(214 days)
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:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Expected Output: Hematocrit equivalent to predicate device | Achieved: "a packed red cell product with a hematocrin... equivalent to that of the predicate device." |
| Expected Output: Anticoagulant washout equivalent to predicate device | Achieved: "a packed red cell product with... anticoagulant washout equivalent to that of the predicate device." |
| Expected Output: Biocompatibility | Achieved: "biocompatibility evaluation of the disposable set has been performed to demonstrate substantial equivalence." |
| Expected Output: Electrical Safety | Achieved: "electrical safety testing... has been performed to demonstrate substantial equivalence." |
| Missing: Quantitative targets for hematocrit, anticoagulant washout, biocompatibility, and electrical safety. The text only states "equivalent." | Missing: Specific numerical results for hematocrit, anticoagulant washout, and other performance metrics. |
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.
§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).