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The VICTUS Femtosecond Laser Platform is indicated for use in:

• · the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea
• · for anterior capsulotomy during cataract surgery
• · the creation of cuts / incisions in the cornea in patients undergoing cataract surgery or other ophthalmic treatment requiring cuts / incisions in the cornea.
• · laser-assisted lens fragmentation of nuclear cataracts during cataract surgery, not for fragmentation of posterior subcapsular (PSC) and cortical cataracts

The VICTUS Femtosecond Laser Platform (VICTUS) is a precision ophthalmic surgical laser and is cleared for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea and for patients undergoing anterior capsulotomy during cataract surgery. The VICTUS has additionally been cleared for patients undergoing cataract surgery or other ophthalmic treatment requiring penetrating arcuate cuts / incisions in the cornea, primary/secondary corneal incisions, and laser-assisted lens fragmentation. This submission includes the next software iteration of version 3.3 and introduces a new S60 patient bed option for the VICTUS Platform. The v3.3 software introduces an additional pattern (grid pattern) which is a variation of currently cleared patterns and is being added to the already cleared lens fragmentation capability. In addition, the software introduces a lens apex detection feature. The previously cleared patient contacting lens and previously cleared suction clip assembly are combined in one convenient package for the user as the VERAFIT patient interface kit. With the exception of the introduction of a new S60 patient bed option, the VICTUS Platform hardware remains unchanged from that described and cleared via K151161. The mode of operation for the VICTUS Platform is using Yb:KYW Femtosecond laser to produce Laser-Induced Optical Breakdown (LIOB) of the corneal tissue. For all indications for use, laser pulses are delivered through a sterile disposable Patient Interface, consisting of a contact lens and suction clip to provide suction. The contact lens and suction clip assembly creates a reference surface for depth control and fix the eye relative to the delivery of the laser beam. Surgical effects are produced by scanning thousands of individual pulses, producing continuous incisions. The location of the tissue photodisruption is controlled by a fixed laser beam focused through a scanning optic system to the desired location.

This document is a 510(k) summary for the VICTUS Femtosecond Laser Platform, Model 14000. It describes the device, its indications for use, and a comparison to a predicate device (K151161). The document's purpose is to demonstrate substantial equivalence to the predicate device, not necessarily to detail comprehensive acceptance criteria and a full study proving the device meets them in the way a medical AI/software device would.

Based on the provided text, the device is a VICTUS Femtosecond Laser Platform, Model 14000, and the submission focuses on new software (v3.3) and a new patient bed option. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" are discussed in the context of demonstrating substantial equivalence to a predicate device, rather than proving a new clinical claim with specific performance metrics against a defined standard.

Here's an attempt to answer your questions based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of clinical acceptance criteria with specific performance metrics (e.g., accuracy, sensitivity, specificity, AUC) for the software changes. Instead, it refers to pre-defined acceptance criteria for non-clinical performance data (bench testing) and compliance with safety standards.

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

• Test Set Sample Size:
  • For Non-Clinical Performance Data (Bench Testing): The document states "A variety of test procedures were conducted" and "Different materials were used for the bench performance testing including: agarose gel, polyethylene terephthalate (PETG), and polymethyl methacrylate (PMMA)." However, it does not specify sample sizes (e.g., number of tests, number of samples of each material).
  • For Clinical Studies: "There was no clinical study performed to support substantial equivalence of this premarket notification." Therefore, there is no clinical test set sample size.
• Data Provenance: Not specified for the non-clinical (bench) testing. Since no clinical studies were performed, there's no clinical data provenance.

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. No clinical ground truth was established as no clinical studies were performed. The "ground truth" for the bench testing would be metrology readings against engineering specifications, not expert consensus on medical images.

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

Not applicable. No clinical ground truth or human interpretation/adjudication was performed for a test set in the context of this 510(k) submission.

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. No MRMC study was done, as this is a laser surgical device, not an AI diagnostic/interpretive tool for human readers.

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

This device is not an algorithm-only device. It's a surgical laser platform. The software (v3.3) introduces features like a new grid fragmentation pattern and an apex detection feature. The apex detection feature is described as "a user convenience and the physician must still review positioning results and confirm the treatment plan prior to initiating treatment," indicating it's a human-in-the-loop system where the software provides assistance, but the human (physician) retains ultimate control and decision-making power. Therefore, no standalone algorithm-only performance was done in the sense of a diagnostic AI.

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

For the non-clinical performance data (bench testing), the "ground truth" would be the engineering specifications and expected outcomes from the laser's interaction with the test materials (agarose gel, PETG, PMMA). This is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model in the sense that it requires a "training set" of data for learning. The software (v3.3) introduces pre-programmed patterns and detection features based on established physics and engineering, not a learned model from data.

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

Not applicable, as there is no training set for a machine learning model.

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