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BT-400 Neonatal phototherapy is designed to emit the blue light wave length range 450-470nm spectrum to treat Neonatal Jaundice to use in Bassinets, Incubators, Open beds or Radiant warmer and consists of Head ( Light Source ) Control box with LCD window Roll Stand ( optional)

AI/ML Overview

This document describes the premarket notification (510(k)) for the BT-400 Neonatal Phototherapy device. It compares the device to a predicate device, the BILI-THERAPY Spot type (K103828), to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the sense of predefined thresholds for a study outcome. Instead, it compares the proposed device's performance to that of a legally marketed predicate device to demonstrate substantial equivalence. The "acceptance criteria" here are implied to be that the proposed device performs comparably to or better than the predicate device across key technical and functional characteristics.

Characteristic	Acceptance Criteria (Implied: Comparable to Predicate)	Reported Device Performance (BT-400)	Predicate Device Performance (BILI-THERAPY Spot type K103828)
Light Source	Blue LEDs	Blue LEDs	Blue LEDs
Wavelength	Peak 450-475nm	Peak 450-475nm	Peak 450-475nm
Intensity	30-40 uW/cm² at 30cm distance	30-45 uW/cm² at 30cm distance	30-40 uW/cm² at 30cm distance
Variation in intensity in 6 hrs	±10% in Illumination area	±10% in Illumination area	Identical
Effective Surface	30x20cm	40x20cm	30x20cm
Head output over 6 hrs	<10°C warmer than ambient	<10°C warmer than ambient	Identical
Electrical Main power	100-120v ac 50/60 hz 70va	100-120v ac 50/60 hz 70va	Identical
Leakage current	<100uA	<100uA	Identical
Audible Noise	<60dB	<60dB	Identical
Maximum height	190cm	200cm	190cm
Header	320x200x700mm	340x210x750mm	320x200x700mm
Light assembly / Roll Stand Weight	3.6kg / 8.4kg	3.6kg / 8.4kg	Identical
Operating Temp/Humidity	10-30°C / 30-85%	10-40°C / 30-75%	10-30°C / 30-85%
Storage Temp / Humidity	0-45°C / 10-90%	0-50°C / 10-100%	0-45°C / 10-90%
Atmospheric Pressure	70 kPa-106 kPa	70 kPa-106 kPa	Identical
Regulatory Standard Compliance	EN6001-1, EN60601-1-2, EN60601-2-50	EN6001-1, EN60601-1-2, EN60601-2-50	Identical
Intended use	Treatment of Neonatal Hyperbilirubinemia	Treatment of Neonatal Hyperbilirubinemia	Treatment of Neonatal Hyperbilirubinema

Note: The document explicitly states: "Note performance is similar since subject device intensity is few microwatts higher and effective area is slightly large compared to the predicate device." This indicates the device meets or exceeds the predicate's performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "Bench Tests" for performance data. These are typically laboratory tests conducted on the device itself, rather than tests on human subjects using a "test set" of patient data. Therefore, concepts like sample size for a test set, country of origin, or retrospective/prospective data are not applicable in this context. The provenance would be the test conditions within a manufacturing or testing facility.

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)

This information is not applicable. The device is a phototherapy unit, not an AI or diagnostic imaging device that requires expert review for ground truth establishment. The performance is assessed through physical and electrical bench testing against established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data (e.g., medical images) where discrepancies need to be resolved. This device underwent bench testing.

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

This information is not applicable. The device is a phototherapy unit, not an AI-assisted diagnostic tool. Therefore, MRMC studies or effect sizes related to human reader improvement with AI are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical medical device (phototherapy unit), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, the "ground truth" for evaluating its performance comes from established engineering and medical device standards. Specifically, the device was tested against:

IEC60601-1 Medical Electrical Equipment: General requirements for basic safety and essential performance.
IEC 60601-1-2: Electromagnetic compatibility test.
IEC60601-2-50 Medical Electrical Equipment part 2-50: Particular requirements for the basic safety and essential performance of Infant Phototherapy Equipment.

The "ground truth" or reference for evaluating its properties (like wavelength, intensity, safety parameters) is defined by the requirements outlined in these standards.

8. The sample size for the training set

This information is not applicable. The BT-400 Neonatal Phototherapy device is a hardware medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable, as there is no training set for a hardware device.

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