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Phacoemulsification/extraction with ultrasonic power of cataractous lens from the eye.

The MicroPulse Phacoemulsification Console and foot switch, with third party accessories, will emulsify a cataractous lens and remove it from the eye, using the same technology that the predicate devices employ by using ultrasonic power. The MicroPulse Phacoemulsification Console modes of operation are similar to the predicate devices such as: Diathermy (Coagulation), U/S Phaco, Irrigation/Aspiration (I/A) and Vitrectomy. The component parts of the MicroPulse Phacoemulsification console include the console and foot switch. The U/S handpiece and tubing set are specified third party accessories. The Diathermy, Irrigation/ Aspiration, and Vitrectomy devices are universal type handpieces that are also considered additional third party accessories to the MicroPulse Phacoemulsification console. Trillium Medical will manufacture the console and foot switch only. Trilliums Distributers will add the third party accessories (see Exhibit B) to the console and foot switch to assemble a complete Phacoemulsification system.

The provided 510(k) summary for the MicroPulse Phacoemulsification Console indicates that the device's acceptance criteria and performance were established through a comparison to predicate devices, rather than a standalone clinical study with specific acceptance criteria in the typical sense (e.g., sensitivity, specificity, accuracy targets).

The core of this submission relies on demonstrating substantial equivalence to legally marketed predicate devices (The Wave Digital Phaco System K981989 and Circuit Tree Phacoemulsifier K954242). This means that the acceptance criteria are implicitly that the new device performs similarly in terms of its intended use and technological characteristics to these predicates.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence claim, the "acceptance criteria" are the characteristics of the predicate devices. The "reported device performance" is the MicroPulse system's characteristics as compared to those predicates.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable in the context of this 510(k) summary. The submission does not describe a clinical study with a "test set" of patients or data points in the conventional sense. The comparison is based on technical specifications and design similarities to predicate devices.
• Data Provenance: Not applicable. No patient data or clinical study data is presented. The information provided is about the device's technical characteristics and design.

3. 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 was no "ground truth" to establish in the context of a performance study on a test set. This was a substantial equivalence submission based on technical comparison.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No test set requiring expert adjudication was described.

5. 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 is not an AI-assisted device, nor was an MRMC study described. The device is a medical console for phacoemulsification.

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

• Not applicable. This is not an algorithmic or AI-based device. The submission focuses on the performance of the physical console and its operational modes. The "software" mentioned in the document relates to embedded microprocessors controlling the device's functions, not an independent algorithm for diagnostic or prognostic purposes.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. No "ground truth" in terms of clinical outcomes or pathology was used or needed for this type of 510(k) submission, which demonstrates substantial equivalence through technical comparison. The implicitly "ground truth" is that the predicate devices are safe and effective.

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or a "training set."

9. How the ground truth for the training set was established

• Not applicable. No training set or ground truth for such a set was part of this submission.

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