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510(k) Data Aggregation
(151 days)
BILI-MIRROR MODEL BLM-1
Bili-Mirrors are intended to attach to overhead phototherapy light fixtures to limit the scattering of light.
The Bili-Mirror is simply a 10"-high by 54"-wide metalized, 3 mil polyester film that removably attaches (like a skirt) to the lower edge of overhead phototherapy devices. It serves three useful purposes. First, the 3 ohm metalized film serves as a mirror to reflect phototherapy light from the overhead device back onto baby - thereby increasing the phototherapy dose by up to 70% depending upon the distance of light-to-baby. Second, the Bili-Mirror decreases by over 95% the bright "scatter" from the phototherapy device from reaching the eyes of caregivers. Third, unlike the predicate device, the 3 ohm metalizing of the Bill-Mirror provides for a seethrough mirror that allows good visibility of baby as viewed through the Bili-Mirror.
The provided 510(k) summary for the Bili-Mirror focuses on demonstrating substantial equivalence to a predicate device for regulatory approval. As such, it presents data to support specific claims related to its performance compared to the predicate, rather than a comprehensive "acceptance criteria and study that proves the device meets the acceptance criteria" in the way one might expect for a novel device undergoing extensive clinical trials for efficacy.
However, we can extract the relevant information to answer your questions based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for an accessory device, the "acceptance criteria" are implicitly tied to demonstrating the device's ability to perform its intended functions without causing harm and to be substantially equivalent to a predicate device. The document primarily focuses on demonstrating these points.
| Acceptance Criteria (Implicit from Testing) | Reported Device Performance |
|---|---|
| Increase Phototherapy Light Dose (Efficacy) | Light doses from overhead devices alone ranged from 21.9 to 27.4 µWatts/cm²/nm. With the Bili-Mirror, doses rose to 30.7 to 32.5 µWatts/cm²/nm (within the recommended 30+ µWatts/cm²/nm range and below dangerous levels of 100+ µWatts/cm²/nm). This demonstrates the Bili-Mirror predictably raises the light dose onto baby — often to a more desirable dose. |
| Maintain Safe Temperature around Baby | Temperature around baby from overhead devices alone rose by 1.5 to 2.9°C. With the Bili-Mirror, temperature rose an additional 0.1 to 0.7°C (still well within the desirable range and below hospital upper limits). This demonstrates the Bili-Mirror predictably raises the temperature... by a relatively small amount - within the desirable range but not to a dangerous level. |
| Prevent Contact with Baby | Bili-Mirror edge remains at least 2 inches from the maximum reach of a baby in a bassinette. This demonstrates the Bili-Mirror does not come in contact with baby during use. |
| Limit Scatter of Light (Primary Intended Use) | Normal scatter of light from an overhead phototherapy device is reduced by 95% in the area covered by the Bili-Mirror. This demonstrates the Bili-Mirror effectively limits the scatter of light. (Also, predicate device equivalence is based on >95% scatter reduction). |
| Allow Visibility of Baby | Visibility of the baby through the Bili-Mirror is deemed to be good. This suggests improved safety over an opaque device. |
| Adhesion without Residue or Marring | Adhesive strip adheres well, releases well without leaving adhesive residue, and does not mar the surface of the phototherapy device. This meets the criteria for attachment and removal. |
| Durability (Resistance to Scratching, See-through capability, Reflection) | 3 mil thick polyester film metalized to 3 ohms tested for: reflection of blue phototherapy light, see-through capability, resistance to scratching. While specific results are not quantified for scratch resistance, the overall description implies these tests were successful. |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: The document performed testing on "two commonly-used overhead infant phototherapy devices: Olympic Bili-Lite and Natus neoBlue." The number of "babies" or subjects involved in these tests is not specified, nor is the number of individual measurements. The testing appears to be conducted in a controlled environment with equipment, rather than a clinical trial with a large patient cohort.
- Data Provenance: The tests described appear to be prospective, laboratory-based testing performed by Physician Engineered Products, Inc. (or their contractors) specifically for this submission. There is no indication of country of origin of the data beyond the submitter's location in Fryeburg, ME, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not explicitly stated for specific quantitative measurements (light dose, temperature, distance).
- Qualifications of Experts: For the "subjective visibility of baby through Bili-Mirror," it is "deemed to be good." The qualifications of the person(s) making this judgment are not provided. Given the nature of a 510(k) for an accessory, formal expert panels for "ground truth" are less common than for diagnostic AI devices.
4. Adjudication Method for the Test Set
- No formal adjudication method (e.g., 2+1, 3+1) is described. The tests appear to be direct measurements of physical properties and effects. For the subjective assessment of visibility, a formal adjudication process is not mentioned.
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
- No, an MRMC comparative effectiveness study was not done. This device is a physical accessory to a phototherapy light, not an AI or diagnostic tool that involves "human readers." Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a "standalone algorithm-only" performance study was not done. This device is a physical product, not an algorithm or software.
7. The Type of Ground Truth Used
- The "ground truth" for the performance claims appears to be:
- Direct Physical Measurements: For light dose (µWatts/cm²/nm), temperature change (°C), and distance (inches). These are objective, quantifiable measurements.
- Observation/Assessment: For adhesion/release properties of the adhesive strip, resistance to scratching of the film, and the subjective "visibility of baby."
- Comparative Assessment: For the reduction of scattered light (95% reduction), which is compared to the performance of the predicate device (also claiming 95% reduction or more).
8. The Sample Size for the Training Set
- This device is a physical accessory and does not employ machine learning or AI. Therefore, there is no training set in the context of an algorithm.
9. How the Ground Truth for the Training Set was Established
- As there is no training set for an algorithm, this question is not applicable.
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