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Single patient use positive end expiratory pressure (PEEP) valve for use in hospital, transport, emergency, and post hospital care settings to evaluate end lung pressure above atmospheric pressure at the end of exhalation in constant and intermittent gas flow conditions.

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This is a 510(k) clearance letter for the Besmed PEEP Valve, a medical device. These letters indicate that the FDA has found the device to be substantially equivalent to a predicate device already on the market. They typically do not contain detailed information about the acceptance criteria and the comprehensive study results in the way one might expect for a research paper or a PMA application.

However, based on the context of a 510(k) and the information provided, I can infer some aspects and highlight what is not present.

Acceptance Criteria and Device Performance for Besmed PEEP Valve (K160112)

Given that this is a 510(k) premarket notification, the "acceptance criteria" primarily refer to the FDA's determination of substantial equivalence to a predicate device, rather than specific performance metrics against a defined clinical endpoint. The submission would have included performance data to demonstrate this equivalence. The letter itself does not detail the specific acceptance criteria values or the reported device performance values but confirms that the device was found substantially equivalent based on the provided data.

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided document is the FDA's clearance letter. It does not include the detailed performance data or the specific acceptance criteria (e.g., "PEEP variability must be within +/- X cmH2O") that were part of the original 510(k) submission. For that level of detail, one would need to access the full 510(k) summary, if publicly available, or the internal submission documents.

Study Information (Based on general 510(k) requirements and inferences):

For a device like a PEEP valve, the "study" would typically involve non-clinical (bench) testing to demonstrate the valve's ability to maintain specified PEEP levels under various flow conditions and over time, as well as biocompatibility testing. Clinical studies are generally not required for Class II devices seeking 510(k) clearance unless there are new or significantly different indications for use or technology.

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

• Sample Size: Not specified in the clearance letter. For bench testing, this would refer to the number of devices tested. It is often a statistically relevant sample size to ensure reproducibility and reliability of the performance data.
• Data Provenance: Not specified, but likely from the manufacturer's internal testing facilities or a contracted testing lab. Given the manufacturer's location, the testing could be international (e.g., Taiwan, where Besmed is located) or in the US. The letter itself does not mention retrospective or prospective data, but bench testing is generally performed prospectively to gather specific performance characteristics.

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

• This question typically applies to studies involving human interpretation (e.g., imaging studies). For a mechanical device like a PEEP valve, "ground truth" is established by physical measurements and engineering standards, not expert consensus in the same way. The "experts" would be engineers and technicians performing the tests, adhering to established test protocols and using calibrated equipment. Their qualifications would involve expertise in medical device testing, respiratory mechanics, and relevant regulatory standards. The number of such individuals involved in test design, execution, and data analysis would vary but is not individually enumerated.

4. Adjudication method for the test set:

• Again, this generally applies to scenarios with subjective human interpretation. For bench testing of a PEEP valve, objective measurement against predefined specifications is the primary "adjudication." Any discrepancies in measurements (e.g., between multiple test runs or different equipment) would be resolved through review of calibration records, re-testing, or technical investigation, not through a consensus panel in the sense of clinical 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. An MRMC study is completely irrelevant for a PEEP valve. This type of study is specific to diagnostic imaging devices or AI-driven decision support tools where human interpretation of medical images or data is involved. The Besmed PEEP Valve is a mechanical breathing attachment; it does not involve AI or human "readers" in its function or evaluation for substantial equivalence.

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

• No. This is also irrelevant. This question pertains to AI/software as a medical device (SaMD) where algorithms perform tasks without direct human intervention. The Besmed PEEP Valve is a hardware device; it does not contain an algorithm in this context.

7. The type of ground truth used:

• For a PEEP valve, the ground truth is based on objective physical measurements against established engineering specifications and recognized consensus standards (e.g., ISO standards for respiratory equipment). This would include measurements of:
  • Pressure control/accuracy (e.g., maintaining a set PEEP +/- tolerance).
  • Flow resistance.
  • Leakage.
  • Durability.
  • Biocompatibility (through laboratory testing of materials).

8. The sample size for the training set:

• Not applicable. The concept of a "training set" applies to machine learning/AI models. A PEEP valve is a mechanical device, not an AI model, and therefore does not have a training set.

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

• Not applicable. As above, there is no training set for a mechanical PEEP valve.

In summary, the provided FDA clearance letter attests to the Besmed PEEP Valve's substantial equivalence to a predicate device, based on a comprehensive 510(k) submission that would have included detailed bench testing and engineering data. However, the letter itself does not provide these detailed technical specifications or study results, and many of the questions (especially those related to AI, human readers, and clinical studies) are not pertinent to this type of device and regulatory submission.

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Single patient use adjustable positive end expiratory pressure (PEEP) valves for use in hospital, transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions. For use with neonates to adults.

The proposed Galemed Disposable Adjustable PEEP valves are identical to their predicate PEEP Valves, K.082092, except we have replaced some components that were magnetic with nonmagnetic material in order to meet the requirements for MR conditional environments of use. Otherwise the PEEP valves are identical.

Galemed disposable adjustable PEEP valves elevate the pressure in a patient's lungs above atmospheric pressure at the end of exhalation.

The Galemed disposable adjustable PEEP valve for use in MR environments is identical to our predicate, K082092, disposable PEEP valve, except we have replaced the materials in 2 components, a push rod and the springs to materials which are less magnetic. Other than these 2 changes, the device is identical to the predicate. These changes / modifications have been evaluated and demonstrated that they do not alter nor change the performance or safety profile of the new device as compared to the predicates.

This 510(k) summary describes a Disposable Adjustable PEEP Valve for use in MR environments. The submission claims substantial equivalence to two predicate devices: the Galemed PEEP valve (K.082092) and the Mercury Medical PEEP Valve (K081266) for its MR conditional characteristics.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria:

• For Leakage, Pressure/Resistance Accuracy, Drop Test, Environmental Conditions, Transportation, and Age Testing, the document states "met the pass/fail criteria" or "met its performance specifications criteria" without explicitly detailing the numerical boundaries of these criteria in the provided text. The criteria are only fully detailed for the MR Conditional test.
• The MR Conditional acceptance criteria for the proposed device (3.0 Tesla, 720 gauss/cm) represent an improvement in capability over the Mercury Medical predicate (1.5 Tesla, 450 gauss/cm).

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

The document does not explicitly state the numerical sample size for the test sets used in the non-clinical testing (e.g., how many PEEP valves were tested for leakage, MR compatibility, etc.). It refers to "the device" or "the sample," implying at least one, but without specific counts.

• Sample Size: Not explicitly stated (implied to be one or more for each test).
• Data Provenance: The tests were performed by the manufacturer, Galemed Corp., in China, as indicated by the company address. These appear to be prospective tests performed specifically for this 510(k) submission.

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

This device is a medical device, not an AI or diagnostic imaging device. Therefore, the concept of "ground truth established by experts" as typically applied to AI models for classification or detection tasks does not directly apply here. The "ground truth" for this device's performance is objective measurements against engineering specifications and recognized standards (e.g., ASTM F2052-02).

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, this is not a diagnostic device requiring expert adjudication of results. Performance is measured against predefined objective physical and engineering criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

Not applicable. This is a physical medical device (PEEP valve), not an AI or imaging system, so an MRMC study is irrelevant.

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

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is objective engineering measurements against:

• Recognized Standards: Specifically, ASTM F2052-02 for MR conditional properties.
• Performance Specifications: Internal specifications for leakage, pressure/resistance accuracy, and durability (drop test, environmental, transportation, age testing). These specifications are based on the predicate device's performance and industry requirements for PEEP valves.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model requiring a training set. The device itself is manufactured, and its performance is verified through testing, not trained.

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

Not applicable, as there is no training set for a physical medical device.

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The B&B Bubbler is intended to provide CPAP, in a hospital environment, to spontaneously breathing neonates and infants

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I'm sorry, but relevant information is not available in the provided context for the given request.

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The PLAXTRON CPAP System is to provide CPAP to spontaneously breathing adult (>30kg) patients in the hospital and pre-hospital (EMS) environment.

The PLAXTRON CPAP System is a state of the art non-invasive, disposable ventilator support system. It is a venturi type oxygen / air mixture delivery device which provides CPAP pressure with a 50 PSI compressed gas source at a low input flow to a spontaneously breathing patient. The controlled airway pressure provides rapid relief for maximum patient benefit with minimal oxygen consumption. The device is low cost and completely disposable for single patient use and it is highly efficient to run from a low flow source for longer cylinder life. It equips with filters on inhalation and exhalation to provide maximum protection.

The provided text describes the PLAXTRON CPAP System, a non-invasive, disposable ventilator support system. The submission mainly focuses on demonstrating substantial equivalence to predicate devices rather than independent performance testing against explicit acceptance criteria. Therefore, several of the requested sections (sample size, expert qualifications, adjudication, MRMC studies, training set details) are not applicable or not explicitly stated in the document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria in a pass/fail format. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to relevant standards. The "reported device performance" is largely framed as alignment with the predicate devices' capabilities and meeting standard requirements.

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

• Sample Size: Not explicitly stated in terms of the number of devices or clinical subjects. The "test set" refers to engineering and biocompatibility testing, not a clinical trial with patient data.
• Data Provenance: The biocompatibility testing likely involved laboratory samples of the materials. CO2 clearance testing would have been conducted in a lab environment. There is no mention of clinical data or patient outcomes. The country of origin for the data (testing location) is not specified, but the manufacturer is Malaysian.

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

Not applicable. The "ground truth" for the non-clinical performance data (CO2 clearance, biocompatibility, engineering specifications) is established by adherence to recognized technical standards (ISO 5356-1:2004, ISO 10993 series) and engineering validation, rather than an expert consensus on clinical diagnoses or outcomes.

4. Adjudication Method for the Test Set

Not applicable. This concept typically applies to clinical studies where different experts might disagree on a diagnosis or outcome, requiring a method to reach a consensus. For engineering and biocompatibility tests, the results are typically quantitative measurements or observations interpreted against predefined criteria in the standards.

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

No, an MRMC comparative effectiveness study was not done. The submission is for a medical device (CPAP system), not an AI algorithm for diagnostic interpretation. The focus is on the device's physical and functional performance, not its impact on human reader performance.

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 a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance data is based on:

• Engineering Specifications and Bench Testing: For characteristics like pressure range, flow, and the functioning of internal components.
• Adherence to Recognized Standards: Specifically ISO 5356-1:2004 for general performance and ISO 10993 series for biocompatibility.
• CO2 Clearance Testing: Demonstrating the device's ability to prevent CO2 rebreathing under specified flow conditions.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm requiring a training set of data.

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

Not applicable.

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o two CPAP System is intended to provide a constant positive airway pressure to spontaneously breathing patients in the hospital environment and emergency medical service applications to treat patients in respiratory distress.

The o two CPAP device provides a constant positive airway pressure to the lungs of patients in respiratory distress from Pulmonary Emphysema, Congestive Heart Failure and a number of other obstructive airway conditions. This open system has no moving parts and uses a "vectored flow valve" to create a wall of resistance to expiration and an additive flow to inspiration. By varying the oxygen flow through the valve the baseline pressure can be raised or lowered to maintain a positive airway pressure. The rise in baseline pressure keeps alveoli from collapsing, forces fluid in the lungs back intro the interstitium and improves medication delivery.

The provided text describes a 510(k) premarket notification for the "o_two CPAP System". This document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting a standalone study with detailed acceptance criteria and performance metrics in the way one might find for a novel AI/software medical device.

Therefore, the requested information elements related to AI/software performance studies, such as sample size for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, and training set details, are not applicable to this 510(k) submission.

The "study" in this context is the comparison against predicate devices to establish substantial equivalence based on design, materials, indications for use, performance, and function.

Here's the information that can be extracted and a clear indication of what is not present given the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable sense for novel performance. Instead, it demonstrates that the o_two CPAP System is comparable to its predicate devices in various characteristics. The "performance" is implied by its similarity to the predicate devices and its stated functional principles.

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

• Not applicable. This submission is a substantial equivalence claim, not a clinical trial or performance study on a test set in the context of an AI/software device. The comparison is based on the technical specifications and intended use of the device against legally marketed predicates.

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

• Not applicable. See point 2.

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

• Not applicable. See point 2.

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 hardware medical device (CPAP system), not an AI/software device intended to assist human readers.

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.

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

• Not applicable. The "ground truth" in this context is the established safety and effectiveness of the predicate devices as determined by their prior clearance by the FDA. The o_two CPAP System is deemed substantially equivalent based on its design and performance characteristics matching or exceeding those of the predicates.

8. The sample size for the training set:

• Not applicable. This is a hardware medical device, not an AI/software device trained on data.

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

• Not applicable. See point 8.

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The WaterPAP Valve is a single patient use positive end expiratory pressure valve for use with infant patients weighing

The WaterPAP Valve is an infant positive end expiratory pressure device used to increase end lung pressure above atmospheric in constant flow conditions.

Here's an analysis of the provided text regarding the WaterPAP™ Valve, structured to address your specific questions about acceptance criteria and the supporting study:

The provided text does not describe traditional "acceptance criteria" in the sense of predefined thresholds for diagnostic accuracy (e.g., sensitivity, specificity), nor does it conduct a study to prove the device meets such criteria for diagnostic performance. Instead, this submission is for a medical device (a Positive Airway Pressure Valve) where the primary evaluation is for substantial equivalence to a predicate device.

The "acceptance criteria" are implicitly derived from the performance of the predicate device and the requirement that the new device performs "in a similar manner" within established specifications. The study described is a comparative performance test to demonstrate this substantial equivalence.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size: Not applicable in the traditional sense of patient data. The "test set" consists of multiple configurations of flow and pressure combinations (flow rates 4-12 L/min and pressures 1-10 cm H₂O). The exact number of unique combinations tested is not specified but described as "a full range."
   • Data Provenance: The data is from bench testing (simulated use), not clinical or patient data. Therefore, country of origin related to patient data is not relevant. It is a prospective bench study comparing the two devices.

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

   • Not applicable. This study is a bench test evaluating physical performance characteristics (pressure, flow, water level changes, resistance) against predefined engineering specifications and comparison to a predicate device. It does not involve expert interpretation or diagnostic ground truth.

3. Adjudication Method for the Test Set:

   • Not applicable. No human interpretation or adjudication was involved in generating the performance data.

4. 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 is not an AI-assisted diagnostic device, nor is it a multi-reader, multi-case study. It's a bench test of a mechanical device.

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

   • Not applicable. This is a mechanical device, not an algorithm. The "standalone" performance is the bench testing of the device itself.

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

   • The "ground truth" here is the measured physical performance characteristics of the predicate device (Babi*Plus Bubble PAP Valve) and the established engineering specifications for such devices (e.g., ± 1 cm H₂O tolerance). The WaterPAP Valve's performance is compared against these established values.

7. The sample size for the training set:

   • Not applicable. This is a mechanical device, not a machine learning algorithm, so there is no "training set."

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

   • Not applicable. There is no training set for this type of device submission.

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The NeoPIP™ Resuscitation Circuit with PEEP is indicated as an accessory to add positive end expiratory pressure breathing capability to a T-Piece Resuscitator. The PEEP valve is incorporated into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube. The NeoPIP Resuscitation Circuit with PEEP is indicated for use in neonatal patients

The NeoPIP™ Resuscitation Circuit with PEEP control valve is a breathing circuit intended for use with manual resuscitation devices for emergency neonatal resuscitation.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML performance. The document describes a 510(k) summary for a medical device called "NeoPIP™ Resuscitation Circuit with PEEP," which is a physical breathing circuit for neonatal resuscitation.

The submission focuses on establishing substantial equivalence to a predicate device based on design, materials, and operational and technological characteristics, not on the performance of a software algorithm or AI model. Therefore, directly answering the questions related to AI/ML performance metrics, sample sizes for test/training sets, experts, and ground truth as outlined in the prompt is not possible from the provided text.

Here's a breakdown of why each requested point cannot be addressed:

1. Table of acceptance criteria and reported device performance: Not applicable. The document discusses "performance data" in the sense of demonstrating equivalence to a predicate device, not in the context of specific quantitative performance metrics for an AI/ML system.
2. Sample size for test set and data provenance: No test set is mentioned, as this is a hardware device.
3. Number of experts used to establish ground truth and qualifications: Not applicable. Ground truth for AI/ML is not relevant for this device.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as it's not an AI-assisted diagnostic tool.
6. Standalone (algorithm only) performance: Not applicable, as there is no algorithm described.
7. Type of ground truth used: Not applicable.
8. Sample size for training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

Instead, the document focuses on:

• Intended Use: An accessory to add positive end expiratory pressure (PEEP) breathing capability to a T-Piece Resuscitator for neonatal patients

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The VentStar Resuscitaire CEU with PEEP valve is indicated as an accessory to add positive end expiratory pressure breathing capability. The valve is designed into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube.

The VentStar Resuscitaire CEU is a disposable breathing circuit for the transmission of breathing gases from a breathing gas source (Resuscitation Module) to the newborn patient in labor and delivery environments. It is suitable for newborn patients from birth to 1 month of age (maximum body weight of 10 kg (22 lb)). It is intended exclusively for use in combination with the Resuscitaire Radiant Warmer.

The VentStar Resuscitaire CEU is a prescription device.

The VentStar Resuscitaire CEU with PEEP valve is indicated as accessory to add positive end expiratory pressure breathing capability. The valve is designed into the T-Piece of the breathing circuit with a standard fitting for face mask, laryngeal mask or endotracheal tube.

The provided text describes the 510(k) summary for the Dräger VentStar Resuscitaire CEU, a medical device for neonates. It focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study proving the device meets specific acceptance criteria in the way a new, innovative AI/software device would. Therefore, many of the requested elements for an AI study are not applicable or cannot be extracted from this document.

However, I can extract information related to the device itself, the comparison to the predicate, and the type of testing performed.

Summary of Acceptance Criteria and Device Performance (Based on Substantial Equivalence):

The acceptance criteria for the VentStar Resuscitaire CEU are rooted in demonstrating substantial equivalence to a predicate device, the NeoPeep Neonatal Resuscitation Circuit. The "acceptance criteria" here are implicitly that the key performance parameters of the new device match or are functionally equivalent to the predicate.

Study Information (Based on provided document):

1. Sample size used for the test set and the data provenance: Not applicable. This document describes a medical device, not an AI/software device that would have a "test set" in the context of data. The testing was primarily non-clinical bench testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. As this is not an AI/software device, there is no "ground truth" derived from expert consensus on images or data.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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 physical medical device, not an AI or software component requiring MRMC studies.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device; there is no "algorithm only" performance to evaluate.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of a "test set" for an AI device. The "ground truth" for this device's performance would be established by physical measurements and adherence to engineering standards (e.g., ISO, internal specifications) during the bench testing. The regulatory ground truth is its substantial equivalence to the legally marketed predicate.
7. The sample size for the training set: Not applicable. This is a physical medical device; it does not have a "training set" in the AI sense.
8. How the ground truth for the training set was established: Not applicable.

Additional Information from the Document regarding "Study":

• Device Performance Assessment: The assessment of the VentStar Resuscitaire CEU involved non-clinical bench testing.
• Standards Used for Bench Testing:
  • ISO 5356 Anesthetic and Respiratory Equipment - Conical Connectors Part 1
  • ISO 5367 Breathing tubes intended for use with anesthetic apparatus and ventilators
  • System compatibility testing
• Biocompatibility Testing: Performed per ISO 10993 - Biological Evaluation of Medical Devices Parts 1, 5 & 12.
• Conclusion of the Study (Bench Testing): "In summary Dräger Medical AG & Co. KG has demonstrated that the proposed device is safe and effective and is substantially equivalent, based on intended use, design, operational and technological characteristics, and principles of operation, to the NeoPeep Neonatal Resuscitation Circuit."

In essence, the "study" demonstrating the device meets "acceptance criteria" for regulatory clearance (510(k)) was a series of non-clinical bench tests and biocompatibility tests designed to show that the VentStar Resuscitaire CEU performs equivalently to its predicate device and meets relevant safety standards for its classification.

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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 Babi*Plus Bubble PAP Valve is a single patient use positive end expiratory pressure valve for use with infant patients weighing

Single patient use water seal positive end expiratory pressure device.

The provided text describes a 510(k) premarket notification for the Babi*Plus Bubble PAP Valve, and it primarily focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the context of AI/ML performance.

Therefore, many of the requested categories for AI/ML device performance studies are not applicable based on the provided document. The document describes a traditional medical device (a mechanical valve) and its regulatory review, not an AI/ML system.

However, I can extract the information relevant to device performance and substantiation that is present in the text:

Acceptance Criteria and Device Performance (as per the 510(k) submission):

Study Details (based on information available in the text):

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

   • The document mentions "Bench testing" but does not specify a sample size for the tests conducted.
   • Data provenance is implicitly from internal A Plus Medical testing (bench testing). No country of origin for the data is specified beyond the manufacturer's location. The tests are explicitly "bench testing," meaning they were laboratory-based, not clinical data (retrospective or prospective).

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

   • Not applicable. This was a physical device undergoing bench testing against engineering standards and functional parameters, not a diagnostic or prognostic AI/ML system requiring expert-established ground truth from clinical cases.

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

   • Not applicable. This concept is for clinical data adjudication, not bench testing of a mechanical device.

4. 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 not an AI/ML device, and no MRMC study was conducted or is relevant for this device type.

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

   • Not applicable. This is not an AI/ML algorithm. The device performance described is standalone in the sense that it operates mechanically.

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

   • The "ground truth" for this device's performance is based on engineering standards (ISO 5356-1:2004) and functional measurements (accuracy at specified gas flows).

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that uses training data.

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

   • Not applicable. This is not an AI/ML device that uses training data.

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