(350 days)
RESCAN 700 provides non-contact, high resolution, optical coherence tomographic (OCT) and biomicroscopic imaging of the anterior and posterior segment of the eye via an ophthalmic surgical microscope. The RESCAN 700 is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging of posterior ocular structures, including retina, macula, and optic disc, as well as imaging of anterior ocular structures, including the cornea, lens and anterior chamber angle.
RESCAN 700 uses the assistance system (CALLISTO eye) that provides non-diagnostic video documentation and image capture for ophthalmic surgeries. The assistance system allows the remote control of RESCAN 700.
RESCAN 700 brings Spectral Domain OCT technology to the Zeiss OPMI Lumera 700 ophthalmic surgical microscope. Used in conjunction with the assistance system, CALLISTO eye, OCT images taken intra-operatively are presented on the monitor and may also be seen within the surgeon's oculars using the OPMI Lumera 700's integrated data injection system (IDIS). OCT images may be stored for subsequent retrieval using CALLISTO eye's data management system. RESCAN 700 can be controlled via the touch panel of the assistance system or via the foot control panel of an ophthalmic surgical microscope.
The proposed RESCAN 700 device and its primary functionality remain unchanged from the previously cleared device while including the following modifications:
Improvement of OCT Visualization
Increased Power of OCT Beam
Increased Scan Depth
RESCAN 700 is used with CALLISTO eye Software version 3.6.
CALLISTO eye Software version 3.6 is an assistance, information, and documentation system to support ophthalmic surgical procedures. CALLISTO eye software operates as an adjunct to the OPMI Lumera family of ophthalmic surgical microscopes to process real-time videos and OCT data (B-Scan images). CALLISTO eye must be installed on a touchscreen Panel PC; the Panel PC is offered as an accessory.
In conjunction with RESCAN 700 the following modifications were added to CALLISTO eye Software version 3.6.
Ability to record surgical videos directly to a connected USB hard drive.
The OCT function was enhanced by adding OCT XY-tracking for the Scan Location Marker. The functionality is similar to the Z-tracking function but works in the XY-plane instead of the Z-axis.
Here's a breakdown of the acceptance criteria and study information for the RESCAN 700 device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary doesn't explicitly define "acceptance criteria" in a quantitative, pass/fail manner for the changes made to RESCAN 700. Instead, it describes general improvements and then presents a clinical study to confirm the acceptability of these changes. The core "acceptance criteria" for this submission would be that the modifications do not raise new issues of safety or effectiveness and that the upgraded device performs at least as well as, or better than, the predicate device, especially regarding image quality at new scan depths.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| OCT Visualization Improvement: Optimized noise reduction and increased OCT beam power should result in improved visual appearance and signal-to-noise ratio of live OCT images. | The modifications were implemented to improve OCT visualization and remained compliant with applicable standards. |
| Increased Scan Depth Acceptability: New scan depths (2.9 mm, 5.8 mm) should provide clinically acceptable image quality. | 2.9 mm scan depth: Image quality was similar to the predicate's 2.0 mm (corneal and glaucoma subgroups), and rated slightly higher in the retinal surgery subgroup. Conclusion: Acceptable. |
| 5.8 mm scan depth: Rated lower than 2.0 mm and 2.9 mm in corneal and glaucoma subgroups, but may provide additional spatial context at the expense of finer detail. Conclusion: Acceptable for specific use cases (additional spatial context). | |
| Safety and Effectiveness: Modifications must not raise new issues of safety or effectiveness compared to the predicate. | The modifications do not raise new issues of safety or effectiveness. The device conforms to applicable FDA recognized, international IEC, and ISO standards for performance and safety (e.g., ISO 14971, ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 62366-1, ISO 10936-2, ISO 15004-2, IEC 62471). |
| Software Functionality: CALLISTO eye software version 3.6 with new features should function as intended without adverse impact on RESCAN 700. | Software verification and validation activities were successfully completed, proving RESCAN 700 and CALLISTO eye meet requirements and perform together as intended. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study): 22 participants
- 11 with corneal conditions
- 7 with glaucoma
- 4 with retina conditions
- A total of 84 images were obtained.
- Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. Given it's a "clinical study" and "participants were enrolled," it suggests a prospective study. The location is not specified, but the manufacturer is Carl Zeiss Meditec AG, Germany, with a US contact, so it could be in either region or internationally.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Three (3) independent, masked graders.
- Qualifications: The document does not specify the exact qualifications (e.g., "radiologist with 10 years of experience"). However, given the context of ocular surgery and OCT images, it's highly probable these were ophthalmologists or similarly qualified eye care specialists with experience in interpreting OCT images. The term "graders" typically implies expertise in evaluating clinical images.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated as a formal adjudication method (like 2+1, 3+1). However, the document mentions "fair to good concordance between graders," suggesting that while there were three independent graders, a formal resolution process for disagreements is not detailed. The results likely involved an analysis of the ratings from all three for each image.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
- MRMC Study: Yes, a type of MRMC study was conducted. The study compared the visualization quality of OCT images from two RESCAN 700 systems (predicate vs. modified with new software/capabilities) using three independent graders across multiple cases (22 participants, 84 images).
- Effect Size of Human Readers' Improvement with AI vs. without AI Assistance: This specific information is not provided. The study aimed to compare image quality between different device versions and scan depths, not explicitly to measure the improvement of human readers with AI assistance versus without. The CALLISTO eye system provides "assistance" (non-diagnostic video documentation, image capture, remote control, and new "Cockpits" for information visualization), but the study's focus was on the inherent image quality differences produced by the hardware/software modifications, not on a human-AI interactive improvement metric.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, a standalone algorithm performance study was not explicitly described for diagnostic purposes. The CALLISTO eye is an "assistance system" that provides "non-diagnostic video documentation and image capture." The "improvement of OCT Visualization" involved optimized standard image processing methods for noise reduction, which could be considered an algorithmic enhancement, but its performance was evaluated via the clinical study where human graders assessed the resulting images. There is no mention of the device making automated diagnoses or measurements that were evaluated in a standalone manner against a ground truth.
7. The Type of Ground Truth Used
- Ground Truth: The clinical utility and quality of the images were assessed by expert consensus/opinion (three independent, masked graders). There's no mention of pathology, long-term outcomes data, or other objective measures being used for ground truth in this specific image quality study.
8. The Sample Size for the Training Set
- Training Set Sample Size: This information is not provided in the document. The general description focuses on the verification and validation of the modified device, not on the development or training of specific machine learning models within the device that would require a distinct training set. The "optimized image processing methods for noise reduction" likely involved internal development and testing, but details on a formal training set for this are not disclosed.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth: As the training set size is not provided, how its ground truth was established is also not described. If "optimized image processing methods" involved machine learning or AI, the ground truth for such internal training would have typically involved expert-labeled images or simulations. However, this level of detail is absent from the 510(k) summary.
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.