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Single patient use manual resuscitation device to temporary ventilate neonate, newborn or infant with a body mass of less than or equal to 3.3 Kg in hospital, transport, emergency and post hospital care environments.

Single patient use medical device, which temporarily augment ventilation insufficiency or ventilatory failure.

The document provided outlines the A Plus Medical Babi.Plus™ Neonatal Resuscitation Bag and its substantial equivalence to a predicate device. The primary study presented relates to comparative technological characteristics rather than a clinical study involving human patients or complex AI algorithms.

Here's a breakdown of the requested information based on the provided text, noting where information is not applicable or not present:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the ISO 10651-4:2002 standard ("Lung ventilators - Part 4: Particular requirements for opered resuscitators") and the predicate device's performance. The "Babi.Plus™" column shows the reported device performance.

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Single patient use device intended for use with neonates, infants and children under 10 Kg requiring a nasal prong interface during intermittent or continuous gas flow therapy in the hospital critical care unit.

Single patient use nasal cannula offered in 8 different sizes which have been specifically designed for patents ≤ 10 Kg. The device includes a short length of 10 mm corrugated tubing allowing connection to a variety of devices. The device also provides a means to monitor delivered pressure at the nasal prong.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Babi.Plus Infant Nasal Cannula System:

The information provided describes a 510(k) premarket notification for a medical device (Babi.Plus Infant Nasal Cannula System), emphasizing its substantial equivalence to a predicate device. The core of the "study" proving acceptance criteria here is a bench testing and dimensional analysis comparison to a legally marketed predicate device, rather than a clinical trial with human subjects.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by demonstrating "substantially equivalent performance" to the predicate device. The performance characteristics compared are "Resistance to gas flow in the inspiratory circuit" and "Resistance to gas flow in the expiratory circuit."

1. Table of Acceptance Criteria and Reported Device Performance:

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Single patient use device intended for neonate, infant or child with a body mass of less than 10 Kg requiring a pressure limitation system to eliminate excessive pressure should an obstruction occur between gas supply and exhalation port during continuous gas flow therapy up to 12 liters per minute in hospital critical care unit.

The Book Plus" single patient use Pressure Limitation Manifold is an accessory to the Book Plus" Infant Nasal Cannula System cleared for sale in K093716. The device is designed to protect patients up to 10 Kg from excessive pressure should a downstream occlusion occur in a positive pressure breathing system. The device is offered in 10 cm H2O and 15 cm HsO pressure relief valve configurations. The device is supplied with oxygen senor port, fresh gas inlet and a 1 meter length of gas supply tubing. The device connector molded in a rigid plastic to which a pressure relief valve is mounted on the vertical axis, the fresh gas inlet and oxygen senror port are located adgacent to each other on the hporzontial axis. The device relieves pressure cause by an occlusion before the expiratory port and automatically resets upon correction of the occlusion. The outlet port of the device is a 22 mm inside diameter connection in compliance with ISO 5356-1, Version 3.

The provided document is a 510(k) Summary of Safety and Effectiveness Information for the Babi.Plus™ Pressure Limitation Manifold. This document focuses on demonstrating substantial equivalence to predicate devices and does not describe acceptance criteria or a study proving the device meets them in the context of diagnostic performance or clinical efficacy.

Instead, the document details non-clinical bench testing to demonstrate the device's functional performance against its design claims. Therefore, a table of acceptance criteria and reported device performance isn't applicable in the way it would be for a diagnostic or therapeutic device that has a "performance" in terms of accuracy, sensitivity, or specificity.

However, I can extract information related to the device's functional claims and the tests performed.

Here's a breakdown based on the provided text, addressing the points where information is available or noting its absence:

1. Table of Acceptance Criteria and Reported Device Performance

General performance claims for the Babi.Plus™ Pressure Limitation Manifold:

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

• Test Set Sample Size: Not explicitly stated. The described tests are bench tests performed on device units. For "accuracy of pressure relief" and "service life testing," multiple units would typically be tested, but the exact number isn't provided.
• Data Provenance: Not applicable in terms of country of origin of patient data, as these are non-clinical bench tests. The tests were performed by "A Plus Medical." Retrospective or prospective classification is also not applicable for these types of engineering/bench tests.

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

• Not applicable. Ground truth as typically understood for clinical/diagnostic devices (e.g., expert consensus on medical images) is not relevant for these non-clinical functional performance tests. The "ground truth" here would be established by validated test equipment and engineering specifications.

4. Adjudication method for the test set

• Not applicable. This is not a study involving human interpretation or subjective assessment that would require 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, a MRMC comparative effectiveness study was not done. This device is a mechanical pressure limitation manifold, not an AI-assisted diagnostic or therapeutic tool.

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

• Not applicable. This is not an algorithm-based device. The "standalone" performance here refers to the device's inherent mechanical function. The described bench tests assess this standalone performance.

7. The type of ground truth used

• For the functional bench tests (e.g., pressure relief accuracy), the ground truth is established by engineering specifications and measurements from calibrated testing equipment. For example, a calibrated pressure sensor would measure the actual pressure at which the device relieves, and this would be compared against the intended relief pressure.

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or AI models, so there is no "training set."

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

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

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Intended for use where monitoring airway pressure is desired by providing a visual indication of airway pressure and may be used on all patient populations in the hospital, post-hospital and home care environments
Intended for use where monitoring airway pressure is desired. This device provides a visual indication of airway pressure and may be used on all patient populations in the hospital, pre-hospital, post-hospital and home care environments.

Single patient use mechanical pressure manometer indicator compresses a spring to a position where the force exerted by the gas equals the force exerted by the compressed spring combinations and graduated marking on individual housings allow the device to be offered in 0 - 60 cm H2O and 0 - 15 cm H2O pressure ranges.

The A Plus Medical VentiPlus™ Disposable Pressure Manometer is compared against an electronic pressure measurement device to assess its accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size for the test set (number of devices tested or readings taken).

Data provenance: The testing appears to be in-house bench testing conducted by A Plus Medical. No information is provided regarding the country of origin of the data or if 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. The ground truth was established using an "electronic pressure measurement device," which is a piece of equipment, not human experts.

4. Adjudication method for the test set

Not applicable. The ground truth was established by an electronic device, not human experts, so no adjudication method was required.

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 comparative effectiveness study was not done. This device is a mechanical pressure manometer, not an AI-assisted diagnostic tool.

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

Yes, a standalone performance test was done. The device's accuracy was tested against an electronic pressure measurement device without direct human interaction being part of the measurement process itself beyond initiating and observing the test.

7. The type of ground truth used

The ground truth used was measurements from an "electronic pressure measurement device."

8. The sample size for the training set

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

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

Not applicable. As stated above, there is no training set for this type of device.

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Single patient use device intended for use with neonates, infants and children under 10 Kg requiring a nasal prong interface during intermittent or continuous gas flow therapy in the hospital critical care unit.

Single patient use nasal cannula offered in 8 different sizes which have been specifically designed for patents ≤ 10 Kg. The device includes a short length of 10 mm corrugated tubing allowing connection to a variety of devices. Pre-conditioned gas (heat, moisture, flow and oxygen concentration) is provided to the device's inspiratory circuit. The gas is channeled to the nasal cannula for inhalation. Expired gas is channeled away from the nasal cannula and eventually is vented to the surrounding environment. The device also includes a pressure monitor nasal prong (proximal airway) pressure.

The provided text describes the Babi*Plus Nasal Cannula system and its substantial equivalence to a predicate device, focusing on technological characteristics and bench testing. However, it does not include information about acceptance criteria or specific studies detailing device performance in the way typically expected for AI/ML medical devices. The document is a 510(k) summary for a physical medical device (nasal cannula), not a software or AI product.

Therefore, many of the requested details, particularly those related to AI/ML development (e.g., sample size for test/training sets, ground truth methodology, expert adjudication, MRMC studies, standalone performance), are not applicable or present in this document.

Here's a breakdown of the available information in relation to your request:

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

The document does not explicitly state "acceptance criteria" in a quantitative, threshold-based manner as might be seen for an AI diagnostic. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The performance is reported in terms of bench testing for specific characteristics.

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

This information is not applicable as the described tests are bench tests on physical devices (nasal cannulas), not data-driven tests on a "test set" in the context of AI/ML or clinical data. There is no mention of human subjects, data provenance, or retrospective/prospective studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable. Ground truth, expert consensus, and expert qualifications are relevant for studies involving human interpretation or complex diagnostic tasks, typically with AI/ML. The evaluation here is based on physical measurements and engineering principles for a medical device.

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

This information is not applicable as there is no "test set" requiring adjudication by experts.

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

This information is not applicable. This is a physical medical device (nasal cannula), not an AI-assisted diagnostic tool. Therefore, MRMC studies and human reader improvement with AI are irrelevant to this submission.

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

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

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

The "ground truth" for the bench tests would be the accurate physical measurements obtained using standard methods and calibrated equipment (e.g., flow meters, pressure transducers). It's based on scientific principles and engineering measurements rather than clinical expert consensus or pathology.

8. The sample size for the training set:

This information is not applicable as there is no "training set" in the context of an AI/ML device.

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

This information is not applicable as there is no "training set."

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Single patient use non self-inflating manual resuscitator for use in hospital and transport to temporary ventilate neonate, infant and pediatric patients. The pressure manometer in this product provides a visual indication of airway pressure during ventilation.

Single patient use hyperinflation bag with pressure manometer offered in 0.25, 0.50 and 1.0 liter ventilation bag sizes. End user manipulates gas flow and respiratory rate and exhalation port to control amount of gas, inspiratory pressure supplied to the patient. Each device has an integrated 0 - 60 cm H2O pressure manometer.

The provided text describes the Venti.Plus Hyperinflation Bag System with Pressure Manometer. While it mentions performance characteristics and equivalence to a predicate device, it does not detail specific acceptance criteria or a dedicated study in the format requested (i.e., a table of acceptance criteria and reported device performance). It primarily focuses on demonstrating substantial equivalence based on indications for use, environment of use, patient population, materials, and overall function, referencing bench testing and adherence to an ISO standard for connectors.

Here's a breakdown of the information that is available in relation to your questions, and what is missing:

Information Provided in the Document:

1. A table of acceptance criteria and the reported device performance: This is not explicitly provided in a table format. The document states:

   • "Bench testing confirmed that the A Plus Medical Venti.Plus Hyperinflation System with Pressure Manometer and predicate device have similar performance characteristics and the accuracy of the integrated pressure manometer in the Venti.Plus Hyperinflation System with Pressure Manometer is equivalent to the predicate device when used with its associated pressure manometer."
   • It also states that both the device and predicate meet "the requirements set forth ISO 5356- 1:2004 entitled 'Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets'." This ISO standard likely contains specific acceptance criteria for conical connectors, but the document doesn't extract or list them.

2. Sample size used for the test set and the data provenance: This information is not mentioned. The document refers to "bench testing" but provides no details on the sample size of devices tested or the origin of any data (e.g., retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not mentioned. The "bench testing" does not involve human readers or experts establishing ground truth in the context of diagnostic performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This is not applicable as there is no mention of a test set requiring adjudication in this context.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is not applicable. The device is a manual resuscitator with a pressure manometer, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the "accuracy of the integrated pressure manometer," the ground truth would presumably be a calibrated reference pressure measurement device. For the "similar performance characteristics," it would involve comparing the Ventin.Plus to the predicate device under various testing conditions, with the predicate serving as a benchmark. For the ISO standard, the ground truth would be the specifications outlined in the standard. However, the document does not explicitly state the type of ground truth or reference standards used for the performance comparisons.

8. The sample size for the training set: This is not applicable as it's not an AI/machine learning device.

9. How the ground truth for the training set was established: This is not applicable.

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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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