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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 Gio Digital Manometer is intended for used on all patient populations to measure airway pressure in respiratory care devices used in the hospital, and post hospital environments. It may be attached by flexible tubing to devices e.g. resuscitation bags; hyperinflation bags, CPAP Masks or Circuits.

The Gio Digital Manometer is light, portable, accurate and can be operate by one hand, monitoring airway pressure during respiratory care. The digital display facilitates easy reading of the pressure value. The manometer displays pressure values on the front panel both digitally and on an analog bar scale. The Gio Digital Manometer also provides a function that display peak pressure when the right button is pressed and the P&H function is activated. The Gio Digital Manometers are available in four different pressure ranges. All four manometers utilize the same mechanism and only differ in their pressure detecting ranges.

Acceptance Criteria and Device Performance for Gio Digital Manometer

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It refers to "Test Report 101004 'Measurement accuracy test'" as evidence of accuracy, but the details of this test, including sample size, are not within this document.

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

This information is not provided in the document. The device is a digital pressure manometer, and its performance is likely assessed against calibrated measurement standards rather than expert-established ground truth in a clinical context.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Performance is likely measured against calibrated standards rather than requiring expert adjudication.

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

No MRMC comparative effectiveness study was mentioned. The device is a measurement tool, not an interpretive diagnostic aid requiring human reader intervention or improvement with AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done to assess the accuracy of the algorithm/device. The document states that the "Accuracy is within ± 0.4 of reading." This performance was evaluated in a "Measurement accuracy test" (Test Report 101004).

7. Type of Ground Truth Used

The ground truth for the "Measurement accuracy test" would have been established using calibrated measurement standards or reference instruments known to be highly accurate in measuring airway pressure.

8. Sample Size for the Training Set

This information is not provided. The device functions based on physical principles (pressure transducer) and likely does not employ machine learning that would require a "training set" in the conventional sense. Its "training" would be in its engineering and calibration.

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

As mentioned above, the concept of a "training set" with established ground truth in this context is not directly applicable. The device's fundamental accuracy is built into its design and calibration process, which would involve comparing its readings against highly accurate, calibrated reference pressure sources.

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Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of:
Infant: 23 Kg

Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of:
Infant: 23 Kg

This manual resuscitator is supplied with a single patient use positive end expiratory pressure (PEEP) valve for use 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.

Single patient use device for use hospital, transport, emergency, and post hospital care for the elevation of lung pressure above atmospheric pressure at the end of exhalation.

GaleMed DISPO-BAG Manual Resuscitation Bags are disposable, medical devices which temporarily augment ventilation in patients during ventilatory insufficiency or ventilatory failure. GaleMed DISPO-BAG Manual Resuscitation Bags use a duck-bill valve in the non-rebreathing valve assembly, attaches the non-rebreathing valve directly onto the ventilation bag and includes an oxygen enrichment (reservoir) system.

GaleMed Disposable PEEP Valves are disposable medical devices which elevate the pressure in a patient's lungs above atmospheric pressure at the end of exhalation. The GaleMed Disposable PEEP Valve is a, spring actuated valve, which when placed into a circuit provides positive end expiratory pressure for the patient. The valve is provided in two pressure ranges (5-20 cmH2O and 2.5 - 10 cm H2O) and several connector sizes which comply to ISO 5356- I "Anesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets". Likewise the GaleMed single patient use fixed value PEEP valve is a, spring actuated valve, which when placed into a circuit provides positive end expiratory pressure for the patient. The valve is provided in two pressure settings of 2.4, 5.0, 7.5 and 10.0 cmHzO) also offered in several connector sizes which comply to ISO 5356- I "Anesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets".

The provided text describes a 510(k) premarket notification for the GaleMed DISPO-BAG Manual Resuscitator, the DISPO-BAG Manual Resuscitator with Disposable PEEP Valve, and the Disposable PEEP Valve. This document primarily focuses on establishing substantial equivalence to predicate devices, rather than detailing a specific study to prove the device meets acceptance criteria in the typical AI/CAD sense.

The "study" referenced here is the bench testing conducted to confirm the accuracy and compliance of the devices with relevant international standards.

Here's an analysis based on the provided text, structured to answer your questions where applicable. However, many of your specific questions related to AI/CAD system studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not relevant or applicable to this type of medical device submission. This submission is for a physical medical device (resuscitator/PEEP valve), not an AI/CAD diagnostic software.

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

The acceptance criteria are primarily defined by compliance with established international standards for resuscitators and connectors. The reported device performance is that the devices meet these requirements.

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

• Sample Size for Test Set: Not specified in the document. This would typically involve testing a statistically representative sample of physical devices according to the test protocols outlined in the relevant ISO standards.
• Data Provenance: The bench testing would have been conducted by the manufacturer, GaleMed Corporation, based in I-Lan, Taiwan. The data is prospective in the sense that the devices were manufactured and then tested to confirm their performance.

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

Not applicable for this type of device. Ground truth for a physical device like a resuscitator or PEEP valve is established by meeting engineering specifications and performance metrics defined by international standards, not by expert interpretation of data or images. The "ground truth" is whether the device physically performs as required by the standards (e.g., delivers the correct pressure, fits correctly, etc.).

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

Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images where expert consensus is needed to establish ground truth for a diagnostic task. This document details bench testing of a physical device.

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 for a physical medical device, not an AI/CAD system. There are no "human readers" or "AI assistance" involved in its primary function.

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

Not applicable. This is not an AI algorithm. The device, when used by a healthcare professional, performs its function directly.

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

The ground truth used for this device is compliance with international performance standards (ISO 10651-4:2002 and ISO 5356-1:2004) and bench testing confirmed accuracy for stated pressure ranges. This is an engineering/performance-based ground truth, not a clinical diagnostic ground truth.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. There is no training set for this device.

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The GaleMed CPAP masks are intended to be used in a home, hospital or institutional environment for patients who have been prescribed CPAP/VPAP therapy. This device is intended to be used under the specific direction of a physician. Disposable and Single patient, multi-use styles.

The proposed CPAP masks incorporate a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use.

• . Full face and Nasal style
• . Integral anti-asphyxia valve
• Headgear for attachment .
• . Single use disposable and Single patient, multi-use

The provided document is a 510(k) premarket notification for a medical device (GaleMed CPAP mask). Such notifications typically aim to demonstrate substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with defined acceptance criteria and performance metrics in the way a clinical trial for a novel drug or a high-risk device would.

Based on the information provided, here's an analysis of the "acceptance criteria" and "study" as they relate to this type of submission:

Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are generally met by demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as the predicate device. In this specific case, the submission asserts that the proposed device is identical to the predicate device (Hsiner K063268) in features, indications for use, environment of use, patient population, contraindications, single patient/multi-use, components, anti-asphyxia valve, and materials.

The "study" that proves this substantial equivalence is described as "Comparative testing for safety and efficacy" including "Flow vs. Leak / Pressure" and "Dead space." The report states these tests are "Identical" to those performed for the predicate. This implies that the GaleMed CPAP mask performed equivalently to the predicate device on these established engineering and performance tests relevant to CPAP masks.

Here's how to frame the information, even though it's not a typical "acceptance criteria" table from a clinical study:

Table: Acceptance Criteria and Reported Device Performance (as demonstrated by Substantial Equivalence)

Additional Information based on the provided document:

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

   • The document mentions "Comparative testing for safety and efficacy" including "Flow vs. Leak / Pressure" and "Dead space." However, it does not specify the sample size for these tests. It simply states that they were "Identical" to the testing for the predicate device.
   • The data provenance is not specified regarding the "Comparative testing." Given that the applicant is from Taiwan (GaleMed, Taiwan), it's plausible the testing was conducted there, but this is not explicitly stated. The nature (retrospective/prospective) of these engineering tests is also not detailed.

2. 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 question is generally not applicable to a 510(k) submission for a device like a CPAP mask, especially when the claim is substantial equivalence based on engineering and material comparisons. "Ground truth" in the clinical sense (e.g., expert consensus on medical images or diagnoses) is not established or discussed here. The "ground truth" for the performance claims rests on the technical specifications and engineering test results being "identical" to a legally marketed device.

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

   • Not applicable. This type of adjudication method is used in clinical studies involving human interpretation (e.g., reading medical images) to resolve discrepancies. The provided document details engineering tests comparing a new device to a predicate, not a clinical study requiring expert adjudication of results.

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 question relevant to AI-powered diagnostic aids, not a CPAP mask. The submission does not involve AI or human "readers" in the context of comparative effectiveness.

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

   • Not applicable. This question relates to AI algorithms operating independently. The GaleMed CPAP mask is a physical medical device, not an algorithm.

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

   • For the performance claims, the "ground truth" is based on engineering performance specifications and measurements (e.g., flow, leak, pressure, dead space) which are asserted to be identical to those of the predicate device. There is no mention of clinical outcomes data, expert consensus on patient outcomes, or pathology results being used as ground truth for this submission.

7. The sample size for the training set:

   • Not applicable. This refers to the training of machine learning models. The submission is for a physical medical device and does not involve a training set for an algorithm.

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

   • Not applicable, as there is no training set for an algorithm in this submission.

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The GaleMed Model 3751 and Model 3752 peak flow meters are intended to measure a patient's peak expiratory flow. The Model 3751 is intended for use by adults, and the Model 3752 is intended for use by children.

Not Found

This FDA 510(k) clearance letter (K022124) for the GaleMed Peak Flow Meter, Models 3751/3752, primarily focuses on establishing substantial equivalence to a predicate device. As such, it does not contain detailed information about a study proving the device meets specific acceptance criteria in the manner of a clinical trial or performance study. The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use, technological characteristics, and safety and effectiveness profiles as a previously cleared device.

Therefore, many of the requested fields cannot be filled directly from the provided text.

Here is an attempt to address the prompt based solely on the provided documents 0, 1, and 2, and highlighting what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. Performance data for a test set is not provided in this 510(k) clearance.
• Data Provenance: Not specified.

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

This information is not applicable and not provided in the context of this 510(k) submission. Establishing ground truth with experts is typically for diagnostic interpretation AI/ML devices, not for
performance of mechanical devices like peak flow meters where ground truth is typically established by instrumental measurement against a reference standard.

4. Adjudication Method for the Test Set

Not applicable and not provided.

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

No. An MRMC study is not relevant for a peak flow meter. This type of study is used for diagnostic systems where human readers interpret medical images or data, and the device assists in that interpretation.

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

This is not an AI/ML device, so "standalone algorithm performance" as typically understood does not apply. The device's performance would be assessed purely on its mechanical and measurement accuracy. Details of such a study are not provided.

7. The Type of Ground Truth Used

• Type of Ground Truth: For a peak flow meter, ground truth would typically be established by a reference spirometer or a calibrated flow generator according to recognized standards (e.g., ISO 23747). The document does not specify the method used to establish ground truth for any potential performance testing.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a "training set."

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

Not applicable. This is not an AI/ML device that requires a "training set" or ground truth for training purposes.

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The GaleMed Neb-Easy Nebulizer is a pneumatic nebulizer which nebulizes specific drugs for inhalation by a patient. It is for adult and pediatric patients.

The nebulizer is a device intended to spray liquids in aerosol form into gasses that are delivered directly to the patient for breathing. It is a Class II device, requlation number: 868.5630.

This device operates on the venturi principle and is refillable. The device is called the GaleMed Neb-Easy Nebulizer. It is made from acrylic and polypropylene plastics, is injection molded and is intended for single patient use for up to 28 days. These material types are used in other predicate devices, such as the Salter Labs and Allegiance Airlife product lines. The specific materials have been tested for biocompatibility to ISO 10993 and results showed them to be non-reactive. All testing requirements contained in the "Reviewer Guidance: Nebulizers, Metered Dose Inhalers, Spacers and Actuators, 10/01/93" have been completed and were submitted by GaleMed for FDA review in their premarket notification submission. Comparative testing data to the predicate device (Allegiance Airlife Misty-Neb, K883964) was also performed at a third party independent test laboratory to the requirements of the "Reviewers Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators, 10/01/93."

The Neb-Easy Nebulizer has several attachments that are used with it during the nebulization process. These include a Tee Connector, which connects to the top of the nebulizer; a mouthpiece and a 6 inch corrugated tube, which connects to the side of the Tee connector opposite the mouthpiece. These are standard accessories to class 1 oxygen masks and breathing circuits as well as being considered standard accessories to a nebulizer devices.

A standard oxygen tube connects to the bottom of the Neb-Easy Nebulizer and serves to connect the nebulizer to a pressurized gas source. This gas source is used to create the venturi and high flow conditions inside of the Neb-Easy that are used to create respirable aerosols. Flow rates are determined by the physician, but are typically between 5 lpm and 9 lpm.

The accessories, attachments, principles of operation and materials are all essentially equivalent to predicate devices already cleared by FDA.

The provided text describes a 510(k) submission for the GaleMed Neb-Easy Nebulizer, focusing on its substantial equivalence to a predicate device. The information primarily covers device description, materials, accessories, and regulatory status, but does not include acceptance criteria for device performance or a study demonstrating those criteria are met.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document mentions "Comparative testing data to the predicate device (Allegiance Airlife Misty-Neb, K883964) was also performed at a third party independent test laboratory to the requirements of the ‘Reviewers Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators, 10/01/93.’" However, it does not provide the results of this testing, specific acceptance criteria, or details about the study design that would allow me to populate the requested table and answer the specific questions about sample size, ground truth, or MRMC studies.

The document is purely a 510(k) summary for regulatory clearance, not a detailed scientific study report.

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