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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:

1. the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.)
2. a sterile, single-use, disposable blood tubing set
3. embedded software

The modification described in this submission introduces a new software version to the Spectra Optia Apheresis System. The current release is Version 11.3 which was cleared in K153601. The new software version is Version 12 and introduces the following new features:

• Data Management Support,
• Network Support,
• Enhancements to existing protocols including the ability to run the Red Blood Cell Exchange procedure in single-needle mode,
• General Software Maintenance Updates

The provided text describes a 510(k) premarket notification for the "Spectra Optia® Apheresis System" with an updated software version (Version 12). The submission aims to establish substantial equivalence to a predicate device (Spectra Optia® Apheresis System with Version 11.3 software).

The information provided is not sufficient to fully answer all aspects of your request, especially regarding specific acceptance criteria values and a detailed study report that would typically accompany a clinical trial or performance study. The document primarily focuses on demonstrating substantial equivalence through software and specification testing, rather than a detailed device performance study against specific, quantified acceptance criteria for clinical outcomes.

However, I can extract the available information as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific, quantifiable acceptance criteria established prior to testing, nor does it present detailed numerical performance results for the device. Instead, it states high-level outcomes indicating that the device met its functional requirements and specifications.

2. Sample Size Used for the Test Set and Data Provenance

• Software Testing: No specific sample size (e.g., number of test cases run) is provided, but it states "All software testing was complete."
• Specification Testing: No specific sample size (e.g., number of tests or subjects) is provided.
• Single-Needle Functionality (Simulated Patient Study): The clinical overview report mentions a "simulated-patient laboratory study evaluating varying performance measures across the multiple RBCX Procedure Types." No specific sample size (number of simulated patients or runs) is given.
• Data Provenance: Not specified. The document does not indicate country of origin or if the "simulated-patient laboratory study" was retrospective or prospective. The "clinical overview report" likely summarizes existing clinical evidence, which would be retrospective if it refers to previously published data.

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

This information is not provided in the document. The studies mentioned (software testing, specification testing, simulated-patient study) do not explicitly refer to "ground truth" established by external experts in the way that, for example, an AI diagnostic device would. For the simulated-patient study, the "ground truth" would likely be the known parameters of the simulated blood and the expected output of the device.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the testing described (software, specification, simulated patient), an external adjudication method (like 2+1 or 3+1 for expert review) is not typically applicable or detailed in this type of submission.

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

There is no indication of an MRMC study being performed. The device is an apheresis system, not an AI diagnostic imaging system that would typically involve human readers.

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

The provided text describes software testing, which inherently assesses the algorithm's functionality. The "simulated-patient laboratory study" for single-needle functionality assesses the device's performance in a controlled environment, which could be considered a standalone performance assessment of the system for that specific function. However, the term "standalone" in the context of AI is usually understood as the algorithm making a decision without human intervention in a diagnostic setting. This is not the context of this device.

7. The Type of Ground Truth Used

• Software and Specification Testing: The ground truth for this testing would be the predefined system requirements and software specifications. The software is expected to operate according to its design and functional specifications.
• Simulated-patient laboratory study: The ground truth would be the known properties of the simulated blood and the expected physiological outcomes or separation efficiencies established as part of the study design.

8. The Sample Size for the Training Set

This information is not applicable / not provided. The Spectra Optia® Apheresis System is a medical device with an updated software version; it is not described as an AI/ML system that utilizes a "training set" in the conventional sense for developing a predictive model. The software is developed through traditional software engineering processes.

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

This information is not applicable / not provided, as there is no mention of a "training set" for an AI/ML model.

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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:

1. the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.)
2. a sterile, single-use, disposable blood tubing set
3. embedded software

The modifications described in this submission are those required to resolve current obsolescence issues for various electronic components found within the Spectra Optia equipment.

The provided text describes a 510(k) premarket notification for the Terumo BCT, Inc. Spectra Optia® Apheresis System. It focuses on demonstrating substantial equivalence to a predicate device, particularly regarding hardware modifications due to obsolescence. Crucially, the document does not contain information about the device's performance through a clinical study with acceptance criteria in the way one might expect for an AI/ML medical device.

Instead, the "performance data" section states: "A summary of the verification testing and a summary of the validation testing was presented to show that the modified device met all the performance requirements and that the subject device is as safe and performs as well as the predicate device." This refers to engineering verification and validation (V&V) activities for hardware changes, not a clinical study involving human subjects or AI performance metrics.

Therefore, many of the requested details, such as sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance with ground truth, and training set information for AI, are not applicable or available in this document.

However, I can extract the acceptance criteria (in terms of performance requirements) as implied by the statement regarding meeting "all the performance requirements" and being "as safe and performs as well as the predicate device." The study proving this is the "verification and validation tests" mentioned.

Here's the breakdown of the available and applicable information:

1. A table of acceptance criteria and the reported device performance

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

• Not applicable/Not provided. The document describes engineering verification and validation for hardware component changes, not a clinical study with a test set of patient data.

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. No "ground truth" in the context of clinical expert review is mentioned, as this is not a clinical study using patient data for diagnostic classification.

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

• Not applicable/Not provided. No adjudication method for a test set is relevant to the type of V&V described.

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/Not provided. This document does not describe an AI/ML device or an MRMC study.

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

• Not applicable/Not provided. This device is a hardware system, not an algorithm.

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

• Not applicable/Not provided. The "ground truth" for the engineering verification and validation would be the design specifications and performance characteristics of the original (predicate) device, against which the modified device was tested to ensure it met those pre-defined engineering and functional requirements.

8. The sample size for the training set

• Not applicable/Not provided. This is not an AI/ML device, so there is no training set.

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

• Not applicable/Not provided. As there is no training set for an AI/ML device, this question is not relevant.

In summary: The provided document is a 510(k) submission for a hardware modification to an existing apheresis system. The "study" proving acceptance criteria is the verification and validation (V&V) tests conducted on the modified system to ensure it performs equivalently to the predicate device, specifically addressing functional and safety requirements rather than clinical performance metrics in a patient population or AI/ML diagnostic accuracy.

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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:

• 1. the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.)
• 2. a sterile, single-use, disposable blood tubing set
• 3. 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.

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).

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T-Cuff is indicated for use in donor populations during apheresis procedures as an alternative method to maintain pressure on the arm and obtain venipuncture. The T-Cuff operates similar to a pneumatic tourniquet intended to partially restrict blood flow on the upper arm to result in optimal venous access during apheresis collection procedures.

The T-Cuff is a pneumatic tourniquet used as an alternative method to maintain consistent pressure on the arm and blood flow at the access site during apheresis procedures. This device is composed of 4 major components and was developed to enhance venous access during venipuncture and help donors maintain a consistent pressure on the arm during apheresis procedures. The catalog number for the T-Cuff is 71252.

T-Cuff is designed to maintain a consistent pressure when applied to the donor's bicep with consistent squeezing of the inflatable bulb. During the apheresis process, the device operates in two modes: Venipuncture and Collection. The mode of operation is changed by adjusting the pressure relief valve cap. During Venipuncture mode, application of T-Cuff to the donor's upper arm prior to obtaining venipuncture allows the T-Cuff to inflate to assist with vein selection. During Collection mode, the T-Cuff maintains a consistent pressure of 20-40 mmHg (millimeter of mercury) on the donor's upper arm to help facilitate optimal blood flow during apheresis procedures. T-Cuff is a non-sterile, non-single use device.

The T-Cuff is a pneumatic tourniquet used as an alternative method to maintain pressure on the arm and, aid in the facilitation of blood flow during apheresis procedures. It operates in two modes, Venipuncture and Collection. During Venipuncture mode, the T-Cuff is inflated to higher pressure (no greater than 120 mmHg) as venipuncture is performed. Once Venipuncture is complete, the device maintains a steady, lower, consistent pressure (20 - 40 mmHg) during Collection mode. The donor squeezes a rubber bulb in continuous intervals to distribute air through the system and, facilitate optimal blood flow during apheresis procedures. The T-Cuff does not contain an energy source. Primary mechanism of action is obtained through the influx of air into the system and, by a modulating pressure relief valve that maintains defined pressure ranges.

The provided document is a 510(k) premarket notification for a medical device called "T-Cuff," a pneumatic tourniquet. The document explicitly states that the T-Cuff is substantially equivalent to a predicate device and does not present acceptance criteria or detailed results from a clinical study designed to prove the device meets acceptance criteria in the typical sense of a novel device demonstrating its efficacy or safety against pre-defined metrics.

Instead, the clinical study mentioned (Section VII.F. Clinical Studies) was designed to determine if manual and/or automatic adjustments to the draw flow rate would decrease operator interventions and overall procedure time when using the T-Cuff in apheresis procedures. The T-Cuff itself was "utilized for all donations in this study," implying it was a tool within a larger study, rather than the primary subject of a performance validation study against specific acceptance criteria for its own function (e.g., pressure accuracy, comfort, etc.).

Therefore, I cannot extract the information required by the prompt's structured questions from the provided text, as the document does not contain:

• A table of acceptance criteria and reported device performance for the T-Cuff meeting those criteria.
• Details on sample size for a test set specifically for T-Cuff performance validation.
• Information on ground truth establishment (number/qualifications of experts, adjudication methods) for T-Cuff performance, as the study focused on apheresis procedure efficiency.
• Mention of MRMC comparative effectiveness studies or standalone algorithm performance, as the T-Cuff is a physical, non-AI device.
• Specific details of the sample size for a training set or how ground truth was established for it, as this is not an AI/ML device.

The document states:

• "The primary endpoint for this study was to determine if manual and/or automatic adjustments to the draw flow rate would decrease the number of operator interventions and overall procedure time."
• "The T-Cuff was utilized for all donations in this study, and it was demonstrated that manual and automatic adjustment to the draw flow rate decreased the number of operator interventions and did not increase the overall procedure time."
• "All products collected met the FDA regulations regarding the level of residual white blood cells (

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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 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 impact the embedded software.

Spectra Optia Machine and Embedded Software: As described previously (K071079, BK140191, K151368), 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 provided text describes a 510(k) premarket notification for the Spectra Optia Apheresis System, specifically a minor software update (Version 11.3). The document focuses on demonstrating that this software update does not impact the device's fundamental scientific technology or principle of operation and that it has been adequately verified and validated.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly linked to the successful completion of various verification and validation tests, ensuring the software update addresses its intended purpose (mitigating use-errors related to patient height and weight entry) without introducing new safety concerns or altering the device's fundamental function. The reported device performance is that all tests passed.

1. Sample Size for Test Set and Data Provenance

• Software Verification Type testing: The "Number of Verifications" column in Table 6-1 indicates the sample size for these tests (e.g., 110 for "New / Updated Requirements"). Data provenance is not specified but appears to be internal testing by Terumo BCT.
• Human Factors Summative Study:
  • Sample size: 23 active Spectra Optia users.
  • Data Provenance: Not explicitly stated, but the users are described as "active Spectra Optia users," suggesting they are likely from real-world clinical or laboratory settings, implying prospective data collection during the study. The study was conducted on a "software simulator," not directly on patients.

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

• Software Verification Type testing: The document does not specify the number or qualifications of experts for establishing ground truth for the software verification tests. These likely involved internal engineering and quality assurance personnel.
• Human Factors Summative Study: The "ground truth" for this study was the successful completion of tasks related to patient height, weight, and TBV entry with correct units and no performance failures. This "ground truth" was established based on the intended correct usage of the software. The study observed user performance to confirm this. No external experts beyond the study design team are explicitly mentioned for establishing this truth.

3. Adjudication Method for the Test Set

• Software Verification Type testing: The document does not describe an adjudication method beyond the pass/fail results for each test. This suggests that the test outcomes were directly assessed against pre-defined criteria without further expert adjudication post-test.
• Human Factors Summative Study: The study observed subjects' ability to use correct units and verify entered data, with "no performance failures observed." This implies direct observation against predefined success criteria, rather than a multi-expert adjudication of ambiguous cases.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance?

• No, an MRMC comparative effectiveness study was not done. This document describes a software update for an apheresis system, which is a medical device for blood component separation, not an AI-assisted diagnostic or image interpretation tool. The device facilitates a physical procedure rather than providing diagnostic interpretations involving human "readers" or "AI assistance." Therefore, this type of study and effect size is not applicable.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done?

• Partially, yes. The "Software Verification Type testing" (Table 6-1) represents standalone algorithm testing to a significant extent, particularly for "New / Updated Requirements," "Safety Regression Tests," "Compatibility (upgrade)," and "Reliability." These tests assess the software's inherent function without necessarily a human actively operating it in a simulated or real patient scenario for every single verification. For instance, safety regression tests would likely involve automated checks against known hazardous conditions.
• However, "Internal Usability" and the "Human Factors (Summative) Study" did involve humans in the loop to assess the human-device interface and mitigate use-errors by operators.

6. The Type of Ground Truth Used

• Pre-defined Engineering/Software Requirements and Safety Criteria: For the "Software Verification Type testing," the ground truth was derived from the established design specifications, functional requirements, safety criteria, and compatibility requirements for the software. A "pass" indicates the software met these predefined criteria.
• Intended Correct User Performance: For the "Human Factors (Summative) Study," the ground truth was the correct execution of critical tasks (entering patient height, weight, and TBV with correct units and verification). The study assessed whether users could achieve this intended correct performance.

7. The Sample Size for the Training Set

• The document does not mention a training set. This is because the device described is an apheresis system with embedded software, not a machine learning or AI-driven system that typically requires a distinct training dataset. The software update is a traditional, rule-based or algorithmic software modification.

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

• As a training set is not mentioned, the method for establishing its ground truth is not applicable/not provided.

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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 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.

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.

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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The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis applications, and may be used to perform Red Blood Cell Exchange, Depletion, and Depletion/Exchange (RBCX) procedures.

The Spectra Optia Apheresis System, a blood component separator, can 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 is a centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems: (1) the apheresis machine itself (centrifuge, pumps, valves. etc.). (2) sterile, single-use, disposable tubing sets and, (3) embedded software.

Modifications to the disposable Exchange Set and embedded software have been made to enable Red Blood Cell Exchange (RBCx) procedures on the Spectra Optia system.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Spectra Optia® Apheresis System for Red Blood Cell Exchange (RBCx)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The document mentions "a prospective, multi-center, single-arm, open-label study," which indicates a clinical study with real patients, but the exact number of patients is not provided.
• Data Provenance: The study was a "prospective, multi-center" clinical study. This implies data was collected from multiple clinical sites (likely within the US, given the FDA submission) actively as the study progressed (prospective).

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

• The concept of "experts establishing ground truth" as seen in diagnostic imaging for example, is not directly applicable here. The device is an apheresis system for treatment, not a diagnostic device.
• The "ground truth" for the primary endpoint (achieving target HbS) would be derived from objective lab measurements of the patients' HbS levels before and after the RBCx procedure, based on the physician's prescription. The "ground truth" for safety would be identified by clinical observation and reporting of adverse events by the clinical staff involved in the study.

4. Adjudication Method for the Test Set

• Adjudication methods (like 2+1, 3+1) are typically used in studies where there's subjectivity in interpreting results (e.g., image reading). This device's primary endpoints (HbS levels, fluid balance, adverse events) are objective measurements or clinical observations. Therefore, a specific "adjudication method" in that sense is not mentioned or likely applicable. The study's design (multi-center, open-label) implies standardized protocols for data collection and reporting.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This device is an automated apheresis system and does not involve "human readers" or "AI assistance" in the typical sense of a diagnostic or interpretive task. The comparison was between the modified Spectra Optia system and its predicate device (COBE Spectra), both being automated systems.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• The device itself is an "algorithm only" in the sense that it is an automated system with embedded software. The clinical study evaluated the performance of this automated system in a real-world clinical setting without direct human intervention in the core RBCx procedure execution by the device itself (though human operators initiate and monitor the procedure).
• The comparison against the predicate COBE Spectra system (also an automated system) effectively acts as a standalone performance comparison between two automated systems.

7. The Type of Ground Truth Used

• Clinical Outcomes/Measurements: The ground truth was based on objective clinical measurements and outcomes.
  • HbS Levels: Objective laboratory measurements of hemoglobin S in the patients' blood, compared against physician-prescribed targets.
  • Safety Data: Clinical observation and reporting of adverse events (SAEs, UADEs).
  • Hematocrit Targets & Fluid Balance: Objective physiological measurements taken during the procedures.

8. The Sample Size for the Training Set

• This device is not a machine learning or AI model in the common sense that requires a "training set" for model development. The software algorithms are likely rule-based or control-system based.
• The software was "verified through a variety of verification testing; including Functional, Reliability, Usability, Exploratory, and Robustness." This indicates traditional software engineering testing rather than machine learning training. Therefore, a "training set" in the context of data for model learning is not applicable or stated.

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

• As concluded in point 8, there isn't a "training set" in the typical machine learning sense for this device. The software was developed using standard engineering practices, and its performance was then validated through non-clinical verification and a prospective clinical study.

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The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis and may be used to perform Therapeutic Plasma Exchange (TPE) procedures.

The Spectra Optia Apheresis System is a centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems: ( ) ) the apheresis machine itself (centrifuge, pumps, valves, etc.), (2) sterile, single-use, disposable tubing sets and, (3) embedded software. A software modification and new disposable connector have been made to accommodate single-needle access for Therapeutic Plasma Exchange (TPE) procedures on the Spectra Optia system. This additional access option does not alter the operating parameters or performance of the Spectra Optia system.

This document describes the acceptance criteria and the study conducted to demonstrate that the Spectra Optia® Apheresis System, with a software modification and new disposable connector for single-needle access during Therapeutic Plasma Exchange (TPE) procedures, meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Sample Size Used for the Test Set: Not explicitly stated in the provided text. The study is described as a "laboratory non-inferiority study."
• Data Provenance: The study was conducted in a "laboratory" setting. No specific country of origin is mentioned, but the manufacturer is based in the USA (Colorado). The study was prospective as it was conducted specifically to validate the new single-needle access option.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. The ground truth for this device's performance (plasma removal efficiency, hematocrit, inlet flow rate) was established through objective laboratory measurements rather than expert interpretation of medical images or conditions.
• Qualifications of Experts: Not applicable for this type of objective performance study.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The study measured objective physiological parameters (plasma removal efficiency, hematocrit, inlet flow rate) rather than subjective assessments requiring adjudication. The comparison was statistical (non-inferiority).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No. This type of study is not relevant for a device that performs automated blood component separation. MRMC studies are typically used to assess the diagnostic accuracy of imaging systems or AI algorithms that require human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

• Standalone Performance Done: Yes, in essence. The study's focus was on the performance of the device's TPE protocol with single-needle access compared to dual-needle access. This measures the algorithmically controlled separation process and fluid dynamics generated by the device itself, independent of immediate human intervention on the separation process itself (though a human operates the machine).

7. Type of Ground Truth Used

• Type of Ground Truth: Objective physiological measurements and device performance metrics. Specifically:
  • Plasma Removal Efficiency (PRE)
  • Hematocrit of processed blood
  • Inlet Flow Rate

8. Sample Size for the Training Set

• Sample Size for the Training Set: Not applicable. This submission concerns a physical device modification (new connector) and a software modification for an existing device's protocol. The software modification likely involves engineering and verification testing rather than machine learning training on a "training set" in the conventional AI sense.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for the Training Set Was Established: Not applicable. There is no mention of a machine learning component requiring a distinct "training set" with established ground truth in the provided information. The device's operation is based on established principles of centrifugation and fluid dynamics.

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