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Optomed Smartscope M5 digital camera with Smartscope FA optics module is intended to capture fluorescein angiograms of the human eye.

Optomed Smartscope M5 camera with Smartscope FA optics module is designed for use in a medical environment. Captured images and video are used for documentation and consultation. Optomed Smartscope M5 camera has a memory card where captured images and recorded videos are saved. Optomed Smartscope M5 camera is used with interchangeable optics modules previously cleared Smartscope EY4 and Smartscope ES2 and subject device Smartscope FA. Optics modules are attached to the camera with bayonet connectors.

Optomed Smartscope FA optics module is designed for fundus fluorescein angiography imaging of the human eye. Optomed Smartscope FA optics module includes two light sources: Blue light and infrared light, optical component that reflects light to the optical path and lenses that guide light through the pupil to the back of the eye and back to the camera sensor. Optomed Smartscope FA optics module has nine internal fixation targets for the patient to fixate on during imaging. Optomed Smartscope FA optics module receives power from Optomed Smartscope M5 digital camera.

Optomed Smartscope M5 camera has a WLAN module inside and when WLAN is used, Optomed Smartscope M5 camera transfers captured images and recorded videos to the PC automatically immediately after imaging. Images and videos can also be transferred to PC from the memory card when the camera is placed on Charging Station and the USB cable is connected between Charging Station and the PC. The image data transfer method to PC is similar as with any other USB mass storage device.

Optomed Smartscope M5 camera has a rechargeable Ni-MH battery that is charged when the camera is placed on Charging Station, which is connected to the mains by power supply cable. Charging Station can also be used as an external battery charger for the spare battery included in sales case. When Optomed Smartscope M5 camera is not used, it may be stored on Charging Station. Storing the device on Optomed Smartscope M5 camera Charging Station is not harmful for the battery.

The provided text describes the regulatory clearance of the Optomed Smartscope M5 with Optomed Smartscope FA. It outlines numerous performance tests and standards met by the device to establish its substantial equivalence to predicate devices. However, it does not include specific acceptance criteria with corresponding reported device performance in the format of a table, nor does it detail a study proving the device meets acceptance criteria in terms of diagnostic performance.

The information provided focuses on demonstrating safety, electromagnetic compatibility, optical safety, software validation, environmental testing, biocompatibility, optical performance (in relation to a standard), and usability. There is no mention of a clinical study assessing the device's diagnostic accuracy or effectiveness in capturing fluorescein angiograms against specific performance metrics (e.g., sensitivity, specificity for a particular pathology).

Therefore, based only on the provided text, the requested information regarding acceptance criteria and a study proving diagnostic performance cannot be fully extracted or answered.

Here's a breakdown of what can be extracted and what is missing:

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

The document lists various standards that the device complies with, which can be considered "acceptance criteria" in a broad sense for safety and basic functionality. However, it does not present these in a comparative table with specific performance metrics as usually seen for diagnostic devices (e.g., sensitivity, specificity, image quality scores).

Missing Information: There are no acceptance criteria or reported device performance metrics related to the diagnostic capability of capturing fluorescein angiograms (e.g., image quality scores deemed acceptable for diagnosis, agreement with expert graders for specific features, etc.). The "Optical performance" entry refers to compliance to an instrument standard (ISO 10940:2009), not clinical performance.

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

Missing. The document does not describe any clinical study involving a test set of patient data to evaluate the device's performance in capturing fluorescein angiograms. The performance data section focuses on engineering and regulatory compliance testing rather than clinical validation on a patient cohort.

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)

Missing. As no clinical test set is described, there's no mention of experts or ground truth establishment.

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

Missing. As no clinical test set is described, there's no mention of an adjudication method.

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

Missing. The document does not describe an MRMC study. This device is an ophthalmic camera for capturing images, not an AI-assisted diagnostic tool for interpretation.

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

Missing. This device is an imaging capture device. There is no mention of an embedded algorithm for standalone diagnostic performance being evaluated.

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

Missing. As no clinical study or test set is described, there's no mention of the type of ground truth used.

8. The sample size for the training set

The document does not describe any machine learning or AI component requiring a training set. The descriptions relate to the hardware and associated software fulfilling design requirements and safety standards.

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

Missing. As no training set or AI component is described, this information is not applicable.

Summary regarding diagnostic performance study:

The provided text details the compliance of the Optomed Smartscope M5 with Optomed Smartscope FA to various safety, electrical, mechanical, biocompatibility, and optical performance standards (e.g., IEC, ISO, ANSI). This typically constitutes the "performance data" required for a 510(k) submission to demonstrate substantial equivalence, particularly for a device primarily focused on image capture over automated diagnosis.

However, the document does not contain information about a clinical study that evaluates the device's effectiveness in terms of diagnostic image quality, accuracy in detecting ocular pathologies from fluorescein angiograms, or any other performance metrics typically associated with studies proving a medical device meets specific diagnostic acceptance criteria based on patient data. The "optical performance" mentioned refers to compliance with ISO 10940:2009 (Ophthalmic instruments - Fundus cameras), which likely deals with technical specifications of the camera itself (e.g., resolution, field of view stability) rather than its diagnostic utility on actual patient cases.

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Optomed Aurora Camera is a medical digital camera that is used with dedicated optics modules intended to capture images and video of the fundus of the eye and surface of the eye.

Optomed Aurora Camera with Optomed Aurora Retinal Module is intended to capture digital images and video of the fundus of the human eye.

Optomed Aurora Camera with Optomed Aurora Anterior Module is intended to capture digital images and video of the surface of the human eye and surrounding areas.

Optomed Aurora device set for ophthalmic imaging consists of Optomed Aurora Camera, Optomed Aurora Retinal Module and Optomed Aurora Anterior Module with following accessories Optomed Aurora Charging Station, USB cable, power supply, eye cups (2 pcs), batteries (2 pcs), USB flash drive and cleaning cloth.

Optomed Aurora Camera is designed for use in a medical environment. Captured images and video are used for documentation. Optomed Aurora Camera has a memory card where captured images and recorded videos are saved. Optomed Aurora Camera is used with interchangeable optics modules Optomed Aurora Retinal Module and Optomed Aurora Anterior Module. Optics modules are attached to the camera with bayonet connectors.

Optomed Aurora Retinal Module is designed for non-mydriatic fundus imaging. In non-mydriatic imaging no mydriasis is needed because infrared light is used for targeting the fundus and white light is flashed when an image is taken. The pupil does not respond to the infrared light so examination is convenient for the patient. With small pupils, it is recommended to use mydriatic drops. Optomed Aurora Retinal Module has nine internal fixation targets for the patient to fixate on during imaging. The middle fixation target provides a macula-centered image. The material of the eye cup is Momentive LIM 6030AB.

Optomed Aurora Anterior Module has two light sources for imaging eye surface and surrounding areas: white and cobalt blue light enables capturing of fluorescent images. There are four focus windows to focus the image. The material of the eye cup is Momentive Silopren LSR 4040.

Optomed Aurora Camera has a WLAN module inside and when WLAN is used, Optomed Aurora Camera transfers captured images and recorded videos to the PC automatically after imaging. Images and videos can also be transferred to PC from the memory card when the camera is placed on Optomed Aurora Charging Station and the USB cable is connected between Optomed Aurora Charging Station and the PC. The image data transfer method to PC is similar as with any other USB mass storage device.

Optomed Aurora Camera has a rechargeable Li-ion battery that is charged when the camera is placed on Optomed Aurora Charging Station, which is connected to the mains by power supply cable. Optomed Aurora Charging Station can also be used as an external battery charger for the spare battery included in sales case. When Optomed Aurora Camera is not used, it may be stored on Optomed Aurora Charging Station. Storing the device on Optomed Aurora Charging Station is not harmful for the battery.

The provided text describes a 510(k) premarket notification for the Optomed Aurora Camera with Optomed Aurora Retinal Module and Optomed Aurora Anterior Module. It focuses on demonstrating substantial equivalence to a predicate device (Optomed Smartscope M5 with Smartscope EY4 and ES2 optics modules) through various performance tests, rather than providing a detailed study that establishes specific acceptance criteria and then proves the device meets those criteria for general effectiveness.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" related to diagnostic performance (e.g., accuracy, sensitivity, specificity) is not explicitly present in the provided document. The document focuses on demonstrating that the new device is as safe and effective as the predicate based on engineering and safety standards, as well as functional similarities.

However, I can extract information regarding general acceptance criteria for safety, performance, and functionality, as well as the studies/tests conducted to meet these.

Here's a breakdown of what can be extracted and what cannot:

Information that can be extracted:

• Table of Acceptance Criteria and Reported Device Performance (interpreted from the document's structure): The document doesn't present a formal table with acceptance criteria versus reported performance in the way a diagnostic study would. Instead, it lists standards followed and states that the device "fulfills the requirements" or "complies with the standards."

Information that cannot be extracted from the document:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable to the types of engineering and safety tests performed. No patient image data test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not established as no diagnostic performance study is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 document does not describe an AI/CADe/CADx device or a clinical comparative effectiveness study involving human readers and AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm-only device. It's an ophthalmic camera.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there is no diagnostic performance study. The "ground truth" for the engineering/safety performance criteria are the standards themselves (e.g., meeting the electrical safety parameters of IEC 60601-1).
8. The sample size for the training set: Not applicable, as there is no AI/machine learning component described that would require a training set.
9. How the ground truth for the training set was established: Not applicable.

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FUNDUS MODULE 300 is an ophthalmic camera that is used as an accessory with dedicated slit lamps to capture digital images and video of the fundus of the human eye.

FUNDUS MODULE 300 device set for retinal imaging consists of FUNDUS MODULE 300 Camera with base plate, lens cover, battery and camera USB cable (0.6 m), and FUNDUS MODULE 300 Cradle with power supply and cradle USB cable (1.5 m). FUNDUS MODULE 300 is used with dedicated HAAG-STREIT slit lamps. FUNDUS MODULE 300 is designed to be used in medical environment and it is intended for nonmydriatic imaging of the fundus of the human eve for documentation and consultation. In nonmydriatic imaging no mydriatic is needed because infrared light is used for the targeting image to the fundus and visible light is flashed when an image is taken. The pupil does not respond to the infrared light so examination is convenient for the patient. Constant white light illumination for targeting can be selected from device menu if mydriatic drops are used. Images can also be taken using infrared lightning for both aiming and capturing. The FUNDUS MODULE 300 has 9 internal fixation targets for the patient to fixate at during imaging. The middle fixation target provides a macula centred image. FUNDUS MODULE 300 can be used together with HAAG-STREIT Release Module RM02 and HAAG-STREIT EyeSuite software. Controlling the FUNDUS MODULE 300 can be performed by Camera keys or by Release Module RM02. Captured images and recorded videos are automatically transferred to the PC (EyeSuite software) after imaging. Images and videos are stored on the micro SDHC memory card and can be also transferred to the PC by using Cradle USB connection. FUNDUS MODULE 300 Camera has rechargeable Li-lon battery and the device is charged by using the Cradle. Materials of outer shells of the FUNDUS MODULE 300 are plastic, aluminum and silicon. There is no applied parts (no parts which are designed to come into physical contact with the patient) in FUNDUS MODULE 300.

The provided document does not describe acceptance criteria for a device's clinical performance, nor does it detail a study proving such performance related to accuracy or effectiveness in a clinical context.

This document is a 510(k) summary for a medical device (HAAG-STREIT FUNDUS MODULE 300), which focuses on demonstrating substantial equivalence to a predicate device. The "Performance data" section refers to engineering and regulatory compliance testing rather than clinical performance testing with human subjects or expert assessment of diagnostic capability.

Therefore, most of the requested information regarding acceptance criteria, clinical study specifics, expert involvement, and ground truth establishment cannot be extracted from this document.

However, I can provide the available information from the document based on the categories you provided:

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Engineering):

Here's the breakdown of why the other requested information is not available and what little can be inferred:

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

   • Not Available. This document describes engineering and regulatory compliance testing (e.g., electrical safety, EMC, software V&V), not clinical efficacy or diagnostic accuracy studies. Therefore, there's no mention of a "test set" in the sense of patient data.

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. As there's no clinical test set with diagnostic outcomes, there's no mention of experts establishing ground truth in this context.

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

   • Not Applicable. No clinical test set data or adjudication process 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:

   • Not Applicable. This device is an ophthalmic camera, not an AI-powered diagnostic system. It captures images and video. No MRMC study is mentioned, nor any AI assistance.

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

   • Not Applicable. This is a hardware device for image capture; there's no "algorithm only" performance reported in a diagnostic context.

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

   • Not Applicable. For the engineering tests, the "ground truth" would be the standard's compliance requirements, not clinical diagnostic ground truth.

7. The sample size for the training set:

   • Not Applicable. This document does not describe an AI/machine learning device that would require a "training set."

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

   • Not Applicable. As above, no training set is described.

In summary, the provided document is a 510(k) summary for an ophthalmic camera, focusing on its technical specifications, changes from a predicate device, and compliance with various engineering and safety standards. It does not contain information about clinical performance studies, diagnostic accuracy, or AI evaluation.

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Optomed Smartscope M5 digital camera with EY4 optics module is intended to capture digital images and video of the fundus of the human eye. Optomed Smartscope M5 with optics module ES2 is intended to capture images and video of the surface of the human eye and surrounding areas.

Optomed Smartscope M5 digital camera with EY4 optics module is intended to capture digital images and video of the fundus of the human eye. The device set for retinal imaging consists of: Camera handset M5, Attachable ophthalmic lens EY4, Eye cup for EY4, Cradle for charging and image transfer, Slit Lamp Adapter. Optomed Smartscope M5 with optics module ES2 is intended to capture images and the surface of the human eye and surrounding areas. The device set for anterior ophthalmic imaging consists of: Camera handset M5, Attachable anterior ophthalmic lens ES2, Cradle for charging and image transfer. EY4 has an LED light source with visible white and infrared light. Also red light target LED's are used to eye position fixation during imaging. ES2 has an LED light source with white light and cobalt blue light. Image data is stored on the Flash memory card using 5 megapixel CMOS sensor and transferred to the PC by using USB connection. Device has rechargeable battery.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Optomed Smartscope M5:

Acceptance Criteria and Device Performance Study

The provided document (K132186) describes the Optomed Smartscope M5 digital camera with EY4 and ES2 optics modules and its substantial equivalence to a predicate device, the Optomed Smartscope M5 with EY3 and ES1 optics modules. The acceptance criteria for this 510(k) submission are primarily based on demonstrating substantial equivalence to the predicate device, particularly regarding safety and effectiveness, which were assessed through comparison of technical information and bench testing.

No specific quantitative clinical performance metrics (e.g., sensitivity, specificity for a diagnostic task) are presented in this 510(k) summary with explicit acceptance criteria and corresponding reported device performance values. Instead, the focus is on technical specifications, safety standards, and modifications that improve image quality or user experience while maintaining or exceeding the predicate's performance.

The "study" that proves the device meets the acceptance criteria is a bench test and comparison study against a predicate device, rather than a clinical trial with human participants assessing diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) summary, the "acceptance criteria" are implied by the technical specifications and safety standards followed, and the "reported device performance" is essentially the device meeting or improving upon these.

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

• Sample Size: Not applicable in the context of clinical images or patient data. The "test set" consists of the physical devices themselves undergoing bench testing.
• Data Provenance: The study is based on technical specifications, comparisons with a predicate device, and measurements from laboratory bench tests. All testing appears to have been conducted by Optomed Oy in Finland.

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

• Number of Experts: Not explicitly stated. The document mentions that the devices were "evaluated by Optomed development team and practicing physicians throughout the product development." No specific number or qualifications (e.g., years of experience, specialization) of these physicians are provided for establishing a "ground truth" for a test set in a diagnostic sense. Their role seems to be more in providing feedback during development rather than ground truth labeling for a specific dataset.
• Qualifications of Experts: The document generically refers to "practicing physicians."

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no mention of a formal adjudication process (e.g., 2+1, 3+1) for discrepant interpretations, as this was not a clinical effectiveness study involving human interpretation of images. The evaluation primarily involved technical measurements and comparisons.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through technical comparisons and bench testing.

• Effect Size of Human Readers Improvement with AI: Not applicable, as no MRMC study or AI assistance is mentioned.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable. This device is a digital camera, an image acquisition device, not an image analysis algorithm or AI system. Therefore, assessing "standalone performance" of an algorithm is not relevant to this submission.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this context is based on:
  • Technical Specifications and Standards: Compliance with international standards such as ISO 15004-2, EN 62471, IEC 60825-1, and ISO 10940 for resolution.
  • Bench Test Measurements: Maximum photometric luminance, ultraviolet, infrared, visible light, and near IR radiation levels.
  • Direct Comparison: Side-by-side comparison of device features and performance to a legally marketed predicate device.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a medical device for image acquisition, not an AI/ML algorithm that requires a training set.

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

• Ground Truth for Training Set Establishment: Not applicable. Since there is no AI/ML algorithm, there is no training set or associated ground truth.

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Optomed Smartscope M5 camera with optics modules EY3 and ES1 is a digital ophthalmoscope intended to capture digital images and video of the fundus of the human eye and surrounding area.

Optomed Smartscope M5 is a hand-held digital ophthalmoscope that together with the optics modules EY3 and ES1 is used to capture digital images and video of fundus and surrounding area of the human eye. M5 EY3 has an LED light source with visible white light and infrared light. M5 ES1 has an LED light source with white light and cobalt blue light. Image data is stored on the Flash memory card using 5 megapixel CMOS sensor and transferred to the PC by using USB connection. Device has rechargeable batteries.

The provided text describes a 510(k) summary for the Optomed Smartscope M5 ophthalmoscope and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (i.e., performance metrics, sample sizes, expert adjudication, etc.).

The document focuses on demonstrating substantial equivalence to predicate devices. It discusses:

• Device description and intended use: Capturing digital images and video of the fundus and surrounding area of the human eye.
• Comparison to predicate devices: Highlighting similar indications for use and technological features like digital image capture, storage, connectivity, illumination, and method of operation.
• Improvements over predicate devices: Such as infrared light for targeting, autofocus, improved image quality due to a new sensor and increased pixel resolution, and better connectivity to newer operating systems.
• Safety information: Specifically, optical radiation hazards as defined by the ISO 15004-2 standard.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and a study proving the device meets those criteria because it is not present in the provided text.

The document states that "Technical Information was gathered by side-by-side comparison and labeling of the devices. Optomed Smartscope M5 with optics modules EY3 and its predicates were also evaluated by Optomed development team and practicing physicians throughout the product development. Outcome of the evaluation is that ease-of-use and effectiveness of the Optomed Smartscope M5 with optics modules EY3 and ES1 is equivalent or better as its predicates." This implies some form of qualitative assessment, but it does not detail a structured study with quantifiable acceptance criteria or the specific elements you requested.

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Optomed Smartscope M3-1 EY1 digital ophthalmoscope is intended to capture digital images and video of the cornea, aqueous, lens, vitreous and retina of the human eye.

Optomed Smartscope M3-1 EY1 is a hand-held digital ophthalmoscope used to capture digital images and video of the cornea, aqueous, lens, vitreous and retina of the human eye. M3-1 EY1 has a LED light source. Image data is stored on the Flash memory card using 6.6 megapixel CMOS sensor and transferred to the PC by using USB connection. Device has rechargeable batteries.

The provided text describes the Optomed Smartscope M3-1 EY1, a digital ophthalmoscope, and its substantial equivalence to predicate devices for regulatory approval (K092056). However, the document does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding a ground truth establishment process for image analysis.

The document primarily focuses on establishing substantial equivalence to predicate devices (WELCH ALLYN 11810 Ophthalmoscope and KOWA GENESIS-D hand-held retinal camera) based on:

• Intended Use: Similar capabilities for capturing images/video of eye structures.
• Technological Features: Similar image capture methods, data storage, illumination, user interfaces, etc.
• Non-clinical Performance Data: Optical Equivalency and Radiation Safety measurements described in FDA's Ophthalmoscope Guidance.
• Field of View Comparison: The Optomed device's field of view is stated to be similar to or larger than the predicate Welch Allyn PanOptic Series 118 ophthalmoscope.

Therefore, it is not possible to fill out the requested table and sections as the provided text does not contain the necessary information regarding acceptance criteria, a specific performance study with a test set, ground truth, or details about training sets, MRMC studies, or standalone performance.

The document is a 510(k) summary, which typically focuses on demonstrating equivalence rather than providing detailed clinical study results against specific performance metrics for a novel technology or AI-driven diagnostic device.

If this were a submission for an AI/ML-driven device, the information requested (acceptance criteria, performance metrics, ground truth, study design, etc.) would be crucial. However, for a digital ophthalmoscope seeking equivalence to existing devices, the focus is on safety and effectiveness through technological similarity and adherence to established guidance.

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