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Emergency airway access via the cricothyroid membrane. Life-threatening dyspnoea that cannot be controlled in any other way.

Surgical Cricothyrotomy set for securing the airway in case of upper airway obstruction, respectively as "Ultima Ratio" if all other attempts to ventilate the patient failed. The set consists of scalpel, bougie, tube, extension tube with swivel connector, syringe and necktape.

The provided text is a 510(k) Premarket Notification for the ScalpelCric device, a cricothyrotomy set. It details the device's characteristics, intended use, and comparison to a predicate device to establish substantial equivalence.

However, this document does not contain information about a study that assesses the device's performance against specific acceptance criteria in the context of an AI/human-in-the-loop system, or a multi-reader multi-case (MRMC) study. The document focuses on the physical and biological characteristics of the medical device itself, its sterilization, biocompatibility, and bench testing, rather than a performance study involving diagnostic accuracy, expert review, or AI assistance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them in the context of an AI-assisted diagnostic system, as that information is not present in the provided text.

The closest information related to "acceptance criteria" is under section 9.4 Bench Testing, which lists features to be tested and the result (all "Passed"). This refers to the physical and functional performance of the device components, not a diagnostic or AI-related performance.

Here's what I can extract from the provided text regarding device testing, but it's important to note this is not a study proving AI performance as requested:

1. A table of acceptance criteria and the reported device performance:

The document provides a table under "9.4 Bench Testing" (page 10), which lists various tests performed on the components of the ScalpelCric set. The "Features to be tested" can be considered the acceptance criteria for those specific physical/functional aspects, and the "Result" indicates "Passed" for all.

The remaining requested information (sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth type, training set details) is NOT available in the provided document, as it pertains to a different type of device evaluation (e.g., AI/diagnostic performance) than what is described here. This document is focused on the substantial equivalence of a physical medical device (a cricothyrotomy set) to a predicate device.

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The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Percutaneous is intended to establish emergency airway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing the percutaneous entry (Seldinger) technique via the cricothyroid membrane.

The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical is intended to establish emergency arrway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing the surgical technique via the cricothyroid membrane.

The Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set is intended to establish emergency arrway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing either the percutaneous entry (Seldinger) technique or the surgical technique via the cricothyroid membrane.

The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Percutaneous, Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical, and the Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set consist of an airway catheter, a loading dilator, a wire guide, a catheter needle, and an introducer needle. In addition to these components, standard preparation components, such as a syringe, scalpel, dilator forceps, gauze, drape, tracheostomy tape, and tracheal hook are included. The sets consist of any combination of components appropriate for either percutaneous or surgical placement of a cricothyrotomy tube, or both.

The curved cricothyrotomy catheter is manufactured as a 22 French catheter with a length of 9 centimeters and an inner diameter of 5 millimeters. The loading dilators are either 11 centimeters or 12 centimeters long. The stainless steel wire guide has a 0.038-inch diameter and a length of 40 centimeters. The catheter needle is a two-part needle comprised of a small hubbed catheter sheath covering a hubbed needle. The sheath of the catheter needle is manufactured from fluorinated ethylene propylene tubing. The catheter needle is manufactured using an 18 gage cannula with a length of 7 centimeters. The introducer needle is also manufactured from 18 gage stainless steel and has a length of either 5 centimeters or 7 centimeters.

The provided document describes a 510(k) premarket notification for the Melker Cuffed Emergency Cricothyrotomy Catheter Set and its variations. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through extensive clinical trials. Therefore, the information provided relates to design validation and performance testing to ensure the device is as safe and effective as its predicate, rather than a clinical study evaluating human-in-the-loop performance or diagnostic accuracy.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

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The Emergency Transtracheal Airway Catheter is intended for emergency airway access when conventional endotracheal intubation cannot be performed.

The Emergency Transtracheal Airway Catheter is composed of a catheter and needle. The catheter-needle assembly cannulates the trachea through the cricothyroid membrane in order to establish an airway. The catheter is designed as a 6.0 French catheters manufactured from reinforced fluorinated ethylene propylene (FEP) tubing fitted to a 15 gage stainless steel needle with a lancet bevel. The nominal length of the catheter measures 5.0 or 7.5 centimeters, depending upon device specification. The catheter French size is stamped on the proximal fitting of the catheter. The Luer hub on the proximal end of the catheter connects to an oxygen source. The needle is manufactured with a nickel plated brass hub. The lancet bevel of the needle extends from the catheter at the beel of the bevel. The needle and the hub are soldered with tin-silver alloy material. The catheter-needle assembly cannulates the trachea through the cricothyroid membrane in order to establish an airway. The needle is removed from the catheter after the catheter-needle assembly establishes an airway through the cricothyroid membrane, leaving the catheter in the trachea.

The provided text describes specific acceptance criteria and the studies conducted to demonstrate that the Emergency Transtracheal Airway Catheter meets these criteria. This submission is for a Class II medical device, and the evaluation focuses on showing substantial equivalence to a predicate device, rather than a de novo effectiveness study requiring advanced statistical modeling like MRMC analyses for AI performance. Therefore, many of the requested elements pertaining to AI models, such as sample sizes for test/training sets, expert qualifications for ground truth, or MRMC studies, are not applicable to this particular device submission.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test. For many of the performance tests (e.g., bending rigidity, insertion force, air leakage, tensile strength), standard engineering and quality control practices would involve testing a representative sample from a production lot. The "Zero Time" and "Three-year Accelerated Aging" indicate testing was performed on new devices and devices subjected to simulated aging, respectively. Data provenance is not described as involving human patient data, but rather simulated or laboratory testing of the physical device. The document does not indicate country of origin for the data, but the manufacturer (Cook Incorporated) is based in Bloomington, IN, USA. The studies are prospective in the sense that they were designed and executed to evaluate the device.

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

Not applicable. This device is a physical medical instrument, not an AI/software device whose performance relies on established ground truth from experts interpreting images or data. The "ground truth" here is determined by engineering specifications and physical measurements against international standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not an AI/software device requiring expert adjudication of results. Testing involved objective measurements against predefined engineering and material standards.

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

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is not an algorithm-based device. "Standalone" performance testing for this device refers to the physical device's performance against specifications without human interaction other than the execution of the test protocols (e.g., measuring forces, leakage, etc.).

7. The Type of Ground Truth Used

The ground truth used for this device is based on engineering specifications and international standards. For example:

• Design Validation: Successful access to a validated anatomical model (AirSim Advance Combo model).
• Mechanical Properties: Numerical thresholds for bending rigidity (e.5 N), tensile load (20 N), maximum compressive load, breaking resistance, unscrewing torque, and separation force.
• Fluid Dynamics: Air leakage requirements of BS EN ISO 10555-1.
• Biocompatibility: Conformance to ISO 10993-1 and FDA guidance.
• Sterility: Conformance to requirements for bioburden, endotoxins, and EO/ECH residuals.
• Aging: Performance after simulated accelerated aging for 3 years (device) and 5 years (packaging) equivalent real-time.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/software device that requires a training set.

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

Not applicable. As above, no training set for an AI model.

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Rusch EasyCric Emergency Cricothyrotomy Set is indicated to provide emergency airway access when conventional ventilation by intubation or face mask cannot be performed.

The Rusch EasyCric Emergency Cricothyrotomy Set is a sterile, single use emergency cricothyroidotomy set available in size 5 mm. The device employs the Seldinger technique to provide an emergency artificial airway when attempts to intubate the trachea fail. Cricothyroidotomy provides faster access in emergency situations than surgical or percutaneous tracheostomy, which are time consuming procedures. The device gains access by cutting the link between the cricoid cartilage and the thyroid cartilage into the ligamentum conicum. It is available uncuffed. Components of the set include the EasyCric tube and insertion dilator, scalpel, puncture needle, syringe, guidewire, comport neckband and saline solution.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

The document describes the Rusch EasyCric Emergency Cricothyrotomy Set and its substantial equivalence to a predicate device. The "study" in this context refers to various performance tests conducted to demonstrate that the new device meets established safety and performance standards equivalent to the predicate. This is not a clinical study involving human patients or complex diagnostic algorithms.

Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample size used for the test set and the data provenance:

   • Sample Size: The document does not explicitly state the numerical sample size for each performance test (e.g., how many connectors were tested for bonding strength). It lists the types of tests performed.
   • Data Provenance: Not specified, but these are likely laboratory-based tests conducted by the manufacturer (Teleflex Medical). No country of origin for the data or whether it's retrospective/prospective is indicated, as this typically applies to clinical or observational studies on patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. These are engineering/performance bench tests, not evaluations requiring expert medical interpretation to establish ground truth such as in diagnostic imaging studies. The "ground truth" is defined by the physical or chemical properties being measured against established standards (e.g., force, dimension, visual integrity, biocompatibility standards).

3. Adjudication method for the test set:

   • Not applicable in the context of expert consensus or multi-reader reviews, as these are technical performance tests against objective criteria. The pass/fail criteria for each test serves as the "adjudication."

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic performance of imaging devices or algorithms with human readers, which is not the nature of this device's submission.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a medical device (cricothyrotomy set), not an AI algorithm. Its performance is assessed through its physical and functional integrity, not through algorithmic output.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the performance tests consists of established engineering standards, physical measurement criteria, and adherence to recognized international standards (e.g., ISO 5366-1, ISO 5356, ISO 10993-1).

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of machine learning or AI models.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device.

Summary of Device Performance Study:

The "study" presented here is a series of bench and laboratory performance tests designed to demonstrate that the Rusch EasyCric Emergency Cricothyrotomy Set is substantially equivalent to a predicate device. The tests evaluate physical characteristics and safety aspects of the device components (e.g., connector strength, coating quality, biocompatibility). The acceptance criteria for these tests are derived from international standards (ISO) or internal specifications designed to ensure the device is safe and performs as intended. The document states that all pass/fail criteria were met, leading to the conclusion of substantial equivalence. This is primarily a regulatory submission focused on engineering and material performance.

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Emergency airway access (when endotracheal intubation is not possible) by percutaneous insertion of a cricothyroidotomy tube through the cricothyroid membrane.

The new cricothyroidotomy kit is designed for introduction of an emergency 6mm cuffed airway tube through the cricothyroid membrane. The airway tube is provided pre-assembled onto a dilator with a Veress needle located in the centre. The kit employs two well-established and understood techniques: Firstly: The use of a Veress needle to provide visual indication of entry into a body cavity. (the trachea). (This can be confirmed by aspiration through the needle as with the predicate Cook Melker product ref. IFU in Attachment B(i)) The Veress needle is usually used for insufflation of the abdomen. It has a central sprung-loaded protective core to the needle that guards the cutting point and gives a visual indication via a "flag" at the hub end of the needle tip is passing through tissues. When the needle tip passes through into the abdominal cavity, or tractica, passure in ough assucer ------------------------------------------------------------------------------------------------------------------------------------------------------ Secondly: the use of a dilator/introducer to enlarge a stomal opening and place an airway tube within the traches. The pre-assembled needle/dilator/tube is inserted through the cricothyroid whill the tracether and the tube is then slid off the dilator fully into the trachea. This is the same principle employed by the Cook Melker Cricothyroidotomy sct. As well as the airway tube assembly, the kit provides the user with scalpel for skin incision, syringe for aspiration to confirm location of the needle in the trachea, sutures and neck-strap to secure the airway tube and a heat and moisture exchanger to reduce patient energy loss and protect the airway from blockage. These are all items that will be well understood by the user. Packaging comprises a rigid hinged blister pack for protection and a polythene/Tyvek welded pouch as the sterile barrier. pouch as ale sterilised and individually packed in a carton together with the directions for use.

The provided text is a 510(k) summary for the Portex Emergency Cricothyroidotomy Kit. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a standalone study with quantitative metrics like sensitivity or specificity.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Here's a breakdown of why the requested information is absent based on the provided text:

1. Table of acceptance criteria and reported device performance: Not present. The document focuses on comparing the new device's technical characteristics and indications for use to those of legally marketed predicate devices to establish substantial equivalence, not to demonstrate performance against pre-defined acceptance criteria.

2. Sample sized used for the test set and data provenance: No test set or associated sample size is mentioned. Clinical studies to evaluate performance against acceptance criteria are not typically required for a 510(k) submission where substantial equivalence is being claimed. The document primarily describes the device and its operational principle.

3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable, as no test set or ground truth establishment is described.

4. Adjudication method for the test set: Not applicable, as no test set or adjudication process is described.

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: Not applicable. This device is a mechanical medical instrument, not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic performance of AI or imaging interpretations.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth is established or discussed in the context of performance evaluation. The "ground truth" for a 510(k) in this context is typically the established safety and effectiveness of the predicate device.

8. The sample size for the training set: Not applicable. This device does not involve machine learning or a "training set."

9. How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary, the provided 510(k) text is a regulatory document seeking market clearance based on substantial equivalence to existing devices. It does not include the detailed performance study information requested, which would be typical for a PMA submission or a de novo classification, or for devices with novel technology requiring specific quantitative performance metrics.

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The Patil Cricothyroid Catheter is used for emergency airway access when conventional endotracheal intubation cannot be performed. It is provided in peel-open packages and is intended for one-time use.

Used for emergency airway access when conventional endotracheal intubation and ventilation cannot be performed.

The Patil Cricothyroid Catheter consists of a connector on the proximal end connected to tubing with an inner diameter. Through the catheter lumen is a dilator. The dilator over a needle is used for insertion. The catheter will be included in a set consisting of appropriately sized components.

This document (K013252) does not contain detailed information about specific acceptance criteria or a dedicated study proving that the device meets those criteria. Instead, it seems to be a 510(k) premarket notification for a medical device (Patil Cricothyrotomy Catheter), which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive performance studies with predefined acceptance criteria.

The phrase "The results of the tests performed provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a cricothyrotomy catheter" (from {1}) indicates that some testing was done, but the specifics of those tests, the acceptance criteria, and the detailed results are not included in this document.

Therefore, most of the information requested in your prompt cannot be extracted from this document. However, I can provide what is available:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified.
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not specified, as no study with a test set requiring expert-established ground truth is detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not specified.

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 comparative effectiveness study is mentioned in this document. The device is a physical catheter, not an AI-assisted diagnostic tool.

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

• Not applicable. The device is a physical catheter.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not specified, as no study with a ground truth determination process is detailed.

8. The sample size for the training set

• Not applicable, as this device is a physical component, not an AI/algorithmic system that typically involves training sets.

9. How the ground truth for the training set was established

• Not applicable.

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Used for emergency airway access when conventional endotracheal . intubation and ventilation cannot be performed.

The Arndt Cricothyroid Catheter consists of a connector on the proximal end connected to tubing with an inner diameter. Through the catheter lumen is a dilator. The dilator provides a transition to a wire guide for insertion. The device is placed using the Seldinger technique. The catheter will be included in a set consisting of appropriately sized components.

The provided information does not contain any data regarding acceptance criteria or a study proving device performance in relation to such criteria. The document is a 510(k) premarket notification for the Arndt Emergency Cricothyrotomy Catheter Set, primarily focusing on its substantial equivalence to predicate devices and its intended use.

The text describes the device, its indications for use, and a comparison to existing predicate devices (Melker Cuffed Cricothyroid Catheter Set and The Pertrach). The FDA letter confirms the substantial equivalence determination, allowing the device to be marketed. However, no performance metrics, acceptance criteria, or study results are presented.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results or effect sizes.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The Melker Emergency Cricothyrotomy Catheter Set is used for emergency airway access.
. In patients whom conventional endotracheal intubation and ventilation cannot be performed.
The device will be supplied sterile and is intended for one-time use.

Used for emergency airway access when conventional endotracheal intubation and ventilation cannot be performed.

The Melker Emergency Cricothyrotomy Catheter with a standard inner diameter of 3.5, 4, or 6 mm and a length of either 3.8, 4.2, 7.5 cm with a proximal fitting and a coaxial dilator tapered to a 0.038-inch wire guide.

This 510(k) premarket notification for the Melker Emergency Cricothyrotomy Catheter Set (K013916) does not contain the detailed information necessary to fully address all aspects of your request. The submission is primarily focused on demonstrating substantial equivalence to a predicate device (K010016) based on indications for use, material, and physical characteristics, and adherence to quality system procedures.

Here's an analysis based on the provided text, highlighting what is available and what is missing:

Acceptance Criteria and Study for K013916: Melker Emergency Cricothyrotomy Catheter Set

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not describe a specific "test set" in the context of a clinical or performance study with human or simulated cases for K013916.
• The comparison is based on the characteristics of the device being "the same" as a predicate device (K010016).
• Therefore, no sample size for a test set is provided, and data provenance for such a test set is not applicable in this submission.

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

• Not applicable. As no specific "test set" or clinical study requiring ground truth establishment is described for K013916, there is no mention of experts or their qualifications for this purpose.

4. Adjudication Method for the Test Set:

• Not applicable. No test set requiring an adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No MRMC comparative effectiveness study was done or reported in this submission. The submission relies on substantial equivalence to the predicate device, not on demonstrating improved human reader performance with or without AI.

6. Standalone Performance Study (Algorithm Only):

• Not applicable. This device is a catheter set, not an algorithm or AI-driven system. Therefore, a standalone (algorithm only) performance study is not relevant.

7. Type of Ground Truth Used:

• Not applicable. As there is no described test set or study involving diagnostic performance, the concept of "ground truth" (e.g., pathology, outcomes data) is not relevant to this 510(k) submission for K013916. The "ground truth" for the clearance is essentially the established performance and safety profile of the predicate device (K010016).

8. Sample Size for the Training Set:

• Not applicable. As this is a physical medical device (catheter set) and not an AI/ML algorithm requiring a training set, the concept of a "training set" is not relevant to this submission.

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

• Not applicable. As there is no training set mentioned, the establishment of its ground truth is also not applicable.

Summary of Study (as presented in the 510(k) for K013916):

The "study" for K013916 is a substantial equivalence comparison to a predicate device (Melker Cuffed Cricothyrotomy Catheter Set, K010016). The manufacturer asserts that the new device is "the same with respect to indications for use, material and physical characteristics" as the predicate device. Therefore, the "acceptance criteria" in this context are that the new device replicates the key attributes of the cleared predicate device. The "study" largely involves documentation of device design, materials, manufacturing processes, and sterilization validation, aligning them with those of the predicate device and the firm's quality system.

The submission does not involve clinical trials, comparative studies against human performance, or studies typically associated with AI/ML devices that would require test sets, ground truth, or statistical power calculations for diagnostic accuracy.

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The device is intended for emergency airway obstruction in a non-clinical environment. The device is intended to be used for less than 24 hours.

Not Found

I am sorry. I cannot provide information about acceptance criteria and study details based on the provided text. The document is a 1997 FDA 510(k) clearance letter for a "ffrench Pocket Emergency Airway" device. It confirms the device's substantial equivalence to a predicate device and its classification.

The letter does not include:

• A table of acceptance criteria or reported device performance.
• Details about a specific study, sample sizes, data provenance, expert qualifications, or adjudication methods.
• Information on MRMC comparative effectiveness studies, standalone performance, or ground truth types and how they were established.

This document is solely an FDA clearance letter, not a clinical study report or a summary of performance data.

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