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The mOm Essential Incubator, ME1, is a neonatal incubator used for thermoregulation for both premature and full-term infants up to a maximum of 6 kg (13 lbs). Power is sourced either from an external AC supply or an internal rechargeable battery.

The mOm Essential Incubator (ME1) is intended to provide a heated environment with a stable temperature for infants who require assistance with thermoregulation but do not require a humidity-controlled environment. The ME1 should only be used within healthcare settings providing neonatal and infant care, by properly trained personnel, as directed by an appropriately qualified attending physician familiar with current known risks and benefits of infant incubator use.

The mOm Essential Incubator provides a filtered air system creating a thermally controlled environment based on air temperature control. It provides incubation as well as a degree of isolation for infants who may be near others or being cared for in clinical areas. The incubator is designed to allow adequate visibility and access to the infant to deliver care.

The Infant Compartment is designed to be disassembled and packed into a compact unit for storage and transportation and must be assembled before use. It has been designed as a cost-effective alternative to traditional incubators.

The mOm Essential Incubator is made up of several key components and sub-assemblies, which are assembled by the user prior to use:

The incubator base unit, which includes the device's electronics, fan, heating system, display and controls.
A rigid front panel which contains a door and two portholes.
A flexible panel that makes up the top and rear of the infant compartment – this includes an inflatable section and is supplied with a manual inflation bulb.
A rigid top and back U-shaped panel which provide the structure for the top and rear of the infant compartment.
Two side panels which form the ends of the infant compartment.

An infant mattress is supplied, which is inserted into the infant compartment. A skin temperature probe is also supplied. An optional cart (trolley) is available.

AI/ML Overview

The provided 510(k) clearance letter pertains to the mOm Essential Incubator (ME1), a Class II medical device. It focuses on the device's technical specifications and comparison to a predicate device (Isolette® 8000 plus), as well as a range of non-clinical bench testing to demonstrate safety and effectiveness.

*Crucially, this document does not describe a study involving a test set, expert ground truth establishment, a multi-reader multi-case (MRMC) study, or a standalone algorithm performance study.

The "study" referenced in the provided text is a collection of non-clinical performance data and bench testing to demonstrate the device meets various safety and performance standards for neonatal incubators. It explicitly states: "Bench testing of the mOm Essential Incubator met all relevant requirements for neonatal incubators. Testing was performed in accordance with applicable standards, to characterize and evaluate the device, including performance testing, functional/operational testing, verification and validation, biocompatibility, human factors, risk analysis and verification of risk control measures. Testing included accessories and optional components."

Therefore, I cannot populate the requested sections related to traditional "studies" with human readers, expert ground truth, or AI performance metrics, as this device is a physical medical device (an incubator) not a software-driven diagnostic or AI-powered system that would require such studies.

However, I can extract the acceptance criteria and the results of the non-clinical testing for critical device features based on the provided document.

Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Bench Testing)

The acceptance criteria for the mOm Essential Incubator (ME1) are largely aligned with international standards for medical electrical equipment and infant incubators (e.g., IEC 60601 series) and are demonstrated through direct comparison to the predicate device and specific non-clinical tests.

Feature / Acceptance Criteria Category	Specific Acceptance Criteria (Implied by Standards/Predicate)	Reported Device Performance (from non-clinical testing)
Intended Use	Neonatal incubator for thermoregulation for premature and full-term infants up to 6 kg (13 lbs). Not for home use.	Device functions as intended for thermoregulation for premature and full-term infants up to 6 kg (13 lbs). Not intended for home use. (Identical to predicate's core function, with a defined max weight for ME1)
Safety & Essential Performance	Compliance with IEC 60601-1 (General requirements for basic safety and essential performance).	Complies with IEC 60601-1:2005 + A1:2012 + A2:2020 (Edition 3.2 2020-08 consolidated version).
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2.	Complies with IEC 60601-1-2:2014+A1:2020 (Edition 4.1 2020-09 consolidated version).
Usability (Human Factors)	Compliance with IEC 60601-1-6 and IEC 62366-1/2.	Complies with IEC 60601-1-6:2010 + A1:2013 + A2:2020 and IEC 62366-1:2015/A1:2020. Summative Human Factors testing conducted.
Alarm Systems	Compliance with IEC 60601-1-8.	Complies with IEC 60601-1-8:2006+A1:2012+A2:2020.
Infant Incubator Specific Requirements	Compliance with IEC 60601-2-19 (Particular requirements for basic safety and essential performance of infant incubators).	Complies with IEC 60601-2-19:2020 (Edition 3.0 2020-09).
Software Level of Concern	Software verified and validated appropriately for its risk level.	Software deemed "major" level of concern. Software verification and validation testing conducted as per FDA guidance (May 2005).
Biocompatibility	Biologically safe for intended use, compliance with ISO 10993 series and ISO 18562 series (especially for breathing gas pathways).	Complies with ISO 10993-1:2018 (corrected 2018-10, Edition 2020-12), ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021, ISO 18562-1:2017, ISO 18562-2:2017, ISO 18562-3:2017. Evaluation of results from material investigations, chemical characterization, and literature shows biological safety.
Cleaning and Disinfection Integrity	Maintain integrity and usability after repeated cleaning/disinfection and assembly/disassembly.	No issues encountered after 3 years of simulated deep cleans and disassembly/re-assembly.
Earth Leakage Current	< 500 µA (Predicate value)	< 350 µA (ME1's reported performance, smaller than predicate).
Parameters Controlled	Temperature control.	Temperature control only. (Predicate offers optional humidity/oxygen). Verified as safe for intended population not requiring these.
Air Temperature Set Point Range	Clinically appropriate range.	28 to 37°C in 0.5°C increments (82.4 – 98.6 in 0.9°F increments).
Air Temperature Deviation Limit (Up/Down)	Within acceptable medical tolerance.	± 1.5°C (±2.7°F).
Warm-up Time	Timely provision of thermal care.	40 minutes (Predicate: < 35 minutes). Deemed clinically acceptable as incubators are typically kept ready.
Variability/Stability	< 0.5°C (<0.9°F)	< 0.5°C (<0.9°F) (Identical to predicate).
Overshoot	Acceptable during warm-up.	2°C (3.6°F) (Predicate: < 0.5°C). Meets IEC 60601-2-19 requirements.
Uniformity (level mattress)	< 0.8°C (<1.4°F)	< 0.8°C (<1.4°F) (Identical to predicate).
Noise Level (inside infant compartment)	Clinically acceptable for infant environment.	≤ 60 dB(A) (Meets IEC 60601-2-19 requirements).
Air Velocity (inside infant compartment)	<0.10 m/sec (Predicate value)	<0.07 m/sec (Maximum measured), 0.054 m/sec average (Meets IEC 60601-2-19 requirements).
Maximum CO2 Level	< 0.8% (Predicate value)	≤ 0.3% (Lower than predicate, deemed safer for infant).
Acoustical Level (all alarms on)	75 dB(A) maximum (Predicate value)	70 dB(A) (Lower than predicate, still acceptable for caregiver notification).
In-Use Battery Life	Maintain set temperature above ambient for a specific duration.	Can maintain set temperature of 11°C (51.8°F) above ambient (20-30°C / 68-86°F) for at least one hour.
Battery Life (Cycles)	Durable battery for repeated use.	1500 charge cycles.

Regarding the Absence of Certain Study Types:

This 510(k) submission is for a physical device (neonatal incubator) whose primary function is thermoregulation, and its safety and effectiveness are established through engineering design, material selection, adherence to electrical and performance standards, and rigorous bench testing. It is not an AI/ML-driven diagnostic or treatment device, nor does it involve image analysis, therefore:

Sample size used for the test set and data provenance: Not applicable in the context of clinical "test sets" as described for AI/diagnostic devices. The "test set" here refers to the actual physical device prototypes subjected to various non-clinical bench tests in a lab environment.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" for an incubator is established by physical measurement against calibrated standards (e.g., temperature probes for thermal regulation, sound meters for noise).
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Performance is measured against engineering specifications and international standards.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, because this device does not involve human "readers" interpreting data or cases. It's an incubator.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, there is no discrete AI algorithm whose performance is being evaluated in isolation. The "algorithm" here refers to the software controlling the physical properties of the incubator, which is verified through functional testing of the device itself.
The type of ground truth used: For performance metrics like temperature, noise, CO2 levels, etc., the "ground truth" is derived from measurements taken with calibrated instruments against established physical and engineering standards (e.g., IEC standards for incubators). For biocompatibility, it's based on laboratory testing of materials as per ISO standards.
The sample size for the training set: Not applicable. This is not an AI/ML model that undergoes "training."
How the ground truth for the training set was established: Not applicable for the same reason.

In summary, the provided document details the regulatory clearance of a physical medical device (an incubator) based on a comprehensive set of non-clinical bench tests and engineering evaluations, rather than clinical efficacy studies involving patient data or AI performance metrics.

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