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The Endoscopy Oxygen Mask is a single patient, disposable device intended for delivering supplemental oxygen and monitoring expired gases from the patient, with ports to allow the clinician to insert scopes, probes, or tubes. It is for non-intubated, spontaneously breathing patients greater than 30 kg.

The Endoscopy Oxygen Mask is a multi-port mask that serves several functions: A standard oxygen mask for when a patient requires supplemental oxygen; Sampling of exhaled gases for monitoring, typically end-tidal CO2; Additional ports (membranes) to allow for most types of scopes, probes, and tubes to be inserted while still delivering supplemental O2 and sampling exhaled gases.

The provided document describes the Endoscopy Oxygen Mask (K220533) and its substantial equivalence to a predicate device, the Panoramic Oxygen Mask (POM) (K172365). The acceptance criteria for the new device are primarily demonstrated through comparative non-clinical testing against the predicate device, showing similar performance in key aspects.

Here's a breakdown of the requested information:

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

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail format for each performance metric. Instead, it relies on demonstrating similarity or equivalence to the legally marketed predicate device (K172365) through non-clinical comparative testing. The performance is reported in terms of this similarity.

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The EMS Talking Trach tracheostomy tube, cuffed, is intended to provide tracheal access for airway management of tracheostomized patient. The device allows tracheostomy patients with a functional larynx and an unobstructed upper airway to vocalize / phonate. The Inner Speech cannula allows vocalization with the tracheostomy tube's cuff to remain inflated for ventilator dependent patients. For adult patients > 30 kg.

The proposed EMS Talking Trach is a tracheostomy tube which allows patients who are ventilator dependent or spontaneously breathing to speak or phonate. It can be used with patients on ventilators while the cuff is "up" or inflated. It is offered in sizes from 4.0 to 10.0 mm with disposable standard and speaking inner cannula.

The provided text describes the EMS Talking Trach, a tracheostomy tube designed to allow patients to speak or phonate, even while on a ventilator with the cuff inflated. The submission focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with detailed acceptance criteria and performance data for a novel device.

Therefore, the requested information about acceptance criteria and a study proving the device meets them cannot be fully extracted in the typical sense for a diagnostic or AI device. However, based on the provided document, here's an interpretation of the performance claims and the study design where applicable:

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

The submission claims "substantial equivalence" as its primary acceptance criterion. The performance attributes mentioned are expected to be "substantially equivalent to predicate" for the EMS Talking Trach.

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

The document does not describe a clinical study with a "test set" in the context of device performance evaluation based on patient data for diagnostic accuracy. The performance claims are based on engineering tests for ventilator compatibility rather than human subject data. Therefore, details like data provenance or test set sample sizes for human subjects are not provided. The testing appears to be primarily bench testing (in vitro simulation) to assess ventilator performance.

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

Not applicable. The submission focuses on physical and functional equivalence to predicate devices, not on a diagnostic task requiring expert-established ground truth. The "ground truth" for ventilator performance would be established by the physical measurements from testing equipment.

4. Adjudication method for the test set

Not applicable, as no human-reviewed test set data for diagnostic performance is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical instrument (tracheostomy tube), not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For the ventilator performance testing, the "ground truth" would be the objectively measured values of peak pressure and expiratory flow from the testing equipment, compared against the values obtained from the predicate devices under similar conditions. This is a form of engineering/bench test data ground truth.

8. The sample size for the training set

Not applicable. There is no training set in the context of machine learning or AI algorithms for this device submission.

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

Not applicable, as there is no training set.

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A patient interface accessory for use with CPAP and bi-level systems used in the treatment of adult OSA and / or ventilatory support. A minimum pressure of > 3.0 cm H₂O at the mask is required. Single patient, multi-use

The EMS Multi-strap Full Face mask covers both the nose and mouth and includes a nonrebreathing / anti-asphyxia valve, which is activated under flow / pressure from a CPAP or bilevel ventilator. It is open to ambient air when the ventilator is not ON allowing the patient to breath ambient air. It has a quick release mask harness system. It is single patient, multi-use.

The information provided describes the Engineered Medical Systems, Inc. Multi-strap Full Face Mask and its 510(k) summary for clearance. However, the document does NOT contain a study that proves the device meets specific acceptance criteria with reported device performance metrics in the way a clinical or performance study for an AI/ML medical device would.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to predicate devices for a physical medical device (a CPAP mask). The "acceptance criteria" here are characteristics and design features that are compared to legally marketed predicate devices, rather than performance metrics from a formal study with a test set, ground truth, or expert review as typically seen in AI/ML device submissions.

Therefore, many of the requested fields cannot be directly answered from the provided text, as they pertain to performance studies not conducted or reported in this type of submission.

Here's the breakdown based on the provided text, addressing the points where information is available or inferable within the context of a substantial equivalence claim for a physical device:

1. Table of Acceptance Criteria and the Reported Device Performance

For this type of device, "acceptance criteria" are typically defined by functional specifications and comparison to predicate devices, demonstrating that the new device performs as intended and is as safe and effective. The "reported device performance" is a demonstration that these specifications are met and that the device is substantially equivalent to predicates.

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

This information is not provided in the document. The submission focuses on substantial equivalence based on design, materials, and intended use comparison to predicate devices, not on a formal clinical or performance test study with a "test set" in the context of an AI/ML device.

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)

This information is not applicable/provided. There was no "test set" requiring expert ground truth in the context of this 510(k) for a physical medical device.

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

This information is not applicable/provided. No "test set" requiring adjudication was reported.

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 information is not applicable/provided. This is a submission for a physical medical device (CPAP mask), not an AI/ML diagnostic tool, and therefore no MRMC study would be relevant or expected.

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

This information is not applicable/provided. This is a physical medical device; there is no "algorithm" or "standalone performance" in the context described.

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

This information is not applicable/provided. For this physical medical device, the "ground truth" for demonstrating equivalence largely relies on engineering specifications, material properties, and comparison of functional design features to existing legally marketed devices.

8. The sample size for the training set

This information is not applicable/provided. This document does not describe a training set as would be relevant for an AI/ML device.

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

This information is not applicable/provided. This document does not describe a training set or its ground truth establishment.

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For patients breathing spontaneously via a tracheostomy tube, the TrachVox provides heat and humidity for entrained air and incorporates a cough relief and suction port valve. The unit may be closed by the patient's finger, which directs the air through the vocal cords to facilitate speech.

For patients breathing spontaneously via an endotracheal tube (ET tube) the TrachVox provides heat and moisture for the inhaled air.

The TrachVox connects to a 15 mm tracheostomy or endotracheal tube connector of a spontaneously breathing patient. It incorporates four (4) key features:

• HME media for humidifying inhaled air
• Suction port
• Method for closing off exhalation to outside and divert the exhaled breathe around the tracheostomy tube and through the vocal cords for speech
• Connector for delivery of supplemental oxygen

The provided text describes a medical device called TrachVox, a Tracheal HME with speech valve and suction port. The submission is a 510(k) premarket notification and focuses on establishing substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study.

Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types for test/training sets, and training set details) are not directly applicable or available in this type of submission.

However, I can extract information related to the device's technical specifications and how its performance is compared to predicate devices, which implicitly serves as the "study" for establishing substantial equivalence.

Here's a breakdown of the available information structured to answer your request where possible, and indicating when information is not present:

Acceptance Criteria and Study Details for TrachVox

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission establishes substantial equivalence by comparing the TrachVox device's attributes and performance characteristics to those of legally marketed predicate devices. The "acceptance criteria" here are implicitly defined by the attributes and performance ranges of these predicate devices, which the TrachVox aims to match or perform comparably to.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (defined by substantial equivalence to predicate devices) is primarily a comparative analysis of specifications and functional features. For quantitative metrics like Dead Space, Resistance to Flow, Weight, and Moisture Output, it is implied that bench testing was conducted on the TrachVox device to obtain these performance values, and these values were deemed acceptable when compared to relevant predicate devices or industry standards (like ISO 9360).

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

• Sample Size for Test Set: Not applicable. This submission relies on engineering specifications and bench testing of the single device model, not a patient-based "test set" in the context of clinical trials or AI/diagnostic studies.
• Data Provenance: The data primarily comes from engineering design specifications and bench testing of the TrachVox device itself, and comparison to publicly available specifications/regulatory submissions of predicate devices. The country of origin for the data generation would be the manufacturer, Engineered Medical Systems, in Indianapolis, IN, USA. The data is prospective in the sense that the new device's performance was measured.

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

• Not applicable. This is not a study involving human interpretation of data where "ground truth" is established by experts.

4. Adjudication method for the test set:

• Not applicable. No expert adjudication was done for this type of submission.

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

• No, an MRMC comparative effectiveness study was not done.

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

• Not applicable. This device is a mechanical medical device, not an AI algorithm.

7. The type of ground truth used:

• The "ground truth" for the TrachVox's performance metrics (dead space, resistance, moisture output) would be derived from direct physical measurements and laboratory bench testing according to established engineering and ISO standards (e.g., ISO 9360 for HME moisture output, ISO 5356-1 for connectors). For functional features, the "ground truth" is its design and operational mechanism. For the comparison to predicate devices, the "ground truth" is the regulatory and published specifications of those predicate devices.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning study.

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

• Not applicable. This is not an AI/machine learning study.

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For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired and / or expired gases is desired and to add maintain and retain moisture for the exhaled breathe of the patient. Model with tidal volumes ranging from 20-70 cc for neonate, 70-250 cc for pediatric and >150 cc for adults. Use up to 24 hours.

The EMS Filter and combined Filter / HME are available in multiple sizes and shapes, rectangular and round, and incorporate standard 15 / 22 mm connectors with a gas sampling luer port. The depth filter uses electrostatic media for filtration and a foam media for the HME media.

Here's an analysis of the provided text regarding the EMS Electra Filter and Filter/HME device, focusing on acceptance criteria and the study proving it meets those criteria:

The provided document is a 510(k) Premarket Notification, which is a submission to the FDA to demonstrate that the device to be marketed is substantially equivalent to a legally marketed predicate device. This type of submission relies on comparing the new device's characteristics and performance to those of existing, legally marketed devices, rather than comprehensive clinical trials for novel devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" as a separate, formal list against which the device was tested as one might see in a clinical trial. Instead, it presents general technical characteristics of the proposed device and demonstrates their equivalence to predicate devices. The "acceptance criteria" are implicitly defined by the performance of the predicate devices and existing standards for such devices.

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

The document details performance data derived from laboratory testing, specifically mentioning "Nelson Lab." for Bacterial and Viral filtration efficiency. This indicates the data is likely from professional testing laboratories rather than human clinical trials.

• Sample Size: Not explicitly stated for each test. For filtration efficiency, usually multiple samples of the filter media are tested. For resistance and humidification, often a set number of devices are tested according to a standard protocol.
• Data Provenance: The document states "Nelson Lab." for BFE and VFE, implying a specialized testing facility. The country of origin is not specified, but Nelson Labs is a well-known US-based testing laboratory. The data is prospective in the sense that the new device was fabricated and then tested to determine its performance characteristics. It is not retrospective in the sense of analyzing past patient data.

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

This information is not applicable as the evaluations are based on objective physical and biological performance tests, not subjective expert assessment of images or patient outcomes. The "ground truth" for these tests are the established scientific methodologies and standards by which filter performance, resistance, and humidification are measured.

4. Adjudication Method for the Test Set:

This is not applicable as the evaluation relies on direct measurement of physical properties and performance characteristics, not on subjective assessments that would require adjudication (e.g., medical image interpretation).

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

This is not applicable. The device is a filter/heat and moisture exchanger (HME), not an imaging or diagnostic AI system. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant to this device.

6. Standalone (Algorithm Only) Performance:

This is not applicable. The device is a physical medical device (a filter), not an algorithm or AI system.

7. Type of Ground Truth Used:

The ground truth used is objective laboratory measurement data and established performance standards. For example:

• For resistance, the ground truth is the measured pressure drop across the filter at specified flow rates.
• For filtration efficiency, the ground truth is the measured percentage of bacteria/viruses removed according to standardized laboratory testing protocols (e.g., using bacterial aerosols like Staphylococcus aureus).
• For humidification output, the ground truth is the gravimetric measurement of water vapor produced by the HME under specific temperature, humidity, and tidal volume conditions as per ISO 9360.

8. Sample Size for the Training Set:

This is not applicable. Since this device is a physical product and not an AI/machine learning model, there is no "training set." Its design and performance capabilities would be based on engineering principles, materials science, and testing iterations, not data training.

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

This is not applicable for the same reason as point 8. The "ground truth" for the device's design would stem from engineering specifications, industry standards (like ISO for connectors and HME moisture output), and the performance characteristics observed in predicate devices.

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For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is desired and to add maintain and retain moisture for the exhaled breathe of the patient

The EMS HEPA Filter and combined HEPA filter / HME are available in multiple sizes and shapes, recogular and round, and incorporate standard 15 / 22 mm connectors with a gas sampling luer port. recoalignar and round, and morporativer for filtration and a foam media for the HME media. Each filter is individually tested for rating performance according to BS 3928 Sodium Flame for Air filters. The "HEPA" performance was in accordance to DOE 3202-97 and ASTM D2986 – DOP.

The provided text describes a 510(k) premarket notification for the EMS HEPA Filter and HEPA Filter / HME, which are bacterial/viral filters and heat and moisture exchangers. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a full study report with detailed performance metrics against those criteria.

However, the "General Technical Characteristics" table [1] lists several performance attributes of the proposed devices, which can be interpreted as acceptance criteria based on established standards and the characteristics of predicate devices. The "Reported Device Performance" column reflects the device's measured or designed specifications.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" and "reported device performance" in separate columns, nor does it present a formal study showing the device meets these criteria with numerical results from a specific test. Instead, it lists technical characteristics, which by their nature in a 510(k) summary, imply that the device performance meets or is equivalent to these values for substantial equivalence.

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For use with pulmonary function testing. To filter air between the patient's exhaled air and the testing equipment. Single patient use.

The EMS PFT Filter is acompact, electrostatic filter with various end-fitting adaptable to various pulmonary function testing circuits. It has 75 ml deadspace and resistance of 07. cm H2O at 720 Ipm per ATS spirometry or 0.5 cm I-120 @ 60 lpm. There are various connectors to allow connection to various PFT equipment. Single patient use.

The provided text describes a Premarket Notification 510(k) for the EMS PFT Filter. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on a study that establishes performance against predefined acceptance criteria for a novel device.

However, the document does list performance attributes for the EMS PFT Filter and compares them to those of a predicate device (PDS KoKo K934475), which can be interpreted as demonstrating that the EMS device meets performance levels comparable to a legally marketed device.

Here's an attempt to structure the information according to your request, with the understanding that this is a 510(k) submission, and the "study" is more of a comparison against a predicate, rather than a de novo clinical trial with specific acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a 510(k) for substantial equivalence, the "acceptance criteria" are derived from the performance of the predicate device. The EMS PFT Filter is considered acceptable if its performance is comparable to or better than the predicate's.

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