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Intended to add moisture to breathing gases for administration to pediatric through adult patients weighing ≥ 10 kg >1 month in homecare, hospital, extended care and hospice.

There are two models of the Hudson RCI Disposable Humidifier. Both models have identical intended uses and modes of operation. One model has a 4 PSI pressure relief valve (referred to as model 3230) and the other has a 6 PSI pressure relief valve (referred to as model 3260). Regardless of device model, the disposable humidifier delivers humidified gases to the patient. Both models of the non-prefilled disposable humidity in water vapor form to respiratory gases delivered to patients to make the gases more comfortable to breathe. The disposable humidifier incorporates a pressure relief valve with an audible alarm at 4 psi or 6 psi. depending on the model selected.

In both models, air is channeled through the water-containing bottle where it becomes humidified before exiting the device and being administered to the patient.

The patient can influence the use of these devices by occluding or loosening secure connections. In cases where the patient is also the user, over or under filling the device and selection of incorrect oxygen percent concentration and gas input pressures may influence the use of the device.

This is a 510(k) premarket notification for the "Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve" and "Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve". The document asserts substantial equivalence to the predicate device "Salter Labs Bubble Humidifier (K161719)".

However, the provided text does not contain a study that proves the device meets specific acceptance criteria in the format requested. Instead, it summarizes non-clinical testing performed to demonstrate safety based on industry standards and establish substantial equivalence to a predicate device.

The document lists various tests performed and standards utilized, but it does not provide:

• A table of acceptance criteria with reported device performance values against those criteria.
• Sample sizes used for test sets.
• Information about ground truth establishment, experts, or adjudication methods.
• Details about MRMC studies or effect sizes for AI assistance.
• Information on standalone algorithm performance or training set details.

The document provides a "Summary of Non-Clinical Testing" and then lists specific types of tests, such as "Humidification Output," "Flow Rate," "Alarm," and "Pull Test." While it states that the results of these tests indicate substantial equivalence, it does not detail the acceptance criteria for each test or the specific reported performance values that met those criteria.

Therefore, I cannot populate the requested table or provide the detailed information about study design, ground truth, and sample sizes that would typically be found in a study demonstrating device performance against acceptance criteria.

The information that is available regarding acceptance criteria and performance is very high-level and can be inferred from the "Comparison of Technological Characteristics" table and the "SUMMARY OF NON-CLINICAL TESTING" section:

Inferred Information from the Document:

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

The document does not provide information for the following points as they are typically associated with clinical studies or more detailed performance reports, which are not present here:

2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a device performance summary focusing on non-clinical engineering and biocompatibility tests, not diagnostic accuracy requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as this is a device performance summary focusing on non-clinical engineering and biocompatibility tests. For these tests, the "ground truth" would be established by the defined test methods and measurement standards (e.g., a specific method to measure humidification output).
8. The sample size for the training set: Not applicable, as this is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable, as this is not a machine learning device.

Conclusion from the document:
The document concludes that "Based on the testing performed, including humidification output and additional gas pathway biocompatibility testing according to ISO 18562, it can be concluded that the subject devices do not raise new issues of safety or effectiveness compared to the predicate device. The similar indications for use, technological characteristics, and performance characteristics for the proposed Hudson RCI Bubble Humidifiers are assessed to be substantially equivalent to the predicate devices." This statement implies that all the non-clinical tests were successfully completed and the devices met the performance expectations for substantial equivalence.

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The APA Oxy Blade™ is a multi-functional, single-use, disposable larynoscope blade intended to assist in direct and indirect laryngoscopy and to facilitate and aid in tracheal intubation in routine and difficult airways in adult patients. The APA Oxy Blade™ incorporates an oxygen tube adaptor and tubing to provide supplemental oxygen to the patient while undergoing endotracheal intubation.

The APA Oxy Blade is a laryngoscope blade intended to be used with the Venner Medical APA™ Video Laryngoscope. The APA Oxy Blade is a standard MacIntosh laryngoscope blade with the addition of an oxygen tube adaptor/holder and tubing to provide supplemental oxygen to the patient when using the Venner APA Video Laryngoscope. The Venner APA Video Laryngoscope, like other rigid laryngoscopes, provides a clear view of the upper airway (trachea/airway) and aids in the placement of an endotracheal tube for intubation.

The provided text describes the 510(k) premarket notification for the APA Oxy Blade, a rigid laryngoscope. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving the device meets specific acceptance criteria in the manner of a clinical trial or algorithm performance study.

Therefore, many of the requested elements (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, training set details) are not applicable as this submission is for a Class I medical device, which typically relies on comparisons to predicates and engineering/performance verification for regulatory clearance, not extensive clinical performance studies or AI algorithm validation.

Here's a breakdown of the available information:

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

The document outlines performance data categories and successful outcomes, which effectively serve as the acceptance criteria and reported performance.

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

• Sample Size: The document does not explicitly state the numerical sample size for each test (e.g., "n=X blades were tested"). Instead, it uses phrases like "The results from testing were provided," "all devices and pouches passed the tests," "All blades successfully passed," and "All devices successfully met the acceptance criteria." This implies that a sufficient number of samples were tested to demonstrate conformity, as per standard engineering verification practices for medical devices of this class.
• Data Provenance: The tests are described as "Performance testing was performed to characterize the APA Oxy Blade," indicating that these were prospective engineering and bench tests conducted specifically for this submission. The country of origin of the testing data is not specified, but the applicant, Venner Medical (Singapore) Pte Ltd, is based in Singapore.

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

• Not Applicable. This device is a physical medical instrument (laryngoscope blade) and its performance is evaluated through engineering and biocompatibility testing, not through expert-reviewed "ground truth" like in an AI/diagnostic study. The "ground truth" here is objective measurement against engineering specifications and biological safety standards.

4. Adjudication method for the test set:

• Not Applicable. As per point 3, this is not an expert-driven diagnostic study requiring adjudication. The tests involve objective measurements (e.g., dimensions, flow rate, pull strength, visual inspection for fogging/leaks, lab results for biocompatibility).

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

• No. This type of study is typically performed to evaluate the diagnostic performance of software or imaging devices, often involving human readers. The APA Oxy Blade is a physical instrument, and its clearance relies on substantial equivalence and bench testing, not MRMC studies.

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

• No. This device does not involve an algorithm. The "standalone performance" is demonstrated through the various engineering and biocompatibility tests described (e.g., flow rate, anti-fogging, mechanical strength, material safety).

7. The type of ground truth used:

• The "ground truth" for this device's performance is established by engineering specifications, standardized test methods (e.g., ISO standards for biocompatibility), and pre-defined acceptance criteria for physical and functional properties. For example, "acceptance criterion of > 15 L/min" for flow testing.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning or AI device that requires a "training set."

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

• Not Applicable. As per point 8.

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The bubble humidifier is intended to add moisture to breathing gases for administration to patients >1 month in homecare, hospital, extended care and hospice.

The bubble humidifier is a non-sterile device indicated for single-patient usage. The device is indicated for patients who require humidification of high flow supplemental breathing gases.

The Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410 mbars) safety valve is an empty, disposable, non-sterile, not made with natural rubber latex, device intended to humidify breathing gas prior to delivery to a patient. The Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410mbars) safety valve is provided with a 6 pounds per square inch (PSI) safety valve and can operate within flow rates of 6 to 15 liters per minute (LPM). The device is used with various breathing gas sources (i.e., oxygen concentrators, gas cylinders and wall outlets) and provides connection for delivery of humidified breathing gas via face masks or cannulas, and use of optional oxygen tubing and water traps (face masks, 21 CFR 868.5580: nasal cannulas, 21 CFR 868.5340; oxygen tubing, 21 CFR 868.5860 and water traps, 21 CFR 868.5995 are 510(k) exempt).

This device is a passive device and is not a cascade humidifier, is not heated and is not prefilled.

The device is made of a humidifier bottle which is used to hold water during use, a lid which seals the humidifier bottle, an audible pressure relief mechanism to notify the user of a downstream occlusion and a diffuser located at the end of a PVC diffuser tube inside the humidifier bottle. The diffusor is designed to uniformly disperse the gas throughout the water. Both the bottle and lid are constructed to be easy to grip and reduce the chance of cross threading. The bottle is permanently marked with "minimum/maximum" water levels. The lid is marked with minimum source pressure, flow ranges and pressure value of the safety valve.

The provided document describes a 510(k) premarket notification for a medical device, specifically a "Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410mbars) safety valve." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel safety and effectiveness through extensive clinical trials. Therefore, the device acceptance criteria and study information provided are tailored to this regulatory pathway, primarily involving performance testing and biocompatibility assessments related to a material change.

The document does not describe the development or evaluation of an Artificial Intelligence (AI) device. Consequently, several of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, training set size, and ground truth for training set) are not applicable to this submission.

Here's an analysis of the provided information, addressing the relevant points:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the performance specifications of the predicate device and relevant international standards. The "Performance Data" section indicates that the focus was on verifying that the material change did not adversely affect performance.

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

The document does not explicitly state the sample size for the performance tests conducted on the modified device (e.g., bond strength, cleaning, useful life studies). However, such tests would typically involve a statistically relevant number of units.

• Data Provenance: The tests were conducted internally by Salter Labs, the manufacturer. No country of origin for test data is specified beyond the manufacturer's location in Carlsbad, California, USA. The studies are prospective in the sense that they were designed and executed to evaluate the modified device.

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

This question is not applicable. The studies involved physical and chemical testing of the device, not the establishment of ground truth by human experts, as would be the case for diagnostic AI.

4. Adjudication Method for the Test Set

This question is not applicable. The tests involved objective physical and chemical measurements against predetermined specifications, not subjective interpretation requiring adjudication.

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 is not an AI device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

This question is not applicable. This is not an AI device.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on:

• Established Performance Specifications: For parameters like flow rate, pop-off pressure, and mechanical integrity (bond strength), the "ground truth" refers to the pre-defined engineering and performance specifications that the device must meet, often derived from the predicate device's performance or relevant industry standards.
• International Standards (Biocompatibility): For biocompatibility, compliance with ISO 10993 standards (e.g., negative cytotoxicity, no irritation/sensitization) serves as the "ground truth."

8. The Sample Size for the Training Set

This question is not applicable. This is not an AI device; therefore, there is no AI model requiring a training set.

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

This question is not applicable. There is no training set for an AI model.

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The Venner™ Tracheal Seal Monitor (TSM) is indicated for use to monitor, maintain and regulate the pressure within the PneuX P.Y.TM Endotracheal or Tracheostomy Tube Cuff in adult patients who have been confined to hospital ICU units where intubation is expected to be more than 24 hours, but less than or equal to 30 days.

The Venner™ Tracheal Seal Monitor consists of an automatic inflation cuff controller (control unit) that connects to the Venner™ PneuX P.Y.TM Endotracheal or Tracheostomy Tube using a single patient use, sterile extension tube. The Venner™ Tracheal Seal Monitor regulates and maintains cuff pressure in endotracheal and tracheostomy tubes in adult patients in the intensive care unit (ICU) setting. The device is intended to measure, monitor and maintain a stable cuff pressure in endotracheal and tracheostomy tubes. The Venner™ Tracheal Seal Monitor consists of an electronic automatic pressure controller with a pressure sensors and a pump, and provides a user interface with adjustable settings, indicators and alarms.

The Venner™ Tracheal Seal Monitor is indicated for use to monitor, maintain, and regulate the pressure within the PneuX P.Y.™ Endotracheal or Tracheostomy Tube Cuff in adult patients in ICU units where intubation is expected to be more than 24 hours but less than or equal to 30 days.

Acceptance Criteria and Device Performance

Study Details

Sample Size and Data Provenance:
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). While "a variety of settings" and "other devices" are mentioned as comparators, specific details are lacking.

Number of Experts and Qualifications:
Not specified. The document does not indicate the number of experts used to establish ground truth or their qualifications.

Adjudication Method:
Not specified. The document does not describe any adjudication method for establishing ground truth.

Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The performance testing focused on the device's technical specifications and engineering performance rather than its impact on human reader performance.

Standalone Performance (Algorithm Only):
Yes, a standalone performance study was done. The performance testing evaluated the device's ability to maintain and regulate cuff pressure, its reaction time to change pressure, and the performance of its safety over-pressure valve. This involved testing the device against its specifications in various physical settings and environmental stresses. The device also underwent system-level software verification and validation testing to ensure it performed as intended and met its requirements.

Type of Ground Truth:
The ground truth used for performance testing appears to be based on engineering specifications and predefined thresholds. For example, the pressure accuracy was compared against a ± 5% tolerance, and the safety valve operation was evaluated against specific pressure thresholds (57 mmHg for opening, 27 mmHg for closing/resetting).

Sample Size for Training Set:
Not applicable. The described testing is not typical for an AI/ML algorithm that would require a "training set." The device is an electro-mechanical control unit with software, and its validation focused on meeting pre-defined engineering and safety standards.

How Ground Truth for Training Set Was Established:
Not applicable, as there was no explicit "training set" in the context of an AI/ML algorithm. The ground truth for the device's performance was established through its design specifications and industry safety standards to demonstrate functional accuracy and safety.

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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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