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The Giraffe Blue Spot PT Lite phototherapy system provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospital.

The Giraffe Blue Spot PT consists of two main sub-assemblies the same as the predicate devices; a sub-assembly that generates the phototherapy light and a sub-assembly that transfers the light to the patient. For the Giraffe Blue Spot PT Lite the two halves are generically known as the Light Pipe and the Light Box. The Light Pipe is a flexible arm that consists of a single optical fiber passing through a set of springs to a shade assembly that will focus the output light to the desired spot size from a given distance. The spring portion of the assembly provides the ability to quickly position the light pipe without the need for tools, while also providing sufficient rigidity to keep light pipe from drooping or rising out of position. The phototherapy light provided to the patient is controlled by the operator by adjusting the positioning of the output shade above the patient. The therapy delivered to the patient varies directly with the distance of the light shade from the patient being treated. The operator changes the intensity and spot size by manually adjusting this distance. The Light Box contains a single blue light LED providing the phototherapy light source that is then transmitted utilizing the Light Pipe. The Light Pipe is used to position and direct the therapy light onto the patient from above. There is no direct contact with the patient. The light source operates at a single light intensity and is not adjustable by the operator or patient. The phototherapy LED emits light in a narrow bandwidth; 400nm - 500nm with a 450nm -475nm peak. As such, and confirmed by physical testing to IEC60601-2-50, there are very low levels of energy in the ultraviolet (UV) or infrared (IR) regions of the light spectrum. The Light Box also contains an internal cooling fan to cool the internal circuitry and the phototherapy LED in order to extend product lifetime. The device is ready for use once connected to an AC power source. The device is equipped with an internal switching power supply that accepts 100-240VAC 50/60Hz power. Power connection is made through supplied power cord connected to an IEC appliance inlet with built-in fuses protection. The front cover of the unit provides numerous operating features including an ON/OFF pushbutton to turn the phototherapy LED on and off, LED indicators for Standby/Ready, phototherapy ON and over/under temperature; and an hour meter that tracks accumulated phototherapy hours on the device. The over/under temperature indicator provides feedback to the operator that the phototherapy LED is currently too hot, or too cold, to allow it to be turned on and that the fan is actively cooling, or warming, the unit until appropriate temperatures are reached. Once the unit is at the appropriate temperature range, the Standby/Ready indicator illuminates. On the bottom of the unit are the IEC power inlet and associated fuses, a potential equalization ground stud and the air intake filter. A mounting bracket on the back of the unit allows the unit to be positioned and secured in the dovetail slot of an accessory rail. Tightening three socket head mounting screws holds the unit in position.

Here's an analysis of the provided text regarding the Giraffe Blue Spot PT Lite's acceptance criteria and the supporting study, structured according to your request.

Please note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial. As such, some of your requested information (particularly around AI-specific details like MRMC studies, training set ground truth, and expert qualifications for ground truth) is not applicable or explicitly stated for this type of medical device which is a physical phototherapy light, not an AI/algorithm-based diagnostic tool. I will indicate where this is the case.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Giraffe Blue Spot PT Lite are primarily tied to demonstrating equivalent therapeutic performance and safety to its predicate device and meeting relevant international standards for medical electrical equipment.

Bench testing showed that the Giraffe Blue Spot PT Lite provides equivalent therapeutic overhead phototherapy treatment as the predicate Giraffe Spot PT Lite. This equivalence was maintained across minimum and maximum environmental conditions. |
| Safety - Electrical & EMC | Compliance with IEC 60601-1 (General Requirements for Safety) and IEC 60601-1-2 (Electromagnetic Compatibility). | Intertek ETL certified the product to IEC 60601-1 (Ed:2, Amd. 1-1991, Amd. 2-1995) and IEC 60601-1-2 (Ed:3.0). |
| Safety - Phototherapy Specific | Compliance with IEC 60601-2-50 (Particular Requirements for the Safety of Infant Phototherapy Equipment), especially regarding UV/IR emissions and sound levels. | Intertek ETL certified the product to IEC 60601-2-50 (Ed:1, with TRFs for UV/IR Testing and Sound Testing to IEC 60601-2-50 2nd edition issue 3/9/2009). Physical testing confirmed very low levels of energy in the ultraviolet (UV) or infrared (IR) regions of the light spectrum. |
| Substantial Equivalence to Predicate Device | Demonstrated equivalence in light delivery system, adjustability, and overall functionality, despite differences in light source type and wavelength. Performance should be comparable to or better than the predicate for its intended use. | Bench testing included comparative spectral irradiance levels with temperature and humidity levels at max device environmental ratings and nominal room environments. Results showed equivalent therapeutic overhead phototherapy treatment to the predicate Giraffe Spot PT Lite. Major differences (LED vs. Metal Halide, blue vs. broad spectrum) were addressed by arguing that LED sources are found in other FDA-approved devices, and the new design eliminated the need for a quartz rod buffer. The overall conclusion was that it is "safe and effective for the treatment of hyperbilirubinemia" based on this comparison and adherence to standards. |
| Light Source Longevity | 7,000 Hours of operation while providing minimum levels of therapy as defined by the American Academy of Pediatrics guideline. | "During normal operating conditions the device is expected to last for over 7,000 hours and provide the minimum levels of therapy as defined by the 'American Academy of Pediatrics...'" (This is a statement of expectation rather than a direct performance measurement result from a specific test in the provided text, but it’s presented as an outcome of design and testing). |

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

The document describes bench testing and 3rd party agency approvals rather than clinical studies with human subjects.

• Sample Size for Test Set: Not applicable in the context of clinical "test sets" as understood for algorithmic performance. The testing involved samples of the device itself and its predicate, subjected to various physical and environmental conditions. No specific number of devices tested is explicitly stated, but the implication is "the Giraffe Blue Spot PT Lite" and "the predicate Giraffe Spot PT Lite."
• Data Provenance: The data comes from "in-house bench testing" by Lumitex, Inc. and certifications by "Intertek ETL," a 3rd party agency. This is retrospective in the sense that the device was developed and then tested, and the data provenance is primarily from laboratory and compliance testing within the US (given the FDA submission).

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 as the device is a physical medical device (phototherapy unit) for which performance is measured by physical parameters (light intensity, wavelength, safety standards compliance) rather than diagnostic accuracy against a ground truth established by experts. The "ground truth" for therapeutic effectiveness is based on published clinical guidelines (American Academy of Pediatrics recommendations for spectral irradiance).

4. Adjudication method for the test set

This is not applicable. There was no need for adjudication as the testing involved objective physical measurements of the device's output and compliance with engineering and safety standards, rather than subjective interpretations or clinical data.

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

This is not applicable. This device is a phototherapy unit, not an AI-assisted diagnostic or treatment planning tool that involves human readers. Therefore, an MRMC study or AI-related comparative effectiveness is outside the scope of this submission.

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

This is not applicable. The device is not an algorithm; it is a physical device providing light therapy.

7. The type of ground truth used

The "ground truth" for the device's therapeutic effectiveness is based on clinical guidelines and established medical consensus: the "American Academy of Pediatrics, clinical practice guideline, subcommittee on hyperbilirubinemia: Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation, 2004; 297-316," which recommends a spectral irradiance greater than 30.0 µW·cm⁻²·nm⁻¹ for effective therapy.

8. The sample size for the training set

This is not applicable. The device is a physical phototherapy unit; there is no "training set" in the context of machine learning or AI. The design was likely developed through engineering principles, prior knowledge, and iterative design processes.

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

This is not applicable for the reasons stated in point 8.

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