Search Results

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.

Ask a specific question about this device

The Cord Wrap with Needle Resheather (Model CN-34) is an accessory to Infusion Stands, Classification (80 FOX).

The Cord Wrap with Needle Resheather comprises a reel for storing electric cords at a pole-type infusion stand. The stand provides a pole stanchion that extends a number of feet and supports an infusion pump and/or bags or bottles of liquid infusants. The Cord Wrap is constructed to conveniently store the electric cord of the infusion pump at the pole during and between use. The cord is coiled about an elongated spool which is retained on the pole via a clamp assembly. The clamp assembly includes a hand wheel and threaded hook arm. The hook arm mounts about the pole, and upon tightening of the hand wheel the hook arm is drawn tight to the infusion stand. Two protrusions are aligned to the hook arm and form a channel space where the infusion stand can nest. The Cord Wrap with Needle Resheather is thereby prevented from rotating about the pole. The position of the Cord Wrap with Needle Resheather along the infusion stand can be varied by loosening the hand wheel and moving the Cord Wrap with Needle Resheather either up or down the infusion stand and retightening the hand wheel. Protruding from the Cord Wrap with Needle Resheather is a needle holder which contains five cavities to receive and retain several cover pieces of needle storage containers. The five cavities are constructed to receive and hold the cover piece. This permits the staff member to de-couple the needle body from the cover with a single hand. The Cord Wrap, hand wheel, and Needle Resheather are molded from a resin Acrylonitrile-Butadiene-Styrene (ABS). The Needle Resheather is glued to the Cord Wrap with Loctite® 494 adhesive. The threaded hook arm is made of stainless steel. The Cord Wrap with Needle Resheather is packaged assembled in polyethylene bags.

The provided text describes a 510(k) premarket notification for a medical device called the "Cord Wrap with Needle Resheather (Model CN-34)". This submission aims to demonstrate substantial equivalence to a predicate device, the Ferguson Medical I.V. Hanger Bag or Holder (K883133).

Crucially, the acceptance criteria and a study to prove the device meets these criteria are NOT present in the provided text.

Here's why and what information would typically be expected for such a request:

• Substantial Equivalence: The 510(k) pathway relies on demonstrating that a new device is "as safe and effective" as a legally marketed predicate device. This is often achieved by showing that the new device has the same intended use and the same technological characteristics as the predicate device, or if there are different technological characteristics, that they do not raise different questions of safety and effectiveness and that the device is as safe and effective as the predicate device.
• No Performance Metrics: The text describes the device's function and components but does not provide any quantitative performance metrics, safety thresholds, or effectiveness targets.
• No Study Details: There is no mention of any formal studies (clinical or non-clinical) undertaken to evaluate the Cord Wrap with Needle Resheather against specific criteria. The submission relies solely on comparing its features to those of the predicate device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are provided.
2. Sample size used for the test set and the data provenance: No test set or data are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No experts or ground truth establishment are discussed.
4. Adjudication method: Not applicable as there's no test set or expert review.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned. This device is not an AI/imaging device where such a study would typically be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical accessory, not an algorithm.
7. The type of ground truth used: Not applicable as no ground truth is established or used for performance evaluation.
8. The sample size for the training set: Not applicable as this is a physical device, not an AI model.
9. How the ground truth for the training set was established: Not applicable.

What the document does describe is:

• Device Name: Cord Wrap with Needle Resheather (Model CN-34)
• Intended Use (implicit): Accessory to infusion stands for cord storage and single-handed needle cap removal.
• Predicate Device: Ferguson Medical I.V. Hanger Bag or Holder (K883133)
• Device Description: A reel for storing electric cords, clamps to an infusion pole, and contains five cavities to receive needle storage container covers. Made of ABS plastic, stainless steel hook arm, and assembled with Loctite 494 adhesive.
• Mechanism of Action: Cord coiling, pole clamping, channel space for stability, and cavities to hold needle covers.
• Key Safety Note: Explicitly states, "The Cord Wrap with Needle Resheather is NOT a SHARPS RECEPTACLE."

In a 510(k) submission, the "acceptance criteria" are often inherent in the demonstration of substantial equivalence. For a simple accessory like this, the lack of new technological characteristics and the demonstration that it performs its intended function similarly to the predicate would be the primary "proof" for regulatory acceptance. There wouldn't typically be a detailed clinical study with performance metrics for such a device.

Ask a specific question about this device