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To evacuate air and/or fluid from the chest cavity or mediastinum.

To help re-establish lung expansion and restore breathing dynamics.

To facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.

Atrium Medical Corporation Express™ Chest Drain

This document is solely a 510(k) clearance letter for the Atrium Express Chest Drain. It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

Crucially, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

Therefore, I cannot populate the requested table and information based on the provided text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a comprehensive premarket notification submission that details the performance data.

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The DigiVent™ Chest Drainage System is indicated to evacuate air and/or fluid from the chest cavity or mediastinum, to help prevent air and/or fluid from reaccumulating in the chest cavity or mediastinum, to help re-establish and maintain normal intrathoracic pressure gradients, and to facilitate complete lung re-expansion and restore normal breathing dynamics.

The DigiVent™ Chest Drainage System consists primarily of a collection chamber and a Controller Unit. Pressure regulator, drainage tubing (with kink prevention), positive- and negative pressure relief valves, and hangers complete the system. Thoracic catheters (chest tubes) are not included.

This document describes the Millicore AB DigiVent™ Chest Drainage System. Based on the provided text, a comprehensive study with specific acceptance criteria and detailed results proving the device meets these criteria is not detailed. The document states that "Design verification and validation testing provided in this premarket notification for the DigiVent™ Chest Drainage System demonstrates that it meets its specifications," but it does not elaborate on what those specifications or the results of the testing were.

Therefore, the following information is an interpretation based on the general context of device approval documents and the lack of specific details in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

As the specific acceptance criteria and detailed performance metrics are not explicitly stated in the provided text, this table will reflect the types of criteria generally expected for such a device and the general assertion of performance provided in the document.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details on the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature of data). It generically mentions "Design verification and validation testing."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. Ground truth establishment, if any, for performance testing is not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

The document does not mention any MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The DigiVent™ Chest Drainage System is a medical device for drainage, not an AI-assisted diagnostic or imaging tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the DigiVent™ Chest Drainage System is a physical medical device, not an algorithm or AI system. Its performance would inherently be in conjunction with human use (e.g., a clinician connecting and monitoring it).

7. The Type of Ground Truth Used

The document does not specify the type of ground truth used for any testing. Given it's a physical device, ground truth would likely be based on objective physical measurements and functional performance against defined engineering and safety standards, rather than expert consensus on medical images or pathology.

8. The Sample Size for the Training Set

This information is not applicable as the DigiVent™ Chest Drainage System is a physical medical device, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above.

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• To evacuate air and/or fluid from the chest cavity or mediastinum. .
• To help re-establish lung expansion and restore breathing dynamics. .
• To facilitate collection of autologous blood from the patient's pleural cavity or . mediastinal area for reinfusion purposes in post-operative and trauma blood loss management.

Not Found

The provided text is a U.S. FDA 510(k) clearance letter for the "Ocean Chest Drain" device. This document confirms the device's substantial equivalence to a predicate device and its approval for marketing.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or similar details that would typically be found in a study report or clinical trial summary.

The letter is a regulatory approval and does not describe the specific tests or data that led to that approval. It only states that the FDA "reviewed your Section 510(k) premarket notification" and found the device "substantially equivalent."

Therefore, I cannot provide the requested information based on the given input text.

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• To evacuate air and/or fluid from the chest cavity or mediastinum. .
• To help re-establish lung expansion and restore breathing dynamics. .
• To facilitate collection of autologous blood from the patient's pleural cavity or . mediastinal area for reinfusion purposes in post-operative and trauma blood loss management.

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the Atrium Medical Corporation Express™ Chest Drain, indicating that the device is substantially equivalent to legally marketed predicate devices.

The letter lists the indications for use but does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or the number/qualifications of experts.
• Information on adjudication methods, MRMC studies, or standalone algorithm performance.
• Specifics about the type of ground truth used or the training set for any AI/algorithm.

Therefore, I cannot fulfill your request for this specific document.

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The Models S-1100, S-1200, S-2100, and S-2200 covered by this submission are sterile, single use devices, that are intended for postoperative chest drainage.

The Pleur-evac Sahara Model S-100 Autotransfusion Bag is a sterile, non-pyrogenic, single-use device, intended for post-surgical collection and reinfusion of autologous blood from the thoracic cavity when attached to a Pleur-evac Sahara Chest Drainage,

Pleur-evac Sahara Adult/Pediatric Chest Drainage System Models S-1100, S-1200, S-2100, and S-2200

Deknatel DSP Worldwide, Inc. has recently acquired the Thora-Klex® Chest Drainage System product lines from Davol Inc., C.R. Bard, Inc. Deknatel DSP Worldwide, Inc. has incorporated certain features of the currently marketed Model 0077000 Thora-Klex Chest Drainage System with the features of the currently marketed Model A-6000 Pleur-evac Chest Drainage System into a new chest drainage system, the Pleur-evac Sahara Adult/Pediatric Chest Drainage System. Combining the proven technologies from the Thora-Klex and the Pleur-evac into one unit, creates a new, completely dry Pleur-evac Chest Drainage Unit. Features from the Thora-Klex and the Pleur-evac were transferred to the Pleur-evac Sahara unit without design changes.

There are two basic Pleur-evac Sahara Chest Drainage models: the S-1100 Chest Drainage Unit which is shorter, wider and deeper than the standard Pleur-evac unit but more like the Thora-Klex Model 0077000 shape: and the S-2100 Chest Drainage Unit which carries the standard dimensions of the Pleur-evac Model A-6000 Chest Drainage unit. The S-1100 and S-2100 Chest Drainage Units are capable of autotransfusion option, by attaching a Pleur-evac Sahara Model S-100 Autotransfusion Bag. The Models S-1200 and the S-2200 are identical to the Models S-1100 and S-2100, but are provided with a Model S-100 Autotransfusion Bag attached. The Pleur-evac Sahara Chest Drainage are three bottle systems that include a means for integral suction control, a one way seal via a check valve, and a chamber for collecting fluids,

Hangers are located on the right and left sides of the chest drainage unit to provide support for the chest drainage unit when it is suspended from a hospital bed rail.

The Pleur-evac Sahara Models S-2100 and S-2200 are provided with an integral rotating floorstand. These units free stand when placed on a leveled surface with the floorstand in the open position. The floorstand rotates freely from the closed position to the open position. Once open, the floorstand requires the actuation of a lever to return to the closed position. The design of the Pleur-evac Sahara Models S-1100 and S-1200 does not require a rotating floorstand, since the base of the unit acts as a floorstand.

Pleur-evac Sahara Model S-100 Autotransfusion Bag

The Pleur-evac Sahara Autotransfusion Bag, includes an Autotransfusion Bag that contains a rigid top plate assembled onto a flexible vinyl bag. The Autotransfusion Bag is mounted over a wire support frame. The wire frame maintains the bag in an open position during the collection phase of operation. The frame is removed from the bag during the reinfusion phase to allow the bag to collapse and the reinfusion of the collected blood to occur.

The Pleur-evac Sahara Autotransfusion Bag operates with either suction drainage or gravity drainage. During operation with suction drainage, the Autotransfusion Bag is connected to an appropriate Pleur-evac Sahara Chest Drainage unit that is connected to a vacuum source. The patient vacuum is controlled by the Pleur-evac Sahara Chest Drainage System. During operation with gravity drainage, the Autotransfusion Bag is connected to an appropriate Pleur-evac Sahara Chest Drainage unit that is not attached to a suction source.

The Pleur-evac Sahara Autotransfusion Bag is connected to the Pleur-evac Sahara S-1100 Chest Drainage Unit by means of the Easy-Link Adaptor. The adaptor, which is attached to the Autotransfusion Bag, locks into the Easy-Link receptor on the Pleurevac Sahara Chest Drainage unit. For the Pleur-evac Sahara Model S-2100 Chest Drainage Unit, the Easy-Link Adaptor is removed from the Model S-100 Autotransfusion Bag by the clinician, and the Autotransfusion Bag is attached directly to the side of the Pleur-evac Chest Drainage Unit, using the metal frame on the bag and the hooks provided on the chest drainage unit. This means of attachment is employed by the currently marketed Pleur-evac Model A-6000 Chest Drainage System. Tubing connectors are provided for attaching the Pleur-evac Sahara Autotransfusion Bag to the appropriate Pleur-evac Sahara Chest Drainage Unit. The connectors are color coded for ease of proper connection.

Tubing clamps are located on each of the tubing ports on the Autotransfusion Bag. The tubing clamps must be closed in order to occlude the patient drainage tube prior to disconnecting the connectors. An injection site is located on one set of connectors through which anti-coagulants may be added to the Autotransfusion Bag or from which samples of the drainage fluid mav be taken.

A hanger strap located on the top of the unit provides a means for suspending the Autotransfusion Bag from an I.V. pole during reinfusion.

The Models S-100 and the A-1500 Autotransfusion Bags have similar face graphics, j box graphics, and instructions for use. The labeling for the Model S-100 Autotransfusion Bag also includes reference and use of the Easy-Link Adaptor.

This is a 510(k) summary for a medical device cleared in 1996. The provided text describes the device, its intended use, and argues for substantial equivalence to previously cleared predicate devices. It does not contain information about the performance or acceptance criteria in the format requested for AI/ML device studies. The "performance equivalence" section discusses engineering and functional comparisons to predicate devices, not clinical efficacy or diagnostic accuracy as would be expected for modern AI/ML submissions.

Therefore, many of the requested fields cannot be filled as the information is not present in the provided document.

Here's an attempt to extract what is available, with explanations for what is missing:

Acceptance Criteria and Device Performance Study

This submission describes the Pleur-evac Sahara Adult/Pediatric Chest Drainage System and the Model S-100 Autotransfusion Bag. The device is a traditional medical device (a chest drainage system), not an AI/ML device. Therefore, the acceptance criteria and study details discussed in the document relate to engineering performance and substantial equivalence to predicate devices, rather than diagnostic accuracy or clinical effectiveness typically evaluated in AI/ML products.

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Found in the Document (Relevant to AI/ML Device Submissions)

The document does not provide the following information as it pertains to a traditional, non-AI medical device:

2. Sample size used for the test set and the data provenance: Not applicable. This was a physical device engineering performance test, not a clinical data-driven study in the context of AI/ML.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML algorithm (e.g., diagnostic labels) is not relevant here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: No. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the engineering tests, the "ground truth" would be established engineering standards and measurements, compared against the predicate devices. For biocompatibility, it's compliance with ISO standards.
8. The sample size for the training set: Not applicable. This device does not have a "training set" in the AI/ML context.
9. How the ground truth for the training set was established: Not applicable.

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This device has been designed to allow the safe and effective drainage of fluid from a patient following disruption in the normal anatomical arrangement of the chest or a disturbance of the intrapleural pressure mechanism causing the entry and accumulation of air and or fluid.

This is achieved by a design incorporating safety features to maintain a constant suction pressure, prevent the ingress of air and fluid back into the chest cavity, whilst maintaining an unobstructed drain from the patient.

The provided document (K961287) describes a medical device, the Pleuraseal III Chest Drainage System, and assesses its safety and effectiveness. However, it does not include information about AI or machine learning models. Therefore, it's not possible to extract the requested information related to acceptance criteria for an AI device, study details for AI performance, sample sizes for AI test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The document is a traditional premarket notification for a Class II medical device, focusing on its design, function, and substantial equivalence to existing devices. The "safety and effectiveness" claims are based on a year of incident-free use in the UK and general safety features of the device, not on AI performance metrics.

Therefore, I cannot provide the requested table and study details as they pertain to AI/ML device evaluations, which are not present in this document.

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Ask a specific question about this device