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The Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD™) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous fistulae and synthetic dialysis grafts.

The Arrow-Trerotola™ PTD™ Catheter Assembly consists of two components, an outer cover sheath and an inner flexible torque cable with a self-expanding fragmentation basket attached to its distal end. The PTD™ fragmentation basket is constructed of four wires that are formed into a helical cage with a soft, flexible tip located on its distal end. The PTD™ catheter is designed to be used in conjunction with the Arrow Rotator Drive Unit that spins the basket at approximately 3000rpm. A drive hub on the proximal end of the catheter assembly mates with a drive gear in the Rotator Drive Unit. The cable stop on the catheter assembly secures the PTD™ Catheter to the Rotator Unit during operation.

The PTD™ outer sheath moves relative to the inner torque cable and is used to collapse and expand the fragmentation basket. The catheter is placed inside the clotted fistula with the basket in the closed position. After insertion, the basket is fully deployed inside the fistula to conform to the fistula wall. The basket is then rotated which pulverizes the clot; the clot is aspirated from the graft through an introducer sheath.

The PTD™ catheter is manufactured in two lengths, 65cm and 120cm, with a basket diameter of 9mm. It is also available in an Over-The-Wire (OTW) version, which allows the device to be passed over a guidewire.

Here's a breakdown of the acceptance criteria and study information based on the provided documents. Please note that the documents are primarily a 510(k) summary and FDA clearance letters, which focus on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical trial results with specific performance metrics and rigorous statistical analysis often seen in PMAs or later clinical studies.

Therefore, much of the requested information (like specific effect sizes for human readers, detailed ground truth establishment for training sets, or exact sample sizes for training) is not explicitly stated in these 510(k) documents.

Acceptance Criteria and Reported Device Performance

The documentation focuses on demonstrating substantial equivalence to a predicate device for an expanded indication for use (native arterio-venous fistulae). The implication is that if the device performs comparably to the predicate for this new indication, it meets the acceptance criteria for safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Implied Criteria: In a 510(k) submission, the primary "acceptance criterion" is often demonstrating substantial equivalence to a device already legally marketed. This means showing that the new device is as safe and effective as the predicate, often through comparable technological characteristics and, if necessary, performance data supporting any expanded or modified indications. Specific numerical performance metrics (like sensitivity, specificity, accuracy) are less common in 510(k)s unless there's a significant technological change or a new "unmet need" being addressed that requires new performance endpoints.

Study Details

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated in these documents. The submission mentions "clinical data presented in the performance section," but does not provide the specific number of patients or cases used.
• Data Provenance: Not explicitly stated. It's generally assumed to be retrospective analysis of existing clinical experience or a prospective study, but the document doesn't specify. The country of origin is also not specified.

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

• Not explicitly stated. The 510(k) summary refers to "clinical data," implying expert interpretation and assessment, but details about the number and qualifications of experts involved in establishing ground truth for this clinical data are absent.

4. Adjudication method

• Not explicitly stated. Given the nature of a 510(k) submission and the focus on "clinical data," it's plausible that standard clinical practice and expert consensus would have been used to determine outcomes, but the specific adjudication method is not described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

• No, not specified. The document does not mention an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device described (Arrow-Trerotola PTD) is a mechanical device, not an AI-powered diagnostic tool, so an MRMC study in the context of "human readers improve with AI" would not be relevant.

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

• N/A. This device is a physical, mechanical thrombolytic device. It does not have an "algorithm-only" or "standalone AI" component in the way a diagnostic AI software would. Its performance is intrinsically linked to human execution and interaction.

7. The type of ground truth used

• Implied Clinical Outcomes/Diagnosis: The "clinical data" likely refers to patient outcomes and successful declotting as determined by clinical assessment (e.g., patency of the fistula, resolution of symptoms, absence of complications). This would be based on expert medical diagnosis and follow-up.

8. The sample size for the training set

• N/A. There is no "training set" in the context of an AI/machine learning model, as this is a mechanical device. The development process would involve engineering design, bench testing, and potentially pre-clinical (animal) studies, followed by clinical evaluation.

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

• N/A. As above, no training set in the AI sense. The "ground truth" for the device's design and engineering would be based on principles of fluid mechanics, material science, and medical best practices for thrombus removal, established through engineering validation and pre-clinical testing.

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The Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit (PT-03000-R), permits mechanical declotting of synthetic dialysis grafts.

The device is a 5 Fr. X 65cm sterile, single use rotatable catheter with a 9mm fragmentation basket. The design of the Arrow-Trerotola PTD™ consists of a 5 Fr. outer sheath with and inner cable connected to a self-expanding fragmentation basket. The device is attached to a hand-held, disposable rotator drive unit that spins at 3000-RPM. The catheter is placed into the thrombosed graft via an introducer sheath. Once placed inside the clotted graft, the basket is deployed to expand and conform to the graft wall. The rotator is then activated and the spinning basket is withdrawn through the graft to macerate the thrombus. The homogenized clot can then be aspirated from the graft via the introducer sheaths.

Acceptance Criteria and Study for Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) Modification

This document outlines the acceptance criteria and study proving the modified Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) meets those criteria, based on the provided text.

The device modification is a "Special 510(k)" submission, which typically focuses on demonstrating that a modified device is as safe and effective as its legally marketed predicate device, rather than establishing de novo effectiveness against a clinical outcome. Therefore, the "acceptance criteria" here refer to the performance requirements demonstrating equivalence, and the "study" is a series of laboratory tests.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this Special 510(k) are implicitly defined by the safety and effectiveness profile of the predicate device. The performance tests conducted aimed to demonstrate that the modified device maintains this same profile. The reported performance is that the results of the laboratory tests demonstrated that the device modification is as safe, and as effective as the legally marketed predicate device.

• Basket cap tensile/torque strength not reduced.
• Basket wires tensile/torque strength not reduced.
• Basket sleeve tensile/torque strength not reduced.
• Torque cable tensile/torque strength not reduced.
• Torque cable drive hub tensile/torque strength not reduced.
• Outer catheter sleeve mold tensile strength not reduced.
• Outer catheter extrusion tensile/torque strength not reduced.
• Extrusion tip tensile strength not reduced. | All tests (tensile/torque, friction) demonstrated that the device modification is as safe and effective as the legally marketed predicate device. |
  | Durability and Functionality:
• Basket/cable fatigue performance maintained.
• Cable torque transmission efficiency maintained.
• Cable/catheter friction within acceptable limits.
• Basket speed in radius maintained.
• Basket abrasion characteristics maintained. | All simulated use tests (fatigue, torque transmission, friction, speed, abrasion) demonstrated that the device modification is as safe and effective as the legally marketed predicate device. |

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

• Sample Size: Not explicitly stated for each individual test. The phrasing "The performance test information in the submission includes" a list of 13 tests, implying that each test was conducted on a sufficient number of samples to generate reliable results.
• Data Provenance: The tests were laboratory-based ("The results of the laboratory tests demonstrated..."), conducted by Arrow International, Inc.
  • Country of Origin: United States (company address is Reading, PA).
  • Retrospective or Prospective: Prospective (tests were conducted specifically for this submission).

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

Not applicable for this type of submission. The ground truth for these engineering performance tests would be defined by established manufacturing specifications, engineering standards, and direct comparison to the predicate device, not by expert consensus in the medical sense.

4. Adjudication Method for the Test Set

Not applicable. The "adjudication" would involve engineering review and comparison to established specifications, rather than a clinical adjudication method like 2+1 or 3+1.

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

No. This submission is for a device modification and relies on engineering performance testing to demonstrate substantial equivalence to a predicate device, not a comparative effectiveness study involving human readers or clinical outcomes.

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

Not applicable. This is a mechanical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used was based on engineering specifications and performance data of the legally marketed predicate device. The modified device's performance in the listed tests had to meet or exceed the performance of the predicate to demonstrate substantial equivalence in safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is a mechanical device, not an AI or machine learning algorithm.

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

Not applicable. There is no training set or associated ground truth establishment process for this device as it is not an AI algorithm.

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