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510(k) Data Aggregation
(13 days)
EyeSuite Imaging is a software program intended for use for controlling digital imaging devices and for acceptance. transfer, display, storage and digital processing of documentational ophthalmic images and videos, acquired from computerized diagnostic instruments, through direct connection or through networks.
EyeSuite Basic is a patient and examination management system, acting as a base and communication platform for other EyeSuite software components.
EyeSuite Imaging is a software used by eye care professionals together with imaging systems on Haaq-Streit slit lamps or other devices. EveSuite Imaging requires a computer running Microsoft Windows in one of the following versions:
- Windows XP, SP3 (32 Bit) ●
- Windows Vista, SP2 (32 and 64 Bit) .
- . Windows 7. SP1 (32 and 64 Bit)
- Windows 8 and 8.1 (32 and 64 Bit) .
A slit lamp is an instrument consisting of a light source that can be focused to shine a thin sheet of light into the eye. It is used in conjunction with a biomicroscope. The lamp facilitates an examination of the anterior segment, or frontal structures and posterior segment, of the human eye. With an imaging system a two dimensional image or video of what is seen through the biomicroscope can be recorded into widely used data formats, such as TIFF or JPEG in case of still images or MJPEG in case of a video. These records can be used for documentational purpose or to explain findings to the patient. It is optionally possible to connect the software to a DICOM PACS for storing the recorded image data.
EyeSuite Imaging allows the user to control the Haag-Streit imaging devices attached to the slit lamp or other devices, enables recording of images or videos, allows to view, modify and store the results together with accompanying information such as patient data, information on camera settings or notes of the examiner. The examiner may also highlight significant image features by using the provided draw and measure tools that allow to add predefined overlays, pixel measurements or angle measurements in the image plane. The software is not able and not intended to provide any diagnosis, but it helps the user to examine the visible structures of the eye and enables him to present and store his findings.
EyeSuite Imaging is a software application which is part of the Haag-Streit EyeSuite software product family that is licensed to customers of Haag-Streit Imaging devices. All imaging data acquisition, processing or consistency-check related features are provided by the EyeSuite Imaging Extension component and the EyeSuite Imaging Viewer component. Standard elements such as user management, patient management. database connections, basic settings, installation and backup routines are provided by the EyeSuite Basic component. The architectural decision of isolating standard features into the EyeSuite Basic component was made to reuse these features in other EyeSuite software products.
The imaging modules supported by EyeSuite Imaging are the Haag-Streit IM900 and the Haag-Streit CM900. The EyeSuite Imaging software allows to take control of camera features such as exposure time, camera gain or white balance settings. The release modules supported by EyeSuite Imaging are the Haag-Streit RM01, the Haag-Streit RMX01 and the Haag-Streit Footswitch. These supplementary devices are registered accessory parts to the class II slit lamp microscope (FDA clearance number K100202),
The provided document is a 510(k) summary for the EyeSuite Imaging software. It describes the device's intended use and compares it to predicate devices to establish substantial equivalence. However, it explicitly states that the device is not intended to provide any diagnosis and therefore no clinical or non-clinical performance data was necessary to verify its safety and efficacy in terms of diagnostic performance. The validation primarily focuses on software functionality and compliance with standards.
Therefore, the requested information regarding acceptance criteria for diagnostic performance, details of a study proving such criteria are met, sample sizes for test/training sets, ground truth establishment, expert involvement, or MRMC studies for diagnostic improvement are not applicable or available in this document.
Here's a breakdown of the requested information based on the provided text, highlighting what is (and isn't) present:
1. A table of acceptance criteria and the reported device performance:
Since the device does not provide diagnosis, there are no diagnostic performance acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported performance metrics for diagnostic tasks. The document focuses on functional performance and compliance with software standards.
| Acceptance Criteria (Functional/Compliance) | Reported Device Performance |
|---|---|
| Software Functional Requirements | |
| Capture Imaging Data (Test Case 006) | Performed as intended |
| Drawing Overlays (Test Case 003) | Performed as intended |
| Quantities and units (Test Case 017) | Performed as intended |
| Image Evaluation (Test Case 007) | Performed as intended |
| Design Verification (Test Case 000) | Met requirements |
| Instructions for Use (Test Case 024) | Met requirements |
| DICOM Compliance | |
| DICOM PS 3:2011 | Compliant |
| JPEG Compression Compliance | |
| IEC 10918-1:1994 + Technical Corrigendum 1:2005 (Test Case U40) | Compliant |
| Risk Management | |
| ISO 14971:2007 + Corrected version 2007-10-01 | Complied with |
| IEC 62366:2007 | Complied with |
| Software Life Cycle Processes | |
| IEC 62304:2006 | Complied with |
| Electrical Safety (for integrated system, not just software) | |
| IEC 60601-1:2005 + A1:2012 | Complied with |
The study that proves the device meets these criteria is the "Software validation testing and image capture testing" mentioned in section 11. Specifically, the test cases listed (e.g., 1182_1021525_06011_Test Case 006) are the documented evidence of this validation.
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/provided. Since the performance validation is focused on software functionality and image handling rather than diagnostic accuracy, specific "test sets" of patient images for diagnostic evaluation, their sample size, or provenance of patient data are not detailed. The testing described appears to be internal software validation.
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):
Not applicable. As the software does not provide diagnosis, there's no "ground truth" to establish for diagnostic purposes in the context of patient data. The validation focused on verifying software behavior and compliance with specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No diagnostic adjudication method is described as the software does not perform diagnosis.
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 document explicitly states: "As the software is not able and not intended to provide any diagnosis, no clinical performance data was necessary to verify the safety and efficacy of the device." Therefore, no MRMC study for diagnostic effectiveness or human reader improvement was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, in a sense, the software validation testing documented in section 11 (e.g., "Software validation testing and image capture testing were performed on the EyeSuite Imaging Software") represents the standalone performance evaluation of the software's specified functionalities (capture, display, storage, processing, control). However, this is for functional performance, not diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the functional software validation, the "ground truth" would be the expected behavior defined by the software's design specifications and the requirements of the standards it aims to comply with. For example, for image capture, the ground truth is that the captured image accurately reflects the input from the device. For DICOM compliance, the ground truth is adherence to the DICOM standard. This is not patient-specific diagnostic ground truth.
8. The sample size for the training set:
Not applicable/provided. This device is not described as an AI/ML diagnostic algorithm that would require a "training set" of data in the common sense. It's an image management and control software.
9. How the ground truth for the training set was established:
Not applicable, as there is no mention of a training set or an AI/ML model for diagnostic purposes.
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(53 days)
An AC-powered slitlamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
An AC-powered Slitlamp Biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light. The slit lamp illumination is composed of the light source, the slit; collimation and imaging optics, and infrared and ultraviolet filters and a dielectric mirror. The slit lamps have the option to combine a background illumination together with the slit illumination.
This 510(k) summary describes a traditional medical device (Slit Lamps BM 900 / BQ 900 / BP 900) and not an AI/ML powered device. As such, the input document does not contain the information required to answer the requested questions about acceptance criteria and a study proving device conformance for an AI/ML device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (Slit Lamp BC 900) based on similar technology and function, and compliance with general safety and performance standards.
Therefore, I cannot provide a response for the following:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
The document only details the comparison of technological characteristics between the new devices and the predicate device, and the general safety and EMC data derived from testing one of the new models (BQ 900) against recognized standards (ISO 15004-2, ISO 10939, IEC 60601-1, IEC 60601-1-2). It concludes that the new devices are substantially equivalent to the predicate device and meet safety and effectiveness standards, but does not provide performance metrics or studies in the format requested for an AI/ML product.
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(385 days)
The LENSTAR LS 900 is a non-invasive, non-contact OLCR (Optical Low Coherence Reflectometry) Biometer used for obtaining ocular measurements and performing calculations to assist in the determination of the appropriate power and type of IOL (intraocular lens) for implantation after removal of the natural crystalline lens following cataract removal. The LENSTAR LS 900 measures:
- Axial eye length
- Corneal thickness
- Anterior chamber depth
- Aqueous depth
- Lens thickness
- Radii of curvature of flat and steep meridian
- Axis of the flat meridian
- White to white distance
- Pupil diameter
The LENSTAR LS 900 is a non-invasive, non-contact system for measuring the parameters of the human eye required to determine the appropriate IOL for implantation and to calculate the optimal power of the IOL. The LENSTAR LS 900 measures: axial eye length, corneal thickness, anterior chamber depth, lens thickness, radii of curvature of flat and steep meridian, axis of flat or step meridian, white to white distance and pupil diameter.
Acceptance Criteria and Device Performance for LENSTAR LS 900
This report details the acceptance criteria and the study conducted to demonstrate the substantial equivalence of the Haag-Streit LENSTAR LS 900 to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state quantitative acceptance criteria for the LENSTAR LS 900. Instead, it focuses on demonstrating "substantive equivalence" to existing, legally marketed predicate devices through a comparison of measurement data. The "acceptance criteria" can therefore be inferred as demonstrating a high degree of statistical correlation or agreement in measurements between the LENSTAR LS 900 and the predicate devices.
| Measurement Parameter | Acceptance Criteria (Inferred from Study Design) | Reported Device Performance (Summary from Clinical Study) |
|---|---|---|
| Axial eye length | Data demonstrates substantial equivalence to predicate devices (IOLMaster, OLCR, Accusonic A-Scan). | Analysis of clinical data substantiates equivalence to all predicates. |
| Corneal thickness | Data demonstrates substantial equivalence to predicate devices (OLCR, Accusonic A-Scan). | Analysis of clinical data substantiates equivalence to all predicates. |
| Anterior chamber depth | Data demonstrates substantial equivalence to predicate devices (IOLMaster, OLCR). | Analysis of clinical data substantiates equivalence to all predicates. |
| Lens thickness | Data demonstrates substantial equivalence to predicate devices (IOLMaster, OLCR). | Analysis of clinical data substantiates equivalence to all predicates. |
| Radii of curvature (flat/steep) | Data demonstrates substantial equivalence to predicate devices (IOLMaster, Keratron). | Analysis of clinical data substantiates equivalence to all predicates. |
| Axis of flat meridian | Data demonstrates substantial equivalence to predicate devices (IOLMaster, Keratron). | Analysis of clinical data substantiates equivalence to all predicates. |
| White to white distance | Data demonstrates substantial equivalence to predicate devices (IOLMaster). | Analysis of clinical data substantiates equivalence to all predicates. |
| Pupil diameter | Data demonstrates substantial equivalence to predicate devices (IOLMaster). | Analysis of clinical data substantiates equivalence to all predicates. |
| Aqueous depth | Data demonstrates substantial equivalence to predicate devices. (No specific predicate mentioned, but included in the list of measured parameters.) | Analysis of clinical data substantiates equivalence to all predicates. |
| IOL Power Calculation Aid | Functionality in assisting IOL power determination demonstrates substantial equivalence to predicate devices that provide similar assistance (e.g., IOLMaster). | The device performs calculations to assist in IOL determination, similar to predicate devices, and its measurements contribute to this equivalence. |
2. Sample Size and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample size for the test set of patients used in the clinical studies. It only states that "Two prospective, non-randomized, single site comparison studies were performed."
- Data Provenance: The studies were conducted in Berne, Switzerland. The data is prospective, as indicated by "Two prospective... studies were performed."
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts used to establish ground truth or their qualifications. The study design primarily focuses on comparing measurements obtained by the LENSTAR LS 900 with those from established predicate devices. The "ground truth" for the test set is effectively derived from the measurements produced by these predicate devices.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. The clinical summary indicates "comparison studies" were performed, meaning the data from the LENSTAR LS 900 was directly compared to the measurements from the predicate devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The studies described are focused on the equivalence of device measurements, not on the improvement of human reader performance with AI assistance. The LENSTAR LS 900 is a measurement device, not an AI-assisted diagnostic tool for human readers in the typical sense of an MRMC study.
6. Standalone Performance Study (Algorithm Only)
Yes, a standalone performance study was done implicitly. The clinical studies evaluated the LENSTAR LS 900's ability to measure various ocular parameters independently and then compared these measurements to those obtained by predicate devices. This constitutes a standalone performance evaluation in terms of its ability to produce measurements, even if the "algorithm" is inherent to the optical low coherence reflectometry technology itself rather than a distinct AI algorithm. The performance of the device's measurements was compared directly without human interpretation of its outputs in the validation.
7. Type of Ground Truth Used
The "ground truth" for the comparison studies was derived from the measurements obtained by legally marketed predicate devices. This means that the established and accepted accuracy of these existing devices (IOL-Master, OLCR, Accusonic A-Scan, Keratron) served as the reference for determining the equivalence of the LENSTAR LS 900's measurements.
8. Sample Size for the Training Set
The document does not mention a separate "training set" or its sample size. This is expected as the LENSTAR LS 900 is based on established optical principles (Optical Low Coherence Reflectometry) and does not describe a machine learning algorithm requiring a distinct training phase. Its development would involve engineering and calibration, not traditional machine learning training.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for a machine learning algorithm, there is no corresponding description of how ground truth for a training set was established. The device relies on physical principles and instrument calibration rather than data-driven learning for its primary function.
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(64 days)
An AC-powered slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used in the fitting of contact lenses and to aid in the diagnosis of diseases or trauma which affect the structural properties or topographic features of the anterior eye segment.
The Haag-Streit brand BC 900 slit lamp is an instrument used for eye examination and the fitting of contact lenses. The device consists of a microscope combined with a light source that can be narrowed into a slit for illumination of the eye. Each is available with accessories to measure characteristics of the eye and to document actual shapes. The device is powered by 7 to 12V AC and 50-60 Hz.
The provided document is a 510(k) summary for the Haag-Streit BC 900 Slit Lamp, a device used for eye examination. It is a pre-market notification to the FDA, asserting substantial equivalence to a predicate device. As such, the document primarily focuses on establishing this equivalence rather than presenting an extensive study with detailed acceptance criteria and performance data as one might find for a novel device or a clinical trial.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a detailed table of device performance metrics in the way a clinical study report would for a new medical device. Instead, the core "acceptance criteria" presented here revolve around the concept of substantial equivalence to a predicate device.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as stated in 510(k) Summary) |
|---|---|
| Indications for Use are Same or Similar: Device diagnoses eye conditions and aids in contact lens fitting. | "The device and accessories are indicated as a non-invasive aid in the examination and diagnosis of eye conditions and in the fitting of contact lenses. The indications are the same as those claimed for the predicate devices." (Page 0, Section 5) |
| Technological Characteristics are Same or Similar: Device operates on the same principles and has comparable features. | "The technological characteristics are the same or similar to those found with the predicate devices where the eye is examined by projecting light onto it. Additionally, standard accessories are used for tonometry, examining the vitreous and fundus of the eye and contact lens fitting as those claimed for the predicate devices." (Page 0, Section 6) |
| Safety and Effectiveness are Equivalent: By demonstrating similar indications and technological characteristics. | Implied by the claim of substantial equivalence to the predicate device (Haag-Streit brand slit lamp 9000 BM). The FDA's letter (Page 1) confirms this determination. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a test set or provide information about data provenance (e.g., country of origin, retrospective/prospective). The submission is a regulatory filing for substantial equivalence, not a report of a specific study involving a test set of data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this submission. The 510(k) process for a device like a slit lamp primarily relies on engineering and performance specifications compared to an existing predicate device, rather than a study requiring expert consensus on a dataset for ground truth.
4. Adjudication Method
This information is not applicable to this submission. There is no mention of a study involving adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this document. This type of study is more common for diagnostic imaging AI systems to evaluate the impact of AI assistance on human reader performance.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not conducted or reported. The device in question, a slit lamp, is an optical instrument requiring a human operator, not an autonomous algorithm.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied in AI/diagnostic performance studies (e.g., pathology, outcomes data) is not directly applicable here. The "ground truth" for this 510(k) submission is the functional and performance characteristics of the predicate device (Haag-Streit brand slit lamp 9000 BM), to which the BC 900 Slit Lamp is being compared for substantial equivalence. The "truth" is that the new device performs within similar parameters and for the same indications as the already legally marketed predicate.
8. Sample Size for the Training Set
This document describes a medical device (slit lamp), not an AI algorithm. Therefore, there is no concept of a "training set" as used in machine learning.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI algorithm, this point is not applicable.
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