(133 days)
Phlebotest 2000 is a system for peripheral vascular diagnostic investigations.
Outflow phethysmography (OP)
Passive Drain and Refill (PDR)
Exercise Venous Plethysmography (EVP)
Triple Test (TTT) Combination of OP, PDR, and EVP
Either Strain Gauges or Air Pressure Cuffs
Prescription device by a physician
The PHLEBOTEST 2000 is a system designed for peripheral vascular diagnostic investigations. The center of the system is a specially developed patient chair, which can be positioned according to the investigation performed. The patient can be in a sitting or laying position, with legs positioned in different angels using the movable heel and foot support. Patient elevation between laying and sitting positions can be carried out in various speeds according to investigational requirements. All movements are carried out with low-voltage electrical motors and are directed by a remote hand controller. A pneumatic system consisting of a compressor, pressure tank and valve system is integrated in the system. Different sensors can be attached to the patients for measuring the various examination possibilities. The sensors and pneumatic system are fully integrated and controlled by hardware and software in connection with a PC Windows-based computer. A number of special developed software programs for various diagnostic tests support the system.
This document is a 510(k) summary for the Phlebotest 2000, a plethysmograph system. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria, a specific study proving device performance against such criteria, or the methodology of clinical trials typically associated with AI/ML devices. Therefore, a direct answer to your detailed request about acceptance criteria and a study proving performance (especially in the context of AI/ML evaluation) cannot be fully provided from the given text.
However, based on the information provided, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not present in the document. The 510(k) submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Eureka Varitest (Phlebotest) K882547), rather than setting and meeting specific performance criteria in a new clinical study. The "Technical Characteristics Summary" states: "Osborn Medical Corporation undertook extensive verifications of the software and testing to appropriate standards to verify the Phlebotest's safety and functional outcomes," but it does not specify what those standards were, what the acceptance criteria were, or the quantitative results of those verifications.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not present in the document. No clinical test set or data provenance details are provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not present in the document. The concept of "ground truth" established by experts for a test set is typically relevant for evaluating diagnostic or predictive devices, especially AI/ML ones, which is not the primary focus of this 510(k) submission for a plethysmograph system.
4. Adjudication Method for the Test Set:
This information is not present in the document.
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 or at least not reported in this document. This type of study is more common for diagnostic imaging AI devices, which is not the nature of the Phlebotest 2000.
6. If a Standalone Study Was Done:
The document mentions "extensive verifications of the software and testing to appropriate standards to verify the Phlebotest's safety and functional outcomes." While this implies some form of standalone testing, the details of a formal "standalone (i.e. algorithm only without human-in-the-loop performance)" study as might be conducted for an AI/ML device are not provided. The device itself is a system with integrated hardware and software, where human interaction is inherent in its intended use (attaching sensors, operating the system).
7. The Type of Ground Truth Used:
This information is not present in the document. Given the device is a plethysmograph for peripheral vascular diagnostic investigations, its performance would likely be evaluated against established physiological measurements or another validated plethysmograph. However, the details of such "ground truth" and its establishment are not in this document.
8. The Sample Size for the Training Set:
This information is not present in the document. The device descriptions do not suggest that it employs machine learning or AI models that would require a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
This information is not present in the document, as there is no mention of a training set for an AI/ML model.
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).