(288 days)
To swaddle infants during neonatal phototherapy in the hospital or home setting. Single patient use only.
The Luma Wrap™ by Beevers Manufacturing & Supply, Inc./Salter Labs is a translucent, highly breathable, phototherapy-compatible, disposable infant swaddling blanket. It is made of spun bond polypropylene non-woven fabric that is more than 90% light-permeable. The Luma Wrap™ provides centered and comfortable boundaries to benefit many babies who exhaust themselves with their hyper-reactive, frantic movements while receiving phototherapy. The Luma Wrap™ is a stand-alone device and has no accessories. It is available in two designs: a square and a shape similar to baseball's home plate. A 2" strip of self-adhesive is an added optional convenience feature to assist the user in positioning the device by adhering two parts of the device together.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Luma Wrap™ device.
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than proving clinical efficacy or diagnostic accuracy for an AI/algorithm-driven device. Therefore, many of the typical AI study components like training sets, ground truth establishment for AI, expert adjudication, or MRMC studies are not applicable here.
Acceptance Criteria and Device Performance for Luma Wrap™
The Luma Wrap™ is a neonatal phototherapy unit (specifically, an infant swaddling blanket). The primary acceptance criteria revolve around its physical properties and performance in allowing phototherapy light to pass through, as well as its safety features.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Light Transmittance | Single layer light transmittance ≥ 92% (to demonstrate substantial equivalence to predicate which had ≥ 90%) | Single Layer: 92.0% - 97.7% (bench test findings) |
- Test 1 (Lab, Overhead LED): 92.0%
- Test 2 (Lab, Overhead LED): 93.7%
- Test 3 (Hospital, Overhead Halogen): 94.0%
- Test 4 (Hospital, Beneath-the-infant Fluorescent): 97.7%
Double- and Triple-Layers: "light transmittances are still quite high" (No specific numeric value provided, but implied to meet an unstated internal acceptance criteria given the overall conclusion of substantial equivalence). |
| Adhesive Pull Strength | Adhesive pull strength to meet performance specification (specific value not explicitly stated as an "acceptance criteria" but implied by meeting the spec) | On average, 200g (measured with a force gauge pulled perpendicular to the adhesive). This "met the performance specification." |
| Adhesive Cycling / Reliability | Adhesive could be opened and closed at least 20 times (to verify functionality) | Adhesive cycle test verified that the adhesive could be opened and closed at least 20 times. |
| Air Flow Resistance (Safety) | Did not exhibit substantial resistance to air flow at rates of 1-12 lpm (to ensure infant's breathing is not impaired if device covers nose/mouth). | For two layers of fabric with an air flow of 8 lpm, resistance was 0.066 mmH2O/sq cm. This "met the device's performance specification and confirmed that an infant's breathing is not impaired if the device slips over the infant's nose and/or mouth." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for each test. The light transmittance tests refer to "Test #" (1-4), suggesting multiple measurements were taken for each. The adhesive pull strength mentions "on average, 200g," implying multiple measurements. The adhesive cycle test is for "the adhesive" (singular, but refers to the general feature). Air flow resistance is a single reported value for "two layers of fabric."
- Data Provenance: The tests were bench tests and performed in a laboratory and an empty hospital room. This is entirely simulation/controlled environment data, not patient-derived data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The device is not an AI/diagnostic device that relies on expert interpretation or ground truth establishment in a human sense. The "ground truth" here is the physical measurement of material properties (light transmittance, strength, air flow) using calibrated equipment.
4. Adjudication method for the test set
Not applicable, as this refers to expert review processes for AI/diagnostic outputs. The tests here are physical measurements.
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. This device is a physical product (a blanket), not an AI system. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm/AI device. The "standalone" aspect refers to the device itself as a physical product, acting without human input for its core function (e.g., transmitting light). The tests performed are analogous to standalone performance tests of the physical properties.
7. The type of ground truth used
The ground truth used for these performance tests is objective physical measurement against established standards and specifications. For example, for light transmittance, it's the measured light passing through the material compared to the light without the material. For adhesive strength, it's the force required to pull it apart. For air flow, it's the measured resistance using specialized equipment.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this physical 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).