RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES

• K Number: K980816
• Device Name: RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES
• Manufacturer: FCI OPHTHALMICS, INC.
• Date Cleared: 1998-09-18 ( 199 days)
• Product Code: HQX
• Regulation Number: 886.3340
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: N/A

Intended Use

Retinal detachment requiring surgical intervention to reattach the retina and preserve/reserve the patient's vision

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the text provided, I cannot fulfill your request. The document is a 510(k) clearance letter from the FDA for a device called "Retinal Detachment Implants." This letter confirms that the FDA has reviewed the device and determined it to be substantially equivalent to a legally marketed predicate device.

However, the provided text does not contain any information about:

• Acceptance criteria for the device's performance.
• A study that proves the device meets specific performance criteria.
• Device performance data (e.g., sensitivity, specificity, accuracy).
• Sample sizes for test or training sets.
• Data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies or their effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for the training set was established.

The document is purely an administrative clearance letter, not a technical report detailing performance studies.

Regulation Number and Section

§ 886.3340 Extraocular orbital implant.

(a)
Identification. An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.(b)
Classification. Class II.