: The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned. The testing described appears to be internal lab testing rather than clinical study data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: This information is not provided. The "ground truth" for this device's performance primarily relates to objective physical parameters (temperature stability, structural integrity, biocompatibility) rather than expert interpretation of images or clinical outcomes.
- Qualifications of Experts: This information is not provided.
4. Adjudication Method for the Test Set:
- Adjudication Method: This information is not provided. Given the nature of the tests (bench testing, biocompatibility), there is no indication of an adjudication process typically associated with subjective assessments or clinical outcomes.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done or mentioned. This type of study is typically relevant for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This device is a transport system, not a diagnostic tool.
6. Standalone (Algorithm Only) Performance Study:
- Yes, a standalone performance study was done in the sense that the "Functional Testing" described ("testing to demonstrate that the Sherpa Pak System provided a transport system robust enough to protect the heart during transport and maintained temperature throughout the duration of transport") and "biocompatibility testing" were evaluations of the device itself, independent of human interaction during the test. There is no "algorithm" in the conventional AI sense for this device.
7. Type of Ground Truth Used:
The ground truth used was based on objective measurements and laboratory standards:
- Functional Testing: Measuring whether the device maintained temperature, its structural integrity under stress (robustness), and protection of the "heart" (simulated or actual, not specified but likely simulated for bench testing).
- Biocompatibility Testing: Adherence to established standards for cytotoxicity, systemic toxicity, genotoxicity, sensitization, and intracutaneous reactivity.
- UNOS Policy 5: Assessed against a defined policy standard.
8. Sample Size for the Training Set:
This device is a physical medical device, not an AI/machine learning algorithm that requires a "training set" in the computational sense. Therefore, the concept of a training set sample size is not applicable.
9. How the Ground Truth for the Training Set Was Established:
As there is no AI/machine learning algorithm with a training set for this device, how ground truth for a training set was established is not applicable.
§ 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).