(157 days)
The neoBLUE blanket LED Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia. It can be used in the clinical setting or in the home.
A neonatal phototherapy system composed of a mobile light box coupled to a fiberoptic blanket. The re-usable fiberoptic blanket is covered with a mattress and a disposable cover.
The provided information describes a medical device, the neoBLUE blanket LED Phototherapy System, and its non-clinical testing for regulatory approval. However, no acceptance criteria or studies proving the device meets those criteria are explicitly stated in a quantifiable manner that fits the table format requested. Clinical trials are noted as "Not Applicable," and the reported device performance is primarily a list of tests passed and measurements taken, rather than a formal set of acceptance criteria with corresponding results demonstrating compliance.
Therefore, the following response will extract the relevant information from the provided text, but it will be largely descriptive for points that cannot be directly populated in the requested format due to the nature of the source document.
Acceptance Criteria and Device Performance
The document describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices, rather than a specific set of numerical acceptance criteria for performance with corresponding study results in the typical sense for AI/medical imaging devices. The "reported device performance" in this context refers to the successful completion and outcomes of specified non-clinical tests.
| Acceptance Criteria Category | Specific Criteria (Implicit from Tests Performed) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993 for patient-contacting materials (mattress, disposable cover) | Mattress and disposable cover passed Cytotoxicity, Sensitization, and Skin Irritation tests. |
| Spectral Output | Measurement of peak wavelength and overall spectrum | Peak wavelength of 460 nm (from device description) |
| Light Irradiance | Sufficient light output for intensive phototherapy | >30 μW/cm²/nm achieved for both large and small blankets. |
| Effective Surface Treatment Area | Measurement of the area of light emission | 504 cm² for the large blanket, 296 cm² for the small blanket. |
| Electrical Safety | Compliance with IEC 60601-1 (2nd edition) and 60601-1-2 (EMI/EMC) | Tested to ensure compliance with all appropriate sections of IEC 60601-1 and IEC 60601-1-2. |
| Phototherapy Safety and Performance | Compliance with IEC 60601-2-50 (1st edition) | Tested to ensure compliance with all appropriate sections of IEC 60601-2-50. |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The document describes non-clinical bench testing and biocompatibility testing of device components, not a test set of patient data.
- Data Provenance: Not applicable, as this refers to physical device characteristics and materials testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a phototherapy system, and its tests relate to physical and electrical performance, and material safety, not diagnostic accuracy based on expert interpretation.
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Adjudication method for the test set:
- Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, which are not described here.
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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. The document explicitly states "Clinical Tests Performed: Not Applicable." Therefore, no MRMC study or AI-related comparative effectiveness study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a treatment system, not an algorithm, and its performance is evaluated through physical and electrical bench tests.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biocompatibility: Standardized laboratory test results (e.g., cytotoxicity, sensitization, skin irritation assays) against established safety limits.
- For performance metrics (irradiance, effective surface area, spectral output): Direct physical measurements using calibrated equipment.
- For electrical safety: Compliance with international standards (IEC 60601 series).
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The sample size for the training set:
- Not applicable. The device is a hardware phototherapy system, not an AI/ML algorithm requiring a training set.
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How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for this device.
§ 880.5700 Neonatal phototherapy unit.
(a)
Identification. A neonatal phototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level). The device consists of one or more lamps that emit a specific spectral band of light, under which an infant is placed for therapy. This generic type of device may include supports for the patient and equipment and component parts.(b)
Classification. Class II (performance standards).