(6 days)
The Wallaby 3 is intended to treat hyperbilirubinemia through phototherapy in a home or hospital environment. Some conditions which may require treatment include (but not exclusive to) are:
- Prematurity .
- . Liver Dysfunction
- ABO Incompatibility ●
- Diabetes in Mother ●
- Certain drugs .
The Wallaby 3 Phototherapy System is a medical device that provides therapeutic light through a fiberoptic cable bundle and panel for the treatment of neonatal jaundice (hyperbilirubinemia). The Wallaby 3 Phototherapy Illuminator, which is a replacement product for the Wallaby II, will work with existing Wallaby phototherapy panels. The Wallaby 3 illuminator operates on both domestic and international voltages (120VAC/230VAC, 50/60 Hz).
The provided text describes a 510(k) summary for the Wallaby 3 Phototherapy System and focuses on its substantial equivalence to the predicate Wallaby II device. It primarily covers technical specifications and compliance with standards rather than detailed performance studies with acceptance criteria in the context of AI/ML devices.
Therefore, many of the requested categories for AI/ML device studies are not applicable or not available in this document.
Here's an assessment based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly stated) | Reported Device Performance |
|---|---|
| Light Intensity Settings: | |
| Smaller Panel (Model EG2000N): | |
| - Level 1: 25 µW/cm²/nm | Identical to Wallaby II illuminator |
| - Level 2: 35 µW/cm²/nm | Identical to Wallaby II illuminator |
| Larger Panel (Model EG2000): | |
| - Level 1: 10 µW/cm²/nm | Identical to Wallaby II illuminator |
| - Level 2: 15 µW/cm²/nm | Identical to Wallaby II illuminator |
| Optical Filter: Block UV or near-IR radiation outside 400-550 nm range. | Both devices have an optical filter to block any UV or near-IR radiation outside the 400-550 nm range. |
| Redundant Lamp System: Ensure therapy with minimum interruption. | Wallaby 3 has an automatic lamp redundancy system that senses failure and moves new lamp into position immediately. |
| Safety Feature: Prevent user from looking directly at light source when panel is detached. | Both devices have this safety feature. |
| Compliance with Standards: | |
| - CSA-22.2 No. 601-1M90 | Complies |
| - UL 2601-1 | Complies |
| - EN60601-1 | Complies |
| - EN60601-2 | Complies |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not available. This document describes a medical device (phototherapy system), not an AI/ML diagnostic or predictive algorithm that typically uses patient data test sets. The testing referenced is purely non-clinical, focusing on compliance with electrical and safety standards and performance specifications of the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not available. As this is a physical medical device, not an AI/ML algorithm requiring expert-labeled ground truth from data, this information is not relevant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not available. This concept applies to human-labeled data for AI/ML development, which is not part of this submission.
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
- Not applicable / Not available. This is a hardware device; no human-AI interaction or MRMC study would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not available. There is no "algorithm only" component to this device in the sense of AI/ML. Its performance is inherent in its hardware design and operation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable / Not available. The "ground truth" for this device's performance relies on physical measurements (e.g., light intensity, spectral output), engineering validation, and compliance with established safety and performance standards for phototherapy equipment.
8. The sample size for the training set
- Not applicable / Not available. This is a hardware device; no AI/ML training set is involved.
9. How the ground truth for the training set was established
- Not applicable / Not available. As there is no training set, this information is not relevant.
Summary of the Study and Device Performance:
The study described is a non-clinical testing of the Wallaby 3 Phototherapy Illuminator. The primary goal was to establish substantial equivalence to its predicate device, the Wallaby II. The performance assessment focused on:
- Identical therapeutic light intensity settings to the Wallaby II.
- Presence of an optical filter to block harmful UV/IR radiation (range 400-550 nm).
- Implementation of an automatic lamp redundancy system, an improvement over the manual system in Wallaby II.
- Retention of a safety feature to prevent direct viewing of the light source.
- Compliance with several electrical and safety standards (CSA-22.2 No. 601-1M90, UL 2601-1, EN60601-1, EN60601-2).
The conclusion of the submission is that "The Wallaby 3 Phototherapy System has the same intended use and functionality as the predicate Wallaby II. The data supports that Wallaby 3 is substantially equivalent to the Wallaby II."
§ 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).