(191 days)
In the creation of corneal cuts/incisions (single-plane, multi-plane and arcuate), 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 corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
The LenSx Laser System is an ophthalmic surgical laser which uses focused femtosecond laser pulses to create incisions and to separate tissue within the lens capsule, crystalline lens, and the cornea. A femtosecond light pulses 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. A computer-controlled scanning system directs the focused laser beam throughout a threedimensional pattern to produce an incision. The surgical effect is produced by scanning thousands of individual pulses per second to produce a continuous incision or tissue separation.
The laser pulses are delivered through a Patient Interface accessory that is placed on the surface of the cornea and fixes the position of the eye with respect to the delivery system. Two models of the Patient Interface accessory are offered for use with the LenSx Laser System: the LenSx Laser Patient Interface and the LenSx SoftFit Patient Interface. Both models consist of a sterile, disposable applanating lens and suction ring assembly that contacts the cornea and fixes the eye with respect to the delivery system. In addition, LenSx SoftFit Patient Interface model comes with a soft contact lens that is positioned against the internal surface of the patient Interface glass. For cataract procedures, the LenSx SoftFit Patient Interface is used. For corneal flap procedures, the LenSx Laser Patient Interface is used.
The provided text describes modifications to the LenSx Laser System and its substantial equivalence to predicate devices, but it does not contain the specific details about acceptance criteria and a study proving those criteria as requested in the prompt.
The document states:
- "Evaluation of the accuracy and reproducibility of the depths and geometry of each of the previously cleared treatment patterns using the modified LenSx Laser in comparison to acceptance criteria established for the predicate LenSx Laser."
- "Evaluation of the accuracy and reproducibility of energy stability using the modified LenSx Laser in comparison to acceptance criteria established for the predicate LenSx Laser."
However, the actual values for these acceptance criteria are not provided, nor are the detailed results of the studies that would prove the device met these criteria. The document summarizes the findings in a high-level manner ("high degree of accuracy and reproducibility").
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, sample size, ground truth details, or info on MRMC studies based solely on the provided text.
Based on the provided information, I can only provide general statements about what was tested and concluded:
Summary of Device Evaluation (Limitations apply as specific criteria and study details are missing):
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Conceptual - specific values not provided in text) | Reported Device Performance |
|---|---|
| Accuracy and reproducibility of depths and geometry of cleared treatment patterns (based on predicate LenSx Laser) | Delivers a high degree of accuracy and reproducibility for corneal flaps, phacofragmentation patterns, capsulotomy, and corneal incisions/cuts. |
| Accuracy and reproducibility of energy stability (based on predicate LenSx Laser) | Delivers a high degree of accuracy and reproducibility in the generation of laser pulse energies up to 2.6 uJ (150 kHz) and 15 uJ (50 kHz). |
| Hardware modification verification criteria | All hardware modifications met required verification criteria. |
2. Sample Size and Data Provenance:
- The document does not specify sample sizes for any of the non-clinical tests.
- The data provenance (e.g., country of origin) is not mentioned. The testing is described as "Non-clinical Testing."
3. Number of Experts and Qualifications:
- The document does not mention the use of experts to establish ground truth for testing. The testing appears to be objective, engineering-focused verification and validation.
4. Adjudication Method:
- Adjudication methods are not applicable or mentioned, as the testing described is non-clinical performance verification.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was performed. The document explicitly states: "The scope of the software and hardware modification did not require clinical testing to establish safety and effectiveness of the modified device."
6. Standalone Performance (Algorithm Only):
- This is not an AI algorithm; it's a laser surgical system. The "performance data" refers to the accuracy, reproducibility, and energy stability of the physical device and its software functions in a non-clinical setting.
7. Type of Ground Truth Used:
- For the non-clinical testing, the "ground truth" would likely be engineering specifications, established physical measurements, and comparison to the performance of the predicate device. Details are not provided.
8. Sample Size for the Training Set:
- This is not an AI/machine learning device, so there is no concept of a "training set" in the context of the device's function or the described testing.
9. How Ground Truth for Training Set was Established:
- Not applicable (see point 8).
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.