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The ClearLumen II Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the coronary and peripheral vasculature.

The ClearLumen II Thrombectomy System is a multi-lumen device that allows for simultaneous hydro-mechanical thrombus disruption and thrombus aspiration. It is designed to simultaneously deliver a stream of high pressure saline via a displacement pump to the distal tip of the catheter, while aspirating thrombotic material macerated by the saline stream.

The system is comprised of three components: The ClearLumen II Catheter, the ClearLumen II Pump Set, and the ClearLumen Saline Drive Unit (SDU). Additional off-the-shelf accessory components are required for device operation and include a vacuum syringe, one way stopcock, aspiration extension tubing and a vacuum sensor.

The 6 Fr, 135 cm, multi-lumen thrombectomy catheter delivers pressurized saline, within the distal catheter inner diameter, to assist in the break-up and removal of soft emboli and thrombus. The distal catheter's 0.014" wire compatible rapid exchange lumen extends and ends in a soft atraumatic tip. The proximal in-line Luer port connects to the pump set, while the Y-connector connects to the vacuum sensor, extension tube, stopcock, vacuum syringe assembly (supplied separately).

The proximal end of the pump set consists of a spike and an in-line drip chamber that is used to pierce the saline bag and connect the pump set to the saline source. The cassette, which is centered in the pump set, contains a piston pump and is mounted onto the SDU. The cassette is powered by the motor contained in the SDU. The distal end of the pump set has a connector, which mounts to the proximal end of the Y-connector of the catheter and delivers the saline to the catheter.

The SDU is a reusable, IV pole mounted device. The fork drive of the SDU is designed to run the piston pump contained in the pump set to deliver the stream of saline to the catheter, when activated by the vacuum sensor. Vacuum is achieved by a vacuum syringe (not provided), which is connected to the vacuum sensor. The vacuum sensor is connected to the aspiration lumen on the Y-connector of the catheter. The SDU contains a microprocessor controlled circuit and firmware that monitors various functions of the motor and vacuum to assure that the device is functioning as expected. Various colored LED lights on the front panel indicate to the user what the current status is of the SDU. Energy is provided by a 24 volt external power supply, which is connected to mains power.

The provided text describes a 510(k) premarket notification for the ClearLumen II Thrombectomy System. This type of FDA submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria for performance metrics like sensitivity or specificity.

Therefore, the document does not contain information typically found in studies designed to prove device performance against specific clinical acceptance criteria. Instead, it details non-clinical (bench) testing to support its substantial equivalence claim.

Here's an analysis based on your requested information, highlighting what is and is not present in the provided text:

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

The document does not present a table with specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) like those found in a diagnostic device study. Instead, it states that "All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements." However, the specific values of these criteria and the quantified reported performance against them are not provided for the individual tests.

It lists types of tests performed:

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 explicitly states: "No pre-clinical or clinical data were generated to establish substantial equivalence." This means there was no "test set" in the sense of patient data. The testing was all in vitro (bench testing). Therefore, details like data provenance (country of origin, retrospective/prospective) and sample size for a clinical test set are not applicable and not provided.

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

Since no clinical data or patient test set was used, there were no experts establishing ground truth in a clinical context (e.g., radiologists interpreting images). The "ground truth" for the non-clinical tests would have been established by engineering specifications and standard test methods.

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

No adjudication method was used, as there was no clinical test set requiring expert consensus for ground truth.

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 MRMC study was conducted. The device is a thrombectomy system, not a diagnostic AI device that assists human readers.

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. Bench testing evaluates its physical and functional performance.

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

For the non-clinical testing, the "ground truth" was based on:

• Engineering specifications and design requirements: For tests like pull strength, pressure, flow, kink resistance, and saline stream containment.
• International standards: For biocompatibility (ISO 10993-1), sterilization (ISO 11135), and electrical safety (IEC 60601-1).
• Validated test methods: For embolic analysis and transportation/shelf life.

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning product that requires a training set.

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

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

In summary: The provided document is a 510(k) summary focused on demonstrating substantial equivalence through non-clinical (bench) testing, rather than establishing clinical efficacy or performance against specific (e.g., diagnostic) acceptance criteria typically found in clinical studies. The "acceptance criteria" referred to are those for engineering and safety performance established through predetermined product specifications and external standards.

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