(145 days)
OptoMedical Technologies OCT-Camera is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SD-OCT). The OCT-Camera is indicated for the use as an aid in the diagnosis of physiologic conditions of the eye through non-contact optical imaging of the various tissues of the eye is supported through the use of interchangeable lenses. It is indicated for use on patient populations from premature and neonatal infants to adult, and is suitable for patients ambulatory or confined. The system is indicated for use in supine imaging, mounted to a surgical microscope HS Hi-R NEO 900A NIR (Haag-Streit), and is suited for imaging patients under anesthesia.
The OCT-Camera can be attached to the camera port of surgical microscopes. The OCT-Camera is completely integrated into the surgical procedure by enabling the OCT imaging before, during, and after microsurgery without disrupting the microscopic view. The individual steps and the outcome of the surgical procedures, such as transplantation of the thin membranes or micro implants, are visualized in real time.
The OCT-Camera by OptoMedical Technologies GmbH facilitates the intraoperative use of OCT (iOCT). It is called OCT-Camera because it can be attached to the camera port of an operating microscope like any common camera that are used for the purpose of providing live view images of the surgical field.
The provided text is a 510(k) summary for the OptoMedical Technologies OCT-Camera. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device, the Bioptigen Envisu™ SDOIS.
However, the document states that NO clinical performance data was required or performed for this device (OCT-Camera). Therefore, the device inherently does not have acceptance criteria or a study that proves it meets acceptance criteria in the way you've requested regarding performance metrics like accuracy, sensitivity, or specificity, which would typically come from clinical evaluations.
The "acceptance criteria" discussed in this document refer to the device meeting specific non-clinical requirements (e.g., electrical safety, compliance with laser safety standards, and overall design and performance functionality) to demonstrate substantial equivalence to the predicate device, not its diagnostic performance against a ground truth.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
Since no clinical performance study was conducted to establish diagnostic acceptance criteria (e.g., sensitivity, specificity, accuracy), this table cannot be populated with such metrics. The acceptance criteria and "performance" are framed in terms of meeting regulatory and safety standards, and demonstrating substantial equivalence to a predicate device through non-clinical testing.
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (as stated in the document) |
|---|---|
| Overall design, performance, and electrical safety requirements met | "The OCT-Camara mets all the requirements for overall design, performance and electrical safety confirms that the output meets the design inputs and specifications. The OCT-Camara passed all testing and supports the claims of substantial equivalence and safe operation." |
| Compliance with light hazard protection | "The OCT-Camera complies with the applicable voluntary standards for light hazard protection and safe laser products." |
| Compliance with national and international standards | "The device passed all the testing in accordance with national and international standards." |
| Electrical Safety Testing | "IEC 60601-1, EN 60601-1-2" (Passed for both subject and predicate device) |
| Electromagnetic Compatibility | "IEC 60601-1: 2005 Medical electrical equipment – Part 1-2, General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests" and "IEC 60601-1-2: 2007 Medical electrical equipment – Part 1-2, General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests" (Passed) |
| Risk Management | "ISO 14971: 2007 Medical devices -- Application of risk management to medical devices" (Compliant) |
| Laser Product Safety | "IEC 60825-1: 2007 Safety of laser products - Part 1: Equipment classification and requirements" (Compliant) |
| Ophthalmic Instrument Requirements | "ISO 15004-2: 2007 Ophthalmic instruments -- Fundamental requirements and test methods -- Part 2: Light hazard protection" (Compliant) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable (no clinical testing was performed).
- Data provenance: Not applicable.
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)
- Number of experts: Not applicable.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: 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
- MRMC study: No. The device is not an AI-assisted diagnostic tool discussed in this context; it's an imaging device. The document explicitly states no clinical testing was required or performed.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: No. The device is not an algorithm, but an imaging camera for human use. No clinical performance testing against ground truth was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Not applicable. No clinical ground truth was established as no clinical studies were performed.
8. The sample size for the training set
- Sample size for training set: Not applicable. The device is not described as an AI/ML algorithm that requires a training set in the context of diagnostic performance studies. Non-clinical testing was performed for safety and effectiveness, but this doesn't involve a "training set" in the AI sense.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable.
§ 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.