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The SunmedTM disposable angio-closure pads is to assist in obtaining and maintaining hemostasis.

disposable angio-closure pads is composed of compression bulb, The compression band and infusion mouth. Compression bulb is made from medical Polyurethane. Compression band is made from medical adhesive tape. Infusion mouth is made from medical Polycarbonate.

The provided text describes a medical device called "SunmedTM Disposable Angio-Closure Pads" and its 510(k) submission to the FDA. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics typically associated with AI/ML or diagnostic devices.

The document primarily focuses on the device's substantial equivalence to a predicate device (Safeguard™ 24cm pressure assisted dressing) based on:

• Intended Use: Both assist in obtaining and maintaining hemostasis.
• Technological Characteristics: Equivalent in terms of fundamental scientific technology, operating principle, sterility assurance level, and method of sterilization.

The non-clinical testing performed includes biocompatibility, package penetration, asepsis, aging, EtO and ECH residue, and bench testing. These are primarily related to safety, sterility, and material properties, not performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot provide the requested information in bullet points 1 through 9 because the provided document does not contain data on acceptance criteria, reader studies, ground truth establishment, or performance statistics typically found for diagnostic or AI-enabled medical devices.

The relevant sections of your request that are explicitly or implicitly addressed as "not applicable" in this document are:

• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: "Clinical Evaluation was not applicable."
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: "Clinical Evaluation was not applicable." (implies no standalone performance study in a clinical context)
• 7. The type of ground truth used: Not applicable as no clinical performance study was done.
• 8. The sample size for the training set: Not applicable as this is not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML device.

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The Sunmed Control Syringes is intended to inject contrast media or saline for angiographic procedures.

The Sunmed™ Control Syringes using dynamics principle, by means of the interference fit between the plunger with piston and the barrel, using the aspirating or driving force generated by manual function to draw or inject angiography medicament or saline for clinical disposable use.
The Sunmed™ Control Syringes is a single-use device that consists of two different structures: one is the standard type; the other is locking plunger type.
The volume of two type control syringes that to be offered in 10ml, 12ml.
The sunmed™ Control Syringes are available with rotating male luer and fixed male luer.
The sterilization method of the Sunmed™ Control Syringes is Ethylene Oxide sterilization.

This document is a 510(k) premarket notification for the Sunmed™ Control Syringes. It describes the device and claims substantial equivalence to predicate devices, but it does not describe a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device.

The document discusses "acceptance criteria" only in a very general sense, referring to standard non-clinical tests for medical devices like biocompatibility, sterility, and bench testing, to demonstrate substantial equivalence to a predicate device. There is no mention of an algorithm, AI, or software performance evaluation.

Therefore, I cannot provide the requested information regarding AI device performance, sample sizes, ground truth establishment, or expert involvement, as these elements are not present in the provided text.

Here's a breakdown of why I cannot fulfill the request based on the provided text:

• No AI or Algorithm: The device is a "Sunmed™ Control Syringes," a physical medical device intended to inject contrast media or saline. This is not an AI or algorithm-based device.
• No "Device Performance" in the AI sense: The document assesses physical characteristics (pressure rating, clarity, sterility, etc.) against predicate devices, not AI performance metrics like sensitivity, specificity, or AUC.
• No Study Design for AI: There's no mention of training sets, test sets, ground truth, expert adjudication, or MRMC studies, all of which are relevant to AI device evaluations.

The document's purpose is to demonstrate substantial equivalence for a physical device, not to evaluate an AI's diagnostic or predictive capabilities.

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