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The T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with patients weighing greater than 10kg (>22lb).

The Mercury T-Piece Resuscitator is manually operated, gas powered resuscitator for use with patients greater than 10 kg (>22 lb).

It is a simple T-piece, with a manometer and the ability to adjust Peak Inspiratory Pressure (PIP) and Positive End-Expiratory Pressure (PEEP). It incorporates a pressure relief valve for excessive pressure.

The T-Piece Resuscitator can be connected to the patient via a face mask, Supraglottic airway or endotracheal tube.

The provided document describes the Mercury T-Piece Resuscitator and its substantial equivalence to predicate devices, focusing on non-clinical testing for performance. This is a 510(k) premarket notification summary, which means the device is being compared to an already legally marketed device (predicate device) and does not involve AI or complex analytical studies in the way modern AI/ML medical devices would.

Therefore, many of the requested categories in the prompt are not applicable to this document. I will focus on the information that can be extracted directly from the provided text.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria are generally aligned with the performance requirements outlined in ISO 10651-5 - Particular Requirements for Basic Safety and Essential Performance for Gas Powered Resuscitators. The "Reported Device Performance" column reflects the specifications of the proposed Mercury Medical T-Piece Resuscitator as presented in comparison tables with its predicate devices.

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The Neo-Tee™ T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb).

The Mercury Medical T-Piece Resuscitator (Neo-Tee™) is a gas power resuscitator for use with neonates / infants

The Mercury Medical T-Piece Resuscitator (Neo-Tee™) underwent performance testing to demonstrate its substantial equivalence to predicate devices and adherence to industry standards, specifically ISO 10651:2006.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:
The summary does not specify a distinct "test set" in the context of clinical data or patient samples. The performance testing described refers to bench tests performed on the device itself. Therefore, information regarding sample size and data provenance (e.g., country of origin, retrospective/prospective) for a clinical test set is not applicable or provided in this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The ground truth for these performance tests is defined by the technical specifications outlined in the industry standard ISO 10651:2006 and the pre-established performance characteristics of the predicate devices. Expert clinical consensus or data annotation by medical professionals is not part of this type of engineering performance testing.

4. Adjudication method for the test set:
Not applicable, as this was a series of bench tests against defined engineering standards and predicate device performance, not a study requiring adjudication of expert opinions.

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 device performance against engineering standards and comparison to predicate device specifications.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The Mercury Medical T-Piece Resuscitator is a mechanical gas-powered device, not an algorithm or AI system. Its performance evaluation is inherently "standalone" in the sense that it refers to the device's physical and functional capabilities, not an algorithm's output.

7. The type of ground truth used:
The ground truth for this device's performance evaluation is based on:

• Industry Standard: ISO 10651:2006 (for "Manually operated resuscitators").
• Predicate Device Specifications: The performance characteristics of the GE Giraffe and Panda (K070210) and Fisher & Paykel NeoPuff (K892885) devices served as benchmarks for substantial equivalence.

8. The sample size for the training set:
Not applicable. This device is not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.

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The Mercury CPAP is intended to provide CPAP to spontaneously breathing patients in the hospital and pre-hospital environment.

The Mercury CPAP is a respiratory aid device intended for use with a facemask and gas supplying device to elevate pressure in the patient's lungs. Alternatively the device may be used in conjunction with an endotracheal tube to generate and maintain constant positive airway pressure during standard intubation procedures.

The Mercury CPAP device is considered substantially equivalent to its predicate device (Vygon Boussignac CPAP - K013884) based on comparative performance testing. The acceptance criteria are implicit in the comparison to the predicate device's performance characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states "We have performed comparative performance testing, Comparative Flow vs. CPAP Pressure" and "Performance of the pressure relief valve." However, specific sample sizes for these tests are not provided in the summary. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It implies the testing was conducted by or for Mercury Medical, Inc.

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

This information is not applicable or not provided. The study is a comparative performance test of a medical device (CPAP machine) against a predicate device, focusing on physical and performance characteristics like gas flow, pressure, and mechanical features. It does not involve human interpretation or subjective assessment that would require expert ground truth establishment in the typical sense (e.g., image interpretation by radiologists).

4. Adjudication method for the test set

This information is not applicable or not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation where disagreements need to be resolved. This study focuses on device performance metrics.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study concerns the physical and performance characteristics of a CPAP device, not an AI or diagnostic imaging system that would involve human readers.

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

No, this is not an AI-driven device, and therefore the concept of "algorithm only" or "human-in-the-loop" performance is not relevant. The testing performed was on the physical device itself.

7. The type of ground truth used

The "ground truth" for this type of device comparison is the established performance characteristics and specifications of the predicate device (Vygon Boussignac CPAP - K013884), as well as engineering standards for CPAP functionality and safety. The Mercury CPAP's performance was compared against these established benchmarks.

8. The sample size for the training set

This information is not applicable. This is a hardware medical device and does not involve machine learning algorithms that require a "training set."

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

This information is not applicable as there is no training set for this type of device.

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The Mercury Medical PEEP Valve is a single patient use device that is attached to manual resuscitators and portable ventilators and is used to provide positiveend expiratory pressure. The device is adjustable from 0-20 cm H2O pressure.

Not Found

I am sorry, but the provided text does not contain the information requested about acceptance criteria and a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for a PEEP Valve, indicating that the device has been found substantially equivalent to a predicate device. It defines the device's indications for use but does not detail specific acceptance criteria, study methodologies, or performance results.

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The Neo-StatCO2

Mercury Medical, Inc. Neo-StatCO2

This document describes the Neo-StatCO2 device, a colorimetric breath indicator for CO2 that helps verify proper intubation. The submission aims to demonstrate substantial equivalence to predicate devices, particularly the Mercury Medical Mini-StatCO2 (K031411).

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines acceptance criteria by comparing the new device (Neo-StatCO2) to predicate devices in terms of its physical, performance, and operating characteristics. The primary new "performance" aspect is the expanded patient population, which required specific testing.

Study Proving Device Meets Acceptance Criteria:

The document explicitly states: "The only difference between the Mercury Mini-Stat CO2 is the expansion of the patient population to include patients with a body weight of 250 g to 6 Kg which we have demonstrated as being effective via comparative bench testing."

This implies that the "comparative bench testing" was the study conducted to ensure the device's effectiveness for the expanded patient population (neonate and infant - 250g to 6 kg) under the specified tidal volumes and breath rates.

Additional Information (Based on the Provided Text):

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

• Sample size: Not specified. The document mentions "comparative bench testing" but does not give specific numbers for the test set used in this bench testing.
• Data provenance: The testing was described as "bench testing," suggesting a laboratory environment. There is no information about the country of origin or whether it was retrospective or prospective.

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

• Not applicable as the testing was "bench testing." Ground truth would likely be established by objective measurements of CO2, tidal volume, and breath rate, rather than expert interpretation of the device's color change.

4. Adjudication method for the test set:

• Not applicable for bench testing. The evaluation would be based on direct measurement outcomes rather than human 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:

• No. This device is a colorimetric indicator, not an AI-assisted diagnostic tool.

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

• Yes, implicitly. The "comparative bench testing" would be a standalone performance evaluation of the device's ability to change color under specific simulated conditions, independent of human interpretation for the physical manifestation of the color change itself. The human-in-the-loop aspect refers to a clinician interpreting the color output. The bench testing would confirm the device produces the correct color change.

7. The type of ground truth used:

• For the "comparative bench testing," the ground truth would be precise, known values of CO2 concentration, tidal volume, and respiratory rate, simulated in a controlled environment. The device's color change would then be observed and compared against these known conditions to verify its accuracy.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/machine learning algorithm that requires a training set in the conventional sense.

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

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

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The Mercury Medical Negative Inspiratory Force (NIF) Disposable Manometer is used to indicate inspiratory force.

The Mercury Medical® Negative Inspiratory Force (NIF) Disposable Manometer is designed to connect to an endotracheal tube. To record the maximum inspiratory pressure, the occlusion knob is held down during patient inhalation. The knob is released immediately after measurement. A memory pointer identifies and remains at the maximum inspiratory pressure to -60cm H2O. Rotating the memory pointer knob counterclockwise resets the memory pointer.

The provided text describes a Premarket Notification (510(k)) for the Mercury Medical® Negative Inspiratory Force (NIF) Disposable Manometer. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study with specific acceptance criteria and performance metrics of a novel device. As such, the information required to fully answer your request regarding acceptance criteria and a study proving the device meets them is not explicitly present in the provided text.

Specifically, the document states:

• "Non-Clinical Data: Performance and specifications of the device are consistent with all requirements for this device type specified by ISO 5356-1: 1987 - Anesthetic and Respiratory Equipment-Conical connectors-Part 1: Cones and Sockets. ASTM F1054 - Standard Specification for Conical Fittings of 15mm and 22mm sizes."
• "The comparison to the predicate devices demonstrates that the proposed device is safe and effective and is substantially equivalent to the predicate device."

This indicates that the "acceptance criteria" are adherence to established standards (ISO 5356-1 and ASTM F1054) and demonstrating substantial equivalence to the DHD Medical Products Negative Inspiratory Force Monitoring Kit. The "study" proving this seems to be a comparison to the predicate device and adherence to these standards, but the specifics of how this comparison was performed, what data was collected, or what quantitative acceptance thresholds were used (beyond general consistency with the standards) are not detailed.

Therefore, many of the requested points cannot be answered from the provided text.

Here's a breakdown of what can be inferred or explicitly stated, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific quantitative thresholds or detailed performance metrics required by ISO 5356-1 and ASTM F1054 are not elaborated upon in this summary.

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

• Not provided. The text does not detail any specific clinical or non-clinical test set, sample sizes, or data provenance for a study. It refers to adherence to standards and comparison to a predicate 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)

• Not applicable/Not provided. This type of information is typically relevant for studies involving subjective human assessment (e.g., image interpretation). For a manometer, ground truth would likely be established by calibrated instruments, not expert consensus in the human sense. The text does not mention any expert involvement in establishing "ground truth" for performance.

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

• Not applicable/Not provided. Given the nature of the device (a pressure manometer) and the focus on standards and substantial equivalence, an adjudication method for a "test set" in the context of human interpretation is not relevant here and is not mentioned.

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

• No. This device is a simple mechanical manometer, not an AI-powered diagnostic tool. MRMC studies are not applicable.

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

• Not applicable. This device is a physical, disposable manometer, not an algorithm. Its "standalone" performance would be its inherent accuracy and compliance with standards, which is generally what the non-clinical data section alludes to. No specific "standalone study" akin to an algorithm's performance is described.

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

• Inferred: Calibrated measurement devices and established industry standards. For a manometer, the "ground truth" for negative pressure measurements would be provided by highly accurate and calibrated reference instruments. The text mentions consistency with ISO and ASTM standards, which would define the acceptable performance against such a ground truth.

8. The sample size for the training set

• Not applicable/Not provided. This device does not involve machine learning or a "training set."

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

• Not applicable/Not provided. This device does not involve machine learning or a "training set."

In summary, the provided document focuses on demonstrating that the Mercury Medical NIF Disposable Manometer is "substantially equivalent" to an existing legally marketed device (the DHD Medical Products NIF Monitoring Kit) and adheres to relevant international and industry standards. It does not provide details of a quantitative study with specific acceptance criteria and performance metrics in the way one might expect for a novel or more complex device. The "proof" lies in its conformance to these established benchmarks and standards.

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The Mercury Medical StatCO2meter™ End Tidal CO2 Detector with Integrated Airway Pressure Manometer is intended to provide a semi-quantitative visualization of the CO2 in the patient airway while measuring Airway and PEEP pressure. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician.

The Mercury Medical StatCO2meter™ is a fast, durable colorimetric breath indicator for visualization of exhaled CO2 and also measures Airway and PEEP pressure. The StatCO2meter™ is designed to connect between an endotracheal tube and a breathing device to help verify proper intubation. Exhaled gas passes through the indicator to detect approximate ranges of end-tidal CO2 by color comparison. The detector may be used during patient transport or in locations where intubations are performed.

Here's an analysis of the provided text regarding the Mercury Medical StatCO2meter™:

Important Note: The provided text is a summary of safety and effectiveness for a 510(k) premarket notification and the FDA's clearance letter. It focuses on demonstrating substantial equivalence to predicate devices rather than a detailed clinical study demonstrating new performance criteria against defined metrics. As such, information typically found in detailed study reports (like precise sample sizes for test sets, expert qualifications for ground truth, specific statistical methods, standalone performance studies, training set details for AI, etc.) is largely not present in this type of document. The device is a physical, colorimetric and manometer device, not an AI/algorithm-driven device, so many of the requested AI-specific points are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the way an AI algorithm might define sensitivity, specificity, etc. Instead, it refers to consistency with established standards for physical devices and substantial equivalence to predicate devices.

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

• Sample Size: Not specified. This document relies on the technical characteristics and consistency with standards for its validation, not a patient-based test set with a specific sample size.
• Data Provenance: Not applicable in the context of a "test set" for this type of device. The evaluation is against engineering standards and comparison to existing, cleared devices.

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

• Number of Experts: Not applicable. The "ground truth" for this device's performance is adherence to industry standards (ISO, ASTM) for its physical design and functional principles, and a comparison of its technical specifications to those of its predicate devices. It's not an AI system requiring expert-labeled data.
• Qualifications of Experts: Not applicable for establishing ground truth in this context. Regulatory bodies (like the FDA) and standards organizations set the requirements.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This device is a physical medical instrument, not a diagnostic AI algorithm that requires adjudicating expert disagreements on ground truth labels. Its performance is evaluated through engineering testing and comparison of technical specifications.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done, and it's not applicable for this type of device. This isn't an AI-assisted diagnostic tool for human readers; it's a direct-reading physical device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: Not applicable. This device does not contain an AI algorithm. It's a physical detector and manometer. Its "standalone" performance would be its ability to display color changes and pressure readings consistently, which is covered by adherence to the cited ISO and ASTM standards.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" implicitly used for this device is compliance with established engineering and performance standards (ISO 5356-1:1987, ASTM F1054) and the established safety and effectiveness of its predicate devices. For a physical device, this typically involves manufacturing specifications, design verification, and bench testing against known reference values, not expert consensus on clinical cases or pathology.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not utilize an AI algorithm, and therefore does not have 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 AI algorithm.

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The Mercury Medical Mini StatCO2™ End Tidal CO2 Detector is to provide a semi-quantitative visualization of the CO2 in the patient airway. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician.

The Mercury Medical Mini StatCO2™ uses the same technology as the Nellcor Pedi-CAP™ (K944400). The Mini StatCQ2™ End Tidal CO2 Detector is a "Single Patient Use" only device. The device assists in verification of tube placement during endotracheal or nasotracheal intubation. It may be used on intubated patients to detect approximate ranges of end tidal CO2 when clinically significant. The device consists of a housing unit made with material of polycarbonate, filter media consisting of 3M Filtrete GSB30 and Bregas C-it Indicator, 510(k) K000520 mounted to the housing.

The provided document does not contain details about specific acceptance criteria, a study proving the device meets those criteria, or quantitative performance metrics for the Mini StatCO2™ device.

Instead, the document focuses on:

• Substantial Equivalence: The primary assertion is that the Mini StatCO2™ is substantially equivalent to the predicate device, Nellcor Pedi-CAP™ (K944400), and shares the same technology and technical characteristics.
• Non-Clinical Data: The "Non-Clinical Data" section states that "Performance and specifications of the modified device are consistent with all requirements for this device type specified by ISO 5356-1: 1987 -Anesthetic and Respiratory Equipment-Conical connectors-Part 1: Cones and Sockets. ASTM F1054 - Standard Specification for Conical Fittings of 15mm." This indicates the device meets certain industry standards for physical characteristics, but not overall performance metrics like sensitivity or specificity for CO2 detection.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, expert details, or study methodologies as these details are not present in the provided text.

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The Mercury Medical STATCO2TM End Tidal CO2 Detector is to provide a semi-quantitative visualization of the CO2 in the patient airway. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician.

The Mercury Medical STATCO2™ uses the same technology as the Nellcor Easy Cap II, (K894053, FENEM submitter). The STATCO2™ End Tidal CO2 Detector is a "Single Patient Use" only device. The device assists in verification of tube placement during endotracheal or nasotracheal intubation. It may be used on intubated patients to detect approximate ranges of end tidal CO2 when clinically significant. The device consists of a housing unit made with material of polycarbonate, filter media consisting of 3M Filtrete GSB30 and Bregas C-it Indicator, 510(k) K000520 mounted to the housing.

The Mercury Medical STATCO2™ End Tidal CO2 Detector is a device designed to assist in verifying tube placement during endotracheal or nasotracheal intubation and to detect approximate ranges of end-tidal CO2. The device's acceptance criteria and the study proving its performance are primarily based on demonstrating substantial equivalence to a predicate device and adherence to relevant technical standards, rather than a traditional clinical study with detailed performance metrics and expert-established ground truth.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided documentation does not detail a specific "test set" in the context of a clinical performance study with a defined sample size. The device's performance is established through a demonstration of substantial equivalence to an existing predicate device (Nellcor Easy Cap II, K894053) and adherence to international and industry standards (ISO 5356-1:1987 and ASTM F1054). This approach is typical for 510(k) submissions where a new device is shown to be as safe and effective as a legally marketed predicate device.

Therefore, there is no explicit sample size reported for a clinical test set to assess device performance in this submission. The data provenance is based on the technical specifications and performance of the predicate device and the adherence of the new device to established engineering standards. The submission itself is a premarket notification (510(k)) from the United States.

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

No explicit "ground truth" establishment by experts for a specific test set is described in the provided documents. The basis for safety and effectiveness relies on:

• The established performance and safety record of the predicate device.
• Compliance with technical standards.
• The regulatory body (FDA)'s review of the submission, where their experts (e.g., in the Division of Anesthesiology, General Hospital, Infection Control and Dental Devices) assessed the data provided by the manufacturer.

4. Adjudication Method for the Test Set

Not applicable. There was no specific clinical "test set" requiring an adjudication method by external experts in the context of this 510(k) summary. The FDA's review process serves as the primary "adjudication" of the submitted information.

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

No. The provided documentation does not mention an MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is a semi-quantitative detector, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical, semi-quantitative CO2 detector, not an algorithm, and its use inherently involves a human (physician or medical professional) interpreting its visual output.

7. Type of Ground Truth Used

The "ground truth" in this submission is implicitly established by:

• The performance of the predicate device, which was previously cleared by the FDA and serves as the benchmark for substantial equivalence.
• The requirements set forth by international and industry standards (ISO 5356-1:1987 and ASTM F1054) for physical and functional characteristics.

There is no mention of "expert consensus, pathology, or outcomes data" being specifically used to establish ground truth for this device's performance in a de novo study.

8. Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The device's design and manufacturing are based on established engineering principles and the specifications of the predicate device.

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

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

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