Search Results

OptoMedical Technologies OCT-Camera ID 21101A3 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 ID 21101A3 is indicated for the use as an aid in the diagnosis of physiologic conditions of the eye through non-contact optical imaging. Imaging of the various tissues of the eye is supported through the use of interchangeable lenses. It is indicated for use on all patient populations except premature and is suitable for patients ambulatory or confined. The system is indicated for use in supine imaging, mounted to the surgical microscope HS Hi-R NEO 900A NIR (Haag-Streit), and is suited for imaging patients under anesthesia.

Device Description

The OCT-Camera ID 21101A3 can connected via the camera port of surgical microscopes. The OCT-Camera ID 21101A3 is completely integrated into the surgical procedure by enabling the OCT imaging before, during, and after microsurgery without disrupting the microscopic view. Individual steps of surgical procedures can be visualized in real time. The OCT-Camera ID 21101A3 by OptoMedical Technologies GmbH facilitates the intraoperative use of OCT (iOCT). It is called OCT-Camera ID 21101A3, 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.

AI/ML Overview

The provided text describes a 510(k) submission for the OCT-Camera ID 21101A3, which is an ophthalmoscope using Spectral Domain Optical Coherence Tomography (SD-OCT). The submission aims to demonstrate substantial equivalence to a predicate device, the OCT-Camera (ID 21101A1).

The information provided is primarily focused on demonstrating substantial equivalence to a predicate device, not on proving that the device meets specific acceptance criteria through a clinical study. The "acceptance criteria" presented are in the context of meeting internal and external regulatory standards, and the "study" referred to is a series of non-clinical performance and safety tests.

Therefore, many of the requested categories for a clinical study proving device performance are not applicable or cannot be extracted from this document, as it is a 510(k) summary for regulatory clearance based on substantial equivalence.

Here's the information that can be extracted and a breakdown of why some fields are not available:

1. A table of acceptance criteria and the reported device performance

The document details various non-clinical performance and safety tests that were passed, rather than clinical performance metrics. The acceptance criteria are "PASSED required testing" for each standard.

Acceptance Criteria (Standard)	Reported Device Performance
Biocompatibility evaluation per ISO 10993-1	Demonstrated no direct patient-contacting materials (PASSED)
Electrical safety testing per ANSI/AAMI ES 60601-1	PASSED required testing
Electromagnetic Compatibility per IEC 60601-1-2	PASSED required testing
Laser Safety testing per IEC 60825-1	PASSED required testing
Light Hazard Protection per ANSI Z80.36-2016	PASSED required testing
Software V&V per IEC 62304/FDA Guidance, Moderate Concern	PASSED required testing (functional, system compatibility, risk analysis)
Usability engineering testing per IEC 62366-1	PASSED required testing
Risk Management per EN ISO 14971	All requirements met, risks reduced as far as possible

The document also provides technological specifications as part of the comparison to the predicate, which can be seen as performance characteristics:

Performance Characteristic	Subject Device (OCT-Camera ID 21101A3)	Predicate Device (OCT-Camera ID 21101A1)
Laser	830 nm	840 nm
Optical Power (OCT Light)	≤1500 μW at cornea during OCT scan	≤2350 μW at cornea during OCT scan
Resolution, Axial	≤ 7.5 μm in tissue	≤ 10 μm in tissue
Depth Range (in tissue)	2.8 mm	3.1 mm
Scan Rate	35000 A-Scans/s	15000 A-Scans/s

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided text. The document describes non-clinical engineering and safety tests, not a clinical study on a test set of patient data.

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)

This information is not available. The document focuses on technical and safety compliance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available. No clinical test set or adjudication process is described.

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

This information is not available. The device described is an imaging camera (OCT-Camera), not an AI-powered diagnostic algorithm designed to assist human readers, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-th e-loop performance) was done

This information is not available. The device is an imaging hardware system, not a standalone algorithm. Its function is to acquire, process, display, and save images for human interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not available. As there is no clinical performance study on a test set mentioned, there is no discussion of ground truth for such a study. The "ground truth" in the context of this document is adherence to various engineering, safety, and regulatory standards.

8. The sample size for the training set

This information is not available. The device is a hardware imaging system, and while it includes software (iOCT-Control3), the document does not suggest the software involves machine learning or requires a "training set" in the AI sense. Software validation is mentioned on a functional level.

9. How the ground truth for the training set was established

This information is not available. As no training set for an AI algorithm is indicated, no ground truth for it would be established based on this document.

Ask a Question

Ask a specific question about this device

K Number

K142953

Device Name

OCT-Camera

Manufacturer

OptoMedical Technologies GmbH

Date Cleared

2015-03-04

(145 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K120057

Intended Use

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.

Device Description

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.

AI/ML Overview

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.