(181 days)
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:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Accuracy and Reproducibility of Depths and Geometry (Previously Cleared Treatment Patterns) | The modified LenSx Laser was evaluated and met acceptance criteria established for the predicate LenSx Laser. |
| Accuracy and Reproducibility of Depths and Geometry (Lamellar Resections) | The modified LenSx Laser was evaluated using the same parameter acceptance criteria as the predicate and met them. |
| Surface Quality of Lamellar Resections | The modified LenSx Laser was evaluated using the same parameter acceptance criteria as the predicate and met them. |
| Energy Stability | The modified LenSx Laser was evaluated and met acceptance criteria established for the predicate LenSx Laser. |
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.
§ 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.