(316 days)
The LenSx 550 Laser System is indicated for anterior capsulotómy during cataract surgery.
The LenSx 550 Laser is an ophthalmic surgical laser intended for use in patients requiring an anterior capsulotomy. The LenSx 550 Laser focuses a beam of low energy pulses of infrared light into the anterior lens. Consistent with commercially available femtosecond lasers used for lamellar resection of the cornea (GEX, 878.4810), the cutting effect is produced by scanning individual pulses to produce a continuous incision. The location of the tissue photodisruption is controlled by moving the focus of the laser beam to the desired location. A computer-controlled scanning system directs the laser beam throughout a three-dimensional pattern to produce an incision. Finally, the laser pulses are delivered through an off-the-shelf disposable contact lens that contacts the cornea and fixes the eye with respect to the delivery system.
Here's a breakdown of the acceptance criteria and study details based on the provided text, where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pre-Clinical: | |
| Uniform capsulotomy | Produced uniform capsulotomies |
| Accurate capsulotomy size | Produced accurate capsulotomies in size |
| Predictable capsulotomy size | Produced predictable capsulotomies in size |
| Smooth capsular edge | Capsular edge was at least as smooth as with manual capsulotomy |
| Clinical: | |
| Successful anterior capsulotomy (complete, no radial tears, IOL in capsular bag) | Anterior capsulotomy was successfully performed in all eyes (complete in all, no radial tears observed intraoperatively or postoperatively, IOL placed in capsular bag) |
| Unremarkable postoperative course & centered IOL | Postoperative course was unremarkable, IOL was centered in all study eyes |
| No posterior capsule tears | No posterior capsule tears were observed |
| Well-centered capsulotomies (visual inspection by surgeon) | All capsulotomies were judged to be well centered by the surgeon using visual inspection |
Note: The document explicitly states "The data demonstrated the LenSx 550 produces anterior capsulotomies that are uniform, accurate and predictable in size over a wide range of depths. The capsular edge created by the LenSx 550 is also at least as smooth as that created during manual anterior capsulotomy." and "Anterior capsulotomy was successfully performed in all eyes using the LenSx 550 Laser. i.e., the capsulotomy was complete in all eyes, with no radial tears observed intraoperatively or postoperatively, and with an intraocular lens placed in the capsular bag. Postoperatively, the course of follow-up in the study population was unremarkable, The intraocular lens was centered in all study cyes, and no posterior capsule tears were observed. All capsulotomies were judged to be well centered by the surgeon using visual inspection in the operating microscope." These statements serve as the direct evidence that the reported device performance met the implied acceptance criteria.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size (Clinical): The document states "Anterior capsulotomy was successfully performed in all eyes" and "The intraocular lens was centered in all study cyes". However, a specific number of eyes/patients for the clinical trial is not explicitly mentioned in the provided text.
- Test Set Sample Size (Pre-clinical): Not specified beyond "porcine eyes and plastic substrates".
- Data Provenance: The document explicitly states a "prospective, single-center clinical trial." The country of origin is not explicitly mentioned, but it is implied to be within the scope of FDA approval (likely US-based or an internationally recognized clinical trial site).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: For the clinical study, the document states "All capsulotomies were judged to be well centered by the surgeon using visual inspection in the operating microscope." This implies at least one surgeon served as the expert for this specific judgment. The exact number of surgeons involved in the study is not specified, nor is their specific level of experience/qualification beyond being a "surgeon."
- Qualifications of Experts: "Surgeon." More detailed qualifications (e.g., years of experience, subspecialty) are not provided.
4. Adjudication method for the test set
- For the judgment of capsulotomy centering, it was done "by the surgeon using visual inspection." This implies a single-reader judgment for this specific criterion, not a multi-reader adjudication method (like 2+1 or 3+1). For other criteria like "no radial tears" or "unremarkable postoperative course," it's not explicitly stated how these were adjudicated beyond general clinical observation by the study team.
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
- No, an MRMC comparative effectiveness study was not done. The document describes a study evaluating the performance of the LenSx 550 Laser in creating anterior capsulotomies, not a comparison of human readers with and without AI assistance. The device itself is a laser system, not an AI diagnostic tool for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance was essentially done. The LenSx 550 laser system operates as a surgical tool. Its "performance" refers to how accurately and effectively it performs the capsulotomy procedure itself, independent of immediate human interpretation of an image or data generated by the device. The "algorithm" here is the laser's internal control system determining the cut. The clinical trial directly evaluated the outcome of the laser's action.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the clinical study was primarily clinical outcome data and surgeon's visual assessment. This included:
- Observation of capsulotomy completeness
- Absence of radial tears (intraoperative and postoperative)
- Placement of IOL in the capsular bag
- Unremarkable postoperative course
- Centered IOL (clinical observation)
- Absence of posterior capsule tears
- Surgeon's visual judgment of capsulotomy centering
- For pre-clinical testing, it involved measurements from porcine eyes and plastic substrates, along with scanning electron microscopy.
8. The sample size for the training set
- Not applicable / Not specified. The LenSx 550 Laser is a surgical device, not a machine learning algorithm that requires a separate "training set" in the conventional sense for its function. Its design and operational parameters would be developed through engineering and iterative testing, not through supervised learning on a "training set" of patient data.
9. How the ground truth for the training set was established
- Not applicable. As above, the concept of a "training set" and associated "ground truth" for a medical device like a surgical laser system doesn't align with the typical machine learning paradigm. The device's operational specifications are derived from engineering principles and tested against established performance requirements.
§ 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.