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The Harvest SmartPReP™ CENTRIFUGE SYSTEM is designed 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. The plasma and concentrated platelets produced can be used for diagnostic tests.

SmartPReP Centrifuge System: Includes a table-top, self-decanting, swinging bucket centrifuge and processing disposable designed to allow for rapid automatic separation of plasma and platelets. The centrifuge spins at a maximum speed of 6000 rpms at a maximum force of approximately 3550g.

Here is an analysis of the provided text regarding the Harvest Technologies SmartPReP Centrifuge System:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, the submission focuses on demonstrating substantial equivalence to a predicate device rather than defining specific acceptance criteria for performance metrics (e.g., specific platelet concentration levels or plasma purity). The "Substantial Equivalence" section states: "The proposed device is substantially equivalent to other table-top centrifuges previously cleared by the FDA via the 510(k) Notification process."

The table below summarizes the comparison of features between the SmartPReP and the predicate centrifuge, effectively acting as the "acceptance criteria" here, where "reported device performance" means demonstrating that the SmartPReP possesses these characteristics as intended.

Notes on Acceptance Criteria:

• The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device. This is achieved by showing similar intended use, technological characteristics, and safety and effectiveness.
• For quantitative features like 'Maximum RPM' and 'Maximum RCF', the SmartPReP exceeds the predicate, which is generally acceptable as long as it doesn't raise new questions of safety or effectiveness.
• For differences like 'Automatic Decanting', 'User Programmable', and 'Speed Control', the submission implicitly argues that these differences do not alter the fundamental mechanism of action or intended use in a way that would require new clinical data or raise significant safety concerns.

2. Sample size used for the test set and the data provenance

The provided 510(k) summary does not contain information about a test set with a specific sample size, data provenance, or a study to prove performance against specific clinical or analytical targets. The submission is a comparison of technological characteristics to a predicate device, not a performance study with a test set of samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As noted above, there is no mention of a test set or ground truth established by experts in this submission.

4. Adjudication method for the test set

Not applicable. There is no mention of a test set or adjudication.

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

Not applicable. This device is a centrifuge for preparing blood components, not an AI-assisted diagnostic device that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical centrifuge, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. This submission is based on a comparison of engineering and design characteristics to a predicate device, not on clinical performance data requiring a ground truth.

8. The sample size for the training set

Not applicable. This device is a centrifuge, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

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The SmartCell™ Processing System is indicated for the processing of autologous shed blood collected intraoperatively or postoperatively to obtain concentrated red blood cells for reinfusion.

The SmartCell System includes the following two components: Reusable SC-1000, SmartCell hardware system that includes the following major system components: start/stop/clear buttons, process indicator display, process indicator lights, HES and blood pumps, two processing chambers (left and right), fluid sensors, optics and drain controls. The system also includes the electronic components and system software that monitors proper installation of the disposable and the sedimentation process. The SCP-1500, Process Pack: a sterile, disposable device to transfer and contain the blood and sedimentation fluid (HES) during concentration and transfer to the preconnected filtered reinfusion bag. Also a separate disposable Processing Bag (SCP-1550) is provided that is a sub-assembly of the Process Pack. The SCP-1550 is provided to allow for processing of additional volumes of blood.

The provided text describes a 510(k) summary for the Harvest Technologies SmartCell Processing System. This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving the device meets those criteria.

Therefore, many of the requested categories cannot be fully answered from the provided text.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified in the provided text. The text mentions "In vitro blood quality studies" but does not give a sample size.
• Data Provenance: Not specified. It's implied to be laboratory-based ("In vitro blood quality studies"), but country of origin or whether it's retrospective/prospective is not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Number of Experts: Not applicable/Not mentioned. The study described is an in vitro blood quality study comparing the device's output to a predicate device, not involving expert interpretation of medical images or conditions to establish ground truth.
• Qualifications of Experts: Not applicable/Not mentioned.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable/Not mentioned. This typically refers to resolving disagreements among experts when establishing ground truth, which is not relevant for the type of study described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• MRMC Study: No, an MRMC study was not done. The described studies are in vitro comparisons of blood product quality and safety, not studies involving human readers or comparative effectiveness in a clinical setting with AI assistance.
• Effect Size of AI Improvement: Not applicable.

6. If a Standalone (algorithm only without human-in-the-loop performance) study was done:

• Standalone Study: Yes, in a way. The studies described (in vitro blood quality, electrical safety, biocompatibility) are assessing the device's performance directly, independent of a human operator's assessment of its output in a diagnostic context. However, it's not an "algorithm-only" study in the typical AI sense, as the device is a mechanical processing system.

7. The Type of Ground Truth Used:

• Type of Ground Truth: The "ground truth" implicitly used is the performance of the legally marketed predicate device (Haemonetics Cell Saver 5 Autotransfusion System) for metrics like hematocrit and anticoagulant washout. For safety aspects, standard regulatory testing for biocompatibility and electrical safety would serve as the "ground truth" for compliance.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This device is a mechanical processing system and does not rely on machine learning or AI models with training data in the traditional sense that would require a "training set."

9. How the Ground Truth for the Training Set was established:

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set in the context of this device.

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