(58 days)
The Spectra Optia® Apheresis System, a blood component separator, is intended for use in therapeutic plasma exchange.
The Spectra Optia® Apheresis System is a centrifugal system that separates whole blood into its cellular and plasma components. The system is used therapeutically to remove and replace the removed plasma with healthy donor plasma (i.e. plasma exchange) from patients who suffer from adverse hematologic and other conditions.
The system includes a disposable Exchange Set through which the patient's blood passes, and a machine that controls the separation of blood and the removal and replacement of plasma. The Spectra Optia system's embedded software has been enhanced to reduce the likelihood of excessive platelet loss/removal during Therapeutic Plasma Exchange (TPE) procedures when there are repeated RBC spillover alerts and no remedial action is taken.
This 510(k) summary describes a software enhancement to the Spectra Optia® Apheresis System. The enhancement aims to reduce excessive platelet loss during Therapeutic Plasma Exchange (TPE) procedures when repeated RBC spillover alerts occur and no remedial action is taken.
Acceptance Criteria and Reported Device Performance
The provided documentation does not include a table of explicit acceptance criteria with numerical targets. Instead, it describes various verification activities to ensure the correct functioning of the software modifications. Since no specific performance metrics or acceptance thresholds are detailed, a table cannot be constructed as requested.
However, the "Discussion of Non-clinical Data" section implicitly outlines the areas where the device's enhanced software performance was assessed. The "Discussion of Clinical Data" explicitly states that clinical validation data were not necessary as the modifications did not impact the performance specifications of the system's therapeutic apheresis protocols.
Summary of Reported Device Performance (as inferred from the document):
| Performance Aspect | Reported Device Performance |
|---|---|
| Reliability | Assessed using tests to simulate expected usage profiles. |
| Usability | Verified with simulated use runs on the affected protocol. |
| Robustness | Boundary condition testing conducted to explore the software for expected behavior, addressing critical values, maximum/minimum values, and values just inside/outside established boundaries. |
| Regression | Specific regression testing conducted related to the software updates for platelet loss mitigation. |
| Clinical Performance | The modifications did not impact the performance specifications of the system's therapeutic apheresis protocols, making clinical validation data unnecessary. |
Study Details
Based on the provided 510(k) summary, the study described is a non-clinical verification study for a software modification, rather than a clinical trial or a comparative effectiveness study involving human readers.
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Sample Size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of patient data or clinical samples. The testing described focuses on software verification.
- The sample sizes for the "tests to simulate expected usage profiles," "simulated use runs," and "boundary condition testing" are not explicitly stated.
- Data provenance is not applicable in the sense of country of origin for patient data, as no clinical data was used for this 510(k) submission. All data used was generated through non-clinical simulation and testing of the software.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. As the study did not involve clinical data or diagnostic interpretation, the concept of "experts establishing ground truth" in the typical sense (e.g., radiologists for images) is not applicable. Software verification likely involved internal engineering and quality assurance teams.
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Adjudication method for the test set:
- Not applicable, as there was no interpretation of clinical data requiring adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. An MRMC study was not conducted. This submission concerns a software modification to an existing therapeutic apheresis system, not a diagnostic device requiring human interpretation of results. The document explicitly states: "Clinical validation data were not necessary, as the modifications did not impact the performance specifications of the system's therapeutic apheresis protocols."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The verification described (reliability, usability, robustness, regression testing) evaluates the software's behavior and its interaction with the device, which can be considered "algorithm only" testing in the context of its function within the automated system. The software enhancement itself is designed to reduce the likelihood of excessive platelet loss when no remedial action is taken by the user, implying that the algorithm acts to mitigate issues without direct human intervention at that specific point.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the software verification, the "ground truth" would be the expected and defined behavior of the software according to its design specifications. This is established through engineering requirements, functional specifications, and predefined output given specific inputs and boundary conditions. It is not based on biological or patient outcomes data for this submission.
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The sample size for the training set:
- Not applicable. This is not a machine learning model that requires a "training set." The software modification described is an update to the system's embedded software based on defined logic and rules, not learned patterns from data.
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How the ground truth for the training set was established:
- Not applicable, as no training set was used.
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