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510(k) Data Aggregation
(139 days)
The Pantheris System is intended to remove plaque (atherectomy) from partially occluded native or restenotic vessels, including in-stent restenosis (ISR), in the peripheral vasculature with a reference diameter of 3.0 mm to 7.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures, and vessel morphologies. The Pantheris system is not intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.
The Pantheris System consists of a Pantheris atherectomy catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and a Lightbox HS Imaging Console (referred to as "Lightbox"). The Pantheris atherectomy catheter is a 7 French device with a working length of 110 cm. It incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology as well as OCT-guided atherectomy during the procedure with its connection to the Lightbox via the Sled accessory.
The following provides an analysis of the acceptance criteria and study findings for the Pantheris System, based on the provided FDA 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Endpoint | Acceptance Criteria (Performance Goal) | Reported Device Performance (Pantheris System) |
|---|---|---|
| Primary Safety: Freedom from Major Adverse Events (MAE) at 30 days | MAEs occurring in < 20% of subjects | 97% freedom from MAEs (3% experienced MAE); 95% one-sided upper confidence bound of 6.5%. Met. |
| Secondary Safety: Absence of new or worsening stent fracture | Not established with a sample size requirement; extremely low incidence expected | 1% (1 out of 97 procedures) inadvertently made contact with a stent. Met (due to low incidence and subsequent physician retraining efficacy). |
| Primary Effectiveness: Technical Success (residual stenosis ≤ 50% post-Pantheris alone) | > 79% | 89% (86 out of 97 subjects) had <50% residual stenosis; 95% one-sided upper confidence bound of 95% and lower confidence bound of 82%. Met. |
| Secondary Effectiveness (Powered): Freedom from Target Lesion Revascularization (TLR) at 6 months | > 61% | 93% (79 out of 85 subjects) freedom from TLR; 95% one-sided upper confidence bound of 98% and lower bound of 87%. Met. |
| Secondary Effectiveness: Procedural Success (residual stenosis ≤ 30% post-Pantheris + adjunctive therapy) | Not explicitly defined as a performance goal with a specific threshold. | 80% (78 out of 97 subjects) had residual stenosis < 30%; mean stenosis of 15% ± 10.1%. |
| Secondary Effectiveness: Change in Ankle-Brachial Index (ABI) | Not explicitly defined as a performance goal with a specific threshold. | ABI improved 39% from baseline at 6 months. |
| Secondary Effectiveness: Change in Rutherford Classes | Not explicitly defined as a performance goal with a specific threshold. | Rutherford Classification improved 71% at 6 months. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A total of 97 subjects were enrolled in the INSIGHT trial.
- Data Provenance: The study was a prospective, multi-center trial conducted across 17 investigational sites in the USA (n=15) and EU (n=2). Therefore, the data is prospective and from both the US and Europe.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document specified that the primary safety endpoint (freedom from MAEs) was adjudicated by an independent Clinical Events Committee (CEC).
- The primary effectiveness endpoint (technical success) and secondary effectiveness endpoint (procedural success) involving residual diameter stenosis were assessed by an independent angiographic core laboratory.
- The specific number or qualifications of experts within the CEC or the core laboratory are not detailed in this summary.
4. Adjudication Method for the Test Set
- For the primary safety endpoint (MAEs), an independent Clinical Events Committee (CEC) was used for adjudication. The specific method (e.g., 2+1, 3+1) is not provided, but the independence suggests a standardized, expert-driven review process.
- For effectiveness endpoints related to stenosis, an independent angiographic core laboratory assessed the outcomes. This implies multiple expert readers are likely involved in standardized image analysis, but the exact adjudication method is not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was reported. The study focused on the performance of the Pantheris System itself, a medical device for atherectomy, not an AI-assisted diagnostic or interpretative system.
6. Standalone Performance
- The study was a "single-arm trial" to determine the safety and performance outcomes of the Pantheris System.
- The primary effectiveness endpoint specifically refers to "residual diameter stenosis ≤ 50% after use of the Pantheris device alone," indicating that standalone performance (algorithm only without human-in-the-loop performance) was assessed for this specific aspect of effectiveness, meaning the intervention of the device itself.
- The "algorithm" in this context refers to the device's mechanism of action, as it's an atherectomy system, not a software-based AI algorithm.
7. Type of Ground Truth Used
- Clinical Outcomes: The ground truth relied on direct clinical outcomes assessed during the study, including:
- Occurrence of Major Adverse Events (MAEs).
- Angiographic measurements of residual stenosis (assessed by an independent core lab).
- Target Lesion Revascularization (TLR) rates.
- Changes in physiological markers (ABI) and clinical classification (Rutherford Classes).
- Expert Adjudication: For MAEs and angiographic assessments, the "ground truth" was established by expert adjudication (independent CEC and independent angiographic core laboratory).
- Histopathology/Pathology: For preclinical animal studies, pathology (light microscopy, radiography, and SEM) was used to assess acute treatment effects on arteries and stents.
8. Sample Size for the Training Set
- The document describes a clinical trial (INSIGHT Trial) which is a clinical validation study for expanded indications, not a training set for an AI algorithm.
- No training set for an AI algorithm is mentioned as the device is a physical atherectomy system, not an AI diagnostic tool.
9. How the Ground Truth for the Training Set Was Established
- As the device is an atherectomy system and not an AI algorithm, there is no mention of a "training set" or "ground truth for a training set" in the context of machine learning. The clinical trial data serves as validation for the device's performance against pre-defined clinical endpoints.
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