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The XVAC is intended for use in autotransfusion, for the aspiration of shed blood (which is subsequently processed and reinfused to the patient) in the operating room or patient care areas.

The XVAC vacuum module is an enhancement of the predicate Dideco Vacuum Pump. Similar to the predicate device, the main components are the housing, the aspiration pump (with the exception that XVAC includes two different pumps: one for intraoperative mode and one for postoperative mode), and cooling fan. The main modifications consist in the newly designed system that integrates software, control and monitoring sensors and an user interface (display, LEDs, speaker and touch panel).

The provided text describes the XVAC vacuum module, an autotransfusion apparatus. Here's an analysis based on your request:

Acceptance Criteria and Study for K110782 (XVAC)

This 510(k) submission for the XVAC demonstrates substantial equivalence to a predicate device (Dideco Vacuum Pump - K936220), rather than establishing new clinical performance criteria for a novel device. Therefore, the "acceptance criteria" here relate to demonstrating that the new device is as safe and effective as the predicate, based on performance specifications and regulatory compliance, rather than specific clinical outcome metrics or diagnostic accuracy.

The provided document does not detail specific quantitative acceptance criteria or a clinical study in the way one might expect for a diagnostic AI device. Instead, it refers to compliance with performance specifications through "electrical testing, electromagnetic compatibility testing, and performance testing."

Here's the information structured as requested, with explanations where direct answers are not available in the text:

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criteria	Reported Device Performance
   Compliance with electrical safety standards.	Electrical testing demonstrates compliance. (Specific standards or quantitative results not provided in this summary.)
   Compliance with electromagnetic compatibility (EMC) standards.	Electromagnetic compatibility testing demonstrates compliance. (Specific standards or quantitative results not provided in this summary.)
   Functionality and performance meeting specifications for aspiration pump operation (intraoperative and postoperative modes).	Performance testing demonstrates compliance with performance specifications. The device is a "AC powered vacuum pump that provides adjustable vacuums," similar to the predicate. (Specific performance metrics like vacuum levels, flow rates, or duration are not provided in this summary, but these would be part of the underlying "performance specifications" tested).
   Intended use: aspiration of shed blood in autotransfusion in operating room or patient care areas.	The device's intended use is identical to the predicate device, confirming its suitability for this purpose.
   Substantial equivalence to the predicate device (Dideco Vacuum Pump K936220) regarding safety and effectiveness.	Sorin Group Italia Srl "believes that the XVAC is substantially equivalent to the Dideco Vacuum Pump. Any differences do not raise any new issues of safety and effectiveness." This claim is supported by the aforementioned testing.

2. Sample size used for the test set and the data provenance

   • Sample Size: Not applicable in the context of a 510(k) for a hardware device like this. There is no "test set" of patient data or images. The "testing" refers to bench testing of the device itself.
   • Data Provenance: Not applicable. The testing is device-based, not data-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

   • Not applicable. This is not an AI diagnostic device that requires expert ground truth labeling.

4. Adjudication method for the test set

   • Not applicable.

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. This is not an AI device.

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

   • Not applicable. This is a medical device (vacuum module), not an algorithm.

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

   • For the performance testing, the "ground truth" would be established by engineering specifications and recognized national/international standards for electrical safety, EMC, and pump performance. These specifications define the expected operational parameters and safety limits against which the device's performance is measured.

8. The sample size for the training set

   • Not applicable. There is no AI model being trained.

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

   • Not applicable.

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