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The autoLog IQ autotransfusion system and Medtronic wash kit are in the collection, concentration, washing, and reinfusion of autologous blood. Areas of application may include, but are not limited to, the following: · Surgeries including general, cardiovascular, orthopedic, vascular, plastic/reconstructive, obstetric/gynecologic, and neurological · Postoperative treatment areas

The autoLog IQ Autotransfusion System is used to collect autologous blood peri-operatively and post-operatively into a collection reservoir with an appropriate amount of anticoagulant. The system refers to the instrument (the subject of this submission); disposable devices are also required to operate the system: the Medtronic wash kit, collection reservoir, and suction line. This autologous blood is first filtered through the prefilter in the collection reservoir, and 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. The autoLog IQ Autotransfusion System (also referred to as the "instrument" or the "system") is not patient contacting. However, the disposable devices needed to operate the system - the Medtronic wash kit, collection reservoir, suction line - are patient contacting, and are the same disposables used by the predicate autoLog Autotransfusion System device (K093535). The collection and concentration/washing of patient blood are handled independently by the system. The collection process requires the installation of a disposable reservoir and the activation and use of the integrated vacuum pump, which is built into the system, or an external vacuum source. The system has an integrated internal regulator which ensures safe vacuum levels. The blood is aspirated through a disposable collection suction tip/cannula and disposable suction line to the reservoir. Anticoagulant is delivered at the cannula through the anticoagulant line. The system's concentration/washing process requires the installation of the Medtronic wash kit and the activation and use of a pump, valve, and centrifuge. When the self-start switch registers a sufficient quantity of blood in the reservoir, the system automatically starts operation. The processing includes one cycle of filling the centrifuge bowl and concentrating the red cells (while transferring effluent waste to the waste bag), one cycle of washing the red cells with saline and one cycle of transferring the packed, washed red cells to the sterile holding bag. The pump pulls blood from the reservoir into the centrifuge bowl until the optical sensor detects a full bowl; then the roller pump stops and the wash solution is pumped into the packed red cell mass. After the washing cycle, the pump transfers the washed, packed red cells to the holding bag. Medical personnel complete the final reinfusion of the collected and washed blood to the patient. Hospital personnel are instructed to dispose the waste bag (containing plasma waste, saline, and contaminating debris) in accordance with hospital guidelines.

Here's an analysis of the acceptance criteria and study information for the Medtronic autoLog IQ Autotransfusion System, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain a detailed report of a specific clinical study with granular data on patient outcomes, expert consensus for ground truth, or statistical power calculations typically found in a full clinical trial report. The "testing" referred to is primarily verification and validation testing for engineering and performance against a predicate device, not a human reader study or a standalone clinical effectiveness study.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the device's performance in terms of clinical outcomes or specific blood parameter thresholds. Instead, it relies on demonstrating that the device "passed" a series of verification and validation tests, and its performance is "substantially equivalent" to the predicate device. For the "Blood Washing Performance," which is the most relevant to the device's function, the reported performance is simply "Pass."

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

The document does not specify a "test set" in the context of a clinical study involving patients or human samples with a defined ground truth for evaluation. The testing described (Software, Enclosure, Cleanability, etc.) is engineering verification and validation. The "Blood Washing Performance" test would likely use simulated blood or animal blood, but the sample size and specific provenance are not detailed. It is not a retrospective or prospective clinical study on human patients.

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

This information is not provided because the type of testing described does not involve expert-adjudicated ground truth as would be relevant for image analysis or diagnostic AI. The "ground truth" for engineering tests would be defined specifications or measurements against known standards.

4. Adjudication Method for the Test Set

Not applicable, as no expert adjudication for a "test set" (in the clinical sense) is described.

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

No, an MRMC comparative effectiveness study involving human readers or clinicians is not mentioned in this document. The device automates a process (autotransfusion), rather than assisting human interpretation (like an AI for radiology). Therefore, the concept of "human readers improving with AI vs without AI assistance" does not apply to this device.

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

Yes, in a sense, the primary evaluation of the autoLog IQ Autotransfusion System is its standalone performance in collecting, concentrating, and washing blood. The listed tests, including "Blood Washing Performance," are evaluations of the algorithm/system only without human intervention during the blood processing steps. The human interaction comes at the "setup and breakdown" and reinfusion stages, but the core function is automated.

7. The Type of Ground Truth Used

For the "Blood Washing Performance" and other engineering tests, the ground truth would be based on:

• Defined engineering specifications: For parameters like vacuum levels, pump rates, and sensor function.
• Laboratory measurements: For blood washing performance, this would likely involve analyzing the post-processed blood for red cell concentration, residual plasma, and contaminant removal, comparing these measurements against predetermined acceptable ranges or against the performance of the predicate device.
• Predicate device performance: The overall "ground truth" for regulatory submission is that the device is "substantially equivalent" in performance to the legally marketed predicate device (autoLog Autotransfusion System, K093535).

8. The Sample Size for the Training Set

This concept is not applicable here. The autoLog IQ Autotransfusion System is not an AI/machine learning model that undergoes a "training phase" with a dataset in the typical sense. It's an automated medical device with programmed functions and controls.

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

Not applicable, as there is no "training set" for this device in the context of AI/machine learning.

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