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The Excipio LV Prime Thrombectomy Device is indicated for the nonsurgical removal of emboli and thrombi from peripheral blood vessels.

The Excipio LV Prime Thrombectomy Device consists of a Thrombectomy Catheter to mechanically displace thrombus when used with an aspiration catheter. The device will be sold as a sterile, single use device.

The Thrombectomy Catheter is a mechanical thrombus displacement device with a nitinol braided component (basket) at the distal end that can be opened and closed via an activation wire that attaches to the distal end of the braid and attaches to a proximal handle. The operator can open the braided component to a diameter that best matches the target vessel (6-16 mm in diameter). The thickness of the basket wires enhances the radiopacity to facilitate visualization under fluoroscopy without the need for additional radiopaque markers.

Let's break down the information regarding the acceptance criteria and study for the Excipio LV Prime Thrombectomy Device, based on the provided FDA 510(k) clearance letter.

It's important to note that this document is a 510(k) clearance letter, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "study" described here is primarily a non-clinical bench testing campaign aimed at proving the new device performs similarly and meets a defined set of engineering and performance specifications. There is no clinical study involving human (or animal) subjects described in this document for the Excipio LV Prime Thrombectomy Device. Thus, concepts like "human readers," "AI assistance," "effect size," or "ground truth for training/test set" in the context of clinical outcomes or diagnostic accuracy are not applicable to this type of device and submission.

Acceptance Criteria and Reported Device Performance

The document describes non-clinical laboratory testing performed to support the substantial equivalence. The acceptance criteria for these tests are implicitly that the device met the criteria and functioned as intended, with a performance profile similar to predicate devices. Specific quantitative acceptance criteria or detailed reported performance values are not explicitly stated in this summary. Instead, it broadly states that the device "met all acceptance criteria" and "functioned as intended."

Table of Acceptance Criteria and Reported Device Performance:

Study Details: Non-Clinical Bench Testing

Since this is a thrombectomy device and the submission is for 510(k) clearance based on substantial equivalence, the "study" referred to is a series of in vitro bench tests.

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

   • The document does not explicitly state the specific number of units tested for each non-clinical test (e.g., how many devices were subjected to kink resistance or tensile testing). This level of detail is typically found in the full 510(k) submission, not the summary.
   • Data Provenance: All data is from in vitro bench testing conducted by the manufacturer, Contego Medical, Inc. The country of origin for this testing is not specified, but it would typically be conducted at the manufacturer's facilities or a contracted testing lab. This is by definition retrospective in the sense that the testing is performed before submission for clearance.

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

   • Not Applicable. For non-clinical bench testing of a medical device, "ground truth" is established by engineering specifications, validated test methods, and industry standards (e.g., ISO standards). There are no "experts" establishing a clinical judgment ground truth in this context. The "experts" involved would be the design engineers, quality engineers, and test technicians who define the test protocols and interpret the results against the defined acceptance criteria.

3. Adjudication Method for the Test Set:

   • None Applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies or image interpretation studies where multiple human readers' opinions need to be reconciled to establish a ground truth. For bench testing, results are typically objective measurements compared directly against predetermined pass/fail criteria.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, not done. An MRMC study is relevant to diagnostic imaging devices or other technologies where human interpretation is involved. This device is a mechanical thrombectomy device; its performance is evaluated by its physical characteristics and efficacy in removing thrombus in a lab setting, not by aiding human readers in diagnosis.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

   • Not Applicable. This device is an invasive medical device, not a software algorithm. Its use inherently involves a human operator (a clinician) and is not "standalone" in the sense of an unassisted algorithm making decisions.

6. Type of Ground Truth Used:

   • For the non-clinical testing, the "ground truth" is defined by:
     • Engineering specifications and design requirements: For dimensional, kink resistance, torsional strength, tensile, radial force, and corrosion testing.
     • Validated test methods and industry standards (e.g., ISO 10993-1): For biocompatibility, simulated use, and clot removal testing.
     • Manufacturer's internal quality standards.

7. Sample Size for the Training Set:

   • Not Applicable. The concept of a "training set" applies to machine learning algorithms. This device is a physical, mechanical medical device, not an AI/ML system.

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

   • Not Applicable. As above, there is no training set for this type of device.

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The Excipio® SV Aspiration Catheter and Tubing is indicated for the non-surgical removal of fresh, soft emboli and thrombi from peripheral blood vessels.

The Excipio SV Aspiration Catheter and Tubing consists of an aspiration catheter which is a single, large inner lumen catheter with a hydrophilic coating (20cm outside the distal end) designed to navigate through the peripheral vasculature and provide the maximum luminal area for aspiration. The aspiration catheter will be available in 7F and 8F sizes. Sterile, single use aspiration tubing will be distributed to facilitate a vacuum connection between the aspiration catheter and the collection canister of the vacuum pump.

Since the provided text describes a medical device (catheter and tubing) rather than an AI/ML powered device, the requested information (such as sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size, etc.) is not applicable or available in the document.

The document discusses the non-clinical testing performed to establish substantial equivalence of the Excipio SV Aspiration Catheter and Tubing to a predicate device.

Here's a summary of the available information based on the provided text, focusing on the acceptance criteria and performance data for this type of medical device:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not specified for individual bench tests. The animal study was conducted using a "porcine model," but the number of animals is not provided.
• Data Provenance: The "non-clinical laboratory testing" and "in vitro bench tests" were performed, indicating laboratory-generated data. The "GLP animal study (porcine)" indicates live animal data. Countries of origin are not specified for these tests. The data appears to be prospective as it was performed to support the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This information is not applicable and not provided. The testing described involves objective physical and biological measurements, not expert interpretation of outputs like in AI/ML performance evaluation.

4. Adjudication Method

• This information is not applicable and not provided. The testing described involves objective measurements against predefined criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to this medical device submission.

6. Standalone Performance

• The document describes "Non-Clinical Testing/Performance Data" and "in vitro bench tests" which evaluate the device's performance properties as a standalone product (i.e., algorithm only without human-in-the loop performance). The animal study also evaluated standalone performance in an in-vivo setting.

7. Type of Ground Truth Used

• The "ground truth" for this device type is established by:
  • Engineering specifications and standards: For dimensional, strength, and functional tests (e.g., kink resistance, tensile strength, vacuum collapse).
  • Validated biological assays: For biocompatibility tests (e.g., cytotoxicity, hemolysis).
  • In-vivo observations and measurements: For the GLP animal study (e.g., thrombogenicity, acute performance, safety).

8. Sample Size for the Training Set

• This information is not applicable and not provided. There is no AI/ML component described, so no 'training set' is used.

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

• This information is not applicable and not provided, as there is no AI/ML component or training set.

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The Excipio LV Thrombectomy Device indicated for the non-surgical removal of emboli and thrombi from peripheral blood vessels.

The Excipio LV Thrombectomy Device consists of a Thrombectomy Catheter to mechanically displace thrombus when used with an aspiration catheter. The device will be sold as a sterile, single use device. The Thrombectomy Catheter is a mechanical thrombus displacement device with a nitinol braided component (basket) at the distal end that can be opened and closed via an activation wire that attaches to the distal end of the braid and attaches to a proximal handle. The operator can open the braided component to a diameter that best matches the target vessel (10-25mm in diameter). The thickness of the basket wires enhance the radiopacity to facilitate visualization under fluoroscopy without the need for additional radiopaque markers.

The provided text describes the Excipio LV Thrombectomy Device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria and a study proving the device meets those criteria, specifically concerning AI/algorithm performance. The document is a 510(k) summary for a medical device which focuses on non-clinical testing for safety and performance compared to existing devices.

Therefore, most of the requested information regarding AI/algorithm performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance cannot be extracted from this document.

However, I can provide the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "The in vitro bench tests demonstrated that the Excipio LV Thrombectomy Device met all acceptance criteria and performed similarly to the predicate device." and "Performance data demonstrate that the device functions as intended and has a performance profile that is similar to the predicate devices."

The acceptance criteria themselves are not explicitly detailed as numerical values or specific thresholds in this document. Instead, they are implied to be met by the successful execution and results of the listed non-clinical tests.

Regarding the AI-specific questions:

2. Sample size used for the test set and the data provenance: Not applicable; this document does not describe a study involving a test set for AI/algorithm performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For the animal study, the ground truth was established by physician venographic assessment and histopathology. For the bench tests, the ground truth was based on engineering and material science standards/measurements.
8. The sample size for the training set: Not applicable; this document does not describe a training set for an AI algorithm.
9. How the ground truth for the training set was established: Not applicable.

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The Excipio SV Thrombectory Device is indicated for the non-surgical removal of soft emboli and thrombi from peripheral blood vessels.

The Excipio SV Thrombectomy Device consists of a Thrombectomy Catheter to mechanically displace thrombus when used with an aspiration catheter. The Device will be sold as a sterile, single use device.

Thrombectomy Catheter
The Thrombectomy Catheter is a mechanical thrombus displacement device with a nitinol braided component (basket) at the distal end that can be opened and closed via an activation wire that attaches to the distal end of the braid and attaches to a proximal handle. The operator can open the braided component to a diameter that best matches the target vessel (4-8mm in diameter). Proximal and distal marker bands delineate the ends of the basket component, and 4 radiopaque markers delineate the circumference of the basket component to facilitate visualization under fluoroscopy.

The provided document describes the Excipio SV Thrombectomy Device and its substantial equivalence to predicate devices, but it does not contain information about the acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device.

The document is a 510(k) summary for a physical medical device (a thrombectomy device), and the testing described is standard for such a device (e.g., visual inspection, dimensional inspection, biocompatibility, animal study for thrombogenicity).

Therefore, I cannot provide the requested information for the following points as they are not applicable to this physical medical device submission:

1. A table of acceptance criteria and the reported device performance: This document refers to meeting acceptance criteria for non-clinical lab tests (e.g., kink resistance, tensile testing) and biocompatibility, but it doesn't provide specific quantitative acceptance criteria or detailed reported performance values for these tests in a table format that would be typical for an AI/ML device. It merely states that the device "met all acceptance criteria."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable to this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The Paladin Carotid PTA Balloon System with Integrated Embolic Protection (IEP), is indicated for Percutaneous Transluminal Angioplasty (PTA) in the carotid arteries with capture and removal of embolic material. This device is also indicated for post-dilation of self-expanding stents in the carotid arteries with capture and removal of embolic material. The diameter of the arterial site for filter deployment should be no more than 7.0 mm. The Paladin Carotid PTA Balloon System with Integrated Embolic Protection (IEP) should always be used in conjunction with an available embolic protection device when used for post-dilation of self-expanding stents.

The Paladin System is a sterile, single use, rapid exchange (RX) PTA catheter with a nitinol-based filter between the PTA balloon and the distal tip of the catheter. The balloon has radiopaque markers to aid in accurate positioning under fluoroscopic guidance. The dilation balloon is designed to inflate to a known diameter and length at a specific inflation pressure. Paladin has balloon diameters Ø of 5.0 mm and balloon lengths of 20 mm and 30 mm. The embolic protection filter is composed of a nitinol braid chassis with an overlying polyurethane membrane with radiopaque markers on either end and radiopaque markers on the filter. The catheter has a guidewire lumen, an inflation/deflation lumen, and a filter activation wire lumen. The quidewire lumen permits the passage of a guidewire to facilitate advancement of the catheter to and through the stenosis to be dilated. The proximal end of the catheter has a handle that controls activation. The filter is identical across all sizes of balloons and can be expanded to a maximum diameter of 7 mm. The Paladin System is designed to be introduced through a 6 French vascular sheath.

This is a 510(k) premarket notification for a medical device, which seeks to establish substantial equivalence to a legally marketed predicate device. As such, it does not typically contain extensive clinical trial data or detailed performance studies in the way a PMA (Premarket Approval) application would. The document explicitly states: "The risk analysis activities for the device changes summarized in this Special 510(k) identified that no additional verification or validation activities are required to establish substantial equivalence with predicate devices." This indicates that the submission relies on the previously established performance of the predicate device (K181128) and demonstrates that the modifications made to the current device do not introduce new risks or alter its fundamental performance.

Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for the current device's performance study is not available in this document. The submission's conclusion is based on showing that the modified device is substantially equivalent to the predicate device, not on new clinical performance data for the modified device.

However, based on the provided text, I can infer some aspects relevant to substantial equivalence:

Indications for Use (Acceptance Criteria for Device Purpose):

The "acceptance criteria" here relate to the device's intended use and functionality being comparable to the predicate. The Indications for Use for both the modified and predicate device are nearly identical, with minor structural variations in the wording.

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

Since this is a 510(k) aiming for substantial equivalence based on no change in performance or risk, there isn't a new performance study with specific acceptance criteria that the modified device had to meet and report on in this document. The "performance" being demonstrated is the equivalence to the predicate. The key "acceptance criteria" being highlighted are the equivalence of design and function to the cleared predicate.

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

Not applicable. No new performance study (test set) for the modified device is documented in this 510(k) submission.

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. No new performance study (test set) for the modified device is documented in this 510(k) submission.

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

Not applicable. No new performance study (test set) for the modified device is documented in this 510(k) submission.

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 device is a physical medical device (balloon catheter with embolic protection), not an AI/imaging device.

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

Not applicable. This device is a physical medical device.

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

Not applicable. No new performance study (test set) for the modified device is documented in this 510(k) submission. The "ground truth" for this submission is demonstrating that the modified device has the same fundamental characteristics and performance as the previously cleared predicate device.

8. The sample size for the training set

Not applicable. No new training set is mentioned as this device is a physical medical device seeking substantial equivalence based on engineering and design comparisons, not a data-driven model.

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

Not applicable. Not applicable. No new training set is mentioned as this device is a physical medical device seeking substantial equivalence based on engineering and design comparisons, not a data-driven model.

Summary of the Study (as presented in the 510(k)):

The "study" presented in this 510(k) is a documentary review and comparison of the modified Paladin System against its predicate device (K181128).

• Objective: To demonstrate that the modified Paladin System is substantially equivalent to the predicate device.
• Methodology: A detailed comparison of the device description, indications for use, fundamental technological characteristics, and performance specifications (as summarized in the table above) between the modified device and the predicate device. A risk analysis was also conducted.
• Findings: The comparison concluded that there are "no change to device design, its principles of operation or expected performance." The risk analysis determined that "no additional verification or validation activities are required" as the changes "do not create any new risks, harms nor were any existing risks altered."
• Conclusion: The information is sufficient to establish substantial equivalence.

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