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Fahl Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.

The Fahl Tracheostomy Tubes (Duravent, Duracuff, Laryngotec, Duratwix, Silvervent, Spiraflex, and Tracheotec) are available cuffed or uncuffed. They can be obtained sieved or unsieved, with or without speaking valve, cuffed or uncuffed, with or without inner cannulas. The accessories comprise different Humid Moist Exchangers (HME), decannulation plugs, neck holders, and stoma buttons. Fahl offers the tubes in varying sizes and length so that the physician can select a tracheostomy tube, which best fits the individual needs of the patient. All Fahl Tracheostomy Tubes are for adults only and available on prescription.

The provided text describes the performance data for Fahl Tracheostomy Tubes (Duravent, Laryngotec, Duracuff, Silvervent, Duratwix, Tracheotec, Spiraflex). The study described is a series of tests against established international standards rather than a clinical trial with human subjects/patients. Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set information) are not applicable or cannot be extracted from this type of regulatory document.

Here's a breakdown of the acceptance criteria and performance as reported:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify the exact number of units or samples tested for each specification. It generally states that "Test results provide reasonable assurance that the tubes are safe for their intended use."
• Data Provenance: The tests were conducted according to international standards (ISO 5356-1, ISO 5366-1, ISO 10993-1, and ISO 10993-7). The manufacturer is Andreas Fahl Medizintechnik-Vertrieb GmbH in Koeln, Germany, suggesting the testing was performed in a controlled laboratory environment, likely in Germany or a location complying with these international standards. This is prospective testing related to regulatory approval, not retrospective patient data.

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

• Not Applicable. This study involves laboratory testing against established engineering and material standards, not expert clinical review or ground truth derived from expert consensus on medical images or clinical outcomes.

4. Adjudication method for the test set:

• Not Applicable. As this is laboratory testing against physical specifications and standards, there is no expert adjudication method as would be typical for clinical studies or AI-driven diagnostic tools.

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 a regulatory filing for a medical device (tracheostomy tubes), not an AI/software as a medical device (SaMD) or diagnostic imaging study. Therefore, no MRMC study was conducted.

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

• Not Applicable. This premarket notification is for physical medical devices and does not involve an algorithm or AI.

7. The type of ground truth used:

• Standard Specifications: The "ground truth" for this study is defined by the technical requirements and acceptance criteria outlined in the referenced ISO standards (ISO 5356-1, ISO 5366-1, ISO 10993-1, ISO 10993-7, ISO 11135). The devices either "Passed" or met "n.a." (not applicable) for these standards.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning or AI study, so there is no training set.

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

• Not Applicable. There is no training set for this type of device performance testing.

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The Primed Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.

The Primed Tracheostomy Tubes consists of various types of tracheostomy tubes, e.g., Primedistom Cannulas w/wo cuff, Silver Cannulas, Priflex Cannulas, Silicone Cannulas (Primedi Silk), and Primedi Star Cannulas. The tracheostomy tubes are made of different materials and offer a variety of inner and outer diameters and varying lengths thus making it possible to meet the individual needs of a patient.

The Primed Tracheostomy Tubes can be obtained sieved or unsieved, with or without speaking valve, cuffed or uncuffed, with or without one or two inner cannulas. The accessories comprise different speaking valves as well as Humid Moist Exchangers (HME) and different types of filters.

The provided 510(k) summary for the Primed Tracheostomy Tubes (K120079) indicates that the device's substantial equivalence was established through performance data related to conformity with recognized international standards, rather than a clinical study comparing device performance against specific acceptance criteria. This means the submission primarily focuses on demonstrating that the device meets established engineering and material standards applicable to tracheostomy tubes.

Here's a breakdown based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The submission states, "The Primed Tracheostomy Tubes conform to ISO 5356-1 and ISO 5366-1." These ISO standards establish requirements for the design, dimensions, materials, and sterile packaging of tracheostomy tubes and their connectors to ensure safety and performance. By conforming to these standards, the manufacturer asserts that their device meets the internationally recognized safety and performance benchmarks for this type of medical device.

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

This information is not provided in the given 510(k) summary. Since the submission relies on conformity to international standards (ISO), the "test set" would likely refer to engineering and material tests performed on samples of the manufactured tracheostomy tubes. The data provenance would be internal laboratory testing by the manufacturer or a certified testing facility, not clinical data from patients.

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

This information is not provided. For standard conformity testing, the "ground truth" is the specifications and testing methods defined by the ISO standards themselves. The experts involved would be engineers and technicians performing the tests according to the standard's protocols, not medical experts establishing clinical ground truth.

4. Adjudication Method for the Test Set

This information is not provided. As explained above, the "test set" refers to engineering and material testing, not a clinical study with human readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, often with and without AI assistance, to assess the AI's impact on diagnostic accuracy. Tracheostomy tubes are mechanical devices for airway management and do not typically involve this kind of comparative effectiveness study.

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

No, a standalone (algorithm only) performance assessment was not done. This concept applies to AI/software as a medical device (SaMD) where an algorithm provides a diagnosis or outcome without direct human interpretation. Tracheostomy tubes are physical medical devices, not algorithms.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by conformity to established international engineering and material standards (ISO 5356-1 and ISO 5366-1). This is not
expert consensus, pathology, or outcomes data in the clinical sense, but rather adherence to predefined technical specifications and performance characteristics.

8. The Sample Size for the Training Set

This information is not applicable and not provided. Tracheostomy tubes are physical devices, and their development does not involve "training sets" in the context of machine learning. The design and manufacturing processes are guided by engineering principles and standards.

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

This information is not applicable and not provided for the same reasons as #8. The "ground truth" for the design and manufacturing of the device is rooted in established engineering specifications and international standards, which are developed through expert committees and consensus over time, not through data labeling for a "training set."

In summary: K120079 is a 510(k) for a physical medical device (tracheostomy tubes). The demonstration of substantial equivalence relies on proving that the device has the same intended use, materials, and functional specifications as predicate devices, and importantly, conforms to relevant international standards (ISO 5356-1 and ISO 5366-1). This type of submission typically uses engineering and bench testing to demonstrate compliance with these standards, rather than clinical studies involving patient data or AI performance assessments.

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CareStar 30 and SafeStar 55 are Breathing System Filters which are designed to reduce possible airborne or liquid-borne cross contamination with micro-organisms and particulate matter via anaesthetic or ventilator breathing systems.

The products may either be used on the patient side or on the device side of the ventilator/ anaesthetic device and are used as a hygienic measure alternatively to decontamination of breathing system and/or breathing gas conveying parts of the ventilator.

TwinStar 55 is a Breathing System Filter and a Heat and Moisture Exchanger. The combination of a filter and a Heat and Moisture Exchanger offer the benefit of both product features. Heat and Moisture Exchanger are used as a conditioning system for mechanically ventilated patients whose upper airways are bypassed. In almost all cases of mechanical ventilation they are a fully valid alternative to heated humidifiers. The products are the only conditioning opportunity of breathing gases in cases of emergency ventilation or during transport since Heated Humidifiers are almost impossible to use.

The products mentioned above are designed for disposable use and should be changed at least every 24 hours.

The filters CareStar 30 and SafeStar 55 are designed to reduce possible air or liquid borne cross contamination with microorganisms via anesthetic or ventilator breathing systems. The strategic use of an effective breathing filter protects, bi-directionally, both the patient and equipment.

The filter CareStar 30 contains an electrostatic filter pad while the filter SafeStar 55 incorporates a mechanical pleated filter pad. Both filters consist of a plastic body which incorporates 22 female / 15 male connectors in accordance with EN ISO 5326 and a luer lock connector which may only be used for gas monitoring.

The Filter/HME TwinStar 55 is designed to combine the feature of reducing possible cross contamination with micro-organisms and an ideal heat and moisture return.

The Filter/HME TwinStar 55 consist of a plastic body which incorporates an electrostatic filter pad, 22 female / 15 male connectors in accordance with EN ISO 5326 and a gas luer lock connector which may only be used for gas monitoring.

Here's an analysis of the provided text regarding the Dräger Medical breathing system filters, focusing on the acceptance criteria and the study proving compliance.

It's important to note that this document is a 510(k) Summary, which typically provides a high-level overview of the device and its substantial equivalence to predicate devices, rather than a detailed study report. Therefore, specific details about study design, raw data, or comprehensive statistical analyses are often summarized or omitted.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides performance specifications for the devices, comparing them to generally accepted standards for breathing system filters. The "acceptance criteria" are implied by the listed performance values and the claim of substantial equivalence to predicate devices.

*BFE: Bacterial filtration efficiency; VFE: Virus filtration efficiency

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

The document states filtration efficiency tests were done "by Nelson Lab." Nelson Laboratories is a well-known contract research organization specializing in microbiology and material testing for medical devices.

• Sample Size for Test Set: Not explicitly stated in the provided document. Standard laboratory testing, especially for filtration efficiency, would involve a statistically significant number of samples, but the exact count is not given here.
• Data Provenance: The document implies the data comes from laboratory testing (Nelson Labs). This is not patient-specific clinical data. It is a prospective test of the physical properties and performance of the manufactured devices. The country of origin for Nelson Labs is the United States.

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

• This type of device (breathing system filter) does not typically involve human expert adjudication for its primary performance metrics like filtration efficiency or resistance to flow. These are objective, quantifiable physical properties measured by laboratory equipment.
• Therefore, the concept of "ground truth established by experts" in the way it applies to image-based diagnostics is not relevant here. The "ground truth" for the test results is established by the methods and standards used by Nelson Laboratories, which are highly specialized technicians and scientists in their field.

4. Adjudication Method for the Test Set

• Not applicable (see point 3). Performance metrics are determined by laboratory measurements according to established test standards (e.g., for BFE/VFE, resistance to flow, moisture loss).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

• No. This is a hardware medical device (breathing system filter), not an AI-powered diagnostic or therapeutic tool. Therefore, MRMC studies and AI assistance are not applicable.

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

• No. This is not an algorithm or AI device. The performance data presented is the "standalone" performance of the physical device itself in a laboratory setting.

7. The Type of Ground Truth Used

• For physical performance metrics (filtration efficiency, resistance to flow, internal volume, moisture loss), the ground truth is derived from standardized laboratory testing methods and measurements. These methods are designed to objectively quantify the device's physical properties under controlled conditions. This is not pathology, expert consensus (in the clinical sense), or outcomes data.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The device's design and manufacturing processes are refined based on engineering principles and material science, not data training.

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

• Not Applicable. (See point 8).

Summary of the Study Proving Device Meets Acceptance Criteria:

The document states that the performance data for filtration efficiency was "[measured] by Nelson Lab." It also lists other performance characteristics such as resistance to flow, internal volume, and moisture loss. The study demonstrating that the device meets criteria is implicitly the laboratory testing conducted by Nelson Laboratories and Dräger Medical's internal R&D, which measured these specific physical and biological filtration properties of the filters.

The overall claim of the 510(k) submission is Substantial Equivalence. This means the applicant argues that the proposed devices (Filter CareStar 30, Filter SafeStar 55, Filter/HME TwinStar 55) are as safe and effective as existing, legally marketed predicate devices (listed in the document). The "study" isn't a comprehensive clinical trial but rather a comparison of key performance data to established values of predicate devices and relevant ISO/EN standards. The document states:

"The comparison of the data shows similar values for the key performance data. Proposed devices show similar values in filtration efficiency, dead space, resistance to flow and recommended tidal volumes when compared to the legally marketed devices."

The acceptance criteria are therefore implicitly defined by the performance benchmarks set by these predicate devices and relevant industry standards (like EN ISO 5326 and ISO 9360), which the new devices' laboratory test results must meet or demonstrate equivalence to. The FDA's clearance (K072002) signifies their agreement that this substantial equivalence has been demonstrated.

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The Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight are heat and moisture exchangers as described in 21 CFR 868.5375 These products are substantially equivalent to the Gibeck Humid-Vent Filter heat and moisture exchanger.

The Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight are similar in design, materials and function to the Humid-Vent Filter with reduced size, dead space and lighter weight. The reduced dead space of the Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight allows for a tidal volume range of 150-1000 ml.

This document, K964382, is a 510(k) summary for a medical device: Gibeck Humid-Vent® Filter Compact Angled/Humid-Vent® Filter Compact Straight. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving performance against specific acceptance criteria through a study measuring diagnostic or predictive accuracy.

Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment cannot be provided from this document for the following reasons:

• No Diagnostic or Predictive Performance: The device is a "heat and moisture exchanger" (21 CFR 868.5375). Its function is to condition inspired air, not to diagnose, predict, or interpret medical conditions. Therefore, metrics like sensitivity, specificity, AUC, or accuracy, which are typical for AI/ML device acceptance criteria, are not applicable here.
• Substantial Equivalence, Not De Novo Performance Testing: 510(k) submissions primarily focus on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing design, materials, intended use, and performance claims to the predicate, rather than conducting new, large-scale clinical studies to establish novel performance metrics or acceptance criteria for diagnostic accuracy.
• Lack of AI/ML Component: There is no indication that this device incorporates AI or machine learning. The questions provided in the template are highly specific to AI/ML device evaluations.

In summary, the provided document does not contain the information requested because it is a 510(k) summary for a non-AI/ML device, focusing on substantial equivalence rather than diagnostic performance studies.

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