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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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Controlled, elective, subcricoid percutaneous insertion of a tracheostomy tube for airway management using a Seldinger guidewire dilation technique.
Controlled, elective subcricoid percutaneous insertion of a tracheostomy tube for airway management using a Seldinger technique to guide the specially designed Guidewire Dilating Forceps into trachea, which are then used to dilate the trachea.

The BLUperc® and BLUgriggs® Percutaneous Dilation Tracheostomy Tube Kits or Trays aid in the tracheostomy tube surgical procedure for adult patients; designed to aid adult patients requiring an artificial breathing airway due to trauma, medical condition and/or for airway maintenance. The tracheostomy tubes (kits or trays) maximum recommended period of use is 29 days. The kit or tray contains all the proprietary procedural components to support tracheostomy insertion, including the BLUselect tracheostomy tube for physician's ease during the clinical procedure flow.

The provided document is a 510(k) premarket notification summary for medical devices (tracheostomy kits). It focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving a device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) is not applicable or cannot be extracted from this type of document.

The document primarily demonstrates that the BLUperc® and BLUgriggs® Percutaneous Dilation Tracheostomy Procedural Kits or Trays are substantially equivalent to existing predicate devices (UltraPerc Percutaneous Dilation Kit and Portex Percutaneous Tracheostomy Kit).

Here's a breakdown of the available information:

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

This document does not present a table of specific performance acceptance criteria in the way it would for a new AI/software device or a device requiring new clinical performance data to demonstrate effectiveness. Instead, the "acceptance criteria" are implied by establishing substantial equivalence to predicate devices. The performance testing conducted (bench testing, packaging validation, design validation/human factors, sterilization/microbiology validation, biocompatibility assessment) ensures the device meets its own specifications and is safe and performs as intended, thereby being equivalent to the predicates.

The study proves the device meets the "acceptance criteria" of substantial equivalence to the predicate device.

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

• Sample Size: Not specified for individual tests. The document refers to "applicable components" for bench testing and mentions that tests were "conducted" without providing specific sample numbers for each test.
• Data Provenance: The studies are described as "Non-clinical testing" and include bench testing, packaging validation, design validation/human factors, sterilization/microbiology validation, and biocompatibility assessment. These are laboratory/engineering tests rather than clinical studies with patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply.

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

This information is not provided. The testing described (bench, packaging, sterilization, biocompatibility, and human factors) relies on engineering and scientific principles and product specifications, not on expert consensus for "ground truth" as might be seen in diagnostic imaging studies. Human factors testing involves users, but their qualifications are not detailed beyond "physician (healthcare staff)".

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

Not applicable. Adjudication methods are typically used in clinical studies where multiple reviewers assess outcomes, which is not the type of study described here.

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 premarket notification for a physical medical device (tracheostomy kit), not an AI/software device. No MRMC study was conducted or mentioned.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for the performance testing is adherence to predefined engineering specifications, performance standards (e.g., fluid flow, material strength), and regulatory standards (e.g., ISO for packaging, sterilization, biocompatibility). It is based on objective measurements and compliance with recognized standards, rather than clinical expert consensus or pathology.

8. The sample size for the training set:

Not applicable. This is not a study involving machine learning or AI models, so there is no "training set."

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

Not applicable (no training set).

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The Noble Anesthesia-Air Snor-Scope Plus™ Electronic Stethoscope is intended as a diagnostic aid in patient monitoring, diagnostics, and treatment under the same conditions that would otherwise require the use of an acoustic (non-clectronic) stethoscope.

In addition, the Noble Anesthesia-Air Snor-Scope Plus Electronic Stethoscope is also intended for electronically amplifying sounds of evolving obstruction of the upper airway in patients without an endotracheal tube undergoing sedation or general anesthesia care professional.

It is not intended to be used for diagnosis and treatment by unlicensed, untrained, or unqualified medical persons.

The Noble Anesthesia-Air Snor-Scope Plus™ Electronic Stethoscope System is a kit comprised of the following components:

• Audio amplifier module and microphone
• Plastic T-connector / diaphragm coupler assembly (airway adapter)
• Single Plastic coupler (stethoscope adapter)
• Stethoscope Head (standard mechanical acoustic)
• Stethoscope (standard mechanical acoustic)
• Wall charger (UL listed, medical grade) and eight (8) batteries (rechargeable)

A shielded microphone and audio cable, with a 3.5mm plug, connects the microphone/coupler assembly to the amplifier module. The speaker volume may be adjusted on the audio amplifier module to allow comfortable listening levels of breathing sounds passing through the airway circuit for Anesthesia Physicians and Clinical Personnel. A standard stethoscope ear piece may also be used for private listening purposes, although it does not provide the same amplification as in electronic stethoscope mode.

The Snor-Scope Plus T-connector is composed of a plastic diaphragm and connector cap which holds the diaphragm tightly in place. This T-connector serves as an attachment for either the manual stethoscope (without head) or to the electronic stethoscope microphone. The device is not sterile, is outside the surgical field, and is a single-use disposable accessory.

A single plastic medical grade coupler may also be used as an interface between the Snor-Scope Plus microphone and standard stethoscope dual-diaphragm head for the same purpose that would otherwise require an acoustic (non-electronic) stethoscope.

The Noble Anesthesia-Air Electronic Stethoscope provides 20 times greater signal amplitude than a standard acoustic stethoscope. The overall frequency response is 15 - 1500 Hertz. This stethoscope is a stand-alone unit, has no software, and operates using an analog audio system without introducing any signals or energy into the patient or anesthesia breathing circuit.

The Amplifier Module is powered by rechargeable Nickel Cadmium Batteries which can be easily replaced. The charger consists of a medical grade UL listed wall adapter. The batteries and charger are of the overall packaged kit. The audio amplifier module controls charging which cannot be performed during use of the Noble Anesthesia-Air Snor-Scope Plus™ Electronic Stethoscope.

Here's a breakdown of the acceptance criteria and the study details for the Snor-Scope Plus Electronic Stethoscope, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• No major external or internal damage (for disposition "Continue tests until final release") | Unit #1 (S/N: 0103): Scratched (X-axis), None (Y-axis), Dent - Corner (Z-axis). No Internal Damage. Passed functional test (Volume Control OK, Connectors OK, Speaker OK).
  Unit #2 (S/N: 0107): None (X-axis), Scratched (Y-axis), Hairline Crack - Corner (Z-axis). No Internal Damage. Passed functional test (Volume Control OK, Connectors OK, Speaker OK. Crack did not affect function).
  Unit #3 (S/N: 0124): None (X-axis), None (Y-axis), Dent - Corner (Z-axis). No Internal Damage. Passed functional test (Volume Control OK, Connectors OK, Speaker OK).

Overall Conclusion stated: "No Internal Damage [...] Disposition: Continue tests until final release. Certified by: [Signature] Date: 01/12/2009" |
| T-Connector Assembly Pressure Test:

• The diaphragm of the Stethoscope-Connector cannot fail (rupture or leak) after being subjected to 25 cycles of 90 cm of water pressure (double the extreme of clinically used pressures: Max PEEP = 30 cm H2O, Max Added PPV = 60 cm H2O). | The text states: "The diaphragm of the Stethoscope-Connector cannot fail after being subjected to 25 cycles of 90 cm of water pressure of the ventilator, i.e., the diaphragm is not ruptured and no leak is produced." This is presented as the criteria for the test, and the "Discussion" section for the T-Connector Test Protocol implies successful completion: "It is possible, but not likely, that the T-connector diaphragm might rupture and cause an anesthesia circuit leak. This occurrence would be detectable by routine pressure checks of the breathing circuit and by listening for a leak over the connecting port of the stethoscope." (This implies it didn't rupture during testing according to the criteria). |
  | Hazardous Conditions Test Protocol - Liquid (Normal Test - Current Leakage):
• No current leakage with or without the charger plugged in under normal operating conditions. | "Test results from these tests have indicated that there is no current leakage, with or without the battery charger plugged in, under normal operating conditions. The unit case and microphone/Tconnector assembly impedance is infinite." |
  | Hazardous Conditions Test Protocol - Liquid (Destructive Test - Current Leakage with Sodium Chloride solution):
• If internal PC board power components are shorted, the micro fuse (Fast Acting, 750 mA, One Time) should indicate no continuity (open circuit) and leakage current should be 0.0mA within ~2-3 seconds.
• With charger plugged in, slight current leakage 0.02 mA - 0.03 mA acceptable before fuse opens.
• Without charger plugged in, current leakage ~0.01 mA acceptable before fuse opens. | "During destructive testing, there was slight current leakage between 0.02 mA - 0.03 mA with the battery charger plugged in... If the internal PC board power components were shorted by the sodium chloride solution, the micro fuse [...] indicated no continuity (open circuit) and leakage current was 0.0mA. Without the battery charger plugged in, current leakage was between 0.01 mA on average. Same micro fuse conditions were found (open circuit) if power components were shorted by the sodium chloride solution. Fuse open time was approximately 2 - 3 seconds as indicated by 0.0 mA current leakage measurements." |
  | Clinical Performance (Detection of Airway Obstruction):
• Accurate detection of stridor in patients undergoing sedation. | "The stridor that was reported in the results was accurately detected by the Snor-Scope Plus." (from the "Pediatric Sedation Outside of the Operating Room" study).
  "The Noble Anesthesia-Air Snor-Scope Plus™ Electronic Stethoscope is a reliable monitor to detect an evolving obstruction of the upper airway." |
  | Safety (Adverse Effects):
• No adverse effects or complications. | "There were no adverse effects or complications." (from the "Pediatric Sedation Outside of the Operating Room" study). |

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

• Clinical Study:
  • Sample Size: 10 patients.
  • Data Provenance: Retrospective, gathered during a study sponsored by Harvard University, San Francisco CA USA, in September 2008. The data was gathered while Dr. James P. Noble was in private practice. The formal study was approved in 2005 by the Western Institutional Review Board (WIRB Protocol #20050216). Patients were "representative of the patient population for which Dr. Noble had cared for over nearly 10 years."
• Drop Test Performance:
  • Sample Size: 3 units (S/N: 0103, 0107, 0124).
  • Data Provenance: Non-clinical bench testing.
• T-Connector Assembly Pressure Test:
  • Sample Size: "Random T-Connector assemblies." (Specific number not provided).
  • Data Provenance: Non-clinical bench testing.
• Hazardous Conditions Test Protocol - Liquid (Current Leakage):
  • Normal Test Sample Size: 5 amplifier module, microphone, and T-connector assemblies.
  • Destructive Test Sample Size: 10 amplifier module, microphone, and T-connector assemblies (5 with charger unplugged, 5 with charger plugged in).
  • Data Provenance: Non-clinical bench testing.

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

• Clinical Study: While the study involved 10 patients and aimed to detect stridor, the documentation states "The stridor that was reported in the results was accurately detected by the Snor-Scope Plus." It doesn't explicitly detail how the ground truth of stridor presence was independently established for each patient in the study or by how many experts. However, the study was conducted by or under the supervision of Dr. James P. Noble, who is an Anesthesiologist ("licensed Anesthesiologist only" mentioned in proposed labeling, and his experience in "improving the safety of anesthesia for cosmetic surgery patients" for nearly 10 years before the formal study). The study sponsor/investigator was Robert N. Cooper, M.D.
• Bench Testing: For non-clinical tests (drop, pressure, leakage), the ground truth is determined by the test criteria themselves (e.g., visual inspection for damage, functional testing, resistance/current measurements). The tests were certified by an unnamed individual.

4. Adjudication Method for the Test Set

• Clinical Study: Not explicitly stated for the clinical study. It implies Dr. Noble's clinical assessment was key, given his experience and the device's role in his "special technique." No formal adjudication method like "2+1" or "3+1" is mentioned for establishing the presence of stridor.
• Bench Testing: Not applicable in the same way as clinical studies. The results are objective measurements or observations against predefined criteria.

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

• No, an MRMC comparative effectiveness study was not done.
  • The submission focuses on the device's standalone performance and its equivalence to predicate electronic stethoscopes in basic functionality, with an additional indication for detecting upper airway obstruction.
  • The "user testing with Anesthesiologists and Clinicians" for overall effectiveness is mentioned generally but no specifics of an MRMC study are provided.
  • The clinical assay describes a study of 10 patients where the Snor-Scope Plus was used, but it does not compare human readers with and without AI assistance or any other comparative effectiveness with human readers.

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

• Yes, a standalone performance assessment was done for the core function of detecting stridor.
  • The device is described as an "Electronic Stethoscope" that "electronically amplifies sounds of evolving obstruction." The clinical assay concludes: "The stridor that was reported in the results was accurately detected by the Snor-Scope Plus." This indicates the device, on its own, detected the stridor.
  • The Snor-Scope Plus is an analog audio system; it "has no software, and operates using an analog audio system without introducing any signals or energy into the patient or anesthesia breathing circuit." Therefore, it's not an "algorithm" in the modern sense of AI, but its ability to amplify and present sounds for human interpretation is its standalone function.

7. The Type of Ground Truth Used

• Clinical Study: Clinical observation/assessment by medical professionals (implied to be Dr. Noble and potentially other clinicians involved in the study) for the presence of stridor, linked to "evolving obstruction of the upper airway." The "stridor that was reported in the results was accurately detected by the Snor-Scope Plus," indicating the reported stridor was the ground truth.
• Bench Testing: Objective physical and electrical measurements against predefined benchmarks and safety standards (e.g., integrity after drops, pressure resistance, current leakage measurements).

8. The Sample Size for the Training Set

• Not Applicable / Not Provided.
  • The Snor-Scope Plus is described as operating using an "analog audio system" and "has no software." This implies it is not a machine learning or AI-driven device that requires a training set in the typical sense. Its design is based on established acoustic and electronic engineering principles for amplification.
  • The "nearly 10 years during the development of his special technique" by Dr. Noble, where the Snor-Scope Plus (in various stages) was an "essential part," could be considered a form of informal, long-term development and refinement, but not a formal 'training set' for an algorithm.

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

• Not Applicable. As noted above, there's no indication of a formal 'training set' or 'ground truth' establishment for a machine learning algorithm given the device's analog nature. The development and refinement would have been guided by traditional engineering and clinical experience/observation.

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The Trach-Assist is an airway connector intended to connect between an endotracheal tube or tracheostomy tube and the ventilator circuit or closed suction system. It can assist in removal of patient secretions that may collect in ventilatory tubing.

Trach-Assist is a simple connector with standard 15 mm fittings permitting connection with an endotracheal tube or tracheostomy tube and the patient wye of a breathing circuit.

The Trach-Assist H has a port for insertion of a suction catheter to remove secretions while Trach-Assist-I uses Closed Suction Catheter system to remove secretions.

The Mergenet Medical, Inc. Trach-Assist device, an airway connector, was determined to be substantially equivalent to existing predicate devices based on a comparison of design and performance characteristics.

Here is a summary of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

• Via a port and use of a standard suction catheter (Trach-Assist H)
• Allows direct connections of a Closed suction catheter system (Trach-Assist I) |
  | Has a reservoir for collection of secretions | Yes (for water drainage in predicate Hudson RCI Water Trap), No (for predicate Swivel connectors) | Yes: Within the housing. (This is a differentiating feature, collecting secretions instead of only water and is deemed not to raise new safety issues, implying its acceptance as a design improvement.) |
  | Standard 15 mm / 22 mm fittings | Yes | Yes |
  | Internal Volume | Not available (for predicate swivel connectors and HME), N/A (for water trap) | 36 ml - "T"
  29.6 ml - "H" (These values demonstrate specific performance, and are not directly compared to a numeric criterion from the predicates, but are implicitly acceptable as the device was found substantially equivalent.) |
  | Resistance to flow | (Example from predicate Sontek Bodai: 0.17 cm H2O @ 30 Lpm, 0.66 cm H2O @ 50 Lpm, 0.95 cm H2O @ 70 Lpm) | 0.12 cm H2O @ 30 Lpm
  0.60 cm H2O @ 50 Lpm
  0.93 cm H2O @ 70 Lpm
  (Trach-Assist-H highest resistance values). These values are comparable to or better than the predicate device's measured resistance, indicating acceptable performance within established ranges for similar devices.) |
  | Duration of use | Single patient use, not specified | Single patient use up to 24 hours. (This aligns with and further specifies the predicate's general use, indicating acceptable duration.) |
  | Provided clean, non-sterile | Yes | Yes |

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

The provided documentation does not specify a separate "test set" sample size or data provenance in the context of a clinical study or performance evaluation with a population of patients. The evaluation appears to be based on:

• Engineering bench testing: For parameters like internal volume and resistance to flow.
• Comparison of design features: Against existing predicate devices.

There is no mention of human subject data, retrospective or prospective studies, or country of origin for such data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the submission does not describe a study involving expert review for establishing ground truth on clinical outcomes or diagnoses. The "ground truth" for the device's technical specifications (e.g., resistance to flow, internal volume) would have been established through standard engineering and laboratory measurements by qualified personnel at the manufacturer.

4. Adjudication Method for the Test Set

This information is not applicable as there is no described test set requiring adjudication in the context of clinical expert review or consensus.

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

No MRMC comparative effectiveness study was mentioned. The submission focuses on substantial equivalence based on design and performance characteristics compared to predicate devices, not on the improvement of human readers with or without AI assistance. The device itself is a physical medical device, not an AI-driven diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No standalone (algorithm only) performance study was done. The device is a physical connector, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" used for this submission is based on:

• Technical specifications and measurements: For properties like internal volume and resistance to flow.
• Design characteristics: Compared against the physical features and functions of legally marketed predicate devices.
• Established regulatory classifications and performance of predicate devices: The FDA's determination of substantial equivalence relies on the known safety and effectiveness of the products it is compared against.

8. Sample Size for the Training Set

This information is not applicable. The submission does not describe a "training set" in the context of machine learning or AI.

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

This information is not applicable as there was no training set for an AI/ML algorithm.

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The Tip Deflecting Endobronchial Blocker is intended for use to differentially intubate a single lumen tube to isolate the left or right lung for procedures which require one-lung ventilation.

The Tip-Deflecting Endobronchial Blocker is designed for use with a standard endotracheal tube and a small diameter fiberoptic bronchoscope to be placed inside a single lumen tube to provide one lung ventilation. It uses a flexible soft tip that can be deflected to more than 90 degrees and easily placed into the desired bronchus to be blocked. The device measures 9.0 French in outside diameter and fits coaxially with a 7.0 mm or larger endotracheal tube. The proximal end of the catheter is made up of a pilot balloon assembly. This balloon assembly has one litting to inflate the distal balloon and maintains inflation until it is deflated. Facilitation of this device will include an Arndt Multiport Airway Adapter (Class I, Exempt, §868.5810), a CPAP Adapter (Class I, Exempt, §868.5810), and a syringe (vendor supplied).

The provided text describes a Special 510(k) Premarket Notification for the "Tip Deflecting Endobronchial Blocker" manufactured by Cook Incorporated. This document focuses on demonstrating substantial equivalence to predicate devices through various tests rather than establishing entirely new performance criteria or clinical efficacy studies.

Therefore, the requested information elements related to clinical trials, expert adjudication, MRMC studies, standalone algorithm performance, and sample sizes for training/test sets are not applicable or not explicitly detailed in this submission, as it falls under a 510(k) pathway which primarily relies on comparison to existing legally marketed devices.

Here's a breakdown of the available information based on the request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify formal, quantifiable "acceptance criteria" with numerical thresholds for performance. Instead, it lists the types of tests performed to assure reliable design and performance, and states that the "results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use." This implies that the device met the internal design and performance expectations for each test, thereby demonstrating substantial equivalence.

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

• Sample size: Not specified. The document refers to "the following tests" which are likely bench tests or in vitro evaluations, not human clinical trials.
• Data provenance: Not explicitly stated, but given the nature of a medical device submission, it would be internal testing data from Cook Incorporated. There is no mention of country of origin of data, retrospective or prospective studies.

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

• Not applicable. This submission describes device performance through engineering and biocompatibility tests, not clinical evaluations requiring expert interpretation or ground truth establishment in a diagnostic context.

4. Adjudication method for the test set

• Not applicable. See point 3.

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 medical device for mechanical intervention (lung isolation for ventilation), not an AI-based diagnostic or assistive technology. No MRMC studies were conducted for this device.

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

• Not applicable. This is a hardware medical device, not an algorithm or software-only device.

7. The type of ground truth used

• Not applicable/Implicit in testing methodology. For mechanical performance tests, the "ground truth" would be established by the physical and chemical properties of the materials and the design specifications against which the device is tested (e.g., a balloon bursting at a certain pressure, a bond breaking at a certain force, biocompatibility standards). These are typically defined engineering and regulatory standards rather than clinical ground truth like pathology or outcomes data.

8. 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.

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

• Not applicable. See point 8.

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The P-M O2 Adapter is designed for use with the companion PMV 2000 (clear) and PMV 2001 (purple) Low Profile Tracheostomy and Ventilator Speaking Valves. The P-M O2 Adapter allows for improved mobility of those patients requiring a tracheostomy tube, speaking valve, and low flow supplemental oxygen.

The Passy-Muir O2 Adapter is a one-piece, injection-molded plastic device designed to attach to the outer surface of either one of the Passy-Muir Low-Profile Tracheostomy and Ventilator Speaking Valves (PMV 2000 or PMV 2001) and provide a means for connecting a supplemental oxygen supply tube

This 510(k) summary describes a device that is an accessory to an existing medical device, rather than a standalone diagnostic or therapeutic device. As such, it does not involve the typical clinical study or performance metrics that would require the detailed breakdown of acceptance criteria, sample sizes, and ground truth establishment you've requested.

The submission focuses on demonstrating substantial equivalence to existing devices, primarily by showing that it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.

Here's an analysis based on the provided text, addressing your points where applicable and explaining why others are not present:

Description of the Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria

This submission is for a Class II medical device accessory, the Passy-Muir Oxygen (O2) Adapter. The acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices, focusing on safety and functional characteristics typical for O2 delivery accessories. No specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for device performance are explicitly stated in the document, nor would they be expected for this type of device. The "study" proving the device meets criteria is primarily a comparison to predicate devices and an assessment of its operational principles.

1. Table of Acceptance Criteria and the Reported Device Performance

As mentioned, explicit quantitative acceptance criteria are not provided for this type of accessory. The "reported device performance" is described through its functional design and how it operates similarly to existing devices.

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

• Sample Size for the Test Set: Not applicable. No clinical "test set" of patients or data was used in the assessment of this device, given its nature as an accessory relying on the established safety and effectiveness of its predicate devices and its simple mechanical function.
• Data Provenance: Not applicable. The submission relies on a comparison to existing, legally marketed devices and general knowledge about oxygen delivery systems. No specific patient data or clinical trial data is presented.

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

• Number of Experts & Qualifications: Not applicable. There was no "test set" requiring ground truth establishment by experts in a clinical context. The assessment is based on engineering principles and comparison to predicate devices, evaluated by the FDA's reviewers.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set requiring clinical adjudication was involved.

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

• MRMC Study: No. Such a study is completely irrelevant for an oxygen adapter. This type of study is typically used for diagnostic imaging devices to assess how AI impacts the performance of human interpreters.

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

• Standalone Performance: No. This device is a mechanical accessory, not an algorithm or an AI system.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the clinical sense. The "ground truth" for this submission revolves around the known functional principles of oxygen delivery accessories and the established safety and effectiveness profiles of predicate devices. The truth is established through engineering design, material compatibility, and comparison to existing products.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a mechanical accessory, not an AI or machine learning algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable. As there is no training set for an algorithm, there is no ground truth to establish for it.

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The Rusch Ultra Tracheoflex Tracheostomy Set-Cuffed is a tracheostomy tube with accessories, intended for intubation through a surgical incision into the trachea, for the purpose of providing a patent airway.

The Ultra Tracheoflex Tracheostomy Set-Cuffed is a sterile, disposable, single use cuffed tracheostomy tube with a fixed flange. The set includes a radiopaque tube, a tube obturator, a cough cap, a 15 mm airway connector, exchangeable inner cannulas, and a neck band. The inner cannula will be also available as a separate item.

The provided text describes a medical device submission (510(k) summary) for the Rüsch Ultra Tracheoflex® Tracheostomy Set - Cuffed. It does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of a performance study involving AI or human readers, as implied by the detailed questions.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and adherence to voluntary standards.

Therefore, I cannot provide answers to most of your questions, as the information is not present in the input text.

Here's what I can extract based on the provided document:

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

• The document doesn't provide specific quantitative acceptance criteria or detailed performance results from a study. It states that the device meets "applicable portions of the following voluntary standards." These standards likely contain implicit acceptance criteria, but they are not explicitly presented as such in the context of a performance study within this document.
  • Voluntary Standards Met:
    • ASTM F1242-89, Standard Specification for Cuffed and Uncuffed Tracheal Tubes.
    • ISO 5366-1, Tracheostomy Tubes, Part 1, Connectors for Tubes for Adults
    • ISO 5366.2, Basic requirements for Tracheostomy Tubes for Adults.
    • ISO 5356: Anesthesia and Respiration Equipment, Conical Connectors, Cones and Sockets.
    • ISO 5361, Tracheal Tubes, Part 5: Requirements and Tests for Cuffs and Tubes.

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

• Not applicable. The document explicitly states: "No clinical testing was completed."

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. No clinical testing was performed, so no ground truth establishment by experts is mentioned.

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

• Not applicable. No clinical testing was performed.

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. No clinical testing was performed, and this device is not an AI-assisted diagnostic tool.

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.

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

• Not applicable. No clinical testing was performed.

8. The sample size for the training set

• Not applicable. This document is not describing an AI/machine learning model, so there is no training set mentioned.

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

• Not applicable. This document is not describing an AI/machine learning model.

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