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The LenSx Laser System is indicated for use:

• In the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
• In the creation of a lamellar cut/resection for lamellar keratoplasty, and in the creation of a penetrating cut/incision for penetrating keratoplasty.
• In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

The LenSx Laser System uses focused femtosecond laser pulses to create incisions and separate tissue in the lens capsule, crystalline lens, and the cornea. Individual photodisruption locations are controlled by repeatedly repositioning the laser focus. The light pulse is focused into a sufficiently small spot in order to achieve photodisruption of the tissue inside the focus. A tiny volume of tissue, a few microns in diameter, is thereby photodisrupted at the laser focus. The surgical effect is produced by scanning thousands of individual pulses per second to produce a continuous incision or tissue separation. The location of the tissue photodisruption is controlled by moving the focus of the laser beam to the desired surgical target location. A computer-controlled scanning system directs the laser beam throughout a three-dimensional pattern to produce an incision. The laser pulses are delivered through a Patient Interface accessory that is placed on the surface of the cornea and fixes the eye with respect to the delivery system. This 510(k) premarket notification is being submitted to seek clearance for an additional patient interface accessory to be offered for use with cataract procedures in addition to the original patient interface accessory to the LenSx Laser System (cleared under K120732 for cataract and lamellar resection procedures). The SoftFit Patient Interface differs from the original Patient Interface (K120732) in that it has an extended suction ring skirt that enables positioning of a soft contact lens against the internal surface of the patient interface glass. The soft contact lens is similar to a standard daily wear contact lens indicated for the correction of ammetropia, with a slightly modified edge to enable fitting into the SoftFit Patient Interface. The materials and manufacturing processes used for the soft contact lens component of the proposed SoftFit Patient Interface accessory are identical to the processes used for the predicate daily wear soft contact lens (K100244). With the soft contact lens insert in place, the SoftFit Patient Interface is then mounted onto the LenSx laser system for docking onto the eye in a manner that is identical to the original LenSx Laser Patient Interface. As a result, use of the soft contact lens substantially reduces intraocular pressure (IOP) during the laser procedure, enhancing comfort and addressing potential concerns in patients with a history of glaucoma. For cataract procedures, either a LenSx Laser Patient Interface or a SoftFit Patient Interface may be used. The original LenSx Laser Patient Interface is used for keratoplasty and corneal flaps.

The provided text describes a 510(k) premarket notification for an additional patient interface accessory (SoftFit Patient Interface) for the LenSx Laser System. The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device and to show that the new accessory does not raise new questions of safety or effectiveness.

Here's an analysis of the acceptance criteria and study information based only on the provided text:

1. Table of acceptance criteria and reported device performance:

The document doesn't explicitly define formal "acceptance criteria" in a quantitative manner (e.g., "accuracy must be >X%"). Instead, it describes performance evaluations conducted to demonstrate substantial equivalence to the predicate device, particularly focusing on the differences introduced by the SoftFit Patient Interface.

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

The document does not explicitly state the sample sizes used for the performance evaluations (e.g., number of eyes, number of procedures).

The data provenance is not explicitly mentioned as retrospective or prospective, nor is the country of origin.

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

This information is not provided in the document. The type of performance evaluation described (holding force, IOP, accuracy of laser patterns) suggests objective measurements rather than expert consensus on a diagnostic outcome.

4. Adjudication method for the test set:

Not applicable, as the performance tests described involve objective measurements rather than subjective assessments requiring adjudication.

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 device is a surgical laser system with a patient interface accessory, not an AI-assisted diagnostic or imaging device that would typically involve a multi-reader multi-case study to assess human reader improvement.

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

Not applicable. The "device" in question is a surgical laser system designed for in-vivo use with human intervention, not a standalone algorithm. The performance tests assessed the physical and mechanical aspects of the new patient interface.

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

The "ground truth" for the performance evaluations would be:

• Intraocular Pressure (IOP): Direct measurement using appropriate medical devices.
• Holding Force: Direct measurement using mechanical testing methods.
• Accuracy and Reproducibility of Cataract Treatment Patterns (depths and geometry): Measurement of the laser's physical output (e.g., incision depth, shape) using precision instruments (e.g., optical coherence tomography, microscopy, or other metrology tools).

8. The sample size for the training set:

Not applicable. The device described is a medical device (laser system accessory) and not an AI/ML model that requires a "training set."

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

Not applicable, as there is no training set for this type of medical device submission.

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The LenSx Laser System is indicated for use:

• · In the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
• · In the creation of a lamellar cut/resection for lamellar keratoplasty, and in the creation of a penetrating cut/incision for penetrating keratoplasty
• · In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea

The LenSx Laser System uses focused femtosecond laser pulses to create incisions and separates tissue in the lens capsule, crystalline lens, and the cornea. Individual photodisruption locations are controlled by repeatedly repositioning the laser focus. The light pulse is focused into a sufficiently small spot in order to achieve photodisruption of the tissue inside the focus. A tiny volume of tissue, a few microns in diameter, is thereby photodisrupted at the laser focus. The surgical effect is produced by scanning thousands of individual pulses per second to produce a continuous incisions or tissue separation.

The location of the tissue photodisruption is controlled by moving the focus of the laser beam to the desired surgical target location. A computer-controlled scanning system directs the laser beam throughout a three-dimensional pattern to produce an incision. The laser pulses are delivered through a sterile, disposable applanating lens and suction ring assembly that contacts the cornea and fixes the eye with respect to the delivery system.

The LenSx Laser System proposed in this 510(k) premarket notification is a modification of the previously cleared LenSx Laser System, manufactured by Alcon LenSx, Inc. (K101626). It is essentially the same laser system with the addition of a new indication for use, namely the creation of a corneal flap in patients undergoing LASIK surgery or other treatments requiring initial lamellar resection of the cornea.

Here's an analysis of the provided text regarding the acceptance criteria and study for the LenSx Laser System:

Acceptance Criteria and Device Performance Study for LenSx Laser System (K120732)

The provided 510(k) summary (K120732) describes modifications to the LenSx Laser System, primarily to add the indication for creating corneal flaps in LASIK surgery. The performance testing focused on demonstrating that the modified device, including the new indication, meets established criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document implicitly defines acceptance criteria by stating that the modified device was evaluated against criteria established for the predicate LenSx Laser and that the output met these. However, the specific quantitative values for these acceptance criteria are not explicitly detailed in the summary. The summary refers to:

2. Sample Size for the Test Set and Data Provenance

The document does not specify the sample size used for the test set. It mentions "Evaluation of the accuracy and reproducibility" but does not give the number of tests performed or the number of samples (e.g., eyes, tissues) used in these evaluations.

The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin. Given that it's a 510(k) submission for a device manufactured by Alcon LenSx, Inc. (USA) and evaluated for FDA clearance, it's likely the testing was conducted to meet US regulatory standards, possibly in the US or collaborating sites.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not explicitly mention the use of experts to establish a ground truth for the test set in the context of human evaluation. The testing described appears to be objective, physical measurements of the laser's output (depths, geometry, surface quality, energy stability).

4. Adjudication Method for the Test Set

Since the described testing primarily involves physical measurements of laser output rather than subjective interpretation, an adjudication method in the traditional sense (e.g., 2+1, 3+1 for expert review) is not applicable or mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed or described in this 510(k) summary. The device is a surgical laser, and the testing focuses on its physical performance rather than diagnostic accuracy involving human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The studies described are inherently "standalone" in the sense that they evaluate the physical output of the laser system itself (accuracy, reproducibility, energy stability). The device is a surgical tool, and its efficacy is determined by its ability to perform precise cuts, not by an algorithm's diagnostic output requiring human interpretation.

7. Type of Ground Truth Used

The ground truth used for these performance evaluations would have been objective physical measurements rather than expert consensus, pathology, or outcomes data. For example:

• Depth and Geometry: Verified by high-precision metrology tools (e.g., optical coherence tomography, microscopy, or other precise measurement techniques) after laser application to an appropriate test material or ex vivo tissue.
• Surface Quality: Evaluated using microscopy or surface profilometry.
• Energy Stability: Measured using appropriate power meters and sensors.

8. Sample Size for the Training Set

The document does not specify a training set size. The device is a physical laser system, and its modifications are based on engineering changes and software updates. It's not a machine learning or AI algorithm that would typically require a distinct "training set" in the conventional sense. The "training" in this context would refer to the engineering and design iterations leading to the final device parameters.

9. How Ground Truth for the Training Set Was Established

As there's no explicitly mentioned "training set" in the context of data for an algorithm, the concept of establishing ground truth for it is not applicable as understood for AI/ML devices. The "ground truth" during device development (analogous to a training phase) would have been the engineering specifications and performance targets that the designers aimed to achieve. These targets would have been derived from clinical needs, existing predicate device performance, and scientific understanding of ophthalmic surgery.

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