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General ophthalmic imaging including retinal, corneal, and external structures of the eye.

The Phoenix ICON system is an updated cart based retinal imaging system covering the design changes to date on the predicate device, Phoenix ICON. The Phoenix ICON GO retinal imaging system is a portable version of the predicate device, Phoenix ICON (K170527) including the design changes in the Phoenix ICON system.

Both the Phoenix ICON and Phoenix ICON GO are wide-field, handheld, high resolution, real-time retinal imaging devices. They are intended to be used for general ophthalmic imaging including retinal, corneal, and external structures of the eye. The intended users of the Phoenix ICON and Phoenix ICON GO are clinical imaging technicians, ophthalmic technicians, nurses, and physicians. The devices may be used in hospitals, medical clinics, and physician's offices.

The Phoenix ICON platform consists of either a cart based (Phoenix ICON) or portable (Phoenix ICON GO) control box used in conjunction with a hand-held camera (Handpiece) using interchangeable LED based light sources (White and Blue light). The Phoenix ICON cart contains an AC mains power attachment, a battery module, a keyboard interface, a monitor, and a computer with Phoenix ICON software. The Phoenix ICON GO contains a portable control box with battery function and has an interface for attachment to a specified laptop computer which runs the Phoenix ICON software. Both systems may be used with a Foot Pedal, White Light Module (standard), Blue Light Module (FA) and/or Diffuser accessory.

The Phoenix ICON Handpiece contains a wide-field, high resolution camera is used in three (3) modes, External Imaging (White Light), Retinal Imaging (White Light), and Fluorescein Angiography (Blue Light). For external imaging, the Diffuser accessory is placed over the lens tip to diffuse the light and provide for images of the outer surfaces of the eye. Both Retinal Imaging and Fluorescein Angiography are performed with the glass lens of the Handpiece coupled to the cornea via an imaging gel. In these imaging methods, LED light is emitted into the eye to illuminate the retina for image capture.

Both the Phoenix ICON and Phoenix ICON GO are software-controlled systems which can capture either video or still images and store them on the control box (Cart computer or GO laptop) for later review. The Phoenix ICON system may be connected to IT networks under IT supervision.

The provided document does not contain details about specific acceptance criteria for a device's performance in a clinical study or a study proving that the device meets those criteria. Instead, it is a 510(k) summary for the NeoLight Phoenix ICON and Phoenix ICON GO ophthalmic cameras, aimed at demonstrating substantial equivalence to a predicate device (K170527, Phoenix ICON by Phoenix Technology Group, LLC).

The document focuses on comparing technological characteristics and safety testing, not on clinical performance acceptance criteria or a study to demonstrate such.

However, based on the Performance Testing section (Table 5.3) related to Simulated Use, it states:
Characteristic: Image Clarity - Comparison between subject and predicate images to ensure equivalent visual quality of the captured images.
Results: Pass.

While this indicates some form of performance assessment related to image quality, it does not provide the specific acceptance criteria (e.g., quantitative metrics, thresholds) or the detailed methodology of the study. It also doesn't present the "reported device performance" in a manner typical for clinical trials (e.g., sensitivity, specificity, or reader agreement scores).

Therefore, a table of acceptance criteria and reported device performance, as well as several other requested details, cannot be fully extracted from the provided text.

Here's an attempt to answer the questions based only on the available information, noting where information is missing:

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

Note: The document only provides a high-level "Pass" result for "Image Clarity - Comparison between subject and predicate images to ensure equivalent visual quality of the captured images." It does not specify quantitative acceptance criteria or detailed performance metrics.

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 mentions "Simulated Use" testing for "Image Clarity - Comparison between subject and predicate images." However, it does not specify the sample size used for this comparison, nor does it provide any information on data provenance (e.g., country of origin, retrospective/prospective nature).

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)

The document does not provide any information about the number or qualifications of experts used for establishing ground truth or evaluating image clarity.

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

The document does not specify any adjudication method used for the image clarity comparison.

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

The document describes the device as an "Ophthalmic Camera" for "General ophthalmic imaging." It is a imaging acquisition device and does not include AI functionality. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not relevant to this submission, and no such study is mentioned.

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

This device is an ophthalmic camera. Its function is to capture images. It does not appear to incorporate an algorithm that independently processes or interprets images to provide a diagnosis or finding, nor does it claim AI capabilities. Therefore, a standalone algorithm performance study is not applicable and not mentioned. The "Simulated Use" test assesses the visual quality of the captured images, not the performance of an interpretive algorithm.

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

For the "Image Clarity" assessment, the implicit "ground truth" was a visual comparison to the predicate device's images to ensure equivalent visual quality. The document does not specify a separate, independent ground truth method like expert consensus on pathology, or outcomes data.

8. The sample size for the training set

The document concerns an ophthalmic camera, not an AI/ML algorithm requiring a training set. Therefore, this question is not applicable.

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

As the device is an ophthalmic camera and not an AI/ML algorithm, there is no training set and therefore no ground truth for a training set.

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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.

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