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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.

Device Description

The Spectra Optia Apheresis System is comprised of three subsystems: the apheresis machine (or equipment), embedded software, and a single-use disposable blood tubing set. The modifications described in this submission enhance the disposable set's manufacturability and usability during therapeutic plasma and red blood cell exchange procedures.

Spectra Optia Machine and Embedded Software: The Spectra Optia Apheresis System is an automated, centrifugal, blood component separation device that uses pumps, valves and sensors to control and monitor a disposable, plastic extracorporeal circuit, during therapeutic apheresis procedures. The system's embedded software controls pump flow rates and centrifuge speed to establish and maintain the required plasma/cellular interface, and ensure patient safety.

Disposable Blood Tubing Set: The disposable Spectra Optia Exchange Set (Catalog No. 10220) is provide sterile and is intended for single-use only. The set is invasive, in that patients are connected to the disposable using a needle or other blood access device (catheter, port, etc.). The patient's blood comes into direct contact with the biocompatible plastics that comprise the set. Key components of the set include the [1] centrifuge channel (inside which the patient's blood is separated into its components), [2] the plastic cassette that integrates the tubing/defines the fluid path for ease of installation and use and, [3] the pre-attached waste bag into which the diseased blood component is collected.

AI/ML Overview

The provided text is a 510(k) Summary for the Spectra Optia Apheresis System. This document describes modifications made to the disposable blood tubing set of an already cleared apheresis system and aims to demonstrate substantial equivalence to its predicate device. It is not a study proving a device meets acceptance criteria in the typical sense of a clinical trial for an AI/ML diagnostic device with performance metrics like sensitivity/specificity.

The "acceptance criteria" here relate to the functional equivalence and safety of the modifications to the disposable blood tubing set, ensuring they do not negatively impact the established performance of the Spectra Optia Apheresis System itself.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present "acceptance criteria" in a typical quantitative clinical performance metric format (e.g., sensitivity, specificity). Instead, the criteria are implicitly tied to maintaining the functional equivalence, safety, and usability of the device after modifications. The "performance" reported is related to how the modifications themselves behave and if they introduce any new risks or alter the system's core function.

Acceptance Criteria (Implicit)	Reported Device Performance
Vent Bag: No functional impact from a slightly larger vent bag.	Result: "None – the original and new vent bags are functionally equivalent."
Needleless Injection Port: Maintains fluid sampling/administration function; enhances usability by reducing needle-stick injuries.	Result: "None - like the original return line injection port, the needleless injection port allows the operator to sample or administer fluids during the procedure." "Comprehensive verification testing confirmed that the new needleless access port performed as designed." This involved "mechanical testing, biocompatibility testing, and evaluations of the modified Exchange Set's sterility, packaging and shelf life."
Sterile Barrier (IV) Filter: Prevents air from an empty AC container from entering the centrifuge and causing alarms; improves usability.	Result: "Air from an empty AC container does not enter the centrifuge and cause an unwanted system alarm." "Simulated-use testing demonstrated that the IV Filter on the AC Line...are functionally compatible with the system's embedded software and that the linear line length of air in the AC Line during an AC bag empty event is reduced when the IV Filter is installed. Specifically, no air was able to travel past the IV Filter, using the modified Exchange Set, during an 'AC Bag Empty Event'. For the unmodified set, the length of air measured in the AC line averaged 13.3 inches (S.D.: 1.3 inches), compared to 0 inches in the modified set."
Overall System: Modifications do not alter the system's fundamental scientific technology, principle of operation, intended use, essential technology, materials, or sterilization/manufacturing processes (when adjusted for modifications).	Result: Confirmed through comparisons of "Intended Use / Labeling," "Essential Technology," "Materials," and "Sterility / Manufacturing" as "Key Similarities – Unmodified vs. Modified Spectra Optia Exchange Set." The core technology of centrifugal blood component separation remains unchanged.

2. Sample Size for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a "test set" in the context of diagnostic accuracy. However, for the simulated-use testing of the IV Filter, quantitative data is provided: "length of air measured in the AC line averaged 13.3 inches (S.D.: 1.3 inches)" for the unmodified set, and "0 inches in the modified set." The number of trials or "samples" for this specific measurement is not provided. General "comprehensive verification testing" and various "evaluations" are mentioned, but without specific unit counts.
Data Provenance: The document does not specify the country of origin for the reported testing or if it was retrospective or prospective. It describes testing performed to support regulatory submission for a device manufactured by Terumo BCT in Lakewood, Colorado, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This type of information is not applicable to this document. The "ground truth" here is based on engineering verification and simulated-use testing outcomes (e.g., presence/absence of air, functional performance of a port), not expert consensus on medical images or patient diagnoses.

4. Adjudication Method for the Test Set

This is not applicable. The assessments are based on direct measurements, observations, and engineering tests of the modified components and their interaction with the system, not on adjudicated interpretations by multiple reviewers.

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 is not applicable. This document describes modifications to an apheresis system's disposable tubing set, not an AI/ML diagnostic device, and therefore no MRMC study or AI assistance evaluation was performed.

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

This is not applicable. This device is an apheresis system, which is a hardware and embedded software system for blood processing, not a standalone AI algorithm. While it has "embedded software" that controls functions, the evaluation is on the hardware modifications (e.g., a filter, a needleless port, a vent bag) and their functional impact.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluations described are based on:

Physical Measurements and Observation: For example, measuring the length of air in the AC line.
Engineering and Functional Testing: Verifying that mechanical designs work as intended, and that new components do not impede existing functions or introduce new risks.
Biocompatibility Testing: Ensuring materials are safe for patient contact.
Sterility, Packaging, and Shelf Life Testing: Standard regulatory requirements for medical devices.

8. The Sample Size for the Training Set

This is not applicable. As a hardware device with embedded control software, there is no "training set" in the context of an AI/ML algorithm that learns from data. The software controls pre-defined processes.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated in point 8.

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