(88 days)
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.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Acceptable, based on components from PMA-approved or 510(k)-cleared devices. |
| Sterility Assurance Level | 10⁻⁶ (stated as met). |
| Shelf Life | 26 months (labeled as met). |
| Bench Testing | All product requirements and acceptance criteria were met. (Specific criteria and results not detailed in this summary). |
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)
§ 876.5880 Isolated kidney perfusion and transport system and accessories.
(a)
Identification. An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.(b)
Classification. Class II (performance standards).