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General ophthalmic imaging including retinal, corneal, and external imaging.
-Photodocumentation of pediatric ocular diseases including retinopathy of prematurity (ROP).
-Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) (zone 1, stage 1 or 2, without plus disease, or zone 2, stage 3, without plus disease) or treatment-requiring ROP, defined as Type 1 ROP (zone 1, any stage, with plus disease; zone 1, stage 3 without plus disease; or zone 2, stage 2 or threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2, with plus disease)* in 35-37 week postmenstrual infants.

RetCam Ophthalmic Imaging Systems utilize a digital camera in a handpiece (with multiple field of view lenses) to capture color ophthalmic images including retinal, corneal, and external images. An on board computer (RetCam 3 Ophthalmic Imaging System) or laptop computer (RetCam Shuttle Ophthalmic Imaging System and RetCam Portable Ophthalmic Imaging System) is used to store, view, retrieve, and export the digital ophthalmic images. A standard Halogen light source is used in all RetCam Ophthalmic Imaging Systems to provide illumination to the eye through the handpiece. An optional Fluorescein light source is also available on the RetCam 3 Ophthalmic Imaging System.

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

Summary of Device and Changes:

The document describes the Natus Medical Incorporated RetCam Ophthalmic Imaging Systems (RetCam 3, RetCam Shuttle, RetCam Portable). These are digital cameras used for general ophthalmic imaging, photodocumentation of pediatric ocular diseases (including Retinopathy of Prematurity - ROP), and screening for specific types of ROP in 35-37 week postmenstrual infants.

The current submission (K182263) is for modified versions of previously cleared RetCam systems (K090326). The modifications include:

• Upgrade of the camera (due to obsolescence).
• Addition of DICOM communication features.
• Software updates to support these modifications.

The fundamental scientific technology and indications for use remain unchanged from the predicate device.

Acceptance Criteria and Device Performance (as reported):

The document does not detail specific, quantitative acceptance criteria in a tabular format, nor does it present specific performance metrics like sensitivity, specificity, or accuracy.

Instead, it states that the modified devices were tested and found to comply with relevant consensus standards and internal tests. The performance assertion focuses on substantial equivalence to the predicate device due to unchanged indications for use, fundamental scientific technology, operating principle, basic design, and materials.

Based on the provided text, the acceptance criteria are implicitly met by:

Detailed Study Information:

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

   • This document does not specify a separate test set or its sample size. The performance data section refers to internal testing of the modified devices (Image Comparison Test, Optics verification and Validation Test, ISTA Test) and compliance with standards. There is no mention of patient data (images) being used for a clinical or performance study to determine algorithm efficacy.

2. 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):

   • Not applicable / not provided. The document describes a medical device (ophthalmic camera system) that captures images, not an AI algorithm that interprets them. The "screening" indication refers to the device's capability to screen by providing images, not an automated diagnostic capability from the device itself. Therefore, there's no mention of experts establishing a ground truth for an algorithm's performance on a test set.

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

   • Not applicable / not provided. As above, no clinical test set for an algorithm is described.

4. 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. This document focuses on the clearance of an ophthalmic imaging system, not an AI-powered diagnostic tool. There is no mention of AI assistance or MRMC studies. The device is a camera system for clinicians to use, not an interpretation algorithm.

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

   • No. The device is an imaging system; it is not an algorithm for standalone performance.

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

   • Not applicable. No ground truth for algorithm performance is discussed. The "ground truth" for the device's function would be its ability to capture clear, diagnostically useful images, which is assessed through the internal tests (Image Comparison, Optics, ISTA) and compliance with imaging and electrical standards.

7. The sample size for the training set:

   • Not applicable. This device is an imaging system, not an AI algorithm requiring a training set.

8. How the ground truth for the training set was established:

   • Not applicable. No training set for an AI algorithm is discussed.

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• General ophthalmic imaging including retinal, corneal, and external imaging. .
• Photodocumentation of pediatric ocular diseases including retinopathy of prematurity (ROP). ♥
• Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) (zone 1, stage 1 or 2, . without plus disease, or zone 2, stage 3, without plus disease) or treatment-requiring ROP, defined as Type 1 ROP (zone 1, any stage, with plus disease; zone 1, stage 3 without plus disease; or Zone 2, stage 2 or 3, with plus disease) or threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2, with plus disease)* in 35-37 week postmenstrual infants.

The RetCam 3 Ophthalmic Imaging System utilizes a digital camera in a handpiece with multiple field of view lenses to capture color ophthalmic digital images including retinal, corneal, and external images. An on board computer is used to store, view, retrieve, and export the digital ophthalmic images. A standard Halogen light source is used to provide illumination to the eye through the handpiece. An optional Xenon light source is also available with the RetCam 3 to facilitate imaging with fluorescein angiography. Light intensity, camera focus, and image capture are controlled by the use of a RetCam 3 footswitch and can also be controlled by a keyboard on the RetCam 3 consoles. A console monitor is provided with the RetCam 3 for viewing images. Proprietary software is installed in the computer to capture, store, view, retrieve, and export ophthalmic images.

A device modification to the RetCam 3 is being made to replace the Xenon light source module with an LED light source module. Third party testing has been performed and formal certification has been obtained verifying compliance with the applicable IEC 60601 electrical safety and electromagnetic compatibility standards. Bench testing has verified comparable safe maximum light irradiance output of the Xenon and LED light source modules. Bench testing has verified comparable fluoresce dye responses to the Xenon and LED light sources.

This document describes the RetCam 3 Ophthalmic Imaging System, and a modification to replace its Xenon light source with an LED light source. The provided text primarily focuses on clinical performance data for screening Retinopathy of Prematurity (ROP) using the RetCam system, which supports the overall indication for use.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of numerical sensitivity and specificity targets. Instead, it presents the results of a clinical study and concludes that these results support the device's indications for use. For the purpose of this response, we'll infer the reported performance as the de-facto "met" criteria. The study aimed to measure the accuracy, reliability, and image quality of RetCam wide-field digital images to screen for ROP.

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

• Sample Size (Test Set): Eyes from 67 consecutive infants. The total number of eyes is not explicitly stated but implies 134 eyes if both eyes were imaged and analyzed per infant. However, the sensitivity and specificity values are based on 26 positive cases for ROP and 94 negative cases, suggesting a total of 120 cases (eyes or infants) for the ROP diagnosis evaluation. The document states "31 to 33 weeks and/or 35 to 37 weeks postmenstrual age (PMA)".
• Data Provenance: The study was a prospective trial. The geographical origin of the data is not explicitly stated, but the study was conducted by "Chiang, et. al." and published in "Archives of Ophthalmology," which suggests it's likely from a US-based medical institution, common for such publications.

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

• Number of Experts for Device Interpretation: Three (3) expert retinal specialist graders interpreted the images. Their specific qualifications (e.g., years of experience) are not detailed beyond "expert retinal specialist graders."
• Number of Experts for Ground Truth: The reference standard (ground truth) was established by experienced pediatric ophthalmologists using binocular indirect ophthalmoscopy (BIO). The exact number of these ophthalmologists is not specified.

4. Adjudication Method for the Test Set

The document states, "Images were interpreted by three expert retinal specialist graders who provided a diagnosis and evaluation of image quality. Findings were compared with a reference standard of binocular indirect ophthalmoscopy (BIO) by experienced pediatric ophthalmologists."

This implies that each of the three graders interpreted the images independently. There is no mention of a consensus or adjudication process among the image graders for their reported performance. Their individual performances are presented. The "ground truth" was established separately by BIO.

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 Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study with AI: The study described is not an MRMC study comparing human readers with and without AI assistance. It focuses on the diagnostic accuracy of human readers interpreting images acquired by the RetCam system compared to a clinical gold standard (BIO). The device is an imaging system, not an AI diagnostic tool.

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

• No Standalone Algorithm Performance: The device being evaluated is an imaging system, not an AI algorithm. The performance reported is that of human experts interpreting images generated by the device. Therefore, no standalone algorithm performance was conducted.

7. The Type of Ground Truth Used

• The ground truth used was expert clinical diagnosis by experienced pediatric ophthalmologists using binocular indirect ophthalmoscopy (BIO). This is a recognized gold standard for ROP diagnosis.

8. The Sample Size for the Training Set

• The document does not describe a training set for an AI algorithm. The study is a prospective trial evaluating the diagnostic performance of human interpreters using the RetCam imaging system.

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

• As there is no mention of an AI algorithm or a training set, the establishment of ground truth for a training set is not applicable to this document.

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Each and all above listed RetCam Systems are indicated for:

• General ophthalmic imaging including retinal, corneal, and external imaging; .
• Photodocumentation of pediatric ocular diseases including retinopathy of prematurity (ROP). .
• Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) (zone 1, stage 1 or 2, . without plus disease, or zone 2, stage 3, without plus disease) or treatment-requiring ROP, defined as Type 1 ROP (zone 1, any stage, with plus disease; zone 1, stage 3 without plus disease; or zone 2, stage 2 or 3, with plus disease) or threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2, with plus disease)* in 35-37 week postmenstrual infants.

RetCam Ophthalmic Imaging Systems utilize a digital camera in a handpiece with multiple field of view lenses to capture color ophthalmic digital images including retinal, corneal, and external images. An on board computer (RetCam II and RetCam 3) or laptop computer (RetCam Shuttle and RetCam Portable) is used to store, view, retrieve, and export the digital ophthalmic images. A standard Halogen light source is used in all RetCam configurations to provide illumination to the eye through the handpiece. An optional Fluorescein light source is also available with the RetCam II and RetCam 3 configurations. Light intensity, camera focus, and image capture are controlled by the use of a footswitch on all configurations and can also be controlled by a keyboard on the RetCam II and RetCam 3 consoles. Console monitors are provided with the RetCam II and RetCam 3 configurations for viewing images. The laptop monitor is used for viewing images with the RetCam Shuttle and RetCam Portable. Proprietary software is installed on the computers to capture, store, view, retrieve, and export ophthalmic images.

Here's a breakdown of the acceptance criteria and the study that supports the RetCam Ophthalmic Imaging System, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are not explicitly stated in a quantitative manner as "acceptance criteria" but are implied by the reported performance metrics of the device in screening for ROP. The study establishes the device's accuracy by demonstrating high sensitivity and acceptable specificity for identifying specific stages of ROP.

• Type 2 pre-threshold ROP (Zone 1, Stage 1 or 2, without plus disease, or Zone 2, Stage 3, without plus disease)
• Treatment-requiring ROP (Type 1 ROP: Zone 1, any stage, with plus disease; Zone 1, stage 3 without plus disease; or Zone 2, stage 2 or 3, with plus disease)
• Threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2, with plus disease) | Grader A: 1.0 (26/26)
  Grader B: 1.0 (26/26)
  Grader C: 1.0 (26/26) |
  | Specificity for Type 2 pre-threshold or worse ROP in 35-37 week postmenstrual infants.
  Same definition as above. | Grader A: 0.883 (83/94)
  Grader B: 0.851 (80/94)
  Grader C: 0.851 (80/94) |
  | Image Quality: Technical quality of images captured at 35-37 weeks PMA by trained NICU nurses. | 93.3% to 100% of images found to be "adequate" or "possibly adequate" |

Study Details

The study referenced is:
Chiang, et. al. (Telemedical Retinopathy of Prematurity Diagnosis Accuracy and, Reliability, and Image Quality: Archives of Ophthalmology; 2007;125(11):1531-1538)

1. Sample size used for the test set and the data provenance:

   • Test set sample size: Images from 67 consecutive infants were used. While the text refers to "eyes," the performance data is given for "26 cases of Type 2 Threshold ROP Or Worse" and "94 cases of no Type 2 Threshold ROP Or Worse," suggesting a total of 120 eyes/instances for the performance evaluation against the reference standard.
   • Data provenance: Prospective trial. Country of origin not explicitly stated, but the journal (Archives of Ophthalmology) is a US-based publication, suggesting US data or an internationally recognized standard of practice.

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

   • Number of experts for image interpretation: Three expert retinal specialist graders interpreted the images. Their specific qualifications (e.g., years of experience) are not detailed beyond "expert retinal specialist graders."
   • Number of experts for ground truth (reference standard): "Experienced pediatric ophthalmologists" performed binocular indirect ophthalmoscopy (BIO) to establish the reference standard. The number of these ophthalmologists is not specified.

3. Adjudication method for the test set:

   • The text describes three individual expert retinal specialist graders (Grader A, B, C) interpreting the images, and their findings were compared to a reference standard. It does not indicate an adjudication method (like 2+1 or 3+1 consensus) among these three graders to form a single "AI" diagnosis. Instead, the performance is reported per grader. The reference standard itself was established by experienced pediatric ophthalmologists using BIO.

4. 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, this was not an MRMC comparative effectiveness study involving human readers with vs. without AI assistance. The study evaluates the standalone performance of reading RetCam images by human experts against a clinical gold standard (BIO). The RetCam system itself produces the images, which are then interpreted by human experts; it does not feature an AI component that assists human interpretation in the sense of a diagnostic algorithm providing results.

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

   • No. The study describes human interpretation of images captured by the RetCam device. The RetCam is an imaging system, not an AI algorithm that provides diagnostic output. The "performance" refers to the accuracy of human graders interpreting the images acquired by the device.

6. The type of ground truth used:

   • Clinical Gold Standard: Binocular Indirect Ophthalmoscopy (BIO) performed by experienced pediatric ophthalmologists. This is a direct clinical assessment by experts, considered the gold standard for ROP diagnosis.

7. The sample size for the training set:

   • The text does not mention a training set. This study describes a clinical validation of an imaging device where human experts interpret the images, not an AI model that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable, as no training set for an AI model is described or implied.

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