(43 days)
A manual device intended to measure intraocular pressure by applanation (applying a small flat disk to the cornea)
Not Found
The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for the CSO Models A900 and F900 Applanation Tonometers. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain the detailed study information typically requested regarding acceptance criteria, device performance, and ground truth establishment.
Therefore, many of the requested details cannot be extracted from this specific document.
Here's what can be inferred or stated based on the provided text:
- Acceptance Criteria and Reported Device Performance: This information is not present in the document. The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical performance studies with defined acceptance criteria for novel device performance claims.
- Sample size for the test set and data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone (algorithm only without human-in-the-loop performance) study: Not mentioned. Since this is a manual tonometer, the concept of an "algorithm only" performance study is not applicable.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Summary based on the document:
This document is a regulatory clearance for a manual applanation tonometer. Its clearance is based on substantial equivalence to predicate devices marketed prior to May 28, 1976. This regulatory pathway means that no specific new clinical performance study, acceptance criteria, or ground truth establishment details are typically required to be submitted or are present in this type of 510(k) summary letter. The device's performance is implicitly considered acceptable because it is substantially equivalent to a device already deemed safe and effective.
§ 886.1930 Tonometer and accessories.
(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.