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The Interpore Cross International Access™ System is intended to separate and collect an autologous plasma fraction rich in platelets and white cells from the patient's whole blood perioperative to a surgical procedure.

The Interpore Cross International Access™ Concentration System consists of a table-top, autotransfusion apparatus provided with an ancillary filtration unit and a single-use processing disposable set designed to allow separation and collection of an autologous plasma fraction rich in platelets and white cells from the patient's whole blood perioperative to a surgical procedure. The Access™ System is comprised of two major components:
a) Reusable table-top apparatus: The Access machine is an electromechanical microprocessor-controlled device contained in an enclosure which incorporates the following system components: the user display and function keys, centrifuge rotor, centrifuge chamber housing, peristaltic pumps, red blood cell sensors, bubble sensor, pinch valves, vacuum pump and power supply units. The system also includes electronic components and system software which control and monitor the blood processing steps.
b) Single Use Processing Disposable set: The Access System Disposable Set consists of a separation chamber, a filter, holding and collection bags, and associated tubing, clamps, connectors and protective caps. Connection of this set to a whole blood reservoir allows the blood processing to be carried out.

The provided 510(k) summary (KO223Y8) for the Interpore Cross International Access™ System does not contain the detailed information required to fill out your request regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document lacks:

• A table of acceptance criteria and reported device performance.
• Information on sample size for test sets, data provenance, number/qualifications of experts, or adjudication methods for ground truth.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or human-in-the-loop performance.
• Details on standalone algorithm performance.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size for training sets or how ground truth for training sets was established.

The document states: "Based on the performance testing conducted, the proposed modified device has been demonstrated to be substantially equivalent to its predicates." However, it does not describe what that performance testing entailed, what specific criteria were met, or the details of the study (e.g., methodology, sample sizes, ground truth establishment).

Therefore, I cannot generate the requested table and information based on the provided text. The 510(k) summary focuses primarily on device description, intended use, and comparison to predicate devices for demonstrating substantial equivalence, rather than a detailed report of performance studies against specific acceptance criteria.

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