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The PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts (2.5-5.0mm) to:

• Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
• To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
• The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.
• The safety and effectiveness of the device as an embolic protection system has not been established in treating patients with acute myocardial infarction.
• The safety and effectiveness of the device as an embolic protection system has not been established in treating native coronaries.

The PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System provides temporary vascular occlusion during diagnostic and interventional procedures in the coronary vasculature, specifically-diseased coronary bypass grafts. It is comprised of four principal components: the GuardWire Temporary Occlusion Catheter, the MicroSeal Adapter, the EZ Flator Inflation Device and the Export Aspiration Catheter. The GuardWire Plus System is a sterile, single-use disposable device.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the PercuSurge GuardWire Plus Temporary Occlusion and Aspiration System primarily establishes substantial equivalence to a predicate device rather than defining new, specific acceptance criteria for performance metrics in a standalone study. Therefore, the "acceptance criteria" are implicitly met by demonstrating comparable safety and efficacy to the predicate device.

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

• Test Set Description: The "clinical performance data" presented is a summary of results from a sub-group analysis of the SAFER study (IDE G980209, cleared under 510(k) K003992). This study was conducted on the predicate device, the GuardWire 3-6 Temporary Occlusion and Aspiration System, and the data is used to support the equivalence of the new device (GuardWire Plus 2.5-5.0mm) for smaller vessel sizes.
• Sample Size:
  • Total GuardWire patients in SAFER study: N=406
  • Total vessels treated: N=417
  • Total lesions treated: N=442
  • Lesions sized at 3.0mm or less: 113 lesions
  • Patients with Reference Vessel Diameter (RVD) < 3mm: N = 111 patients (used for the efficacy analysis presented in Table 2)
• Data Provenance: The document does not explicitly state the country of origin. However, IDE studies approved by the FDA are typically multi-center clinical trials conducted primarily within the United States. The data is retrospective in the sense that this 510(k) is using previously collected data from an already-cleared device's clinical trial (SAFER study) to support the new device.

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

The 510(k) summary does not provide information on the number of experts used to establish the ground truth for the SAFER study data, nor does it specify their qualifications. Clinical trial endpoints like MACE (Major Adverse Cardiac Events) are typically adjudicated by clinical Event Adjudication Committees composed of qualified medical professionals, but this detail is not present in the provided text.

4. Adjudication Method for the Test Set

The 510(k) summary does not specify the adjudication method (e.g., 2+1, 3+1, none) used for the SAFER study's clinical endpoints.

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 submission is for a medical device (catheter system), not an AI algorithm or a diagnostic imaging device that would typically involve MRMC studies. The "effectiveness" is shown through clinical outcomes of the device itself.

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

No, a standalone study (in the context of an algorithm's performance) was not done. This device is a physical medical instrument (catheter system) and its performance is inherently linked to human use in a medical procedure.

7. The Type of Ground Truth Used

The "ground truth" for the SAFER study data (used to support this 510(k)) is based on clinical outcomes data related to patients undergoing the cardiac procedures, specifically:

• Major Adverse Cardiac Events (MACE): Death, Myocardial Infarction (MI), Emergent Coronary Artery Bypass Graft (CABG), Target Lesion Revascularization (TLR), and Target Vessel Revascularization (TVR). These are hard clinical endpoints observed in patients.
• Quantitative Coronary Angiography (QCA): Used to determine Reference Vessel Diameter (RVD). QCA measurements are typically performed by trained experts, though it's not explicitly stated if consensus methods were used.

8. The Sample Size for the Training Set

The concept of a "training set" is not directly applicable here. This 510(k) is for a device, not an AI algorithm. The closest equivalent would be the development and testing phases of the device, which would involve bench testing and in-vitro simulated use, but not a "training set" in the machine learning sense. The clinical data presented is for the predicate device's performance, not for training this specific device, but rather for demonstrating its equivalence.

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

As there is no "training set" in the context of an AI algorithm, this question is not applicable. The device's design and manufacturing are based on established engineering principles and internal testing (bench testing, in-vitro simulated use) to ensure performance specifications are met.

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The PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts to:

• Contain and aspirate embolic material (thrombus/debris) while performing . Somain and aspenary angioplasty or stenting procedures.
• To subselectively infuse/deliver diagnostic or therapeutic agents with or . without vessel occlusion.
• · The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the PercuSurge GuardWire Plus Temporary Occlusion and Aspiration System. This document does not contain information regarding acceptance criteria for a device, nor does it detail a study proving the device meets said criteria.

The letter only states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the indicated uses. It outlines the regulatory classification and general controls.

Therefore, I cannot provide the requested information based on the input text. The information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in this document.

Ask a specific question about this device