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The autoLog is intended for use in the collection, concentration, washing, and reinfusion of autologous blood. Such areas of application may include, but are not limited to, the following:

• General, Cardiovascular, Orthopedic, Vascular, Plastic/Reconstructive, Obstetric/Gynecologic and . Neurosurgical
• . Postoperative treatment areas

The autoLog Autotransfusion System is an autotransfusion apparatus (including disposable kit). The system is a centrifugal unit that is used to collect autologous blood peri-operatively and post-operatively into a collection reservoir with an appropriate amount of anticoagulant. This autologous blood is then processed by centrifugation, separating the red cells from the plasma. Contaminating debris is subsequently washed out by the introduction of normal saline in a wash cycle. The resulting packed red cells, suspended in normal saline, are pumped to a transfer bag, and may be reinfused to the patient.

Here's an analysis of the provided text regarding the autoLog Autotransfusion System and its acceptance criteria and study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a modification to an existing device, the autoLog Autotransfusion System (K972894), specifically allowing for "the use of an adjustable external vacuum regulator." As such, the submission focuses on demonstrating that this modification does not introduce new risks or alter the fundamental performance of the device. Consequently, the "acceptance criteria" are framed around maintaining the performance equivalence to the predicate device.

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

The document mentions "A qualification was done to confirm that no functional differences between the predicate and the modified device exist. This testing was specific to the changes proposed." However, specific details regarding the sample size used for this test set are not provided in the summary. The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given the nature of the modification (mechanical/performance testing of a vacuum regulator), it is highly probable this was laboratory-based testing rather than clinical data involving patients.

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

This information is not applicable in the context of this 510(k) submission. The "ground truth" here is the functionality and performance of the device components, not a diagnostic interpretation that would require expert consensus. The testing would have involved engineering and quality assurance personnel.

4. Adjudication Method for the Test Set

This information is not applicable for the type of qualification testing described. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or subjective assessments. The testing described here would involve objective measurements and comparisons.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for medical imaging or diagnostic AI devices where human readers interpret cases with and without AI assistance. The submitted device is an autotransfusion system, not an imaging or diagnostic device.

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

No, a standalone (algorithm only) performance study was not done. This concept is relevant for AI or software-as-a-medical-device (SaMD) where an algorithm makes a determination. The autoLog Autotransfusion System is a physical medical device; its "performance" is assessed through functional and safety testing of its mechanical and operational characteristics.

7. The Type of Ground Truth Used

The "ground truth" for this modification essentially revolved around engineering specifications and established performance characteristics of the predicate device. The testing aimed to confirm that the modified device's performance, particularly regarding vacuum regulation, met pre-defined engineering standards and did not deviate from the predicate's established safe and effective operation. It was not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device and its modification. Training sets are used in machine learning and AI development. This submission describes a mechanical modification to an existing medical device, not the development or training of an algorithm.

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

Since there is no "training set" in the context of this device, this question is not applicable.

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