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Kendall Monoject PreFill™ ADVANCED™ 0.9%Sodium Chloride Flush Syringes for Sterile Delivery is indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

The proposed device is an extension to the Kendall Monoject PreFill™ ADVANCED™ Flush Syringe line is to include one or more PreFill syringe configurations equivalent to those already marketed by Tyco Healthcare with the syringe delivered to the customer in a package that will maintain the sterility of the syringe exterior surface.

The provided text is a 510(k) summary for a medical device: "Kendall Monoject PreFill™ ADVANCED™ 0.9%Sodium Chloride Flush Syringes for Sterile Delivery." This document describes the device, its intended use, and its substantial equivalence to a legally marketed predicate device.

However, the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria in the context of an algorithm or AI performance. The document is for a physical medical device (pre-filled syringes) and a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device, primarily through nonclinical testing (like biocompatibility) and comparison of technological characteristics.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and reported device performance (for an algorithm).
• Sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth used, or training set details.

The nonclinical testing mentioned in the document is:

Nonclinical Testing:

• Biocompatibility testing against ISO Standard 10993, Part 1 and FDA modified matrix (G95-1).

This testing is relevant to the safety and compatibility of the physical syringe and its contents with the human body, not to the performance of any AI or algorithmic component.

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The Kendall SCD™ System is designed to increase venous blood flow in at risk patients, including bariatric and morbidly obese patients, in order to help prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

Kendall SCD™ and SCD Express™ Sleeves (Extra Large Knee, Extra Large Thigh) are pneumatic compression devices for applying pressure to a patient's leg for the prevention of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

The SCD™ System is an intermittent pneumatic compression device for applying sequential, gradient pressure to a patient's legs for the prevention of DVT and PE. The SCD" System consists of a controller, a pair of tubing sets, and a pair of single-patientuse disposable sleeves. The SCD™ product line has been a standard in the mechanical DVT and PE prevention industry.

The provided document is a 510(k) premarket notification for Kendall SCD™ Sleeves and Kendall SCD Express™ Sleeves. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics, detailed study designs, sample sizes for test or training sets, expert qualifications, ground truth establishment, or comparative effectiveness studies (MRMC or standalone).

Therefore, I cannot provide the requested information from the given text. The document focuses on regulatory approval based on substantial equivalence rather than detailed performance study results.

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The SCD Express" system is designed to apply intermittent pneumatic compression to the lower limbs to help prevent deep vein thrombosis in patients at risk.

Indications for use:

• · Circulation Enhancement
• · Deep Vein Thrombosis Prophylaxis
• Edema Acute
• Edema Chronic
• · Extremity Pain Incident to Trauma or Surgery
• · Leg Ulcers
• · Venous Stasis / Venous Insufficiency

The SCD EXPRESS*Compression System is designed to increase venous blood flow in at-risk patients in order to help prevent deep vein thrombosis and pulmonary embolism. The System consists of the Controller, the Tubing Sets (provided with the Controller) and single-patient use garments (purchased separately from this Controller). The garments, both leg sleeves and foot cuffs, compress the limbs to enhance venous blood movement. After the compression, the Controller measures the time it takes for the limbs to refill with blood and waits that period of time before the next compression is initiated.

The use of the SCD EXPRESS Compression System with Foot Cuffs is also indicated for: (a) circulation enhancement, (b) edema -- acute, (c) edema -- chronic, (d) extremity pain incident to trauma or surgery, (e) leg ulcers, and (f) venous stasis /venous insufficiency.

The SCD Express™ Controller is an intermittent pneumatic compression device for applying sequential, gradient pressure to a patient's legs for the prevention of Deep Vein Thrombosis (DVT). This new SCD Express™ system has the potential to provide uninterrupted DVT prophylaxis as it is used throughout the hospital, and it can be worn and used continuously by the patient during the entire period of risk.

The SCD Express" system has been designed to be more compact, quieter, lightweight, and offer battery power. Additional features also include the ability to provide sequential, gradient compression to each limb individually and the flexibility to provide compression to various sleeves consisting of up to three bladders each.

The SCD Express™ Controller will also have the potential to be used as a compression foot device. A new feature for an SCD-based system, the SCD Express™ Foot Cuff will provide DVT prophylaxis in situations that allow for a wrap only on the foot due to obstacles on the leg (e.g., surgery). In addition, the product has been designed to have the capability of providing high pressure, compression to a foot garment. In this configuration, the SCD Express™ system would still include the controller and a pair of tubing sets, but a pair of single patient use, single bladder disposable foot garments would be used in place of the aforementioned sleeves. The SCD Express " system will also allow for mixed configurations where a foot garment could be used on one limb while a sleeve was used on the other.

The provided text is related to a 510(k) premarket notification for the SCD Express™ Portable Compression System (PCS). Unfortunately, the document does not contain the specific information required to complete the requested table and answer the study-related questions.

This document primarily focuses on:

• Device Description: What the device is, how it works, and its features.
• Intended Use and Indications for Use: The medical conditions the device is designed to treat or prevent.
• Substantial Equivalence: Comparing the new device to previously cleared predicate devices.
• Regulatory Information: Classification, contact details, and FDA's clearance letter.

There is no mention of:

• Specific acceptance criteria (e.g., performance metrics, thresholds).
• Any studies conducted to demonstrate device performance against such criteria.
• Details about sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader studies.
• Standalone algorithm performance.

Therefore, I cannot populate the table or answer the questions as the necessary information is not present in the provided text.

In summary: The document is a regulatory submission for device clearance based on substantial equivalence, not a detailed report of performance studies against pre-defined acceptance criteria.

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Intended for use in patients with any condition requiring enteral feeding and/or enteral hydration, which can be accomplished by means of an enteral feeding, pump and pump set. The pump and feeding sets are intended to be used in alternate, acute and home care settings by users ranging from laypersons to clinicians. The purpose of this device is to deliver enteral nutrition at a controlled rate to a patients gastrointestinal system.

The ePump "" platform is a new enteral feeding system comprised of an enteral feeding pump and disposable Enteral Feeding Sets. This Class II device is an enteral feeding pump that delivers formula via rotary peristaltic tension loop pumping to provide nutrition for those who do not have the ability to orally ingest food. This enteral feeding pump is an attitude independent pump offering a streamlined graphical user interface that walks the user through the ePump" setup and operation with many new features to allow the ability to both feed nutrition and flush when required.

The ePump™ Enteral Feeding Pump Sets are compatible with standard prefilled formula containers presently available on the market. The ePump" enteral feeding pump sets are also designed to be compatible with present marketed enteral access devices and accessories (extension sets).

The provided text describes the Kendall ePump™ Enteral Feeding Pump and Enteral Feeding Sets, submitted for 510(k) clearance in 2004. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics, especially in the context of AI/ML or diagnostic performance studies.

Instead, this document focuses on:

• Device Description: What the device is and how it works.
• Intended Use: For whom and in what settings the device is to be used.
• Predicate Device Comparison: Establishing substantial equivalence to an already marketed device (Kangaroo 524 Enteral Feeding Pump & Administration Sets).
• Nonclinical Testing (Biocompatibility): Mention of biocompatibility testing according to ISO Standard 10993, Part 1. This is a safety test, not a performance study as typically understood for AI/ML devices.
• FDA Clearance Letter: Official communication from the FDA granting 510(k) clearance based on substantial equivalence.

Therefore, I cannot provide the requested table and study details because the information is not present in the provided text. The document is for a medical device approval that predates the common application of AI/ML in medical diagnostics and does not include the type of performance study details you are asking for.

If you have a different document that describes such acceptance criteria and a study for an AI-powered device, please provide that text.

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