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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 safety during therapeutic plasma (TPE) and red blood cell exchange (RBCX) procedures and usability with the optional Wireless Solution.

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.

The disposable Spectra Optia Exchange Set (Catalog No. 12220) is provided 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.) during the procedure. The patient's blood comes into direct contact with the biocompatible materials 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 unwanted blood component is collected. Terumo BCT is replacing the standard spike located on the anticoagulant line with a unique luer that is not compatible with any other connection on the set to decrease operators from connecting the wrong solutions bag.

The Spectra Optia Wireless Solution includes both a mounting system and a wireless appliance. No modifications were made to the Spectra Optia device in support of the wireless solution. Neither the intended use of the device nor the intended use environment of the Spectra Optia has been modified in support of the wireless solution option.

The Exchange tubing set, catalog number 12220, is identical to the previously cleared Exchange set, catalog number 10220 (K141938), except the AC spike port is replaced with the new unique AC luer connector. The AC line is used to carry anticoagulant from the AC container to the inlet line manifold.

The Anticoagulant (AC) Connection Adapter, catalog number 11221, is used to connect an apheresis tubing set that has a luer connector to an anticoagulant solution container that has a spike receptor. The anticoagulant solution container can be collapsible, such as a bag, or hardsided, such as a bottle. The Anticoagulant Connection Adapter is sterilized by Ethylene Oxide, for single use only, and includes the following components:

1. AC (anticoagulant) connector with end cap: used to connect to the luer connector on the AC line of a tubing set
1. Vent: used when connecting to a hard-sided AC container
1. Spike with end cap: used to connect to the spike receptor on the AC container

AI/ML Overview

This document describes the marketing clearance (K151368) for the Terumo BCT Spectra Optia Apheresis System, including specific modifications to the Exchange Set and the introduction of a Wireless Network Solution. However, the provided document does not contain the detailed study information typically associated with AI/ML device evaluations. Instead, it focuses on the performance testing of the physical device components and the wireless connectivity.

Therefore, for aspects related to AI/ML (like sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.), the document does not provide the requested information. The Spectra Optia Apheresis System is an automated, centrifugal, blood component separation device, which is a physical medical device, not an AI/ML algorithm or software. It would not typically involve the kinds of studies requested in the prompt (e.g., human reader improvement with AI, standalone algorithm performance).

Here's an attempt to answer the questions based only on the provided document. Many fields will be marked as "Not Applicable" or "Not Provided" because the document focuses on a non-AI/ML device.

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Specification)	Reported Device Performance (Result)
Wireless Solution:
Max allowable dimensions: Height: 14.9 cm, Width: 15.2 cm, Depth: 3.8 cm	Not explicitly stated if tested dimensions met criteria, but "Pass" for Verification Summary Report for Wireless Network Solution.
Input voltage range: 100 V AC to 240 V AC, 50/60 Hz	Not explicitly stated if tested voltage met criteria, but "Pass" for Verification Summary Report for Wireless Network Solution.
Input power maximum: 200 VA	Not explicitly stated if tested power met criteria, but "Pass" for Verification Summary Report for Wireless Network Solution.
Operating temperature range: 0 °C to 40 °C	Not explicitly stated if tested temperature met criteria, but "Pass" for Verification Summary Report for Wireless Network Solution.
Storage temperature range: 0 °C to 60 °C	Not explicitly stated if tested temperature met criteria, but "Pass" for Verification Summary Report for Wireless Network Solution.
Network interface: RJ45 Ethernet connector (10 base-T)	Not explicitly stated if tested interface met criteria, but "Pass" for Verification Summary Report for Wireless Network Solution.
Wireless standard: IEEE 802.11b, g, n	Not explicitly stated if tested standard met criteria, but "Pass" for Verification Summary Report for Wireless Network Solution.
Security protocol: WPA2	Not explicitly stated if tested protocol met criteria, but "Pass" for Verification Summary Report for Wireless Network Solution.
AC Connection Project:
Mechanical Testing: Passing within acceptance criteria	All results passing within acceptance criteria.
Biocompatibility: In accordance with ISO-10993	Evaluation conducted in accordance with ISO 10993.
Electrical Safety & EMC: IEC/EN 60601-1-2: 2007 compliant when configured with three different Ethernet routers	All results passing within acceptance criteria.
Software Verification & Validation: Conducted as per FDA guidance	Conducted and documented for Version 11.2 software.
Sterility: Sterility assurance level < 10^-6	Demonstrated with validated ethylene oxide cycle.
Residual limits: Met according to predetermined acceptance criteria	Met using validated outgassing process.
Stability/Shelf Life: Not specified	Determined to be 2 years.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Provided. The document refers to "test data" and "verification testing" for mechanical, biocompatibility, electrical safety, software, and sterility, but does not specify sample sizes for these tests. This is a physical device, and the testing described is typically lab-based and does not involve patient data sets in the way AI/ML algorithms do.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable / Not Provided. This type of expert assessment is not relevant for the physical and functional performance testing of an apheresis system and its wireless component.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not Provided. Adjudication methods are typically used for expert evaluations of medical images or symptoms to establish ground truth for AI/ML validation, which is not relevant here.

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 is not an AI-assisted diagnostic or interpretative device. Therefore, no MRMC study with AI assistance would be conducted.

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

Not Applicable. The device is a physical system with embedded software, not a standalone AI algorithm. While software verification was done, it relates to the control of the physical system, not an AI performance metric.

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

Not Applicable / Not Provided. Ground truth in this context would be defined by engineering specifications, scientific standards (e.g., ISO for biocompatibility, IEC/EN for EMC), and validated test methods to confirm specific physical and functional performance characteristics.

8. The sample size for the training set

Not Applicable / Not Provided. This type of "training set" does not apply to the hardware and embedded software verification of this medical device.

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

Not Applicable / Not Provided. As above, the concept of a "training set" and "ground truth" establishment in this manner does not apply to the type of device and testing described.

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