ALPHAMED SURGICAL SPEAR, MODEL 70-5000

• K Number: K091240
• Device Name: ALPHAMED SURGICAL SPEAR, MODEL 70-5000
• Manufacturer: ALPHAMED INC.
• Date Cleared: 2009-10-23 ( 179 days)
• Product Code: HOZ
• Regulation Number: 886.4790
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: N/A

Intended Use

AlphaMed Surgical Spears are intended to absorb fluids from the operative field during ophthalmic surgery

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for the AlphaMed™ Surgical Spear, and it primarily focuses on regulatory approval and substantial equivalence to a predicate device.

The document does not contain details about:

• A table of acceptance criteria or reported device performance.
• Sample sizes for test sets or data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone (algorithm only) performance studies.
• Types of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is a regulatory communication, not a scientific study report.

Regulation Number and Section

§ 886.4790 Ophthalmic sponge.

(a)
Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.