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K Number
K972727
Device Name
CBALK-1000 BLADE
Manufacturer
HOWARD INSTRUMENTS, INC.
Date Cleared
1997-10-10

(81 days)

Product Code
HNO
Regulation Number
886.4370
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The CBALK-1000 blades are to be used with the Chiron Microkeratome.

Device Description

CBALK-1000 Blades

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the CBALK-1000 Blades manufactured by Howard Instruments, Inc. This letter determines substantial equivalence to a predicate device, allowing the product to be marketed.

However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria. It is a regulatory clearance, not a performance study report.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for this specific device based on the given text.

§ 886.4370 Keratome.

(a)
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.(b)
Classification. Class I.