Search Results

The ELITA™ Femtosecond Laser System is an ophthalmic femtosecond laser indicated in the creation of corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea.
The ELITA™ Femtosecond Laser System is used in conjunction with a sterile disposable Patent Interface, consisting of a pre-sterilized suction ring assembly and pre-sterilized applanation cone, intended for single-use.

The ELITATM Femtosecond Laser System is an ophthalmic laser for corneal surgical operation. The system accurately cuts cornea tissue through a high pulse repetition rate and ultra-fast scanner to place pulses tightly next to each other, generating a continuous cutting surface. The system is controlled by the graphical user interface and software real-time controls. The optical delivery system determines a 3-dimensional position in the cornea at which the laser focuses. When the laser is emitted, the energy delivered is sufficient to photo-disrupt a small volume of tissue. The process of cutting involves repetitively setting a focus point and translating the laser cutting line generated by the resonant scanner. The ELITATM Femtosecond Laser System is a CDRH Class IV laser per 21 CFR 1040.10 and 1040.11 due to intentional laser exposure of the eye.

The provided text does not contain specific acceptance criteria, reported device performance metrics, or detailed study information for the ELITA™ Femtosecond Laser System and ELITA™ Patient Interface.

Instead, it is a 510(k) summary for a medical device seeking substantial equivalence to existing predicate devices. The core argument for acceptance is based on demonstrating that the new device is as safe and effective as the predicate devices, primarily through non-clinical testing and comparison of technological characteristics.

Therefore, I cannot populate a table of acceptance criteria and reported device performance, nor can I provide details on sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not discussed in the document in the context of specific quantitative criteria for this device.

Key points from the document regarding acceptance and studies:

• Acceptance Criteria: The primary acceptance criterion for the 510(k) submission is demonstrating substantial equivalence to predicate devices. This is achieved by showing that the ELITA™ system has:
  • Similar intended use.
  • Similar indications for use.
  • Similar fundamental scientific technology.
  • No new harms or unacceptable risks.
• Study That Proves the Device Meets Acceptance Criteria:
  • Type of Study: Non-clinical studies were performed, including:
    • Bench testing.
    • Electromagnetic Compatibility (EMC) testing.
    • Software verification and validation testing.
    • Design verification and validation testing.
  • Conclusion: These tests "demonstrate the system's ability to meet all intended design specifications" and provide "reasonable assurance that the system remains safe and effective for its intended use" and "is substantially equivalent to the iFS predicate device."
  • Clinical Data: "Clinical Data was deemed not necessary for the ELITA™ Femtosecond Laser System and ELITA™ Patient Interface" because the device does not introduce new indications/intended use or new harms/unacceptable risks.
  • Comparison to Predicates: A detailed comparison (Table 1) of the subject device (ELITA™) with a primary predicate (FEMTO LDV™ Z8) and a secondary predicate (iFS Advanced Femtosecond Laser System) was used to highlight similarities in:
    • Technological characteristics (e.g., femtosecond pulsed laser, operating principle, resection method, patient interface).
    • Indications for Use (with a note that ELITA™'s indications are "similar, more concise").
    • Laser type, wavelength, repetition rate, pulse duration, and spot size.

In summary, the document states that the device was accepted based on non-clinical testing demonstrating its performance against design specifications, and a detailed comparison showing substantial equivalence in functionality, safety, and effectiveness to legally marketed predicate devices, negating the need for clinical studies. Specific quantitative acceptance criteria or detailed results of these non-clinical tests are not provided in this 510(k) summary.

Ask a specific question about this device