Search Results

The transport incubator is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring are not standard equipment. The system is to be operated by trained medical technical personnel.

The A750i Transport Incubator with PulseOx (hereafter referred to as the transport incubator) maintains a thermally regulated environment to prevent infant heat loss when transporting neonatal infants to hospitals prepared for neonatal infant care. The transport incubator maintains a thermally regulated environment with either externally supplied power or internal power supplied by a rechargeable battery. The transport incubator is also designed to offer integrated pulse oximetry and oxygen monitoring capability on the display panel. The transport incubator is also designed to carry equipment designed for life support and monitoring of the neonatal infant's status. The equipment includes but is not restricted to: hand and mechanical operated ventilator's; ventilator monitors; infusion pumps; patient monitors indicating blood pressure, respiration, electrocardiogram, oxygen saturation, pulse, etc.; suction pumps; oxygen analyzers; air and oxygen cylinders; air compressors; etc. The integrated pulse oximeter feature is designed to use either Nellcor or Masimo technology. The Nellcor PulseOx model utilizes a daughter board and patient cabling provided by Nellcor. The Masimo PulseOx model utilizes a daughter board and patient cabling provided by Masimo.

The provided text describes a Special 510(k) for a device modification: A750i Transport Incubator with PulseOx. This document focuses on demonstrating substantial equivalence to a predicate device and adherence to recognized consensus standards for safety and performance, rather than presenting a study specifically designed to establish "acceptance criteria" and subsequent "device performance" in the way one might for an AI/CADe device.

Therefore, many of the requested fields related to AI/CADe study design (like sample size for test sets, data provenance, expert ground truthing, MRMC studies, standalone performance, training sets) are not applicable to this type of submission. This document highlights compliance with engineering and safety standards for a modified medical device.

However, I can extract the relevant information from the provided text as best as possible, interpreting "acceptance criteria" as compliance with recognized standards.

Here's the breakdown of the information that is available or can be inferred from the provided text:

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

For a device modification like this, acceptance criteria primarily refer to compliance with established medical device safety and performance standards. The "reported device performance" is the statement that the testing indicates compliance.

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

• Sample Size for Test Set: This information is not provided in the document. The performance testing mentioned is for "functional and design verification and validation," which typically involves engineering tests on the device itself, rather than a clinical "test set" in the context of an AI/CADe device.
• Data Provenance: Not applicable in the sense of clinical data. The testing is likely internal to the manufacturer (International Biomedical, based in Austin, TX, U.S.A.). It's functional testing of a physical device.

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

• Not Applicable. This type of information is relevant for studies involving human interpretation or diagnostic accuracy, which is not the primary focus of this device modification submission. The "ground truth" for this device would be its conformance to engineering specifications and safety standards.

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

• Not Applicable. See point 3.

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 device modification for a transport incubator with integrated pulse oximetry, not an AI/CADe device.
• Effect Size: Not applicable.

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

• No. This is not an algorithm-only device. The pulse oximetry is an integrated feature, and its performance would be assessed against the ISO 9919 standard.

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

• The "ground truth" here is the established specifications and requirements of the recognized consensus standards (IEC and ISO standards listed above). The device's performance is measured against these technical and safety requirements.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device that would require a "training set."

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

• Not Applicable. See point 8.

In summary, this 510(k) submission demonstrates that a modified medical device (an incubator with integrated pulse oximetry) meets its design and safety objectives by complying with relevant international standards. It is not an AI/CADe device submission, and as such, many of the typical questions for such studies do not apply.

Ask a specific question about this device