(15 days)
Keeler PSL Classic Slit Lamp is an AC-powered Slit lamp biomicroscope. It 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 affects the structural properties of the anterior eye segment.
The Keeler Portable Slit Lamp comprises a rechargeable hand held portable illuminated biomicroscope system and a desk mounted base charger unit that is powered from a low voltage (12V) power supply.
The hand held unit incorporates a built-in rechargeable battery powering the illumination system. The illumination system and fixation targets are activated using a single/double click trigger located on the front of the grip/handle. To increase or reduce the light intensity there is a rheostat located below the eyepieces on the rear of the grip /handle.
The 10 x and 16 x magnifications optical system is controlled using the lever located under the adjustable eyepieces.
The Keeler PSL Classic Slit Lamp is a medical device designed for non-invasive illumination, magnification, and observation of the human eye. It is used to examine the anterior and posterior segments of the eye, aiding in the diagnosis of various eye conditions.
Here's an analysis of its acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific numerical acceptance criteria for performance metrics. However, based on the Summary of Performance Testing and the regulatory context of a slit lamp, the implicit acceptance criteria are related to safety, effectiveness, and functional equivalence to the predicate device.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on document) | Reported Device Performance (Summary) |
|---|---|---|
| Safety | Compliance with Optical Radiation Safety Standards | Met acceptance criteria |
| Compliance with Electrical Safety Standards | Met acceptance criteria | |
| Compliance with Electromagnetic Compatibility (EMC) Standards | Met acceptance criteria | |
| Reduced risk of physical injury | Risk reduced as much as practicably possible | |
| Effectiveness/Functionality | Operating range and usability | Met acceptance criteria |
| Performance in comparative study with predicate device | Judged to be as safe, as effective, and performs as well as predicate devices | |
| Clinical Performance | Performance in field trial in clinical environment | Met acceptance criteria and usability |
| Quality System Compliance | ISO 9001:2000 and BS EN 13485:2003 compliance | Keeler is a compliant company |
Note: The 510(k) summary does not provide specific quantitative metrics or thresholds for "acceptance criteria" (e.g., minimum luminescence, maximum scatter, specific dimensions of the slit). Instead, it relies on demonstrating compliance with recognized safety standards and functional equivalence to a legally marketed predicate device.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for any specific "test set" in the context of device performance. It mentions "units under test" for the safety evaluations and "field trial in clinical environment" for performance, but no numbers are provided for either.
The data provenance is not specified regarding country of origin, nor is it explicitly stated whether the clinical data was retrospective or prospective. Given the nature of a 510(k) summary for a slit lamp, any clinical "field trial" would likely be a limited prospective observation to confirm usability and basic functionality rather than a large-scale, long-term clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The relevant "ground truth" for a slit lamp device would typically involve clinical observations and diagnoses made by healthcare professionals. While a "field trial in clinical environment" is mentioned, there's no detail on how many experts were involved or their qualifications.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. This type of detail is typically not included in a 510(k) for a device like a slit lamp, especially when demonstrating substantial equivalence. The focus is more on demonstrating that the device functions correctly and safely, rather than on diagnostic accuracy studies requiring expert adjudication.
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 explicitly mentioned or indicated in the provided 510(k) summary. These types of studies are more common for diagnostic imaging devices where human interpretation interacts with AI algorithms. The "comparative study with its predicative devices" mentioned seems to refer to a technical and functional comparison rather than a human reader study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the Keeler PSL Classic Slit Lamp is a physical optical instrument, not an AI algorithm. Its performance is always "standalone" in the sense that it is the direct observation tool, with the human eye being the "reader."
7. The Type of Ground Truth Used
For the safety and technical performance tests (Optical Radiation Safety, Electrical Safety, EMC), the "ground truth" would be established by compliance with recognized international and national standards (e.g., IEC standards for medical electrical equipment).
For the "comparative study with its predicative devices" and "field trial in clinical environment," the "ground truth" would implicitly be the established clinical utility and performance of existing slit lamps, particularly the predicate KOWA SL-15, as interpreted by healthcare professionals using the device for its intended purpose. The document states its performance was "judged to be as safe, as effective and performs as well to predicate devices," implying informal clinical observation and feedback.
8. The Sample Size for the Training Set
This is not applicable. The Keeler PSL Classic Slit Lamp is an optical-mechanical device, not a machine learning or AI system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no "training set" for this type of device.
§ 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.