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The Cell Saver 5 Autologous Blood Recovery System is intended for use as an autotransfusion apparatus in conjunction with the Cell Salvage and Sequestration Protocols and single use sterile disposable sets. The Cell Saver 5 Autologous Blood Recovery System is intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient. The intended use of the Sequestration Protocol is to collect an autologous preoperative platelet rich plasma product.

LN291A Haemonetics Basic Mini Volume (70mL) Cell Saver 5 Bowl Set is a functionally closed systems intended to be used to perform cell salvage using the CS5 Autologous Blood Recovery Svstem.

LN242 10L Waste Bag is intended to be used as an alternate waste bag with the CS5 Autologous Blood Recovery System.

This Special 510(k) premarket notification describes a modification to Haemonetics' currently legally marketed CELL SAVER 5 SYSTEM and the Cell Saver 5 Protocols and associated disposable sets. The proposed modifications involve the addition of a new smaller volume, blow molded bowl disposable set, the LN291A Basic Mini Volume (70mL) Cell Saver 5 Bowl Set and the associated software and hardware changes required to accommodate the smaller volume set. It also includes the addition of an alternate 10L waste bag, LN242. The intended use of the modified device is the same as for the predicate device and has not changed as result of the changes in software for the Cell Salvage and Sequestration Protocols.

Additionally, the design configuration, material composition, manufacturing methods and operational principles for the changed device are equivalent to those of the predicate device.

This document is a 510(k) premarket notification for a modification to an existing medical device, the Haemonetics Cell Saver 5 Autologous Blood Recovery System. The modification involves adding a new, smaller volume bowl disposable set (LN291A) and an alternate waste bag (LN242), along with associated software and hardware changes.

Therefore, the submission is focused on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and reported performance metrics in the way a novel device might. The document explicitly states: "These changes do not affect the intended use or alter the fundamental scientific technology of the device."

Given this context, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, how ground truth for training set was established) are not applicable because the submission is about demonstrating equivalence of a modified, existing device, not a de novo clearance requiring extensive clinical performance studies.

Here's an attempt to answer the questions based on the provided text, while acknowledging the limitations of the document's purpose:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance metrics in a table format. The basis for acceptance is a demonstration of substantial equivalence to the predicate device. The "performance" assessment is qualitative, focusing on whether the modifications adversely affect performance.

The key claim relating to performance is:

• "Verification testing has been performed and demonstrated that the performance of the modified device is not adversely affected by the software changes." (Section: DESIGN CONTROL ACTIVITIES)
• "The Cell Saver 5 Autologous Blood Recovery System, the Cell Saver 5 Protocols, software revision K, and its associated disposable set LN291A are substantially equivalent to legally marketed devices." (Section: CONCLUSION)

There are no specified numerical targets (e.g., specific recovery rates, wash efficiencies, or platelet counts) or measurements presented for the modified device to compare against. The "acceptance criteria" can be inferred as maintaining the established performance characteristics of the predicate device, which is considered satisfied by the "substantial equivalence" determination.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of a clinical study or data-driven performance evaluation. The "verification testing" mentioned is likely internal engineering and quality assurance testing related to the software and hardware changes, rather than a clinical trial. Therefore, sample size, data provenance (country of origin), and retrospective/prospective nature are not described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. The submission does not detail a study involving expert-established ground truth. The assessment is based on design control activities and verification testing to ensure the modified device functions as intended and is equivalent to the predicate.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. There is no "test set" or adjudication process described for clinical performance.

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 device is an autotransfusion apparatus, not an AI-driven diagnostic or imaging device used with human readers.

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

Not Applicable. This is a hardware and software modification to a medical device, not an algorithm being evaluated in isolation. The "software changes" are integrated into the device's operation.

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

Not Applicable. The submission focuses on substantial equivalence based on engineering and performance characteristics relative to a predicate device, not on specific clinical endpoints validated by ground truth methods like pathology or expert consensus. The "ground truth" (if one could even apply the term loosely) would be the established performance and safety profile of the predicate device.

8. The sample size for the training set

Not Applicable. This document describes a modification to an existing device, not the development of a machine learning model that requires a training set.

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

Not Applicable. As per point 8, there is no training set mentioned or implied in this 510(k) submission.

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