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510(k) Data Aggregation
(381 days)
The Fehling SUPERPLAST Probes are intended to be used to enlarge or calibrate vessels during coronary artery bypass and angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.
The Fehling SUPERPLAST Probes are intended to be used to enlarge or calibrate vessels during coronary artery bypass and angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels and to perform various maneuvers of dilation and measurement of annulus and lumen diameters. The coronary probe is available in different lengths and diameters to accommodate the needs of various surgical procedures and vessel anatomies. The probe is constructed of Titanium Alloy (TiAl6V4), Nitinol, and Titanium (Grade 2). Coronary probes are supplied non-sterile.
The provided text describes a 510(k) premarket notification for Fehling Surgical Instruments, Inc.'s SUPERPLAST Double-Occluder and SUPERPLAST Vascular Probe. It focuses on demonstrating substantial equivalence to a predicate device through technological characteristics, performance testing, and biocompatibility testing.
However, the document does not provide the specific details requested regarding acceptance criteria and the study proving the device meets them as would be expected for a product involving AI or complex performance metrics. The information is geared towards demonstrating substantial equivalence for a Class II surgical instrument, not an AI/ML powered device. Therefore, many of the requested fields cannot be populated from the given text.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in a table format with specific numerical acceptance criteria. The performance testing focuses on demonstrating mechanical integrity and successful reprocessing.
| Performance Metric | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Probes withstand clinical forces and do not break prematurely. | "Probes can handle the forces clinically required" and tested "to the point of failure on the worst-case configuration." |
| Tensile Strength | (Not explicitly defined with a numerical value) | Demonstrated ability to withstand tension; tested to failure. |
| Force to Remove from Vessel | (Not explicitly defined with a numerical value) | Preliminary data collected to determine this force. |
| Dimensional Verification | (Not explicitly defined with a numerical range) | "Probes are dimensionally verified." |
| Reprocessing (Cleaning & Sterilization) | Device is effectively cleaned and sterilized according to standards. | "Validation of the end user automated cleaning procedures, end user steam sterilization process, and drying time after sterilization was conducted." Conducted per FDA Guidance Document. |
| Biocompatibility | No cytotoxicity, irritation, sensitization, acute systemic toxicity, hemocompatibility, or pyrogenicity. | Passed testing for "cytotoxicity, irritation, sensitization, acute systemic toxicity, hemocompatibility, and pyrogenicity" per ISO 10993-1. |
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated for performance testing. It mentions "Devices were tested to the point of failure on the worst-case configuration," implying a selection of probes, but no specific number. For preliminary data on force to remove a probe, it's also not specified.
- Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is unlikely to be relevant for mechanical and biocompatibility testing of a physical probe.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as this is a physical medical device (vascular dilator) and the testing described is mechanical and biological, not related to expert interpretation for ground truth establishment.
4. Adjudication method for the test set
Not applicable for mechanical and biocompatibility testing of a physical medical device.
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 surgical instrument (vascular dilator), not an AI/ML-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used
For mechanical testing, the "ground truth" would be the physical properties and failure points of the material and device design. For biocompatibility, it's compliance with ISO 10993-1 standards (absence of adverse biological reactions). For reprocessing, it's demonstrating effective cleaning and sterilization. These are established through standardized testing methodologies, not "expert consensus, pathology, or outcomes data" in the typical sense for an AI/ML context.
8. The sample size for the training set
Not applicable. This is not an AI/ML-powered device with a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML-powered device with a training set.
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