Search Results

The BiliWrap Phototherapy System is intended for use to treat infants who have been diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The Phototherapy system can be used in a hospital or at home. The device is intended to be used in infants up to the age of 3 months, weighing less than 10 kg.

The BiliWrap Phototherapy System is a portable phototherapy light system that delivers a narrow band of high-intensity blue light via blue light-emitting diodes (LEDs) to provide treatment for neonatal unconjugated hyperbilirubinemia. The device is comprised of a control box and pad including a disposable pad cover and AC/DC power supply. The pad is designed to cover the torso and legs and provide phototherapy treatment on large surface area of the baby.
The BiliWrap Phototherapy System emits light in the spectrum of 450 to 475 nm, a spectrum known as effective to reduce bilirubin concertation in the body of infants. Treatment is intended to be applied until the bilirubin levels have dropped sufficiently that the child no longer suffers from jaundice. Phototherapy treatment of neonatal jaundice using the device can be applied at home or in a hospital.

The provided FDA 510(k) clearance letter for the BiliWrap Phototherapy System (K243372) clearly states: "No clinical data was required for this submission." (Page 11)

Therefore, the device's acceptance criteria and the study proving it meets these criteria are based entirely on non-clinical tests, specifically bench testing and compliance with various recognized consensus standards.

Here's a breakdown of the information requested, based on the provided document:

Acceptance Criteria and Device Performance Study for BiliWrap Phototherapy System (K243372)

The BiliWrap Phototherapy System's acceptance was established through non-clinical performance and safety testing, demonstrating its substantial equivalence to the predicate device (BiliTouch, K210289). No clinical data was required for this submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by compliance with recognized consensus standards and meeting specified performance characteristics that demonstrate substantial equivalence to the predicate device.

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

• Sample Size: Not applicable. No human clinical test set was used. The evaluation was based on bench testing of the device prototypes/production units. The exact number of physical units tested for each non-clinical test (e.g., durability, electrical safety) is not specified but would typically involve a statistically relevant sample as defined by internal quality systems and testing protocols.
• Data Provenance: The data is derived from retrospective (design-stage, in-house) and prospective (final product verification and validation) non-clinical laboratory testing performed by Gerium Medical, Ltd. and/or their contracted testing facilities, as per the listed industry standards. The country of origin of the data is implied to be Israel (where Gerium Medical, Ltd. is located) and potentially international testing laboratories.

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

Not applicable. As no clinical test set was used, there was no "ground truth" derived from expert consensus on patient data. The "ground truth" for non-clinical tests is established by:

• Engineering specifications and design requirements.
• Industry consensus standards (e.g., IEC, ISO).
• Predicate device performance characteristics.

The "experts" involved would be the engineers, quality assurance personnel, and regulatory affairs specialists at Gerium Medical, Ltd. and their third-party testing partners, qualified in device design, testing, and regulatory compliance.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring expert adjudication was used. Non-clinical test results are compared against predefined technical acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states "No clinical data was required for this submission."

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

This question is not applicable to the BiliWrap Phototherapy System. The device is a physical medical device that emits light for phototherapy, not an AI algorithm or software-only diagnostic tool. Its "performance" is its ability to emit light at the specified wavelength and intensity, safely and reliably.

7. The Type of Ground Truth Used

For this device, the "ground truth" is based on:

• Engineering Specifications and Design Requirements: The device must meet its own design specifications (e.g., light intensity, dimensions, weight).
• Compliance with Recognized Consensus Standards: Many standards (e.g., IEC 60601 series for safety, ISO 10993 for biocompatibility) define quantifiable and verifiable criteria.
• Predicate Device Characteristics: Substantial equivalence often relies on demonstrating that the new device performs comparably to a legally marketed predicate device (BiliTouch in this case) on key performance parameters.

8. The Sample Size for the Training Set

Not applicable. As a physical medical device for phototherapy, there is no "training set" in the context of machine learning or AI models. The "training" for such a device is its design, engineering, and manufacturing process.

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

Not applicable. See point 8.

Ask a specific question about this device

The BiliTouch™, model Motif Phototherapy Blanket and Infant Phototherapy Equipment, model BT-450 for use to treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The devices can be used in a hospital or at home.

The device is designed to use for patient population described in the infant, who is age up to 3 months and weight less than 10 kg.

Infant phototherapy equipment is a portable phototherapy light system delivers a narrow band of high-intensity blue light via blue light-emitting diodes (LEDs) to provide treatment for neonatal unconjugated hyperbilirubinemia. The device is comprised of a control box and pad including a disposable pad cover, rechargeable battery and AC/DC power supply. The pad is designed to provide phototherapy treatment from underneath the baby.

Infant phototherapy equipment provides blue LEDs to achieve intensities by two-level with emitting light from blue LEDs (bandwidth 400 - 550 nm used).

Treatment is intended to be applied until the bilirubin levels have dropped sufficiently that the child no longer suffers from jaundice. Phototherapy treatment of neonatal jaundice using the device can be applied at home or in a hospital.

This document is an FDA 510(k) Premarket Notification summary for the BiliTouch™ (Motif Phototherapy Blanket) and Infant Phototherapy Equipment (BT-450). It details the device's characteristics and its substantial equivalence to a predicate device, focusing on non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present "acceptance criteria" for an AI/algorithm's performance or "reported device performance" in the typical sense of metrics like accuracy, sensitivity, and specificity for diagnostics. Instead, it describes compliance with various safety and performance standards for a medical device (infant phototherapy equipment).

However, we can infer some "acceptance criteria" and "reported performance" from the "Summary table of technological characteristics of the device compared to the predicate device" and the "SUMMARY OF NON-CLINICAL TESTS" section.

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 explicitly states: "No clinical data were submitted." This implies that the 'test set' for demonstrating the device's safety and effectiveness was based purely on non-clinical, bench testing and adherence to recognized standards, rather than patient data. Therefore, there is no information on sample size, country of origin, or retrospective/prospective nature of a clinical test set.

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 section is Not Applicable as no clinical data or expert-adjudicated ground truth was used for assessing the device's performance in a diagnostic or AI context. The assessment was based on compliance with device performance standards rather than a clinical ground truth derived from expert interpretation.

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

This section is Not Applicable as no clinical data requiring expert adjudication was used.

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

An MRMC study was Not Done. The device is an Infant Phototherapy Equipment, which is a physical device delivering light therapy, not an AI or imaging diagnostic aid that would assist human readers.

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

This section is Not Applicable as the device is not an algorithm for diagnosis or image interpretation. It is a phototherapy device.

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

For the purpose of this 510(k), where "No clinical data were submitted," the "ground truth" for the device's performance is established by its compliance with internationally recognized electrical, mechanical, biocompatibility, and phototherapy-specific safety and performance standards (e.g., IEC 60601 series, ISO 10993) and successful completion of internal bench performance tests.

8. The sample size for the training set

This section is Not Applicable. As stated, "No clinical data were submitted." The device is a physical medical device, not a software algorithm that requires a training set of data.

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

This section is Not Applicable as there was no training set in the context of an AI/algorithm development.

Ask a specific question about this device

The Neonatal Phototherapy System, Model: KANGALITE is intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates: gestational age ≥38 weeks and weight within 2500-4500 grams. It can be used in the clinical setting or in the home environment. It should be used for neonates whom phototherapy has been prescribed.

The Neonatal Phototherapy System, Model: KANGALITE is a wearable phototherapy system that consists of six components: Light Source with AC Power Cord, Dual Fiber Optic Panels (Standard accessory) /Single Fiber Optic Panel (optional accessory), Swaddle, Strap, Disposable Covers and Table Mounting Clip (optional accessory). The Neonatal Phototherapy System, Model: KANGALITE delivers a narrow band of high-intensity blue light emitting diode (LED), in order to provide phototherapy treatment for neonatal hyperbilirubinemia.

The Neonatal Phototherapy System, Model: KANGALITE Light Source contains a blue LED which emits light in the range 400-500 nm (peak wavelength 455±10 nm). The system gives only one blue light irradiance output level which is not adjustable. This blue light is directed through the optical fiber bundle to the illuminating area of the Fiber Optic Panel where the newborn receives blue light therapy.

The Fiber Optic Panel is inserted into the Disposable Cover and is placed in a soft and comfortable Swaddle, while the baby is wrapped inside to receive phototherapy. Baby is allowed to receive kangaroo care. Besides, compare to conventional phototherapy, no eye protection for the baby is required as blue light will not leak out when properly set up.

The light output (>30 µW/cm²/nm) is sufficient to provide intensive phototherapy which is defined as in the American Academy of Pediatrics (AAP) standard.

Average irradiance for:

Dual Fiber Optic Panels: 50 µW/cm2/nm (±25%);

Single Fiber Optic Panel: 60 uW/cm2/nm (±25%).

The spectrum range of the blue LED light matches with the spectral absorption of bilirubin. Under blue light irradiation, subcutaneous bilirubin absorbs strongly in the blue region of the light spectrum and converts into less lipophilic waste products which can be excreted through the bile or urine without the need for conjugation.

The Neonatal Phototherapy System, Model: KANGALITE can be directly connected to nominal voltages readily available throughout the world as the Light Source is affixed with a wide-range medical adaptor, rated from 100-240 VAC and 50/60 Hz. It converts the power to 15 VDC to power up the Light Source.

The provided text describes a 510(k) premarket notification for a medical device, the Neonatal Phototherapy System, Model: KANGALITE. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for a novel AI/device.

Therefore, many of the requested details regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI models or new clinical devices, are not explicitly provided in this 510(k) submission.

Here's a breakdown of what can be inferred or stated based on the given information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of explicit acceptance criteria with numerical performance targets typical for clinical efficacy studies (e.g., sensitivity, specificity, or improvement in bilirubin levels). Instead, the "acceptance criteria" for this 510(k) submission are met by demonstrating substantial equivalence to a previously cleared predicate device (Bili-Tx, K070180) through various non-clinical tests and comparisons of technological characteristics.

The "reported device performance" is largely qualitative, asserting that the device meets relevant safety and performance standards established for such phototherapy systems.

Here's what can be extracted regarding performance and comparison:

Ask a specific question about this device

The bill-hut™ provides phototherapy for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the clinical or home setting.

The bili-hut™ is a modular, portable blue LED-based phototherapy device intended to treat neonatal hyperbilirubinemia, commonly known as infant jaundice. The bili-hut™ consists of the assembled hut (shell with light source, base mattress, base), nest components (nest, nest liner, nest mattress, nest mattress cover), and power supply. It has an optional accessory, the perch, which is a bassinet stand insert. Features include a timer for total LED use and an Environment High Temperature Warning with automatic shutoff. The principle of operation is phototherapy using blue light to break down bilirubin. The device is powered by a 12V medical grade power supply and uses an LED light array. The materials include fabric-based, plastic, metal, and electronic components.

The bili-hut™ device is a phototherapy unit for treating neonatal hyperbilirubinemia (infant jaundice). The provided text describes the acceptance criteria and the studies performed to demonstrate substantial equivalence to a predicate device, the Ultra Bili Light™ Model 2000 (K974830).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by compliance with recognized standards and performance characteristics comparable to the predicate device. The performance data is primarily non-clinical.

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 primarily discusses non-clinical bench testing.

• Biocompatibility testing: The "sample size" here refers to the materials tested (disposable covers and nest mattress). The studies were likely performed in a laboratory setting by certified testing facilities. The provenance would be the testing lab.
• Electrical Safety, EMC, and Bench Performance tests: These are performed on the device itself. The "sample size" is the device(s) tested. These are laboratory tests, not human data.

There is no mention of a clinical test set or human data used to evaluate the device's performance in treating hyperbilirubinemia.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable as there was no clinical test set for which ground truth would be established by experts. The performance evaluation was primarily through non-clinical bench testing against established engineering and medical device standards.

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

Not applicable as no clinical test set requiring expert adjudication was used.

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. The bili-hut™ is a phototherapy device, not an AI-assisted diagnostic or interpretative system requiring human readers.

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

Not applicable. The bili-hut™ is a medical device, not an algorithm. Its performance as a standalone phototherapy unit was assessed via bench testing against engineering and medical device standards, and comparison to a predicate device.

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

For the non-clinical and bench performance tests, the "ground truth" or reference points were:

• Recognized international and FDA-recognized standards: (e.g., AAMI ES60601-1, IEC 60601-1-x series, ISO 10993 series).
• American Academy of Pediatrics (AAP) standards: Specifically for therapeutic irradiance (irradiance > 30 µW/cm²/nm) and peak wavelength (430-490 nm).
• Predicate device characteristics: The Ultra Bili Light™ Model 2000 (K974830) served as a benchmark for comparison to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable as this is a medical device, not an AI/machine learning algorithm requiring a training set.

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

Not applicable.

Ask a specific question about this device

The neoBLUE blanket LED Phototherapy System is indicated for the treatment of unconjugated hyperbilirubinemia in a hospital environment, and administered by trained professional medical staff, on the order of a physician, or in the home environment administered by a trained caregiver. The neoBlue blanket device provides intensive phototherapy underneath the patient and can be used with a bassinet, open bed, radiant warmer, incubator, or while holding the patient.

The neoBLUE blanket LED Phototherapy System is a portable phototherapy system that consists of five components: the neoBLUE blanket phototherapy light box, fiber optic blanket with attached cable, blanket mattress, disposable mattress covers, and power supply. The neoBLUE blanket LED Phototherapy System delivers a narrow band of high-intensity blue light via a blue light emitting diode (LED), in order to provide treatment for neonatal hyperbilirubinemia.

The portable neoBLUE blanket light box contains a blue LED which emits light in the range of 400 – 550 nm (peak wavelength 450-475 nm). This blue light is directed through an optical fiber cable to the fiber optic blanket pad. The fiber optic blanket pad is composed of high performance optical fibers enclosed in a vinyl material. A polyurethane mattress is placed on top of the fiber optic blanket, and a disposable polypropylene cover is placed around the blanket pad and mattress. The fiber optic blanket generates sufficient light output to provide intensive phototherapy which is defined as ≥30µW/cm²/nm.

The provided text describes a 510(k) premarket notification for a medical device called the "neoBLUE® blanket LED Phototherapy System." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical or standalone performance studies with acceptance criteria for an AI/ML device.

Therefore, many of the requested details regarding acceptance criteria, study design for AI/ML performance, sample sizes for training/test sets, expert involvement for ground truth, and MRMC studies are not present in this document. The device in question is a phototherapy system, not an AI/ML diagnostic or therapeutic device.

Here's an analysis based on the available information and an explanation of why other requested information is not applicable:

1. A table of acceptance criteria and the reported device performance:

The document describes performance specifications that the device meets, rather than acceptance criteria for an AI/ML model's output. The criteria are related to the physical and functional characteristics of the phototherapy system.

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

This information is not applicable as the document explicitly states "Clinical Tests: N/A" and focuses on non-clinical engineering and performance testing of the physical medical device (phototherapy unit), not a software or AI/ML-based diagnostic system that would require a test set of data.

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. Ground truth, expert consensus, and qualifications of experts are relevant for AI/ML models that interpret medical images or data. The neoBLUE blanket LED Phototherapy System is a physical device delivering light therapy, not an interpretive AI.

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

This information is not applicable for the same reasons as point 3.

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. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. The neoBLUE blanket LED Phototherapy System is a therapeutic device, not an diagnostic AI assistant.

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

This information is not applicable as there is no algorithm/AI in this medical device. Its performance is based on its physical specifications and light output.

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

This information is not applicable. For this physical device, "ground truth" relates to measurable physical properties and operational performance tested against engineering specifications and recognized standards (e.g., light intensity measurements, electrical safety).

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/ML device.

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

This information is not applicable for the same reason as point 8.

Summary of the Study Proving Device Meets Acceptance Criteria (Non-Clinical):

The study proving the device meets its performance specifications (which serve as "acceptance criteria" for a physical device) was based on non-clinical tests and design verification and validation.

• Type of Study: Non-clinical tests, design verification and validation.
• Purpose: To ensure the device meets performance specifications and demonstrates equivalence to the predicate device (K103589).
• Tests Performed: Specific testing for device power, electrical safety, indicators, LED performance, intensity levels, intensity range, effective area, and usability.
• Standards Applied: Where appropriate, testing was performed to recognized international and industry standards, including:
  • IEC 60601-2-50:2009 +A1 / ED 2.1: 2016-04 (Particular Requirements For The Basic Safety And Essential Performance Of Infant Phototherapy Equipment)
  • IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (General Requirements For Basic Safety And Essential Performance)
  • IEC 60601-1-11:2015 (Second Edition) (Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment)
  • IEC 60601-1-6:2010, AMD1:2013 (Usability)
  • IEC 60601-1-2 ED 4.0: 2014-02 (Electromagnetic disturbances)
  • An AIM Standard 7351731 Rev 2.0: 2017-02-03 (Electromagnetic disturbances)
• Conclusion: The verification and validation summary and risk analysis documentation supported the conclusion that the device is as safe and effective as the predicate device and is substantially equivalent.

No human data, expert review of images, or AI/ML model performance evaluation was part of this submission, as it is for a physical phototherapy device.

Ask a specific question about this device

The BiliLux phototherapy light is designed to reduce the serum bilirubin concentration in premature babies and neonates with unconjugated hyperbilirubinemia by means of phototherapeutic radiation. It is intended for use with patients up to 3 months of age who weigh less than 10 kg (22 lb).

The device BiliLux is a configurable LED phototherapy light designed to reduce serum bilirubin concentration in premature babies and neonates with unconjuqated hyperbilirubinemia by means of phototherapeutic radiation. It is intended for use with patients up to 3 months of age who weigh less than 10 kg (22 lb).

The phototherapy light houses the 20 blue lights that provide therapy as well as 2 white lights used for observation. The blue light of the phototherapy light lies within the wavelength range of 460 nm to 490 nm. The front panel has a display screen and keys to control functions and change settings. There are five intensity settings (20%, 60% 80% and 100% of nominal intensity). On the user interface, the user can see session time and any software errors that may occur.

The BiliLux phototherapy light can be placed directly on an incubator hood or be combined with a spring arm and trolley. An optional radiometer is also available to measure the phototherapeutic effective irradiance produced by the phototherapy light.

The provided document is a 510(k) premarket notification for the BiliLux® Phototherapy Light. It describes the device, its intended use, and a comparison to a predicate device (NanoBlu™ 500).

However, the document explicitly states:

• "No clinical testing was performed."
• The discussion focuses on "Non-Clinical Studies," specifically bench testing and adherence to standards.

This means that there are no acceptance criteria, performance data, or studies related to clinical effectiveness or comparison with human readers as typically found in AI/ML device submissions. The document focuses on demonstrating substantial equivalence to a predicate device through technical specifications and compliance with standards.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance in the context of an AI/ML device, as this device is a phototherapy light and was not evaluated based on AI/ML performance.

If this was a misunderstanding and you were looking for information about a different type of device or performance evaluation, please provide a different document.

Ask a specific question about this device

Skylife™ is intended for the treatment of neonatal unconjugated hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath the baby. Skylife™ must be used within a patient enclosure, such as a bassinet, an open crib, a warming table or an incubator. Skylife™ can be used in a clinical setting or in the home.

Skylife™ is a portable phototherapy light system that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal unconjugated hyperbilirubinemia. Skylife™ is designed to provide phototherapy treatment from underneath the baby. The system must be used within a patient enclosure, such as a bassinet, an open crib, a warming table or an incubator. Skylife™ utilizes blue LEDs to achieve intensities from 25 uW/cm²/nm to >55 uW/cm²/nm, emitting light in a narrow bandwidth between 430-475 nm. This light bandwidth corresponds to the spectral absorption of light by bilirubin. Skylife™ utilizes blue LEDs in this range to achieve peak intensities between 25 to 35, and over 55 uw/cm²/nm at low, high settings. Skylife™ at the Very High setting provides an average intensity of 56.3 uw/cm/nm over the treatment area with peak at 72.4 uw /cm-/nm. Treatment is intended to be applied until the bilirubin levels have dropped sufficiently that the child no longer suffers from jaundice. Phototherapy treatment of neonatal jaundice using Skylife™ can be applied at home or in a hospital. Skylife™ consists of the following components: Light bed and light modules, GelMat, disposable mattress cover (Cloud Swaddle), controller, and power supply.

The NeoLight Skylife™ phototherapy unit for neonatal unconjugated hyperbilirubinemia underwent performance testing to demonstrate its substantial equivalence to predicate devices. The studies focused on electrical safety, electromagnetic compatibility, biocompatibility, and human factors usability.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document refers to various performance tests against international standards (IEC and ISO). These types of tests typically involve specific sample sizes prescribed by the standards for evaluating materials, electrical components, and hardware. However, the exact numerical sample sizes for each specific test (e.g., number of units tested for electrical safety, number of material samples for biocompatibility) are not explicitly stated in this summary.

For the Human Factors Usability study:

• Number of participants: 2 user groups
• Data provenance: Not explicitly stated, but based on the nature of human factors usability, it would be prospective data collection (users interacting with the device).

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

For the technical performance tests (electrical safety, EMC, biocompatibility), the "ground truth" is established by adherence to the specified international standards. The evaluation is typically performed by trained engineers and technicians in accredited testing facilities. The document does not specify the number or qualifications of experts explicitly.

For the Human Factors Usability study:

• The document implies that the study was conducted by human factors experts. However, the number of experts used to establish "ground truth" (e.g., identifying usability issues or defining successful use) and their specific qualifications are not provided. The "ground truth" for usability is generally derived from user performance and expert observation against established usability principles.

4. Adjudication Method for the Test Set

The document does not describe specific adjudication methods for the performance tests in the context of clinical endpoints or expert review. For objective technical tests, the results either meet the standard's criteria or they don't, often without a need for "adjudication" in the sense of resolving inter-rater disagreement.

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, the provided document does not describe an MRMC comparative effectiveness study, nor does it mention AI in any context. This device is a phototherapy unit, not an AI-powered diagnostic or assistive tool.

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

No, as mentioned, this device is a phototherapy unit and does not involve an algorithm or AI for standalone performance evaluation in that manner.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• For Electrical Safety, EMC, and Safety of Infant Phototherapy Equipment: The ground truth is established by the requirements and methodologies defined within the respective IEC standards. Compliance with these standards indicates safety and essential performance.
• For Biocompatibility: The ground truth is established by the requirements and testing protocols defined within the ISO 10993 series of standards. Non-cytotoxicity, non-sensitization, and non-irritation are the "ground truth" criteria.
• For Human Factors Usability: The ground truth is established by the requirements of IEC 60601-1-6 and IEC 62366, which focus on preventing use errors and ensuring that the device can be used safely and effectively as intended. User performance during the study, observed errors, and successful task completion against defined criteria form the basis of the ground truth.

8. The Sample Size for the Training Set

This information is not applicable as the device is a phototherapy unit and does not rely on a "training set" in the context of machine learning.

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

This information is not applicable for the same reason as above.

Ask a specific question about this device

The BiliCocoon™ Phototherapy System is intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates and infants under 3 months old and weighing less than 10kg. It can be used in the clinical setting or in the home.

The BiliCocoon™ Phototherapy System is a phototherapy system designed to treat unconjugated hyperbilirubinemia in newborns and infants under 3 months old and weighing less than 10kg. It is a phototherapy device, which emits light in the absorption spectrum of the bilirubin, from 430 to 490 nm. A custom optic directs light from the LEDs into the fiberoptic Pad. The system is composed of a blue light electronic generator - the Light Box - and of a light emitting fabric – the Pad – which transmits the blue light to the newborn. The Pad is provided in two versions: Bag Pad. The Light Box has a user interface to set the session time and inform the user about eventual errors. The other parameters of the therapy (irradiance level, light wavelength, etc.) are fixed.

The BiliCocoon™ Phototherapy System is used with the BiliCocoon™ Disposable, a non-woven disposable designed to fit the Pad which interfaces between the newborn. The disposable is the only part which contacts the newborn skin.

The BiliCocoon™ Phototherapy System can be fixed on the BiliCocoon™ Fixation system.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BiliCocoon™ Phototherapy System (K163526).

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not necessarily proving efficacy through a clinical trial. Therefore, the information provided primarily pertains to bench testing and comparison, rather than comprehensive clinical study data as might be expected for novel devices or PMAs.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance for a specific statistical endpoint (e.g., accuracy, sensitivity, specificity) relevant to a diagnostic or AI-driven device. Instead, the "acceptance criteria" are implied by the performance of the predicate device and relevant industry standards. The "reported device performance" is largely described through a comparison against the predicate and adherence to safety and performance standards.

The closest equivalent to "acceptance criteria" for a phototherapy device would be its light output specifications and safety characteristics.

Ask a specific question about this device

The neoBLUE compact LED Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia. The light can be used for infants in a bassinet, incubator, open bed, or radiant warmer.

The neoBLUE compact LED Phototherapy System utilizes a portable phototherapy light that delivers a narrow band of high-intensity blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia.

The neoBLUE compact LED Phototherapy System light consists of a lightweight plastic light enclosure which can be used independently by placing directly on top of an incubator, or with the arm, or with the arm and roll stand together. The arm can be attached to the pole mount accessory on most incubators and radiant warmers. The arm, when attached to the roll stand, can be used for infants in a bassinet, incubator, open bed, or radiant warmer.

The neoBLUE compact LED Phototherapy System light is equipped with a treatment timer to track the total number of treatment hours per patient, a device timer to track the total number of operating hours for the blue LEDs, and an exam light.

The provided text describes the neoBLUE Compact LED Phototherapy System and its substantial equivalence to predicate devices, not a study evaluating its performance against specific acceptance criteria in a clinical setting. Therefore, many of the requested categories for a study are "Not Applicable" or "Not Provided" in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific quantitative acceptance criteria for clinical performance or a clinical study to prove the device meets them. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and compliance with safety standards.

Note: The "acceptance criteria" here are implied from the comparison to predicate devices and the mention of standards compliance for safety and performance testing. There are no explicit, quantifiable clinical efficacy acceptance criteria provided within this document for a clinical study.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not Applicable. This document describes a premarket notification (510(k)) seeking substantial equivalence, not a clinical trial with a patient test set. Performance testing mentioned (electrical safety, LED performance, etc.) would be conducted on units of the device, not a patient sample.
• Data Provenance: Not Applicable. No patient data or clinical data is mentioned for a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. No clinical ground truth or expert adjudication for patient data is mentioned.

4. Adjudication method for the test set

• Not Applicable. No patient test set or adjudication process is described.

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 phototherapy system, not an AI-assisted diagnostic or interpretative tool for human readers. No MRMC study was conducted or is relevant.

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

• Not Applicable. This is a medical device (phototherapy system), not a standalone algorithm.

7. The type of ground truth used

• Not Applicable. For the technical performance aspects, the "ground truth" would be established by reference standards, engineering specifications, and validated measurement methods, rather than clinical ground truth (pathology, expert consensus, outcomes data).

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device that requires a training set.

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

• Not Applicable. This is not an AI/machine learning device.

Ask a specific question about this device

The Airborne Phototherapy Light System is intended to be used in one of two modes: observation light mode or phototherapy light mode. The observation light mode utilizes white light and is intended to be used as auxiliary lighting that supplements the ambient lighting. The phototherapy light mode utilizes blue light and is intended to be used in the treatment of neonatal hyperbilirubinemia.

The Airborne Observation and Phototherapy Light is an LED phototherapy (and observation) light. The LED light has both white and blue LED lights that are designed to serve as an observation light or a phototherapy light for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice. The phototherapy light can be used for infants in incubators by mounting it on the hood

The provided text describes a 510(k) premarket notification for a medical device called the "Airborne Phototherapy Light". This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and studies in the manner typically seen for novel AI/ML-driven devices or those undergoing rigorous clinical efficacy trials.

Therefore, the information required to answer your specific questions about acceptance criteria, test set details, expert ground truth, MRMC studies, standalone performance, training set details, and specific effect sizes is not present in the provided document.

This document is a marketing clearance notification for a phototherapy light for neonatal hyperbilirubinemia. The "performance testing" mentioned refers to compliance with electrical and medical device safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-50), which are general safety and performance requirements for a device of this type, not specific outcome-based acceptance criteria or a study proving its efficacy for treatment in a clinical sense.

The core argument for clearance is substantial equivalence based on:

• Similar indications for use (treatment of neonatal hyperbilirubinemia).
• Similar environment for use (hospital/institution).
• Similar patient population (neonatal).
• Similar technology (blue light-emitting diodes - LEDs).
• Compliance with relevant safety standards.

The discussion about irradiance levels (5 µW/cm²/nm resulting in a 15% decrease of serum bilirubin) refers to published guidelines from the American Academy of Pediatrics, not to a performance study conducted on the Airborne Phototherapy Light itself. The device's irradiance is stated to be within the therapeutic range suggested by these guidelines, even if slightly less than the predicates.

In summary, this document does not contain the information needed to fill out your request because it's a regulatory submission for a device demonstrating substantial equivalence to existing, well-understood technology, not a novel device requiring extensive performance studies as you've outlined.

To answer your request, if this were a document about a software with AI/ML components for diagnosis or treatment, it would typically include a dedicated section on clinical performance testing, often with a detailed statistical analysis plan, acceptance criteria, and specific study results. This document does not describe such a study.

Ask a specific question about this device