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The COBE BRAT® 2 Standard Volume Processing Set is indicated for use for recovery and/or processing of autologous blood.

A Standard Volume BRAT® 2 Processing Set consists of a plastic disposable 250 ml centrifuge bowl, a tubing harness to connect the centrifuge bowl with other disposables, a waste bag, and a reinfusion bag. The tubing harness consists of tubing, a pump/valve cartridge, and various connectors.

Modifications to the BRAT® 2 Standard Volume Processing Set covered in this 510(k) consist of addition of a one-year expiration date to the Modified Standard Volume processing set covered in 510(k) K973627 and a design change to the internal spacer of the Baylor centrifuge bowl.

Here's an analysis of the provided information regarding the acceptance criteria and study for the COBE® BRAT® 2 System with Modified Standard Volume Processing Set (K974897):

Given the nature of the device (a processing set for autologous blood salvage), the "performance" discussed here relates to its functional specifications and its ability to process blood effectively, rather than diagnostic accuracy metrics like sensitivity or specificity.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample size for the in vitro blood testing (number of processing sets or blood samples tested).
• Data Provenance: The testing was in vitro using bovine blood. This indicates the data is from a laboratory setting, not human subjects. It does not state the country of origin, but given the submitter is in Arvada, CO, USA, it's highly likely the testing was conducted in the US. The study was prospective in the sense that the testing was specifically designed and performed to evaluate the modified device for this 510(k) submission.

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

• This device is a medical device for blood processing, not an AI or diagnostic imaging device that typically requires expert consensus for "ground truth." Therefore, the concept of "experts used to establish ground truth" in the traditional sense (e.g., radiologists interpreting images) does not apply here.
• The ground truth for performance relied on established laboratory protocols and quantitative measurements derived from the in vitro blood tests (e.g., measurement of heparin load, which would be an objective chemical or biological measurement using standard lab techniques/equipment). The expertise involved would be in medical device engineering, laboratory science, and potentially hematology, but not in visual interpretation or clinical diagnosis by multiple expert readers.

4. Adjudication Method for the Test Set

• This concept is not applicable to the type of device and testing performed. Adjudication methods like "2+1" or "3+1" are used in studies where human readers provide subjective interpretations (e.g., image diagnosis) that need to be reconciled to form a ground truth. The testing here involved objective, quantitative measurements from in vitro blood processing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done.
• MRMC studies are typically performed for diagnostic devices, especially those involving human interpretation of imaging or other complex data, to assess the impact of a device (like AI assistance) on reader performance. This submission is for a physical medical device (blood processing set) and its functional performance, not a diagnostic aid.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• This question is also generally not applicable to this type of device. The device is a "processing set," which is a consumable component of a larger system (COBE BRAT® 2 Autologous Blood Salvage System). Its "performance" is inherently tied to its function within that system, and there isn't an "algorithm only" component in the way one would consider it for an AI diagnostic tool. The performance evaluated was the standalone physical device's characteristics and its functional performance in processing blood in vitro.

7. The Type of Ground Truth Used

• The ground truth in this context was based on objective, quantitative measurements obtained from established in vitro laboratory protocols using bovine blood. Specifically, it included:
  • Functional specifications: Verification of the device's physical and operational attributes against engineering requirements.
  • Biochemical/physiological measurements: Data such as "reduction in estimated Heparin Load to Patient" are objective measurements.

8. The Sample Size for the Training Set

• This information is not provided in the document.
• The concept of a "training set" as understood in machine learning/AI is typically not directly applicable to the development and testing of a physical medical device like a blood processing set. Device modifications are often based on engineering design principles, material science, and prior predicate device performance, rather than iterative "training" with a dataset. Any "training" or optimization during the development phase would involve engineering iterations and testing, but not in the sense of a machine learning training set with ground truth labels.

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

• As mentioned above, the concept of a "training set" in the AI sense does not apply here. Therefore, the establishment of its "ground truth" is also not an applicable concept. Any design verification and validation during the device's development would rely on engineering specifications, material testing standards, and established laboratory methods.

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The COBE BRAT® 2 Standard Volume Processing Set is indicated for use for recovery and/or processing of autologous blood.

A Standard Volume BRAT® 2 Processing Set consists of a plastic disposable 250 ml centrifuge bowl, a tubing harness to connect the centrifuge bowl with other disposables, a waste bag, and a reinfusion bag. The tubing harness consists of tubing, a pump/valve cartridge, and various connectors.

Modifications to the BRAT® 2 Standard Volume Processing Set covered in this 510(k) consists of a design change to the internal spacer of the Baylor centrifuge bowl. No other material or design feature changes to the Processing Set disposables are required. No hardware or software changes are required to the BRAT® 2 instrument to support this device modification.

This 510(k) summary describes a modification to an existing medical device, the COBE BRAT® 2 Standard Volume Processing Set, rather than a novel device. Therefore, the "acceptance criteria" discussed here relate to demonstrating that the modified device's performance is comparable to or improved over the predicate device, specifically regarding its "Wash Efficiency." The study is designed to show substantial equivalence, not to establish de novo safety and effectiveness benchmarks for a new type of device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as a numerical count of individual blood samples or processing runs. The text mentions "In vitro bovine blood testing" and "Human blood testing...in a laboratory setting at the Mayo Clinic." The number of times these tests were performed is not given.
• Data Provenance:
  • Bovine Blood Testing: In vitro (laboratory setting).
  • Human Blood Testing: In vitro (laboratory setting) at the Mayo Clinic. The country of origin is the USA.
  • Retrospective or Prospective: Both bovine and human blood tests appear to be prospective, specifically designed to evaluate the modified device.

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

This submission does not involve expert review or adjudication of the test results in the way one might see for image-based diagnostic AI. The performance metrics (Wash Efficiency, Heparin Load) are objective, quantitative measurements derived from laboratory tests.

The "ground truth" for the performance expectations is based on:

• Comparison to the predicate device's known performance.
• Reference to published medical literature: Yawn's recommendations for "Ensuring Quality Intraoperative Blood Salvage" (LABORATORY MEDICINE, Vol. 25. No. 10, October 1994, p. 629) are cited for acceptable Heparin Load values.

4. Adjudication Method for the Test Set

Not applicable. The tests measured objective performance parameters, rather than requiring subjective interpretation or consensus among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not an image-based diagnostic or an AI-assisted device. It's a physical medical device (processing set for blood salvage).

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

Yes, in a sense. The "device" being tested is the modified processing set itself. Its performance was evaluated purely based on its ability to process blood and achieve desired efficiency metrics in a laboratory setting, without the variable performance of human interaction during the test measurement. However, it's not an algorithm in the traditional AI sense.

7. The Type of Ground Truth Used

The ground truth is based on:

• Objective Laboratory Measurements: Quantified values for "Outlet Hct" and "Wash Efficiency," and specifically "estimated Heparin Load to Patient."
• Predicate Device Performance: Used as a baseline for comparison to demonstrate "comparable" performance.
• Published Medical Standards/Recommendations: The reference by Yawn' provides a benchmark for acceptable Heparin Load values.

8. The Sample Size for the Training Set

Not applicable. This device is a physical processing set, not an AI algorithm that requires a "training set."

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

Not applicable, as there is no training set for this type of device.

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