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ThromCat™ Thrombectomy Catheter System is indicated for mechanical removal of thrombus from synthetic hemodialysis access grafts and native vessel dialysis fistulae.

ThromCat™ Thrombectomy Catheter System is a single-use, disposable device that performs percutaneous maceration and removal of thrombus and restoration of blood flow. The device consists of a 5.5 Fr infusion/extraction catheter, a DC-powered infusion/extraction pump, and an extraction line and bag. The stainless steel helix is enclosed within a radiopaque, atraumatic flexible tip and shaft, preventing direct contact with the vessel wall. The integrated pumps, tubing, and 150cm length catheter provide an infusion flow to "wash" the vessel, while simultaneously providing an extraction flow to remove thrombus.

The provided document is a 510(k) summary for the ThromCat™ Thrombectomy Catheter System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, the document does not contain a study that proves the device meets specific acceptance criteria.

The "Non-Clinical Summary" section states: "Non-clinical verification has been verified through in-vitro bench testing and biocompatibility testing. Results of this testing indicate that the ThromCat design meets all specifications and intended use." This is a general statement, but no specific acceptance criteria or detailed study results are provided.

Therefore, I cannot fulfill all parts of your request as the necessary information is not present in the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document states that "non-clinical verification has been verified through in-vitro bench testing and biocompatibility testing" and that "results of this testing indicate that the ThromCat design meets all specifications and intended use." However, it does not provide any specific acceptance criteria (e.g., "thrombus removal efficiency > 90%") or reported device performance metrics tied to those criteria.

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

• Cannot be provided. The document only mentions "in-vitro bench testing" and "biocompatibility testing" but does not detail sample sizes, data provenance, or whether the testing was retrospective or prospective.

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 / Cannot be provided. Since the studies mentioned are "in-vitro bench testing" and "biocompatibility testing," they are likely physical or chemical tests that do not involve human expert interpretation for establishing ground truth in the way a clinical image analysis study would.

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

• Not applicable / Cannot be provided. As above, this is not relevant for the type of bench and biocompatibility testing described.

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. The document does not describe any MRMC comparative effectiveness study, nor does it involve AI assistance. This device is a physical thrombectomy catheter.

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

• N/A. This device is a physical medical device, not an algorithm.

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

• Cannot be provided definitively for "in-vitro bench testing." For "biocompatibility testing," the ground truth would typically be established by standardized toxicological and immunological assays against established safety limits or comparison to predicate device materials, rather than expert consensus on medical images or pathology.

8. The sample size for the training set

• Not applicable. This device is a physical medical device, not an algorithm that requires a "training set."

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

• Not applicable. As above, this is not relevant for a physical medical device.

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ThromCat™ Thrombectomy Catheter System is indicated for mechanical removal of thrombus in synthetic hemodialysis access grafts and native vessel dialysis fistulae.

ThromCat Thrombectomy Catheter System is a single-use, disposable device that performs percutaneous maceration and removal of thrombus and restoration of blood flow. The device consists of a 5.5 Fr x 4.5 Fr infusion/extraction catheter, a DC-powered infusion/extraction pump, and an extraction line and bag. The stainless steel helix is enclosed within a radiopaque, atraumatic flexible tip and shaft, preventing direct contact with the vessel wall. The integrated pumps, tubing and 150 cm length catheter provide an infusion flow to "wash' the vessel, while simultaneously providing an extraction flow to remove thrombus.

This document is a 510(k) summary for the Kensey Nash ThromCat™ Thrombectomy Catheter System. It describes the device, its intended use, and provides information on non-clinical testing for substantial equivalence to predicate devices.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria (e.g., performance thresholds like "achieve X% thrombus removal") or quantifiable reported device performance results for the ThromCat™ Thrombectomy Catheter System.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It asserts that "Results of bench testing and animal studies demonstrate ThromCat is as safe and effective as the legally marketed predicate devices." This is a qualitative statement of equivalence rather than a report of specific performance metrics against defined criteria.

To fully answer this question, more detailed testing reports would be needed, which are not present in this 510(k) summary. However, based on the information given, a conceptual table might look like this, with the understanding that specific numerical criteria and results are missing:

• Biocompatibility: Passed relevant tests (implied, no specific results)
• EMC (Electromagnetic Compatibility): Passed relevant tests (implied, no specific results)
• Electrical Safety: Passed relevant tests (implied, no specific results)
• Mechanical Testing: Passed relevant tests (implied, no specific results)
• Animal Studies: Demonstrated safety and effectiveness (implied, no specific results)
• In vitro Comparison Testing: Conducted against X-Sizer Catheter, providing reasonable assurance of safety and effectiveness (implied, no specific results)
• In vivo Comparison Testing: Conducted against X-Sizer Catheter, providing reasonable assurance of safety and effectiveness (implied, no specific results) |
  | Mechanical Removal of Thrombus: Ability to achieve mechanical removal of thrombus from synthetic hemodialysis access grafts and native vessel dialysis fistulae. | This is the intended use, and the non-clinical testing (especially in vitro and in vivo comparison testing) aimed to confirm this capability and its equivalence to predicate devices. No specific "percentage of thrombus removed" or "time to removal" metrics are provided. |
  | Prevention of direct contact with vessel wall: The stainless steel helix is enclosed within a radiopaque, atraumatic flexible tip and shaft. | This is a design feature claimed to prevent direct contact. The "animal studies" and "in vivo comparison testing" would implicitly assess the effectiveness of this design in a physiological environment, but no specific data is presented. |

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

The document mentions "bench testing" and "animal studies" and "in vitro and in vivo comparison testing." However, it does not specify the sample sizes used for these test sets.

• Test Set Sample Size: Not specified.
• Data Provenance: The studies are described as "non-clinical testing," "in vitro," and "in vivo (animal studies)." The country of origin is not specified but implicitly would be related to the submitting company (Kensey Nash Corporation, USA). The studies are not described as retrospective or prospective in a human clinical trial sense, but rather as pre-market, non-clinical evaluations.

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

This information is not provided in the 510(k) summary. Non-clinical studies (bench and animal) typically do not involve human "experts" establishing ground truth in the same way clinical studies do (e.g., radiologist reviews). Instead, performance is measured against established scientific principles and metrics in a laboratory or animal model.

4. Adjudication Method for the Test Set

Since this relates to expert review of clinical data, and the studies mentioned are non-clinical (bench and animal), there is no information provided on an adjudication method.

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 done. The device described is a mechanical thrombectomy catheter system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, this question is not applicable.

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

This question is not applicable as the device is a mechanical catheter system, not an algorithm.

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

For the "non-clinical testing" including "bench testing" and "animal studies" and "in vitro and in vivo comparison testing," the ground truth would be established by:

• Quantitative measurements of performance parameters (e.g., flow rates, thrombus removal efficiency, force measurements for mechanical tests).
• Histopathological analysis in animal studies to assess tissue damage or healing.
• Direct observation and measurement in controlled in vitro environments.
• Comparison to known performance characteristics of the predicate devices under similar conditions.

There's no mention of expert consensus, pathology in human cases, or human outcomes data for these non-clinical studies.

8. The sample size for the training set

This information is not applicable. This device is a mechanical medical device, not an AI/machine learning system that requires a "training set" in the computational sense.

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

This question is not applicable for the same reason as point 8.

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