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The OCS™ Heart Leukocyte Depleting Filter is indicated for the reduction of leukocytes from donor blood prior to its introduction into the OCS™ Heart System for the preservation of a donor heart from the same donor.

The OCS™ Heart Leukocyte Depleting Filter is a sterile, single-use filter intended for depletion of leukocytes in donor blood prior to its introduction into the OCS Heart system. The polycarbonate housing is 3.2" high and 3.0" in diameter. It has 1/4" fittings and includes a hydrophobic gas-permeable membrane and vent port to allow air to efficiently vent during priming and use. The leukocyte depleting material is a melt blown polyester media supplied by Pall Biomedical (the same material as is used in the predicate device). It has 6 layers, approximately 5 pleats per inch. It includes a polypropylene extruded diamond mesh that provides support for the polyester filter media. The priming volume is 273.5 mL and the anticipated flow rate (associated with gravity feed from a blood collection bag) is 1.9 L/min. During use, the blood enters through the inlet port, flows through the filter media to the interior of the filter element, and then exits through the outlet port. The device is sterilized by ethylene oxide and is provided in a Tyvek pouch packaged in a corrugated box.

This document describes the TransMedics, Inc. OCS™ Heart Leukocyte Depleting Filter, for which a 510(k) premarket notification (K231362) was submitted. The device is a sterile, single-use filter intended to reduce leukocytes from donor blood before it is introduced into the OCS™ Heart System for heart preservation. The submission claims substantial equivalence to the legally marketed predicate device, LeukoGuard BC2 (K902518) by Pall Biomedical.

The document does not contain a table of acceptance criteria or specific reported device performance values for the OCS™ Heart Leukocyte Depleting Filter, nor does it detail a study that explicitly proves the device meets these criteria with quantitative results. Instead, it broadly states that "Bench testing has demonstrated acceptable performance of the device, that it meets all acceptance criteria and that the OCS Heart Leukocyte Depleting Filter is acceptable for clinical use."

However, based on the provided information, we can infer some aspects related to its performance and the studies conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

As mentioned, a direct table is not present. However, the document lists areas of testing that imply acceptance criteria would be related to:

• Leukocyte and platelet depletion: The device is expected to effectively deplete leukocytes (and platelets). It's stated that the proposed device removes more leukocytes and platelets due to its larger size, implying higher effectiveness in this aspect. For the predicate, the acceptance criteria would be established historical performance data.
• Filtration time: The device must filter blood within an acceptable timeframe.
• Hold-up volume, priming volume, and pressure drop: These physical characteristics must be within specifications.
• Maximum flow rate: The device must be compatible with the OCS Heart system's flow requirements (antecedently, 1.9 L/min).
• Structural integrity: The filter must maintain its structural integrity during use.
• Hemolysis: The device should not cause excessive hemolysis.
• Biocompatibility: Meet ISO 10993-1 standards (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Hemocompatibility, Genotoxicity, Pyrogenicity, USP Physicochemical Test for plastics).
• Sterility: Achieve a sterility assurance level (SAL) of 10^-6.
• Shelf life: Maintain integrity and performance for 12 months.

Reported Device Performance:
The document states that "The testing demonstrated that the OCS Heart Leukocyte Depleting filter met all specifications and was shown to be equivalent to the predicate device."
Specifically, regarding leukocyte and platelet depletion, it mentions: "The OCS Heart Leukocyte Depleting Filter is larger (273.5 mL priming volume compared to 95 mL priming volume for the LeukoGuard BC2) and therefore removes more leukocytes and platelets than the predicate device." It further clarifies, "an increased level of leukocyte depletion does not raise a different question of safety or effectiveness."

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

• Test Set Sample Size: Not explicitly stated. The testing includes "Bench performance testing" and "Pre-Clinical Validation using the OCS Heart Leukocyte Depleting Filter with the OCS Heart System to preserve swine hearts." The number of "swine hearts" or other samples used for bench testing is not provided.
• Data Provenance: The biocompatibility studies were conducted by NAMSA (Norwood, OH) and Ethide Laboratories (West Warwick, RI), both in the USA. The "Pre-Clinical Validation" using swine hearts suggests an animal model, likely conducted in a controlled laboratory setting. The data is retrospective in the sense that the testing was performed to support the 510(k) submission, not as a continuous monitoring effort.

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

• General Assessment: This information is not applicable in the context of device performance testing for a medical filter. The "ground truth" for the performance tests (e.g., leukocyte count, flow rate, hemolysis level) would be established by scientific measurement techniques and validated laboratory standards, not by expert consensus in the typical sense of diagnostic accuracy studies.
• Biocompatibility Testing: Conducted in compliance with 21 CFR Part 58 (GLPs) and according to ISO-10993-1 and USP standards. Experts involved would be qualified laboratory personnel in toxicology, microbiology, and materials science.

4. Adjudication Method for the Test Set:

• Not applicable. This concept is typically relevant for studies involving human interpretation (e.g., imaging studies) where discrepancies among readers need to be resolved. Performance testing of a filter involves objective measurements against predefined specifications.

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

• No. An MRMC study is not relevant for this device. This type of study assesses diagnostic accuracy and inter-reader variability, usually in imaging or pathology. The OCS Heart Leukocyte Depleting Filter is a physical device with measurable performance characteristics.

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

• Yes, in a sense. The bench testing and pre-clinical validation (swine hearts) represent "standalone" performance evaluations as they assess the device's function directly without human interaction being the primary variable. The device itself does not involve an algorithm or AI.

7. The Type of Ground Truth Used:

• Objective Measurements/Scientific Standards: The "ground truth" for the device's performance is based on objective measurements against established scientific and engineering standards.
  • Leukocyte/Platelet Depletion: Laboratory assays to quantify cell counts before and after filtration.
  • Filtration Time, Flow Rate, Volumes, Pressure Drop: Engineering measurements.
  • Structural Integrity: Physical stress tests and observation.
  • Hemolysis: Laboratory assays to measure hemoglobin release.
  • Biocompatibility: Results from validated in vitro and in vivo toxicological tests (e.g., cytotoxicity, sensitization tests according to ISO 10993-1).
  • Sterility: Microbiological validation tests to confirm SAL.
  • Pre-Clinical Validation (Swine Hearts): Likely physiological measurements of heart function and integrity after blood processing by the device in an isolated organ system.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical filter, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device's design, materials, and manufacturing process are based on established engineering principles and the performance of the predicate device.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as there is no training set for this type of device.

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The OCS™ Lung Donor Flush Set is a single-use device indicated for hypothermic flushing and replacement of residual blood in donor lungs with a legally marketed organ preservation solution at the time of organ removal from the donor during the preparation of these organs for transplantation.

The OCS Lung Donor Flush Set is a sterile single-use device indicated for hypothermic flushing and replacement of residual blood in donor lungs with a legally marketed organ preservation solution at the time of organ removal from donor during the preparation of these organs for transplantation. It is comprised of an already 510(k) cleared cannula (K132811, Sarns Soft-Flow Extended Aorta Cannula) along with the donor flush lines subassembly. The donor flush line assembly consists of silicone tubing, clamps and two spike connectors to enable connection between donor lungs and bags of organ preservation solution. The clamps are used to control the gravity flow of solution from bags to the donor organ.

The device is sterilized by ethylene oxide and is provided in a Tyvek pouch packaged in a corrugated box.

The provided FDA 510(k) summary document for the TransMedics, Inc. OCS™ Lung Donor Flush Set focuses on establishing substantial equivalence to a predicate device for medical device clearance, not on providing a study proving a device meets specific clinical performance acceptance criteria in the context of an AI/algorithm-based device.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable as they pertain to the evaluation of AI or algorithmic performance, which is not the subject of this medical device submission.

The document describes a physical medical device used for organ preservation, not an AI or software-driven diagnostic or treatment tool. The "performance data" section refers primarily to bench testing, biocompatibility, sterilization, and shelf-life, which are standard for physical medical devices.

Here's an attempt to answer the questions based only on the provided document, noting where information is not available or not applicable:

Acceptance Criteria and Study for the OCS™ Lung Donor Flush Set

This document describes the 510(k) submission for the OCS™ Lung Donor Flush Set, a physical medical device. The "study" referenced in the document is primarily bench testing to verify product requirements, not a clinical trial or AI performance study.

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Performance testing was done to verify that OCS Lung Donor Flush Set meets all of its product requirements. The testing demonstrated that all acceptance criteria were met and that the OCS Lung Donor Flush Set was acceptable for clinical use."

However, the specific "acceptance criteria" (e.g., tensile strength, flow rate, leak integrity) and the detailed results of "reported device performance" are not explicitly listed in the provided 510(k) summary. These details would typically be found in the full submission, but are summarized as met for the purpose of demonstrating substantial equivalence.

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

Not applicable in the context of an AI/algorithm test set. The "test set" for this physical device was likely a series of units manufactured for bench testing. The document does not specify the number of units tested. The data provenance would be from internal lab testing by TransMedics, Inc.

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

Not applicable. This is not an AI/diagnostic device that requires expert ground truth for image or data interpretation.

4. Adjudication Method for the Test Set

Not applicable. (See #3)

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI systems where human readers interpret cases. The OCS™ Lung Donor Flush Set is a physical device for organ preservation.

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

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

7. The Type of Ground Truth Used

The "ground truth" for this device is its adherence to engineering specifications, material properties, and functional performance (e.g., flow rates, leak integrity, sterility) as verified through design verification and validation testing, often against established standards (e.g., ISO for biocompatibility and sterilization). It does not involve expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. (See #8)

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OCS™ Lung Solution is intended for flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.

The OCS Lung Solution is a colorless, sterile, pyrogen-free solution for cold flushing, storage and transport of donor lungs for transplantation. The OCS Lung Solution is a colloid-based extracellular low potassium solution for cold flushing and storage of donor lungs for transplantation. The OCS Lung Solution is used to flush and store a lung after removal from the donor. Administration of the solution at the recommended temperature will effectively cool the organ to reduce its metabolic requirements.

This document, K211314, is an FDA 510(k) Premarket Notification for the OCS™ Lung Solution. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of studies typically associated with AI/ML evaluations.

Therefore, the information required to answer your prompt about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device is largely not present in this 510(k) summary.

Specifically, the document states:

• "Software Verification and Validation Testing: Not applicable. The device contains no software."
• "Clinical Data: Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device."
• "Animal Testing: Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device."

This indicates that this is a medical solution (a chemical product), not an AI/ML device, and thus the type of performance evaluation typically performed for AI/ML devices (e.g., assessing accuracy, sensitivity, specificity, or human reader improvement with AI assistance) was not conducted.

However, I can extract information regarding the "device" as described in this 510(k) submission, even if it doesn't align with an AI/ML context:

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

Since this is a solution and not an AI/ML device, typical "performance" metrics like accuracy, sensitivity, or specificity are not applicable. The closest aspects to "acceptance criteria" for a solution would be its chemical composition, sterility, and shelf life. The document focuses on demonstrating substantial equivalence to an existing predicate device (Perfadex®) rather than meeting defined performance criteria through a study.

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

This information is not applicable as no "test set" in the context of an AI/ML algorithm was used. The evaluation for this device focused on bench testing (chemical analyses) and demonstrating similarity to a predicate device.

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)

This information is not applicable. No ground truth for an AI/ML test set was established. The "ground truth" for this product type is its chemical composition, sterility, and demonstrated biocompatibility, which are verified through standard laboratory testing methods and comparison to an established predicate.

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

This information is not applicable. No test set or expert adjudication was performed in the context of an AI/ML device.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a solution, not an AI-assisted diagnostic tool.

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

This information is not applicable. There is no algorithm, so no standalone performance testing was conducted.

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

Since this is a medical solution and not a diagnostic AI/ML device, the concept of "ground truth" as typically defined for AI/ML is not directly applicable. For this product, "ground truth" would relate to:

• Chemical Analysis: Verifying the exact composition of the solution.
• Sterility Testing: Verifying the absence of microorganisms.
• Biocompatibility Testing: Verifying that the materials do not elicit adverse biological responses.
• Bench Testing: Comparison to established standards for solutions for organ preservation.

8. The sample size for the training set

This information is not applicable. There is no AI/ML model, and therefore no training set.

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

This information is not applicable. There is no AI/ML model or training set.

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