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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

• 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.

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The Little Angels Swaddling Blanket developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting.

It is intended to be used by or under the direction of a licensed physician.

The Little Angels Swaddling Blanket is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting. The Little Angels Swaddling Blanket is similar in composition and function to other devices used as adjuncts to current neonatal phototherapy systems used to treat neonatal hyperbilirubinemia.

The Little Angels Swaddling Blanket is comprised of a sheet of spun bond polypropylene material that is die-cut and heat welded in a pattern that allows an infant undergoing phototherapy for hyperbilirubinemia to be tightly swaddled in a fashion such that only a single layer of material is ever interposed between the infant and the phototherapy source.

Spun bond polypropylene is a commonly used fabric in medical products and garments. Spun bond polypropylene is non-irritating to the skin. soft, and has a good drape that allows it to easily conform to body contours. Spun bond polypropylene is available in different fabric weights, depending on the tightness of the weave and fabric density. Light-weight spun bond polypropylene fabric is used in the Little Angels Swaddling Blanket to ensure maximum light transmittance from the phototherapy source to the patient's skin. {See section on "Bench Testing".)

In use, an infant undergoing phototherapy for hyperbilirubinemia is first laid atop the Little Angels Swaddling Blanket, and the blanket is then folded around the infant in a prescribed fashion that ensures the infant is tightly swaddled and that only a single layer of fabric lies between the phototherapy source and the infant's skin. When an overhead phototherapy source is used, the swaddled infant is then placed under the light source in the usual fashion in order to receive the phototherapy treatment. The Little Angels Swaddling Blanket also has a pocket formed in its rear panel (under the infant). If a light emitting pad type phototherapy source is to be used, the light emitting pad is placed in this pocket and phototherapy is administered to the swaddled infant in the usual fashion. Also, double phototherapy can be administered to an infant swaddled using the Little Angels Swaddling Blanket by combining an overhead phototherapy source together with a light emitting pad type phototherapy source, each used as described above.

The provided text describes a 510(k) summary for the "Little Angels Swaddling Blanket". The primary acceptance criterion investigated here is light transmittance, specifically comparing it to a predicate device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for the new device are implicitly that it should perform at least as well as the predicate device, or ideally, better, in relevant metrics like light transmittance for effective phototherapy. The table shows the new device significantly surpasses the predicate device in light transmittance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: For light transmittance testing, 2 samples of the "Little Angels Swaddling Blanket" material and 2 samples of the "BiliSoft Cover" material were tested for each phototherapy light source (GE Giraffe SPOT PT LITE and Drager PT 4000). This means a total of 4 material samples were tested.
• Data Provenance: This was "Bench Testing" conducted on material samples, not patient data. The origin of the material samples (e.g., country of manufacture) is not specified. It is a retrospective analysis of material properties.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Not applicable. This device is not an AI/ML device, and no human experts were involved in establishing ground truth for the light transmittance bench testing. The ground truth (actual light transmittance values) was established by direct physical measurement using a light meter.

4. Adjudication Method for the Test Set

• Not applicable. There was no need for adjudication as the testing involved direct physical measurements of light transmittance and fabric weight.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This is not an AI/ML device requiring human reader interaction or MRMC studies.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• No. This is not an AI/ML algorithm; it is a physical medical device (a swaddling blanket).

7. The Type of Ground Truth Used

• Direct Physical Measurement: The ground truth for light transmittance and fabric weight was established through direct physical measurements using a light meter and standard laboratory methods (not explicitly detailed but implied by "Fabric weights of the materials used in each device were also determined").

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device, so there is no training set in the AI/ML sense.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set, this question is irrelevant.

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