(156 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Optical radiation safety according to ISO 15004-2 | Classified as Class 2 instrument per ISO 15004-2:2007 (meets standard) |
| Safety: Classified as "Exempt Group" LED product per EN 62471:2008 | "Exempt Group" LED product per EN 62471:2008 (meets standard) |
| Safety: Classified as Class 1 LED per IEC 60825-1:2001 | Class 1 LED per IEC 60825-1:2001 (meets standard) |
| Technical Equivalence (EY4 vs. EY3): Resolution | Improved to meet ISO10940 (Fundus camera standard) |
| Technical Equivalence (EY4 vs. EY3): Target LEDs | New target LEDs for eye position fixation |
| Technical Equivalence (ES2 vs. ES1): Illumination concept | Improved illumination concept and diffuser structure |
| Technical Equivalence (ES2 vs. ES1): Image Quality | New diffuser structure to improve image quality |
| Technical Equivalence (ES2 vs. ES1): Contrast | Separate baffle to enhance image contrast |
| Technical Equivalence (ES2 vs. ES1): Integration Times | Allows shorter camera integration times to reduce motion blur |
| Indications for Use: Capture digital images/video of fundus | Intended to capture digital images and video of the fundus |
| Indications for Use: Capture images/video of surface/surrounding areas | Intended to capture images and video of the surface and surrounding areas |
| Dioptre compensation (patient) | at least -20 D to +20 D (matches predicate) |
| Picture angle | 40 degrees (similar to predicate's "Over 40 degrees") |
| Storage media | Flash memory card (matches predicate) |
| Image data format | JPEG, MPEG-1, MPEG-4 (matches predicate) |
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
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MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through technical comparisons and bench testing.
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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.
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.