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The COMPACT INTUITIV System is an AC-powered device with a fragmenting needle for cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

The Single-Use Pack is used with the COMPACT INTUITIV System. The Single-Use Pack is sterilized using Ethylene Oxide and is designed for single use only.

The COMPACT INTUITIV System is a modular ophthalmic microsurgical system that is intended for use in anterior segment (cataract) surgery. The device is used to emulsify and extract a cataractous lens. The system has the same surgical functionality and software features found in the primary predicate device, the SOVEREIGN Compact Phacoemulsification System (K111446) cleared on December 29, 2011. Like the predicate, the COMPACT INTUITIV is a mid-tier peristaltic system with a user-friendly interface that has updated technology and hardware to meet current electrical and material safety standards. The COMPACT INTUITIV consists of the System Console, the Wireless Remote Control, the Four-Button Foot Pedal, and the Single-Use Fluidics Pack, Model OPO80

The provided text is a 510(k) Summary for a medical device called the "COMPACT INTUITIV System," a phacoemulsification system used for cataract surgery. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a standalone study with acceptance criteria and performance metrics for a novel technology.

Therefore, many of the requested details, such as a table of acceptance criteria for a novel algorithm, sample sizes for test sets, expert-established ground truths, and multi-reader multi-case studies, are not applicable or not provided in this document. The device in question is a physical surgical system, not an AI or imaging diagnostic tool that would typically involve such performance metrics.

However, I can extract information related to the device's validation and the methods used to demonstrate its safety and effectiveness, which serves as its "acceptance criteria" in the context of a 510(k) submission.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Device Performance

The acceptance criteria for the COMPACT INTUITIV System are fundamentally tied to its substantial equivalence to predicate devices (SOVEREIGN Compact Phacoemulsification System and SOVEREIGN Compact Disposable Tubing Set) regarding safety, effectiveness, and performance. The "performance" here refers to its functional operation in all anterior segment ophthalmic surgery modes.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Study Details:

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not specified. The document states that "Testing of all anterior segment ophthalmic surgery modes, including phacoemulsification, diathermy, irrigation, and vitrectomy, was conducted." This implies an engineering/bench testing approach rather than a patient-based test set with a specific sample size.
   • Data Provenance: The document does not specify a country of origin for any "data" in the sense of clinical or image data. The testing was non-clinical, involving engineering verification and validation. The manufacturer is Abbott Medical Optics Inc., located in Santa Ana, CA, USA.
   • Retrospective or Prospective: Not applicable as no clinical or human-subject data was used. The testing was non-clinical (bench testing) and prospective in nature for validating the new device design.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. As this is a physical surgical device undergoing non-clinical technical and safety testing, "ground truth" established by human experts in the context of diagnostic interpretation is not relevant. The "ground truth" for these tests would be the established performance characteristics and safety standards outlined in the regulatory guidances and predicate device specifications.

3. Adjudication method for the test set:

   • Not applicable. Since there's no diagnostic task or human variable interpretation, there's no need for an adjudication method like 2+1 or 3+1. Test results are objective (e.g., meeting a power output specification, passing a bio-compatibility test).

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC study was done. This type of study is relevant for diagnostic systems (e.g., AI in radiology), not for a surgical device like the COMPACT INTUITIV System. The device does not involve "human readers" or "AI assistance" in that context.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a surgical device, not an algorithm, so the concept of "standalone algorithm performance" is not relevant. The device itself operates, but always with a human surgeon-in-the-loop.

6. The type of ground truth used:

   • For the non-clinical tests, the "ground truth" was based on:
     • Compliance with recognized industry standards: (e.g., IEC 60601 series for electrical safety, ISO 10993 series for biocompatibility, ISO 14971 for risk management).
     • Performance specifications of the predicate devices: The COMPACT INTUITIV System was tested to perform "as safely and as effectively as" the predicate devices.
     • Internal AMO requirements and specifications: The device was developed and tested against these.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of an AI/machine learning model. This is a hardware device being validated against engineering and safety specifications.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for an algorithm.

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