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The Maxtec MaxBlend 2+p is intended to provide a continuous air/oxygen gas mixture and to continuously monitor the concentration of oxygen and pressure being delivered to infant, pediatric, and adult patients. It is a restricted medical device intended for use by qualified, trained personnel, under the direction of a physician, in professional healthcare settings, i.e., hospital, subacute, and nursing-care facilities where the delivery and monitoring of air/oxygen mixtures is required. This is not intended as a life-supporting device or life sustaining device.

The Maxtec MaxBlend 2+p is an oxygen delivery device which incorporates an air/oxygen blender, battery powered oxygen and pressure monitor, and an adjustable flowmeter, all in a single assembly. The integral air/oxygen blender provides precise mixing of medical grade air and oxygen. The flowmeter provides control of the flow rate delivered. The oxygen monitor measures the oxygen concentration from the blender's gas flow, displays these measured concentrations, and provides user selectable high and low oxygen alarms. It also allows the user to monitor pressure simultaneously using adjustable high and low alarm limits.

The document describes the Maxtec MaxBlend 2+p, a medical device combining an air/oxygen blender, oxygen monitor, pressure monitor, and flowmeter. The 510(k) submission seeks substantial equivalence to existing predicate devices (Maxtec MaxBlend 2 - K161718 and MaxO2ME+p - K221734), particularly highlighting the addition of a pressure monitoring feature.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for several performance aspects are implicitly derived from the comparative tables (Table 1 and 2) where the subject device's specifications are listed and compared to the predicate devices. The "Reported Device Performance" for the subject device is simply its stated characteristics, which are claimed to meet or be identical to the predicate device specifications, thereby meeting the acceptance criteria based on substantial equivalence.

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

The document explicitly states:

• Non-clinical Testing: "We performed a number of tests to demonstrate that the proposed device performed as intended." It then lists several international standards that the device met. It does not specify a sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing appears to be primarily related to engineering and performance validation against standards rather than clinical data.
• Clinical Testing: "No human clinical testing was performed."

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

Since "No human clinical testing was performed," and the primary testing involved adherence to international standards and non-clinical performance, there is no mention of experts establishing ground truth for a clinical test set. The "ground truth" for the non-clinical testing would be the defined requirements and specifications within the cited standards.

4. Adjudication Method for the Test Set

Not applicable, as no human clinical test set is mentioned, and the testing focuses on compliance with technical standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical gas mixer and monitor, not an AI-assisted diagnostic or interpretation tool that would involve human readers or image analysis.

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

The device is a hardware product with integrated monitoring capabilities. Its "standalone" performance is measured through its adherence to the technical specifications and international standards listed under "Non-clinical Testing." The document states: "In all cases the subject device met the standard requirements." This implicitly confirms standalone performance against established benchmarks.

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

For the performance specifications (e.g., oxygen accuracy, pressure accuracy, flow rates), the ground truth is based on metrological standards and calibrated equipment used in accordance with the listed international standards (e.g., ISO 80601-2-55, ISO 11195). For biocompatibility, the ground truth is established by adherence to ISO 10993 and ISO 18562 standards.

8. The Sample Size for the Training Set

Not applicable. This is a hardware medical device with integrated sensors and controls, not a machine learning or AI algorithm 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 an AI algorithm.

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The Puffin Lite Infant Resuscitator is intended to provide the basic equipment required for pulmonary resuscitation of neonatal infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the neonatal infant.

The resuscitation system provides the basic equipment required for pulmonary resuscitation of neonatal infants. The Puffin Lite Infant Resuscitator is a gas powered emergency resuscitation system. It is intended to be used inside the hospital by trained medical professionals to provide precise FIO2 delivery, and manual ventilation as established by resuscitation guidelines to neonatal infants weighing less than 10 kg (22 lb). The resuscitation system includes two medical gas flowmeters, an integrated oxygen blender, airway pressure manometer, peak inspiratory pressure (PIP) control, positive end expiratory pressure (PEEP) control, a gas supply pressure alarm and T-piece resuscitator.

The Puffin Lite Infant Resuscitation System underwent bench testing to demonstrate conformance to performance specifications.

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 explicitly state the specific sample sizes used for each individual bench test. The testing was described as "bench testing," which typically involves laboratory-controlled environments and simulated conditions rather than real patient data. The data provenance is from this bench testing, not from human subjects or real-world clinical data. Therefore, there is no information on country of origin or whether the data was retrospective or 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 applicable. The study involved bench testing of a medical device, where acceptance criteria were based on engineering and performance specifications (e.g., pressure, flow, FIO2 accuracy) rather than expert interpretation of medical images or data. Ground truth was established by measuring the physical performance parameters of the device against predefined technical requirements.

4. Adjudication method for the test set:

Not applicable. As the study was bench testing against predefined technical specifications, there was no need for an adjudication method by human experts for the "ground truth." The "passing" or "failing" of a test was determined by whether the device's measured performance fell within the specified limits.

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 510(k) submission for a physical medical device (infant resuscitator) and not an AI or imaging diagnostic device. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.

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

Not applicable. This device is not an algorithm or an AI system. It is a physical medical device (infant resuscitator) that is intended for use by trained medical professionals.

7. The type of ground truth used:

The ground truth used for this study was the engineering and performance specifications outlined in the acceptance criteria. The device's performance was measured against these objective, predefined technical requirements. There was no reliance on expert consensus, pathology, or outcomes data in the context of this bench testing.

8. The sample size for the training set:

Not applicable. This device is not an AI or machine learning system that requires a "training set" of data.

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

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

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The MaxBlend 2 and MaxBlend Lite are designed to provide a continuous air/oxygen gas mixture and to continuously monitor the concentration of oxygen being delivered to infant, pediatric, and adult patients. It is a restricted medical device intended for use by qualified, trained personnel, under the direction of a physician, in professional healthcare settings, i.e.. hospital, sub-acute, and nursing-care facilities where the delivery and monitoring of air/oxygen mixtures is required. This is not intended as a life supporting device.

The MaxBlend family of blenders, MaxBlend 2 and MaxBlend Lite, are oxygen delivery devices which incorporate an air/oxygen blender, battery powered oxygen monitor, and an adjustable flowmeter, all in a single assembly. The air/oxygen blender provides precise mixing of medical grade air and oxygen. The flowmeter provides control of the flow rate delivered. The oxygen monitor measures the oxygen concentration from the blender's gas flow, displays these measured concentrations, and provides user selectable high and low oxygen alarms.

The MaxBlend 2 incorporates the air/oxygen blender within its enclosure. The MaxBlend Lite may be provided with or without the blender component pre-assembled, allowing the user to install the oxygen monitor/flowmeter module, the MaxBlend Lite component, on an existing compatible blender. The addition of the MaxBlend Lite module is intended to improve the safety of an existing air/oxygen blender that is in the user's possession. Both devices use the exact same oxygen monitor sensor and electronics, MaxO2ME (K153659). Both devices use the exact same components/assemblies in the flowmeter and sensor bleed manifold which form the gas pathway to the patient. The only substantive difference is the form of the enclosure for the monitor electronics.

This document is a 510(k) Premarket Notification from Maxtec, LLC, regarding their MaxBlend 2 and MaxBlend Lite devices. It aims to demonstrate substantial equivalence to a predicate device, the Bird Sentry Blender (K973646), and references other cleared devices (K153659 – Maxtec MaxO2ME, K883038 - CareFusion / Bird - Blender, K925982 - BioMed Devices - Blender).

Here's an analysis based on your request, highlighting that this document outlines non-clinical testing for a medical device that mixes and monitors breathing gases, not a typically AI-powered diagnostic imaging device. Therefore, many of the requested categories (like MRMC studies, roles of experts for ground truth, sample sizes for training/test sets for AI models, etc.) are not applicable or are addressed differently in the context of hardware device performance testing.

Acceptance Criteria and Device Performance (Non-Clinical/Hardware)

The acceptance criteria are primarily based on meeting the performance specifications of the predicate device and established standards for medical devices of this type. The "reported device performance" is generally stated as "passed" or "meets the acceptance criteria" for various tests.

1. Table of Acceptance Criteria and Reported Device Performance

Overall Conclusion found in the document: "In all cases the proposed device passed or meets the acceptance criteria. One can find the proposed device substantially equivalent to the predicate Bird Sentry Blender (K973646)."

Regarding the AI/Diagnostic-Specific Questions (Not Directly Applicable to this Hardware Device but Addressed for Completeness):

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

• Not Applicable in the AI/ML sense. This submission relates to physical device performance and safety testing. The "test set" would refer to devices manufactured and subjected to various non-clinical engineering and performance tests (e.g., electrical safety, EMC, accuracy, durability, environmental conditions, etc.). The sample size for these tests is not explicitly stated in terms of a "data set" but rather implies a sufficient number of representative devices for engineering validation.
• Data Provenance: The testing was conducted by or on behalf of Maxtec, LLC, in the USA (Salt Lake City, Utah). It's "prospective" in the sense that the new devices were built and tested to meet pre-defined criteria, not a retrospective analysis of patient data.

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

• Not Applicable in the AI/ML sense. Ground truth for device performance is established by engineering specifications, international and national standards (e.g., ISO, IEC, ANSI/AAMI), and comparison to a legally marketed predicate device.
• Qualifications of Experts: The experts are likely engineers, quality assurance personnel, and regulatory affairs professionals involved in device design, manufacturing, and testing, potentially with input from clinical users for usability studies. Their qualifications would be in engineering, quality management systems (QMS), and regulatory compliance for medical devices.

4. Adjudication Method for the Test Set:

• Not Applicable in the AI/ML sense. Device performance testing involves objective measurements against a standard or specification. There isn't an "adjudication" process like a clinical expert consensus on an image. Test results either pass or fail the predetermined criteria.

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

• No, not done. This is a hardware device focused on gas mixing and oxygen monitoring, not a diagnostic imaging AI algorithm that assists human readers. Therefore, an MRMC study is not relevant.

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

• Not applicable as an "algorithm only" study. The core components (oxygen monitor and blender) are "standalone" in function (they perform their tasks independently) and their performance was evaluated by integrating them into the MaxBlend family. The document states "The major components... have already been cleared for the identical indications for use, population, and environment of use. Integrating them into a single assembly for user convenience does not alter their performance."

7. The Type of Ground Truth Used:

• The "ground truth" for this device's performance is based on:
  • Engineering specifications and design requirements.
  • Performance characteristics of the legally marketed predicate device (Bird Sentry Blender - K973646).
  • Compliance with recognized industry standards (e.g., ISO, IEC, ANSI/AAMI).
  • Comparison to previously cleared reference devices (K153659 – Maxtec MaxO2ME, K883038 - CareFusion / Bird - Blender, K925982 - BioMed Devices - Blender) which contribute components to the MaxBlend family.
  • Objective physical measurements and test results (e.g., accuracy of oxygen control, response time, flow rates, pressure, etc.).

8. The Sample Size for the Training Set:

• Not Applicable in the AI/ML sense. There is no "training set" for an AI model. This is a hardware device.

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

• Not Applicable in the AI/ML sense. No training set exists.

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The LifeBorne Infant Resuscitator is intended to provide the basic equipment required for pulmonary resuscitation of neonatal infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the neonatal infant.

The resuscitation system provides the basic equipment required for pulmonary resuscitation of neonatal infants. The LifeBorne Infant Resuscitator is a gas powered emergency resuscitation system. It is intended to be used inside the hospital by trained medical professionals to provide precise FIO2 delivery, manual ventilation, and emergency airway clearance as established by resuscitation guidelines to neonates and infants weighing less than 10 kg (22 lb).

Here's a breakdown of the acceptance criteria and study information for the LifeBorne Infant Resuscitator, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

• Sample Size: Not explicitly stated as a separate "test set" sample size. The document refers to "bench testing" as the method for performance evaluation. The tests themselves are functional evaluations of the device's components and overall system.
• Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory or simulated environment. The country of origin of the data is not specified, but the submission is from International Biomedical, located in Austin, TX, U.S.A. It is retrospective in the sense that the testing was completed before the 510(k) submission.

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

• Not applicable. This device's performance was evaluated through bench testing against predefined technical specifications, not by expert interpretation of data. Therefore, no experts were used to establish ground truth in this context.

4. Adjudication method for the test set:

• Not applicable. As described above, the evaluation was based on meeting objective technical requirements through bench testing, not on human interpretation requiring 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 is a medical device (resuscitator) that does not involve "human readers" interpreting medical cases or utilizing AI. Its effectiveness is determined by its mechanical and functional performance.

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

• Yes, in a way. The device itself operates "standalone" in performing its functions (e.g., delivering precise FIO2, controlling PIP/PEEP). The "bench testing" represents the performance of the algorithm/device without human intervention during the test itself (though humans operate the test setup). There is no "algorithm" in the sense of AI or image analysis involved.

7. The type of ground truth used:

• The ground truth for the device's performance was based on predefined technical specifications and engineering standards. Each test had a specific, measurable requirement (e.g., FIO2 within 5%, dead space less than 7 mL) which served as the objective ground truth against which the device's performance was measured.

8. The sample size for the training set:

• Not applicable. This device is a mechanical/electronic system, not one that uses machine learning or AI that would require a "training set" of data.

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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