(18 days)
The NON-MYDRIATIC RETINAL CAMERA TRC-NW8F is intended for use in capturing images of the retina and the anterior segment of the eye and presenting the data to the eye care professional, with the use of a mydriatic or without use of a mydriatic.
This product is a retinal camera designed to observe, photograph or record the fundus oculi of a patient without coming into contact with the patient's eye and provide as an electronic image the obtained fundus oculi information for subsequent diagnosis. This product can take both color photography and fluorescein angiography. This product is equipped with an observation monitor used for observation purpose and display of a photographed image. This product uses attached commercial digital single-lens reflex camera to photograph or record the fundus oculi of a patient. A photographed image may be recorded on a commercial memory card built into an commercial digital single-lens reflex camera or a personal computer (hereinafter referred to as a PC) or commercial memory devices (flash memories, hard disc, etc.). A commercial digital printer is connected and can print the observed images and the photographed images of the fundus.
Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets them:
Acceptance Criteria and Device Performance Study for NON-MYDRIATIC RETINAL CAMERA TRC-NW8F
Based on the provided 510(k) summary (K100207), the device is a retinal camera intended for capturing images of the retina and the anterior segment of the eye. The acceptance criteria and the studies that demonstrate the device meets these criteria are focused on safety and functional performance, primarily by adherence to established international standards and demonstrating substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance and Method of Assessment |
|---|---|---|
| Safety | Light Hazard Protection: Maximum exposure must be below accepted threshold limits. | "The maximum exposure has been demonstrated to be well below the accepted threshold limits set out in ISO 15004-2:2007." (See Attachment 3 for Test Reports). |
| General Electrical Safety: Conformity to IEC 60601-1 standards. | "Conformity to following standards: Medical Electrical Equipment Part 1: General Requirements for IEC 60601-1 Safety, 1988; Amendment 1, 1991; Amendment 2, 1995" (See Attachment 1 for Test Reports). | |
| Electromagnetic Compatibility (EMC): Conformity to IEC 60601-1-2 standards. | "Conformity to following standards: IEC 60601-1-2 basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, Edition 3:2007" (See Attachment 1 for Test Reports). | |
| Fundamental Requirements (General Ophthalmic Instruments): Conformity to ISO 15004-1 standards. | "Conformity to following standards: ISO 15004-1:2006 Ophthalmic instruments - Fundamental requirements and test Part 1: General requirements applicable to all methods ophthalmic instruments" (See Attachment 2 for Test Reports). | |
| Functional Performance | Resolving Power: Meets requirement values set out in TOPCON self-standards based on ISO 10940:1998. | "The resolving power... as defined in ISO 10940:1998 'Ophthalmic instruments -- Fundus cameras' have been measured and the result meet the requirement value set out in TOPCON self standards." |
| Photographic Angular Field of View: Meets requirement values set out in TOPCON self-standards based on ISO 10940:1998. | "...the photographic angular field of view as defined in ISO 10940:1998 'Ophthalmic instruments -- Fundus cameras' have been measured and the result meet the requirement value set out in TOPCON self standards." | |
| Overall Functionality | The device functions as intended. | "In all instances, the NON-MYDRIATIC RETINAL CAMERA TRC-NW8F functioned as intended." (Implied by successful completion of other tests and substantial equivalence claim). |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size or data provenance (e.g., country of origin, retrospective or prospective) for a clinical test set in the traditional sense of evaluating diagnostic accuracy.
The performance evaluation is based on engineering and performance testing against international standards (ISO, IEC) and internal TOPCON standards, which typically involve testing units of the device in a controlled environment, not on human subjects or clinical data in the context of diagnostic accuracy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in the context of the provided performance data. The device's performance is not being evaluated for diagnostic accuracy against a ground truth established by medical experts. Instead, it is being evaluated for compliance with technical standards related to safety and imaging capabilities by engineers and testing facilities.
4. Adjudication Method for the Test Set
The concept of an adjudication method (e.g., 2+1, 3+1) is not applicable here. Adjudication is used to resolve disagreements among experts when establishing ground truth for diagnostic accuracy studies. The studies described are technical compliance tests, not diagnostic performance evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on device safety and technical performance through compliance with standards, and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance. This device is a camera, not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This device is a retinal camera, a hardware device for image capture, not an algorithm. Therefore, an algorithm-only performance study is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance, in this context, is defined by:
- International Standards: e.g., ISO 15004-2:2007 (light hazard), ISO 10940:1998 (resolving power, field of view), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC).
- TOPCON Self Standards: For resolving power and photographic angular field of view, these internal standards serve as the performance benchmarks.
There is no "expert consensus," "pathology," or "outcomes data" ground truth utilized for the acceptance criteria described.
8. The Sample Size for the Training Set
Not applicable. This submission describes a medical imaging device (a camera), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As this is not an AI algorithm, there is no training set or ground truth establishment related to AI.
§ 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.