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ProCell™ facilitates the extraction of blood from surgical sponges as a preliminary step in the process of intraoperative autotransfusion or IAT.

ProCell™ functions as a blood collection device only and does not filter or otherwise process the blood recovered. As an accessory to IAT, it is used in conjunction with standard IAT equipment which processes the blood retrieved from ProCellTM prior to reinfusion into the patient (autologous blood transfusion).

Designed for ease-of-use directly on the surgical instrument table, the disposable ProCell™ can be used repeatedly during a surgical case and provides an alternative to other sponge-blood recovery methods including hand-wringing.

The ProCell™ Surgical Sponge - Blood Recovery Unit ("ProCell") automates the manual hand-wringing process to extract blood from surgical sponges. The ProCell unit consists of three components 1) a piston Lid, 2) a perforated Sponge Basket, and 3) a Reservoir. The Sponge Basket is inserted into the Reservoir, and the piston Lid is placed on the top opening of the Reservoir. Through the use of standard Operating Room vacuum suction, blood is extracted from the sponges and is collected in the Reservoir.

ProCell is used in conjunction with standard intraoperative autotransfusion devices (IAT) which must process the blood retrieved from ProCell prior to reinfusion into the patient. ProCell functions as a blood collection device only, is not a blood storage container, and does not filter or otherwise process the recovered blood. The recovered blood from ProCell is not intended to be infused directly back into the patient.

The provided text describes the regulatory clearance for the ProCell Surgical Sponge-Blood Recovery Unit. While it lists various performance tests and standards compliance, it does not explicitly detail acceptance criteria in a table format with reported performance for device metrics. It also does not include information about studies involving human readers, ground truth establishment methods for training or test sets, or sample sizes specific to AI/algorithm development.

The document focuses on the mechanical and biocompatibility aspects of the device, rather than its performance in the context of an AI/ML algorithm. Therefore, many of the requested items related to AI/ML studies are not applicable or present in this document.

However, based on the information provided, here's what can be extracted and inferred:

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

The document does not provide a specific table of acceptance criteria for device performance in terms of quantitative metrics for blood recovery efficiency or quality within this 510(k) summary. Instead, it lists areas where testing was conducted to ensure safety and functionality.

Inferred "Acceptance Criteria" represented by the standards:

• ISO 10993-4: Selection of tests for interactions with blood
• AAMI/ANSI/ISO 10993-5: Tests for in vitro cytotoxicity
• ISO 10993-10: Tests for irritation and skin sensitization
• ISO 10993-11: Tests for Systemic Toxicity
• ISO 10993-12: Sample preparation and reference materials
• USP NF36:2018 Bacterial Endotoxins Test (USP Rabbit Test)
• ASTM F2382-18: Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT)
• ASTM F2888-19: Platelet Leukocyte Count - In-Vitro Measure For Hemocompatibility
• ASTM F756-17: Assessment of Hemolytic Properties of Materials | Device meets these standards, ensuring biocompatibility and hemocompatibility, as implied by the FDA clearance based on these tests. |
  | Sterilization | - ISO 11137-1: Requirements for development, validation, and routine control of a sterilization process
• ISO 11137-2: Establishing the sterilization dose
• ISO 11737-1: Determination of a population of microorganisms on products
• BS EN ISO 11737-2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization process
• USP NF36:2018 Pyrogen Test | Device meets these standards, ensuring it is sterile and non-pyrogenic. |
  | Packaging & Shelf Life | - ASTM D4169-16: Performance testing of shipping containers and systems
• ASTM F88/F88M-15: Seal Strength of Flexible Barrier Materials
• ASTM F2096-11: Detecting gross leaks in packaging by internal pressurization
• ANSI/AAMI/ISO 11607-1: Packaging for terminally sterilized medical devices
• ASTM F1980-16: Accelerated Aging of Sterile Barrier Systems
• ASTM D5276-98(2017): Drop Test of Loaded Containers by Free Fall
• ASTM D642-15: Determining Compressive Resistance of Shipping Containers
• ASTM D999-08: Vibration Testing of Shipping Containers
• ASTM F4728-17: Random Vibration Testing of Shipping Containers | Device meets these standards, ensuring packaging integrity and shelf life under various transport and storage conditions. |
  | Functional & Structural Integrity | - Not explicitly detailed as separate standards in the provided text, but implied by the "Functional and structural integrity" and "Operational performance" test categories. This would typically involve physical durability, leak testing, and proper operation of its mechanical components (piston lid, sponge basket, reservoir). | Device performs as intended for blood extraction from sponges. The FDA clearance confirms that the device has demonstrated it will perform per its intended use based on these tests. |
  | Red Blood Cell Viability | - "Red blood cell viability" was a specific test conducted. (No explicit standard mentioned in this section for this specific test, but likely covered under hemocompatibility standards like ISO 10993-4 and ASTM F756-17) | Information on the specific metrics (e.g., % viability) and acceptance limits is not provided in this summary, but the clearance implies acceptable viability. |

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

The document does not provide details on sample sizes for test sets in the context of clinical or AI/ML performance. The "testing" mentioned is laboratory-based (biocompatibility, sterilization, packaging, functional), and the sample sizes for these types of tests would be determined by the specific standards and protocols involved, not typically reported in this summary document. Data provenance is not applicable here as these are not clinical data studies.

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. This device is not an AI/ML diagnostic tool that requires expert-established ground truth for image or data interpretation. Its function is mechanical blood recovery.

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

Not applicable. This is not a study requiring adjudication of expert interpretations.

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-assisted diagnostic device.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For the types of tests conducted (biocompatibility, sterilization, etc.), the "ground truth" is typically established by physical/chemical laboratory measurements and adherence to specified performance limits defined in the referenced ISO and ASTM standards. For example, for sterility, it's the absence of microbiological growth, which is a definitive laboratory outcome. For hemocompatibility, it's compliance with established limits for coagulation times or hemolysis.

8. The sample size for the training set

Not applicable. This device does not involve AI/ML and therefore does not have a training set.

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

Not applicable. This device does not involve AI/ML.

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