(192 days)
The femoral compression system is indicated for the compression of the femoral artery or vein following catheterization.
The femoral compression device is used to provide compression of the femoral artery for hemostasis management after catheterization. The device is comprised of an arch with an attached sterile pneumatic pressure dome, connector tube, stopcock and belt locks. A woven belt is used to secure the device onto the patient. In use, the belt is placed under and around the patient's hips and the arch is placed over the patient's groin with the dome atop the puncture site. The belt is attached to the arch via the adjustable belt locks and is tightened. A pneumatic pump and manometer are attached to the stopcock connector. The user controls the mechanical pressure applied to the puncture site by increasing or decreasing air pressure applied to the dome. The arch and belt absorb and distribute the opposing force from the dome. Vanguard receives previously used compression devices from healthcare facilities; cleans, inspects, tests, repackages and sterilizes the devices; and returns them to the healthcare facility.
This document is a 510(k) premarket notification for a reprocessed medical device, specifically the "Vanguard Reprocessed Femoral Compression Device." The core of the submission is to demonstrate that the reprocessed device is substantially equivalent to the original equipment manufacturer (OEM) device.
Here's an analysis based on your request, keeping in mind that this document refers to physical device testing, not an AI/algorithm-based system:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list a table of quantifiable acceptance criteria with corresponding performance metrics in the format typically seen for algorithms. Instead, it states that the reprocessed device undergoes "Decontamination and cleaning, sterilization validations and functional/performance and biocompatibility testing." The conclusion is that these tests demonstrate the reprocessed devices "perform as intended and are safe and effective."
Given the context of a physical medical device, the "acceptance criteria" can be inferred as:
- Decontamination and Cleaning: The device must be adequately cleaned of biological and other contaminants after a single use. (Performance: "Decontamination and cleaning... demonstrates that the reprocessed devices perform as intended")
- Sterilization: The device must be effectively sterilized to remove viable microorganisms for safe reuse. (Performance: "Sterilization validations... demonstrates that the reprocessed devices perform as intended")
- Functional/Performance: The reprocessed device must function identically and maintain the same performance characteristics as the original OEM device. This would include aspects like pneumatic pressure integrity, structural integrity, and proper operation of all components (e.g., belt locks, dome, connector tube). (Performance: "Functional/performance... testing demonstrates that the reprocessed devices perform as intended and are safe and effective. The Vanguard reprocessed compression device is essentially identical to the currently marketed OEM compression device. No changes are made to the currently marketed device's specifications and they possess the same technological characteristics.")
- Biocompatibility: The materials of the reprocessed device, after reprocessing, must remain biocompatible and not pose new risks to patients. (Performance: "Biocompatibility... testing demonstrates that the reprocessed devices perform as intended and are safe and effective.")
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the test set used for decontamination, cleaning, sterilization, functional/performance, or biocompatibility validation. It also does not specify the provenance (country of origin, retrospective or prospective) of any data beyond the fact that Vanguard receives "previously used compression devices from healthcare facilities." This implies the devices being reprocessed come from real-world use, but the testing itself would likely be conducted in a controlled lab environment.
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)
This information is not applicable as the document describes a physical medical device reprocessing and not an AI or algorithm-based system requiring expert-established ground truth. The "ground truth" here is the physical state and performance of the device itself, assessed through standardized engineering, microbiological, and chemical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as point 3. Physical device testing relies on objective measurements against established specifications, not human adjudication of subjective assessments.
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
This information is not applicable as the document describes a physical medical device and not an AI-based system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the document describes a physical medical device and not an AI-based system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained in point 3, the concept of "ground truth" in the AI/algorithm sense is not applicable here. For this physical device, the "ground truth" or reference for evaluating the reprocessed device's performance would be:
- Original OEM device specifications: The reprocessed device must meet the same specifications as the new, unused OEM device.
- Industry standards/guidelines: For cleaning, sterilization, and biocompatibility, the tests would be conducted against recognized standards (e.g., ISO for sterilization).
- Functional integrity: The device must operate as designed, which is an objective measurement of mechanical and pneumatic function.
8. The sample size for the training set
This information is not applicable as the document describes a physical medical device and not an AI-based system that uses a training set.
9. How the ground truth for the training set was established
This information is not applicable as the document describes a physical medical device and not an AI-based system that uses a training set.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).