Search Results

The ASSOCIATE is intended for ophthalmic anterior and posterior segment surgery. It provides capabilities for phacoemulsification, phacofragmentation, diathermy coagulation, irrigation/aspiration, vitrectomy, illumination, air/fluid exchange and silicone oil injection & extraction.

The Associate is medical electrical equipment to be used during eye surgery. The Associate is intended for ophthalmic anterior and posterior segment surgery. It provides capabilities for phacoemulsification, phacofragmentation, diathermy coagulation, irrigation/ aspiration, vitrectorny, illumination, air/fluid exchange, silicone oil injection and extraction. The equipment has a display with touch screen for selecting and activating the functions. With the equipment a footswitch and a remote control are delivered for control by the surgeon. The equipment can be installed on a trolley and is able to control an automated infusion pole.

This document is a 510(k) summary for the ASSOCIATE Phacoemulsification/vitrectomy System. It primarily focuses on demonstrating substantial equivalence to existing predicate devices based on device description, intended use, and compliance with non-clinical safety standards. This particular submission does not contain information about acceptance criteria or a study proving the device meets those criteria from an AI/algorithm performance perspective.

The provided text describes a medical device, the "ASSOCIATE Phacoemulsification/vitrectomy System," and its intended use in ophthalmic surgery. It lists predicate devices and compliance with various safety standards (IEC, ISO). The FDA's 510(k) clearance letter confirms substantial equivalence to predicate devices.

Therefore, based on the provided text, I cannot extract the information required for your request.

The request specifically asks for information related to:

• A table of acceptance criteria and reported device performance.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size and ground truth establishment for the training set.

These details are characteristic of studies evaluating the performance of an AI/algorithmic diagnostic or prognostic device, often involving classification, detection, or measurement tasks. The ASSOCIATE device described here is a surgical instrument (hardware) used during eye surgery. Its performance is typically evaluated through different means, such as:

• Engineering specifications and tests: Flow rates, vacuum levels, ultrasonic power output, precision of controls, sterility, durability, etc. These would be detailed in technical specification documents and test reports, not typically in a 510(k) summary focused on substantial equivalence to predicates.
• Safety and biocompatibility testing: As indicated by the listed IEC and ISO standards.
• Usability studies: Ensuring the device is safe and effective for surgeons to operate.

Since the submission is for a surgical system and not an AI/algorithm, the concepts of "acceptance criteria," "test set," "training set," "ground truth," and "reader studies" in the context you've outlined for AI performance are not applicable to this document.

Ask a specific question about this device