(185 days)
The Vizual™ Phacoemulsification System is intended for use in the disruption and extraction of cataractous lens material from the eye with ultrasonic energy; a process known as phacoemulsification.
The Vizual™ Phacoemulsification system is a complete anterior segment surgical system, offering Irrigation, Phaco or Ultrasonic (U/S), Irrigation/Aspiration (I/A), Vitrectomy, and Coagulation modes of operation. The device can be operated as a standalone unit, or connected to an optional cart with electric I/V pole where bottle height can be controlled by the software. The Vizual™ Phacoemulsification System includes the Phaco unit, U/S handpiece, tubing cartridge, and foot pedal. The device has been designed to work with commercially available (and 510k cleared) components and accessories including Phaco tips and sleeves, vit cutters, cautery pencils, and cautery forceps. The Vizual™ Phacoemulsification System utilizes a non-invasive vacuum sensing system including an external tubing cartridge that vents to the bottle versus air, thus minimizing the possibility of introducing contamination into the fluid path. The external tubing cartridge design is advantageous as the fluid path is visible to the user, and can be easily installed or removed in a single step. The Vizual™ Phacoemulsification System uses a LCD touch panel interface to allow access to all modes of operation. The system software allows for storing up to twenty-four different user profiles.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Vizual™ Phacoemulsification System, Model 551:
This document is a 510(k) summary for a medical device. In the context of 510(k) submissions, the "acceptance criteria" are typically demonstrating substantial equivalence to a predicate device, rather than specific performance metrics like those for AI algorithms. The "study" proving this substantial equivalence usually involves comparing the new device's technological characteristics and intended use to those of a legally marketed predicate device.
The provided document does not describe a study involving AI or machine learning algorithms. Therefore, questions related to AI-specific performance metrics (such as sample sizes for test/training sets, ground truth establishment methods, expert adjudication, or MRMC studies) are not applicable.
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, the primary "acceptance criterion" is demonstrable substantial equivalence to a predicate device. The device performance is assessed by comparing its characteristics to the predicate.
| Acceptance Criterion (Implicit for 510(k) Substantial Equivalence) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Intended Use Equivalence: The new device must have the same intended use as the predicate device. | Vizual™ Phacoemulsification System: Intended for use in the disruption and extraction of cataractous lens material from the eye with ultrasonic energy, a process known as phacoemulsification. |
| Predicate Device (K020527): Implied to have the same intended use as the basis for substantial equivalence. | |
| Technological Characteristics Equivalence: The new device must have the same or similar technological characteristics as the predicate device, or any differences must not raise new questions of safety or effectiveness. | Display: LCD Touch Screen (Same as Predicate) |
| Pump: Peristaltic, low pulsation (Same as Predicate) | |
| Pump Vacuum Range: 0 to 500 mmHg (Same as Predicate) | |
| Aspiration Rate: 0 to 50 cc/min (Same as Predicate) | |
| Fluidics: External Fluid Path (Same as Predicate) | |
| System Tubing: Tubing/Cartridge unit (reusable and disposable models) (Same as Predicate) | |
| Vent: Fluid Vent (Same as Predicate) | |
| Modes: Irrigation, Phaco, Irrigation/Aspiration (I/A), Vitrectomy, and Coagulation (Same as Predicate) | |
| Programmable User Parameters: Yes (Same as Predicate) | |
| Safety and Effectiveness Equivalence: The new device must be as safe and effective as the predicate device. | Based on the presented characteristics, the sponsor asserts that "The Vizual™ Phacoemulsification System has the same technological characteristics as the predicate device cleared under 510(k) K020527," implying no new questions of safety or effectiveness are raised. The FDA's 510(k) clearance letter (K080803) confirms this determination of substantial equivalence. |
Regarding the Study:
The "study" to prove the device meets the acceptance criteria is a 510(k) substantial equivalence comparison. This is a regulatory pathway, not a clinical trial or performance study in the AI sense. The manufacturer compares their new device (Vizual™ Phacoemulsification System) to a legally marketed predicate device (K020527, Horizon Phacoemulsification System) to demonstrate that it is equally safe and effective.
Here's why the subsequent questions are not applicable to the provided document:
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This device is a surgical instrument (phacoemulsification system), not an AI algorithm that processes data. No "test set" of images or patient data is mentioned in this summary for performance evaluation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There is no "test set" or diagnostic ground truth being established as this is not an AI diagnostic device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or human adjudication process is described for this type of device submission.
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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
- Not applicable. This device is a surgical system, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. There is no "ground truth" in the AI sense required for this type of device. The "ground truth" for a 510(k) is the predicate device's established safety and effectiveness.
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The sample size for the training set
- Not applicable. This is not an AI algorithm requiring a training set.
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How the ground truth for the training set was established
- Not applicable. There is no training set for this device.
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.