(78 days)
The SmartPReP2 Centrifuge System is intended to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow.
The Harvest Technologies SmartPReP2 System includes a table-top, self-decanting swinging bucket centrifuge. The SmartPReP2 Bone Marrow Procedure Pack includes a Process Disposable and other accessories to allow for separation of cells from bone marrow aspirate.
This document is a 510(k) premarket notification summary for the SmartPReP2 Centrifuge System. It describes the device and its intended use, indicating that it is substantially equivalent to a previously cleared device. However, it does not contain a detailed study with acceptance criteria and reported device performance in the way a clinical trial or a performance study for AI device would.
Therefore, most of the requested information cannot be extracted from this document, except for the following:
1. A table of acceptance criteria and the reported device performance:
The document states: "Performance Testing: Results of biocompatibility and performance testing have established that the SmartPReP2 System is suitable for the intended use indicated." However, it does not provide specific acceptance criteria or quantitative performance results (e.g., in a table format) for aspects like platelet concentration efficiency, cell viability, or purity of separation which would typically be included for such a device. Without this information, a table cannot be constructed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document.
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):
This information is not applicable and not provided. The device is a centrifuge system, not an AI diagnostic tool requiring expert ground truth establishment in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided.
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:
This information is not applicable. The SmartPReP2 Centrifuge System is a medical device for preparing biological samples, not an AI system for diagnostic imaging or interpretation that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a centrifuge, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
This information is not applicable in the context of an AI device requiring ground truth. For a centrifuge, "ground truth" would be related to the accuracy and efficiency of its physical separation process, likely measured by laboratory tests on the processed samples (e.g., cell counts, viability assays), but these specific details are not provided in this summary.
8. The sample size for the training set:
This information is not applicable. The device is a centrifuge, not an AI system that undergoes "training."
9. How the ground truth for the training set was established:
This information is not applicable.
Summary of available information:
The document is a 510(k) summary focused on demonstrating "substantial equivalence" to a predicate device (SmartPReP Centrifuge System, K991430) and other table-top centrifuges. It states that "Performance Testing" was conducted to establish suitability for intended use, but does not detail the specific criteria, study design, or quantitative results of this testing. The information requested aligns more with the evaluation of AI/diagnostic software, which is not the nature of this particular device.
§ 862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.
(a)
Identification. General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.(b)
Classification. Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.