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The Fenestrated Flexible D.I.C. Tracheostomy Tube is indicated for airway management of the tracheostomized patient for providing tracheal access where the use of a fenestration is desirable in order to allow for safe and effective weaning from mechanical ventilation or adjunctive airway support. With the cuff deflated, primary ventilation is allowed to be spontaneous through the fenestrations and around the main tube. This provides a means for phonation when the patient breaths through his/her upper airway. A red decannulation cap can be used to occlude the proximal end of the tracheostomy tube.

The Fenestrated Flexible D.I.C. Tracheostomy Tube is made of implant tested, polyvinyl chloride with compatible profile, high volume, low pressure cuff. Radiopaque material is incorporated into the full length of the Fenestrated Flexible D.I.C. Tracheostomy Tube. The cuff inflation line has an inflation indicator and a self sealing luer one-way valve. The tracheostomy tube has three fenestrations on the radius of the tube.

The provided document is a 510(k) summary for the Fenestrated Flexible D.I.C. Tracheostomy Tube. It explicitly states in the "SUMMARY OF PERFORMANCE DATA", "SUMMARY OF NONCLINICAL AND CLINICAL TESTS", and "CONCLUSION OF NONCLINICAL AND CLINICAL TESTS" sections that these are "Not required."

Therefore, based on the provided text, there is no information available regarding:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with/without AI assistance.
6. If a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The 510(k) pathway for this device relied on demonstrating substantial equivalence to predicate devices already on the market, rather than requiring new performance studies. The document states: "The location of the fenestrations are relocated to accomodate a greater percentage of the population. The location of the fenestrations has been determined based on a literature search taking into account the mean sagittal diameter and mean skin to trachea dimension." This indicates that design decisions were based on existing medical literature rather than new clinical or non-clinical studies for performance criteria.

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SIMS' Regional Anesthesia Trays are used to administer to a patient regional or local anesthesia.

Regional Anesthesia Trays cover a broad product range, including; Continuous Epidural, Single Shot Epidural, Spinal, Nerve Block, Pediatric Epidural, and Combined Spinal/Epidural Trays. These trays are a compilation of the preparatory and surgical components required for administering anesthesia. The trays may include components such as: needles, syringes, filters, catheters, gloves, gauze sponges, drapes, The components are placed into a plastic tray, wrapped in CSR wrap, sealed, and sterilized by ethylene oxide.

The trays are available in standard component configurations or can be customized to meet the needs of an individual user. All componentry supplied in these kits are from an approved list of components which are legally marketed devices.

This submission does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It is a 510(k) summary for Regional Anesthesia Trays, focusing on demonstrating substantial equivalence to predicate devices and outlining the device's characteristics and intended use.

Specifically, the document states:

• "There were no nonclinical or clinical tests submitted with this submission." and "There were no nonclinical or clinical tests submitted with this submission:".
• It mentions "Testing of the epidural catheter connector was performed in accordance with BS 6196. Performance testing of the proposed modification to the epidural catheter connector demonstrates that it performed equal to or better than our current epidural catheter connector." However, this is a summary statement about testing a component (epidural catheter connector) and the standard it followed (BS 6196), not a detailed study description for the entire Regional Anesthesia Tray device, nor does it provide specific acceptance criteria or performance metrics.

Therefore, I cannot extract the requested information regarding acceptance criteria or a study that proves the device meets them from the provided text.

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The PORTEX® Adjustable Flange Tracheostomy Tube is indicated for airway management of tracheostomized patients where the ability to adjust the depth of insertion may be advantageous.

The PORTEX® Adjustable Flange Tracheostomy Tubes are made of implant tested, polyvinyl chloride with compatible profile, high volume, low pressure cuff. Radiopaque material is incorporated into the full length of the Adjustable Flange Tracheostomy Tube. The trachesstomy tube has an adjustable neck flange and a bonded 15 mm connector. The cuff inflation line has an inflation indicator and a self sealing luer one-way valve.

This document does not describe acceptance criteria for a device, nor a study performed to prove a device meets acceptance criteria. Instead, it is a 510(k) summary for the PORTEX® Adjustable Flange Tracheostomy Tube, a medical device.

The section titled "SUMMARY OF PERFORMANCE DATA" explicitly states: "Performance assessment was not required to demonstrate substantial equivalence of the proposed device to the predicate devices."

Therefore, I cannot provide the requested information. The document indicates that no formal performance acceptance criteria or a study designed to prove the device met such criteria were necessary for this 510(k) submission, as the device was deemed substantially equivalent to predicate devices.

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The SIMS Pro-Vent® 250 (500) Plus is intended for obtaining small volume samples of blood for the measurement of pH, pO2, pCO2, CO-oximetry, electrolytes (Ca++, Mg++, Na+. Cl-, K+) and the metabolites (Glucose and Lactate).

The SIMS Pro-Vent® 250 (500) Plus contains a precision small volume sampling device for obtaining an arterial blood sample. The device consists of a small gauge needle (25g) attached to a single cannula vented tube with a micro volume of 250ul or 500pl (.25 or .50cc). The SIMS Pro-Vent® 250 (500) Plus is ideal for obtaining blood samples from pediatric, neonatal and geriatric patients. Each device contains approximately 40 units of Calcium Neutralized Dry Lithium Heparin per ml. The 250pl device contains approximately 10 U.S.P. units of heparin and the 500ul device contains approximately 20 U.S.P. units of heparin.

The provided text describes a 510(K) summary for the SIMS Pro-Vent® 250 (500) Plus, an arterial blood sampling kit. The summary focuses on demonstrating substantial equivalence to predicate devices, particularly in terms of performance for blood gas analysis and fill time.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a formal table format. Instead, it describes performance in relation to a predicate device. The primary acceptance criteria appear to be:

• No statistical difference in key blood gas parameters (pO2, pCO2, pH, Ca++, Na+, K+, Cl-, Glucose) compared to the predicate device.
• No drift in CO-oximetry measurements compared to baseline.
• Faster fill time and ability to fill under lower pressure compared to a competing predicate device.

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

• Sample Size for Test Set: The document does not specify a sample size for the "side-by-side comparison" or the "fill time" comparison studies. This information is crucial for evaluating the statistical power of the conclusions.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the nature of a 510(k) submission for a medical device (blood sampling kit), it's highly probable the studies were prospective clinical or laboratory evaluations, but this is an inference.

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

• This question is not applicable in the context of this device. The "ground truth" for the test set was established by direct laboratory measurements of blood parameters and fill times, not by expert interpretation or consensus. The comparison was against measurements from predicate devices or baseline values.

4. Adjudication Method for the Test Set

• This question is not applicable for this type of device and study. Adjudication methods like "2+1" or "3+1" are typically used in studies where human interpretation of medical images or other subjective data is involved. Here, the outcome measures (blood gas values, fill times) are direct quantitative measurements.

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

• This question is not applicable. This document describes a medical device (blood sampling kit), not an AI-powered diagnostic or interpretive system that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• This question is not applicable. This device is a physical blood sampling kit, not an algorithm.

7. The Type of Ground Truth Used

• The ground truth was established through direct laboratory measurements of various blood parameters (pO2, pCO2, pH, Ca++, Na+, K+, Cl-, Glucose, CO-oximetry) and physical performance characteristics (fill time, pressure). These measurements were acquired using the proposed device and compared to measurements obtained using established predicate devices or baseline values.

8. The Sample Size for the Training Set

• This question is not applicable. The device is a physical product, not a machine learning model, so there is no "training set" in the computational sense. The design and validation of the device rely on engineering principles and performance testing, not on data training.

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

• This question is not applicable as there is no training set for this type of device.

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The SIMS Lumbar Puncture (LP) Kit is indicated for sampling of Cerebrospinal Fluid (CSF) and the measurement of CSF pressure as indicated in standard textbooks.

The SIMS LP Kits are intended to be used when Lumbar Puncture is performed to obtain a CSF specimen for diagnostic study when possible CNS infection is suspected, such as sepsis and/or meningitis. The procedure can also be used to measure intracranial pressure which can result from infection, tumor, hemorthage or edema. This technique is also used to lower intracranial pressure by CSF drainage. CSF pressure is measured prior to CSF sampling using a manometer.

The SIMS Lumbar Puncture (LP) Kit is available in adult or pediatric configurations. The kit includes the preparatory and procedural components to perform Lumbar Puncture. A manometer may be included with the kit, depending upon the kit selected.

The SIMS LP Kits with a manometer are used to measure cerebrospinal fluid pressure in centimeters of water (cm of H2O). The manometer consists of two calibrated sections of tubing with a connector welded to the upper portion of the tubing.

Lumbar puncture is performed with standard prep and procedural componentry, similar to those used in spinal anesthesia kits, with the addition of a two part manometer, a 3-way stopcock and 5 inches of small bore extension tubing for the measurement of intracranial CSF pressure.

This document, a 510(k) summary for the SIMS Lumbar Puncture (LP) Kit, explicitly states:

"There were no nonclinical or clinical tests performed with these kits."

Therefore, based on the provided text, there is no study described that proves the device meets specific acceptance criteria.

Consequently, I cannot provide information for the following points as no such data is present in the document:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are provided.
2. Sample sized used for the test set and the data provenance: No test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth established from experts for a test set.
4. Adjudication method for the test set: No test set means no adjudication method.
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 MRMC study was performed, and this device is not an AI-based system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone performance study was done for an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth established.
8. The sample size for the training set: No training set was used.
9. How the ground truth for the training set was established: No training set means no ground truth establishment for it.

The document does offer a "SUMMARY OF PERFORMANCE DATA" for the manometer component stating: "Performance testing of the proposed kits show the SIMS manometer performed equal to or better than the predicate manometer from Abbott, both for the range in accuracy and for the average variance in accuracy." However, it does not detail the methodology, sample size, specific acceptance criteria, or raw performance data for this comparison. It only states a general outcome of comparison with a predicate device.

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The SIMS PER-FIT™ Percutaneous Tracheostomy Kit with Portex® Tracheostomy Tube and Disposable Inner Cannula is indicated for use in providing percutaneous temporary tracheal access for airway management.

The Disposable Inner Cannulae are indicated for use in maintaining airway patency of the outer cannula in the presence of thick tenacious secretions or when it is desirable to minimize the cleaning materials and the nursing time required. The Disposable Inner Cannulae provide a means to protect against the risk of airway obstruction, contamination, and infection.

The Per-Fit™ Percutaneous Tracheostomy Tube is intended for use as a replacement tube for the percutaneous tracheostomy tube that is supplied in the Per-Fit™ Percutaneous Tracheostomy Kit. It is intended to be used for replacement during the initial procedure or as a change-out tube following the procedure.

The SIMS PER-FIT™ Percutaneous Tracheostomy Kit with Portex® Tracheostomy Tube and Disposable Inner Cannula is designed to permit percutaneous insertion of a specifically designed tracheostomy tube. This single cannula Percutaneous Tracheostomy Tube has a radiopaque blue line and is constructed of biocompatible polyvinylchloride material and incorporates a tapered and beveled distal tube tip to facilitate insertion through the percutaneously dilated stoma site. The tracheostomy tube has a neck flange, an integral l 5 mm connector, and a cuff which deflates to a low profile on the tube for a smooth transition during insertion. The cuff inflation line has a self sealing luer valve. The tracheostomy tube is supplied with a disposable inner cannula of the appropriate size. The Percutaneous Tracheostomy Kit comes with the necessary components for percutaneous tracheostomy tube insertion into a stoma created by serial dilation.

The Disposable Inner Cannula is made of polyethylene and is ethylene oxide sterilized. The cannula is designated as a single use disposable device for use only with the Portex Percutaneous Tracheostomy Tube.

The Portex® Percutaneous Tracheostomy Tube is designed for insertion via the percutaneous route utilizing the Per-Fit™ Percutaneous Tracheostomy Kit. The tracheostomy tube has a radiopaque blue line and is constructed of biocompatible polyvinylchloride material and incorporates a tapered and beveled distal tip to facilitate insertion through the percutaneously dilated stoma site. The tracheostomy tube features a flexible flange, an integral 15 mm connector, and a cuff that deflates to a low profile for a smooth transition during insertion. The cuff inflation line has a self sealing luer valve. The tracheostomy tube is supplied with a disposable inner cannula of the appropriate size. The tube is supplied with an obturator/dilator sized to match the outer tube and to facilitate insertion.

The provided text is a 510(K) summary for a medical device (SIMS PER-FIT™ Percutaneous Tracheostomy Kit with Portex® Tracheostomy Tube and Disposable Inner Cannula). It describes the device, its indications for use, and a conclusion about its safety and effectiveness based on testing and comparison to predicate devices.

However, this document does not describe a study that uses acceptance criteria to evaluate the performance of an AI/ML powered device. The document pertains to a traditional, non-computerized medical device. Therefore, it does not contain the specific information requested in the prompt regarding AI/ML study design, such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance of an algorithm.

The core of the document's "conclusion" is that the device is "substantially equivalent" to predicate devices, which is a regulatory pathway for non-AI/ML devices.

Therefore, I cannot extract the requested information from the provided text based on the nature of the device and the document type.

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