(92 days)
KOWA SL-17 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.
The KOWA SL-17 is a non-invasive ophthalmic device that is able to illumination, magnification and observation of the human eye. It consists of a hand-held, battery powered slit-lamp biomicroscope with viewing and illumination optical systems and a stand.
The document provided (K133755) describes the KOWA SL-17, a non-invasive ophthalmic device intended for eye examination of the anterior eye segment. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device (KOWA SL-15, K063640), rather than proving the device meets specific performance criteria for novel claims.
Therefore, the study described is a substantial equivalence comparison to a predicate device, not a performance study against acceptance criteria in the typical sense for a new clinical claim. The "acceptance criteria" here refer to conformance with various standards and safety requirements to demonstrate that the new device is as safe and effective as the predicate.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for substantial equivalence, the "acceptance criteria" are compliance with relevant safety and performance standards, and the "reported device performance" is the confirmation that the device met these standards. There are no specific clinical performance metrics (e.g., sensitivity, specificity) listed for the KOWA SL-17 itself, as its function is observation and illumination, and its equivalency is largely based on technical specifications and safety.
| Acceptance Criteria (Standard / Evaluation) | Reported Device Performance |
|---|---|
| Performance: ISO10939 | The KOWA SL-17 met all requirements of the standard. |
| Electrical Safety: IEC60601-1 | The KOWA SL-17 met all requirements of the standard. |
| Electromagnetic Compatibility: IEC60601-1-2 | The KOWA SL-17 met all requirements of the standard. |
| Optical Safety: ISO15004-2 | The KOWA SL-17 met all requirements of Group 2 instrument in the standard. |
| Software Evaluation: FDA Guidance (2005, 2002) | Software was evaluated and confirmed to be appropriate. |
| Biocompatibility: Assessment | Biocompatibility assessment performed. Materials used are the same as other legally marketed devices (K063640). |
| Risk Management: ISO14971 | Risk management evaluation deemed satisfactory; no remnant risk. |
| Substantial Equivalence: CDRH Guidance 6/30/86 | KOWA SL-17 and the predicate device (KOWA SL-15) are substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
This submission focuses on engineering and safety testing. There is no clinical "test set" or patient data mentioned for validating clinical performance in the provided document. The testing involved compliance with various international standards for medical devices (ISO, IEC, FDA guidance), which typically involve laboratory or bench testing rather than patient data.
- Sample Size for Test Set: Not applicable as no clinical test set is described.
- Data Provenance: Not applicable as no patient data (country of origin, retrospective/prospective) is described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This type of submission relies on engineering standards and comparisons, not on expert-established ground truth for clinical performance.
4. Adjudication Method for the Test Set
Not applicable. There is no clinical test set requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. The document does not describe an MRMC comparative effectiveness study. The submission is for substantial equivalence to a predicate device, focusing on technical and safety aspects, not on improving human reader performance with AI assistance.
- Effect size of human readers improve with AI vs without AI assistance: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. The KOWA SL-17 is a physical medical device (a slit lamp biomicroscope) used directly by a human operator, not an algorithm that performs standalone analysis.
7. The Type of Ground Truth Used
Not applicable as there is no mention of a ground truth for clinical performance. The "ground truth", in this context, would be the requirements of the standards (e.g., ISO, IEC) which were met by the device.
8. The Sample Size for the Training Set
Not applicable. The KOWA SL-17 is a physical optical device, not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. 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.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.