(64 days)
An AC-powered slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used in the fitting of contact lenses and to aid in the diagnosis of diseases or trauma which affect the structural properties or topographic features of the anterior eye segment.
The Haag-Streit brand BC 900 slit lamp is an instrument used for eye examination and the fitting of contact lenses. The device consists of a microscope combined with a light source that can be narrowed into a slit for illumination of the eye. Each is available with accessories to measure characteristics of the eye and to document actual shapes. The device is powered by 7 to 12V AC and 50-60 Hz.
The provided document is a 510(k) summary for the Haag-Streit BC 900 Slit Lamp, a device used for eye examination. It is a pre-market notification to the FDA, asserting substantial equivalence to a predicate device. As such, the document primarily focuses on establishing this equivalence rather than presenting an extensive study with detailed acceptance criteria and performance data as one might find for a novel device or a clinical trial.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a detailed table of device performance metrics in the way a clinical study report would for a new medical device. Instead, the core "acceptance criteria" presented here revolve around the concept of substantial equivalence to a predicate device.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as stated in 510(k) Summary) |
|---|---|
| Indications for Use are Same or Similar: Device diagnoses eye conditions and aids in contact lens fitting. | "The device and accessories are indicated as a non-invasive aid in the examination and diagnosis of eye conditions and in the fitting of contact lenses. The indications are the same as those claimed for the predicate devices." (Page 0, Section 5) |
| Technological Characteristics are Same or Similar: Device operates on the same principles and has comparable features. | "The technological characteristics are the same or similar to those found with the predicate devices where the eye is examined by projecting light onto it. Additionally, standard accessories are used for tonometry, examining the vitreous and fundus of the eye and contact lens fitting as those claimed for the predicate devices." (Page 0, Section 6) |
| Safety and Effectiveness are Equivalent: By demonstrating similar indications and technological characteristics. | Implied by the claim of substantial equivalence to the predicate device (Haag-Streit brand slit lamp 9000 BM). The FDA's letter (Page 1) confirms this determination. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a test set or provide information about data provenance (e.g., country of origin, retrospective/prospective). The submission is a regulatory filing for substantial equivalence, not a report of a specific study involving a test set of data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this submission. The 510(k) process for a device like a slit lamp primarily relies on engineering and performance specifications compared to an existing predicate device, rather than a study requiring expert consensus on a dataset for ground truth.
4. Adjudication Method
This information is not applicable to this submission. There is no mention of a study involving adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this document. This type of study is more common for diagnostic imaging AI systems to evaluate the impact of AI assistance on human reader performance.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not conducted or reported. The device in question, a slit lamp, is an optical instrument requiring a human operator, not an autonomous algorithm.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied in AI/diagnostic performance studies (e.g., pathology, outcomes data) is not directly applicable here. The "ground truth" for this 510(k) submission is the functional and performance characteristics of the predicate device (Haag-Streit brand slit lamp 9000 BM), to which the BC 900 Slit Lamp is being compared for substantial equivalence. The "truth" is that the new device performs within similar parameters and for the same indications as the already legally marketed predicate.
8. Sample Size for the Training Set
This document describes a medical device (slit lamp), not an AI algorithm. Therefore, there is no concept of a "training set" as used in machine learning.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI algorithm, this point is 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.