(185 days)
The Spectra Optia® Apheresis System, a blood component separator, may be used to perform therapeutic plasma exchange.
The Spectra Optia® Apheresis System, a blood component separator. may be used to perform Red Blood Cell Exchange (RBCX) procedures for the transfusion management of Sickle Cell Disease in adults and children.
The Spectra Optia® Apheresis System, a blood component separator, may be used to reduce White Blood Cells for patients with leukocytosis at risk for leukostasis.
The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The cleared system is comprised of three major subsystems:
-
- the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.)
-
- a sterile, single-use, disposable blood tubing set
-
- embedded software
This 510(k) involves no change in the components (design or material) of the Spectra Optia® Apheresis System. Instead, the purpose of this 510(k) is to expand the indications for use to include reduction of White Blood Cells (WBCs) for patients with leukocytosis at risk of leukostasis.
The provided text describes the performance study for the Spectra Optia® Apheresis System, specifically for its expanded indication of reducing White Blood Cells for patients with leukocytosis at risk of leukostasis.
Here's an analysis of the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria values in a table format for the effectiveness endpoints. Instead, it compares the observed performance to existing guidelines and predicate device performance.
| Acceptance Criteria (Implicit from ASFA Guidelines/Predicate) | Reported Device Performance (Spectra Optia®) |
|---|---|
| Effectiveness: | |
| Reduction in WBC count (ASFA guideline: 30% to 60% for single procedure) | Mean Percent Decrease in WBC count: 54.7% (SD: 21.3%) |
| Collection Efficiency (CE) for WBC (Bench testing indicated predicate at 70.6% ±12.9%) | Mean CE for WBC: 58.7% (SD: 16.1%) |
| Ability to operate across broad range of patient/procedural parameters (HCT, inlet/collect flow rates) | Confirmed: "Can collect under a wide range of patient/procedural parameters including hematocrit, inlet flow rate, and collect flow rate" |
| Non-inferiority to predicate (COBE Spectra WBC Depletion Protocol) in bench testing | Confirmed: "The testing demonstrated that the Spectra Optia® WBC Depletion Protocol is non-inferior to the predicate the COBE Spectra WBC Depletion Protocol." |
| Safety: | |
| No observed safety signals associated with the device beyond expected AEs for the patient population | Confirmed: "no observed safety signals associated with the Spectra Optia® device." |
| Acceptable frequency and type of AEs for the patient population | Confirmed: "The frequency and type of AEs observed is reflective of the very sick leukemia patient population..." |
| No serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) | Confirmed: "No serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) were reported." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Data/Test Set): 43 subjects who underwent a total of 58 WBC Depletion procedures.
- Data Provenance:
- Country of Origin: Europe (UZ Leuven, Belgium; Institute for Transfusion Medicine and Immunohematology, Frankfurt, Germany; Saint Istvan and Saint Laszlo Hospital, Budapest, Hungary).
- Nature: Retrospective data collection study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not describe the use of experts to establish ground truth for this specific study. The "ground truth" for effectiveness (WBC reduction, CE) was based on measured physiological parameters directly obtained from the device and patient samples. For safety, it was based on reported adverse events. This is a clinical performance study of a therapeutic apheresis system, not an AI/imaging diagnostic study that typically involves expert panel review.
4. Adjudication Method for the Test Set
Not applicable, as this was a clinical performance study involving direct measurements and adverse event reporting, not a study requiring expert adjudication of interpretations (like in imaging studies).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study focuses on the direct physiological performance and safety of the device itself, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense, the primary clinical effectiveness and safety endpoints evaluate the "standalone" performance of the Spectra Optia® Apheresis System in affecting WBC counts in patients. The system itself is an automated device, and its performance metrics (WBC reduction, CE) reflect its direct action on blood.
7. The Type of Ground Truth Used
The ground truth for this device's performance was established via:
- Direct Physiological Measurements: Percent decrease in WBC count in subject blood post-procedure, and percent of processed WBCs collection efficiency (CE). These are objective, quantitative measurements from the patient samples.
- Clinical Outcomes/Adverse Events: Evaluation of clinical safety through the reporting and assessment of adverse events.
- Comparison to Established Guidelines/Literature: The observed WBC reduction was compared against ASFA (American Society for Apheresis) guidelines.
8. The Sample Size for the Training Set
This document describes a clinical performance study for an established medical device (with an expanded indication), not a study involving the training of a new AI algorithm. Therefore, there is no mention of a "training set" in the context of machine learning. The device's operation is based on established engineering principles of blood separation, not on a data-trained AI model.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI algorithm, this question is not applicable to the provided information. The device's operational parameters and algorithms are determined through engineering design and historical data from previous clearances (e.g., K071079, K153601, K132429, BK120012, BK150251, BK130065, BK140191).
N/A