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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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