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The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for:

• viewing the posterior segment of the eye, including two- and three-dimensional imaging
• cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT)
• fundus imaging
• fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA)
• autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak)
• performing measurements of ocular anatomy and ocular lesions.

The device is indicated as an aid in the detection and management of various ocular diseases, including:

• age-related macular degeneration
• macular edema
• diabetic retinopathy
• retinal and choroidal vascular diseases
• glaucoma

The device is indicated for viewing geographic atrophy.

The SPECTRALIS HRA+OCT and SPECTRALIS OCT include the following reference databases:

• a retinal nerve fiber layer thickness reference database, which is used to quantitatively compare the retinal nerve fiber layer in the human retina to values of Caucasian normal subjects – the classification result being valid only for Caucasian subjects
• a reference database for retinal nerve fiber thickness and optic nerve head neuroretinal rim paramements, which is used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values of normal subjects of different races and ethnicities representing the population mix of the USA (Glaucoma Module Premium Edition)

The Heidelberg Engineering SPECTRALIS HRA+OCT is a device used to image the anterior and posterior segments of the human eye and to aid in the assessment and management of various diseases of the posterior segment, such as age-related macular degeneration, diabetic retinopathy, and glaucoma. The device is capable of acquiring infrared and blue reflectance images (K101223), as well as a composite color image referred to as "MultiColor image" due to addition of a green laser light source (K121993). New reference data for peripapillary retinal nerve fiber layer thickness and optic nerve head parameters have been added in K152205, as well as two (2) new accessory objective lenses (Wide Field, Ultra-Widefield), and OCT Enhanced Depth Imaging mode. In K172649, an updated 55° objective lens (WFO2) with enhanced anti-reflective coating was added to allow for Widefield MultiColor imaging, as well as an updated and faster spectrometer, called OCT2 module, a replacement of the patient and data management system, named Heyex 2, restructured user documentation, and Windows 10 support.

The modification to the SPECTRALIS is:
Widefield OCT - In addition to OCT imaging with the standard objective (for posterior segment imaging; 30° field of view) and the Anterior Segment Objective (anterior segment imaging; 30° field of view), OCT imaging is enabled with the Wide Field Objective (WFO) and Wide Field Objective 2 (WFO2). Both objectives provide a 55° diameter circular field of view. The field of view can be reduced by software to 35° and 25°. The only difference between WFO and WFO2 is an enhanced antireflective coating to allow for MultiColor imaging on the WFO2 (cleared in K172649). Both coatings cover the OCT wavelength, so OCT imaging can be enabled for both objective lenses.

This document describes the 510(k) summary for the SPECTRALIS HRA+OCT and variants, a medical device for ophthalmic diagnostic imaging.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria described for this device are primarily related to non-clinical performance (bench testing) and maintaining substantial equivalence to a predicate device. There are no explicit quantitative clinical acceptance criteria provided in the document in the format of a table with reported device performance against them.

However, based on the "NON-CLINICAL PERFORMANCE SUMMARY" and "OPTICAL RESOLUTION TESTING" sections, we can infer some criteria and reported performance:

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

The document does not describe a test set involving human subjects or clinical data in the traditional sense for evaluating device performance against a diagnostic endpoint. The performance evaluation is based on non-clinical bench testing.

• Sample Size for Test Set: Not applicable, as performance was assessed through bench testing on the device itself and a resolution test chart, not a separate clinical test set.
• Data Provenance: Not applicable, as it's not clinical data. The testing was performed by Heidelberg Engineering GmbH as part of their design control process.

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

Not explicitly applicable to this submission, as the evaluation is primarily for technical performance and substantial equivalence based on bench testing. There is no mention of "ground truth" derived from expert consensus for clinical disease states in this context. The "ground truth" for optical resolution, for example, is established by the known properties of the 1951 USAF resolution test chart.

4. Adjudication Method for the Test Set

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

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this document. This submission focuses on the technical modifications and substantial equivalence of the device, not an AI-assisted diagnostic workflow.

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

This device, the SPECTRALIS HRA+OCT, is a diagnostic imaging device that produces images for human interpretation and aids in detection and management. It is not an "algorithm only" device in the sense of AI-driven interpretation. Therefore, a standalone algorithm-only performance study is not directly relevant to this device's function as described. Its performance is related to its ability to acquire high-quality images and measurements, which are then used by clinicians.

7. The Type of Ground Truth Used

For the bench testing described, the "ground truth" effectively refers to physical standards and theoretical evaluations:

• Physical standards: Use of a 1951 USAF resolution test chart to objectively quantify optical lateral resolution.
• Theoretical evaluations: The measured optical resolution values were compared to theoretical expectations.
• Predicate device's established performance: The primary "ground truth" for this 510(k) is the performance and safety profile of the legally marketed predicate device (K172649), to which the modified device claims substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This document describes a modification to an existing imaging device, not a machine learning or AI algorithm that requires a training set of data.

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

Not applicable, as there is no training set for an AI algorithm mentioned for this device submission.

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The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for viewing the posterior segment of the eye, including two- and three-dimensional imaging, cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT), fundus photography, fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA), autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak) and to perform measurements of ocular anatomy and ocular lesions. The device is indicated as an aid in the detection and management of various ocular diseases, including age-related macular degeneration, macular edema, diabetic retinopathy, retinal and choroidal vascular diseases, glaucoma, and for viewing geographic atrophy as well as changes in the eye that result from neurodegenerative diseases. The SPECTRALIS HRA+OCT and SPECTRALIS OCT include reference databases for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which are used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values found in normal subjects.

The Heidelberg Engineering SPECTRALIS HRA+OCT is a device used to image the anterior and posterior segments of the human eye and to aid in the assessment and management of various diseases of the posterior segment, such as age-related macular degeneration, diabetic retinopathy, and glaucoma. The device is capable of acquiring infrared and blue reflectance images (K101223), as well as a composite color image referred to as "MultiColor image" due to addition of a green laser light source (K121993). New reference data for peripapillary retinal nerve fiber layer thickness and optic nerve head parameters have been added in K152205, as well as two (2) new accessory objective lenses (Wide Field, Ultra-Widefield), and OCT Enhanced Depth Imaging mode.

The modifications to the SPECTRALIS are:

1. OCT2 Module (OCT2) replacement of the Line Scan Camera and PC interface. OCT2 was developed due to the discontinuation of components.
2. Wide Field Objective 2 (WFO2) The WFO provides a 55° diameter circular field of view. The field of view can be reduced by the software to 35° and 25°. The AR-coating of the WFO was optimized in order to reduce the remaining reflections at the MultiColor wavelengths 486 nm. 518 nm and 815 nm. The AR-coating also allows for MultiColor imaging.
3. An upgrade to the data and patient management system (Heyex 2). Heyex 2 has the same basic functionality as the data and patient management system of the cleared SPECTRALIS, Heyex 1. The main improvements of Heyex 2 compared to Heyex 1 are an up-to-date and more scalable underlying image database, and a modern User Interface.
4. Windows 10 Operating System support.
5. Labeling The user manual has been updated to (1) improve clarity, (2) improve grammar and (3) include the modifications made to the SPECTRALIS HRA+OCT and variants. The Intended Use/Indications for Use of the modified device, as described in the labeling has not changed as a result of the modifications.

This FDA 510(k) summary does not contain information about a study that assesses a device's performance against specific acceptance criteria. Instead, it details modifications made to an existing device (SPECTRALIS HRA+OCT and variants) and argues for its substantial equivalence to a previously cleared predicate device (K152205).

The document's primary argument is that the modifications (OCT2 Module replacement, Wide Field Objective 2, Heyex 2 software upgrade, Windows 10 support, and labeling updates) do not change the intended use, indications for use, or fundamental scientific technology of the device. Therefore, no new clinical studies demonstrating performance against acceptance criteria are presented.

Here's a breakdown of why the requested information cannot be fully provided from this document:

• Acceptance Criteria & Reported Performance: No specific acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) are defined or reported. The document focuses on demonstrating that the modified device functions similarly to its predicate.
• Sample Sizes (Test/Training) & Data Provenance: No test or training sets are mentioned, as this is not a study assessing new clinical performance.
• Expert Ground Truth & Adjudication: These concepts are relevant to clinical performance studies, which are not detailed here.
• MRMC Comparative Effectiveness Study: There is no mention of a comparative effectiveness study, with or without AI assistance, as AI is not a component of this device as described.
• Standalone Performance: The document doesn't describe a 'standalone' performance study in the context of an algorithm's diagnostic accuracy. It's about ensuring the modified hardware and software components maintain the proven functionality of the predicate.
• Type of Ground Truth: Not applicable, as no performance study is being presented.
• Training Set Sample Size & Ground Truth: Not applicable, as no machine learning algorithm is being trained for diagnostic purposes in this context.

In essence, this 510(k) submission relies on the concept of substantial equivalence, where the modified device is deemed safe and effective because its changes are minor and do not alter its fundamental nature or intended use compared to a device already cleared by the FDA. The "study" here is more accurately described as a technical and risk assessment to confirm that the modifications do not negatively impact the device's established safety and effectiveness.

The "Non-Clinical Performance Summary" section mentions evaluations against recognized consensus standards (ISO 14971, AAMI/ANSI ES60601-1, IEC 60601-1-2, ISO 10993 series, IEC 60825-1, and AAMI/ANSI/IEC 62304). These standards cover aspects like:

• Risk management (ISO 14971)
• Medical electrical equipment safety (AAMI / ANSI ES60601-1)
• Electromagnetic compatibility (IEC 60601-1-2)
• Biocompatibility (ISO 10993 series)
• Laser product safety (IEC 60825-1)
• Medical device software lifecycle processes (AAMI / ANSI / IEC 62304)

Meeting these standards serves as the "acceptance criteria" for the non-clinical aspects of the device's modifications, ensuring that the new components and software continue to meet established safety and quality requirements. However, these are not tied to specific diagnostic performance metrics (e.g., sensitivity/specificity for disease detection) because the device's core diagnostic capabilities are considered unchanged from the predicate.

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