(281 days)
The Femtec Laser System for Capsulotomy is indicated for anterior capsulotomy during cataract surgery.
The Femtec Laser System for Capsulotomy is a precision ophthalmic surgical laser indicated for use in patients undergoing anterior capsulotomy during cataract surgery. Capsular dissection is achieved through precise individual micro-photodisruption of tissue, measuring a few microns in diameter, created by tightly focusing ultrashort laser pulses into the targeted capsular tissue. Surgical effects are produced by scanning thousands of individual pulses, producing a continuous incision. The location of the tissue photodisruption is controlled by a fixed laser beam focused through a scanning optic system to the desired location. Pre-programmed patterns produce capsular resections of predetermined diameter and height. Laser pulses are delivered through a sterile (disposable) Patient Interface, consisting of a contact lens and suction clip to provide suction. The contact lens and suction clip assembly creates a reference surface for depth control and fix the eye relative to the delivery of the laser beam.
Here's a breakdown of the acceptance criteria and the study details for the Femtec Laser System for Capsulotomy, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Capsulotomy Completion | Capsulotomy completed in all eyes. | Successfully performed in all eyes. |
| Radial Tears | No radial tears observed intraoperatively or postoperatively. | No radial tears observed intraoperatively or postoperatively. |
| IOL Placement | Intraocular lens placed in each capsular bag. | Intraocular lens placed in each capsular bag. |
| Postoperative Course | Unremarkable postoperative course of follow-up. | Unremarkable postoperative course. |
| IOL Centration | Intraocular lens centered in all study eyes. | Intraocular lens centered in all study eyes. |
| Posterior Capsule Tears | No posterior capsule tears observed. | No posterior capsule tears observed. |
| Capsulotomy Centration | Well-centered capsulotomies (visually and quantitatively). | All capsulotomies were judged to be well-centered by the surgeon using visual inspection in the operating microscope. The system produced significantly more pupil-centered capsulorhexis compared to manual capsulotomy. |
| Capsulotomy Circularity | Circular capsulorhexis. | Produced significantly more circular capsulorhexis than the manual technique. |
| Capsular Edge Smoothness | Capsular edge at least as smooth as that created during anterior capsulotomy. | Data demonstrated the capsular edge created by the Femtec Laser system is also at least as smooth as that created during anterior capsulotomy (from preclinical data, not explicitly re-stated for clinical but implied by successful performance and comparison to manual technique). |
| Accuracy & Predictability | Accurate and predictable in size, shape, and centration. | The data demonstrated that the Femtec Laser System produces anterior capsulotomies that are accurate and predictable in size, shape, and centration over a range of depths (from preclinical data). |
Study Details
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Sample sizes used for the test set and the data provenance:
- Clinical Trial: The document states "A clinical trial of the Femter Laser System was conducted to evaluate the performance of the laser system..." and "Anterior capsulotomy was successfully performed in all eyes using the Femtec Laser System..." However, the exact number of eyes/patients in the clinical trial (the test set) is not explicitly stated in the provided text.
- Pre-clinical Testing: "Testing and analyses included accuracy and reproducibility of capsulotomy incisions in porcine eyes, as well as in plastic and agar gel optical phantoms." The specific number of porcine eyes, plastic phantoms, or agar gel phantoms used is not specified.
- Data Provenance:
- Clinical Trial: The text implies a prospective clinical trial. The country of origin of the clinical data is not specified.
- Pre-clinical Testing: The pre-clinical data was derived from bench testing using porcine eyes, plastic, and agar gel optical phantoms.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the clinical trial, "All capsulotomies were judged to be well-centered by the surgeon using visual inspection in the operating microscope." This indicates at least one surgeon acted as an expert. No specific number of experts beyond "the surgeon" is mentioned, and their specific qualifications (e.g., years of experience) are not detailed.
- For preclinical testing, there is no mention of experts establishing ground truth; it relies on objective measurements of physical properties.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not specify an explicit adjudication method for the clinical trial results beyond "judged to be well-centered by the surgeon." It does not mention multiple reviewers or a tie-breaking mechanism.
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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 involving AI assistance for human readers was not done. This device is a laser system that performs the capsulotomy, not an AI diagnostic or assistance system for human interpretation. The comparison was between the automated Femtec Laser System and the manual technique for capsulotomy.
- Effect Size (Laser vs. Manual): The study found the Femtec Laser System produced:
- "significantly more circular capsulorhexis than the manual technique"
- "significantly more pupil-centered capsulorhexis compared to manual capsulotomy"
- While the exact numerical effect sizes (e.g., specific metrics and p-values) are not provided in this summary, the use of "significantly more" indicates a statistically demonstrable improvement.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The Femtec Laser System itself performs the anterior capsulotomy based on its internal programming and mechanical actions, without continuous human intervention during the laser firing sequence for the cut. The outcome metrics (circularity, centration, completeness, lack of tears) are direct performance indicators of the device on its own. While a surgeon initiates and monitors the procedure, the cutting itself is an automated function of the device that was evaluated.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Clinical Trial: A combination of surgeon visual inspection (for centration), intraoperative and postoperative observations (for tears, IOL placement, overall course), and presumably objective measurements or assessments for circularity and pupil-centration (given the "significantly more circular" and "significantly more pupil-centered" statements, implying quantitative comparison).
- Pre-clinical Testing: Objective measurements (for size, shape, centration, smoothness) in porcine eyes and optical phantoms.
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The sample size for the training set:
- The document does not specify a separate "training set" here, as this is a medical device for surgical intervention, not a machine learning model in the typical sense that would have a distinct training phase on a dataset of cases. The development process likely involved iterative design, bench testing, and optimization before the formal clinical trial. However, no specific "training set" figures are provided.
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How the ground truth for the training set was established:
- As no explicit "training set" for an AI algorithm is mentioned, this question is not applicable in the context of this device's description. The "training" for such a system would typically involve engineering development, calibration, and iterative testing to meet design specifications, guided by ophthalmic expertise and performance requirements, rather than a labeled dataset in the AI sense.
§ 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.