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The Medix Natal Care ST-MX/LX/BX Intensive Care Incubator provides a controlled thermal environment for neonates who are unable to provide their own thermoregulation. The Medix Natal Care ST-MX/LX/BX Intensive Care Incubator can be used in two operating modes: Air Control Mode and Skin Control Mode with two probes that can be used with twins or for a follow up of central/peripheral temperature variations in a patient as a tool for the early detection of thermal stress-effect on the newborn.

The NATAL CARE ST-MX/LX/BX incubator is a new updated line of intensive care incubators with skin and air microprocessor temperature control. incorporating the latest technical and design advances for neonatal care.

The distinctive features of an intensive care incubator are offered: together with large displays showing skin and air temperature, with their respective control temperatures. A graphic display (electroluminescent or LCD) allows the selection of a conflagration options menu, and checks modular accessories that are optionally incorporated (pulse oximetry, humidity servo control, oxygen servo control, weighing scales).

NATAL CARE ST-MX/LX/BX incubator is comprised of three main elements: the clear hood, shell and stand. Together they measure H 53 in X W 41.3 in X D 23.5 in.

Two skin temperature probes are incorporated, allowing its use with twins or for a follow up of central/peripheral temperature variations in a patient as a tool for the early detection of thermal stress- effect on the newborn.

The Medix NATAL CARE ST-MX/LX/BX incubator is a neonatal incubator. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than primary evidence of meeting specific acceptance criteria through a dedicated study.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state a table of quantifiable acceptance criteria with corresponding device performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety/effectiveness.

The document states:

• "Testing of the Medix NATAL CARE ST-MX/LX/BX incubator included functional performance and electrical safety testing as outlined in FDA Guidance Documents and regulations."
• "Based upon the testing and comparison to the predicate devices the Medix NATAL CARE ST-MX/LX/BX incubator has the same intended use, with similar technological characteristics. The system performs as intended and does not raise any new safety or effectiveness issues."

This implies that the device "performed as intended" and met the "functional performance and electrical safety" requirements of relevant FDA guidance and regulations, but no specific numerical criteria or results are provided in this summary.

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

The document does not specify a "test set" in the context of a clinical study or evaluation involving patient data. The testing mentioned appears to be engineering/functional performance and electrical safety testing.

• Sample Size: Not applicable/not specified for a clinical test set. The testing was likely performed on units of the device itself.
• Data Provenance: Not applicable, as there's no clinical data explicitly mentioned. The testing was presumably conducted by Medix i.c.s.a.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This is not applicable as the document describes functional and electrical safety testing, not a study requiring expert-established ground truth on patient data.

4. Adjudication Method

Not applicable, as there's no mention of a human-centric study requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. This type of study is typically used for diagnostic or imaging AI devices, not for
neonatal incubators where the primary assessment is functional and safety performance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a physical medical device (an incubator), not an algorithm or software-only device.

7. Type of Ground Truth Used

The "ground truth" for the functional and electrical safety testing would be the pre-defined engineering specifications, regulatory standards (e.g., electrical safety standards), and performance requirements for neonatal incubators. There's no mention of clinical patient data, pathology, or outcomes data being used as ground truth for this type of device's 510(k) submission.

8. Sample Size for the Training Set

Not applicable. The device is a physical medical device and does not involve AI or machine learning algorithms that require a training set.

9. How Ground Truth for the Training Set Was Established

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

In summary, the provided 510(k) document indicates that the Medix NATAL CARE ST-MX/LX/BX incubator underwent functional performance and electrical safety testing to demonstrate its performance and safety, satisfying regulatory requirements by establishing substantial equivalence to predicate devices. However, it does not contain the details of acceptance criteria or study methodologies typically associated with clinical performance studies or AI/ML device evaluations as requested in your prompt.

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