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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

Study Details

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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The VisuMax Laser Keratome is indicated for the following:

• In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea;
• In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea;
• In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty;
• In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting.

The VisuMax Laser Keratome is an ophthalmic surgical femtosecond laser intended for use in patients requiring corneal incisions. The cutting action of the VisuMax Laser Keratome is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.

The provided text describes a 510(k) premarket notification for the Carl Zeiss Meditec VisuMax Laser Keratome. It focuses on demonstrating substantial equivalence to predicate devices and expanding indications for use.

However, the document does not contain specific acceptance criteria, a detailed study proving the device meets those criteria, sample sizes for test or training sets, information about ground truth establishment, expert qualifications, or MRMC study results. The information provided is primarily focused on the device's technical characteristics, intended use, and a summary of pre-clinical testing, which is often used to demonstrate substantial equivalence rather than explicitly proving performance against predefined acceptance criteria for a new device.

Therefore, I cannot populate the requested table and answer many of the questions directly from the provided text. I will indicate where information is missing or not applicable based on the document.

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it aims to demonstrate substantial equivalence in performance to predicate devices for expanded indications. The "reported device performance" in this context refers to the findings from the ex-vivo studies.

Study Details:

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided text for either the porcine eye studies or the human globes study.
   • Data Provenance:
     • "Ex-vivo porcine eye studies"
     • "Ex-vivo study in human globes"
     • The location of these studies (country of origin) is not specified.
     • Both are "pre-clinical" studies, implying they are not retrospective or prospective clinical studies on live patients.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not specified. The studies are ex-vivo (on animal and human globes), and the evaluation of "accuracy," "reproducibility," and "quality" would likely involve objective measurements or expert assessment, but the number and qualifications of evaluators are not detailed.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not specified.

4. 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. This is a medical device (laser keratome), not an AI diagnostic tool. Therefore, an MRMC comparative effectiveness study with human readers assisting/being assisted by AI is not relevant to this device's evaluation as described. The comparison is between the new device and predicate devices in performing surgical cuts.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, implicitly. The performance data presented refers to the device's ability to make incisions ("accuracy and reproducibility," "quality of performance") when compared to predicate devices, during ex-vivo studies. This evaluates the device's intrinsic function. The device's operation still requires a human operator, but the performance "testing" as described focuses on the machine's output in isolation (the cut it makes).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not explicitly stated. For "accuracy," "reproducibility," and "quality" of surgical incisions, the ground truth would likely be based on objective measurements (e.g., microscopy, optical coherence tomography to measure incision depth, diameter, smoothness, and morphology against predefined surgical targets) possibly interpreted or confirmed by expert ophthalmologists/pathologists, but this is not detailed in the summary.

7. The sample size for the training set:

   • Not applicable. This device is a surgical laser, not a machine learning model, so there is no "training set" in the sense of data used to train an algorithm. The device's design and engineering would have involved extensive testing and calibration during development, but this is distinct from "training data" for an AI.

8. How the ground truth for the training set was established:

   • Not applicable (as it's not an AI/ML device with a training set).

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The LensAR Laser System is intended for use in anterior capsulotomy during cataract surgery.

The LensAR Laser System is an ophthalmic surgical laser intended for use in anterior capsulotomy in cataract surgery. The System employs a mode-locked Nd: Y VO4 laser which generates a high frequency series of ultrashort, low energy pulses at a wavelength of 1064 nm. The system is designed to cut the lens capsular tissue, with minimal collateral damage, by the mechanisms of plasma mediated ablation and photodisruption of targeted tissue at the beam focus. The precision capsulotomy is generated by computer-controlled scanning of the position of the laser beam focus in three dimensions at the target location of the anterior capsulotomy. The laser energy is delivered to the eye through a disposable, patient interface device consisting of an Index Matched Eye Docking device (IMED) designed to match the refractive index of the cornea to optimize beam targeting accuracy. The IMED device is docked to the eye via an accessory component comparable to those used with other ophthalmic lasers used as keratomes.

This document describes the premarket notification 510(k) for the LensAR Laser System for Anterior Capsulotomy.

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criteria	Reported Device Performance
   Creation of uniform, accurate, and predictable anterior capsulotomies (size and depth).	The data demonstrated the LensAR produces anterior capsulotomies that are uniform, accurate, and predictable in size (based on testing in porcine eyes and plastic substrates). Clinical analysis included pointing accuracy and performance characteristics for achieving an effective anterior capsulotomy cut.
   Safety with respect to corneal endothelium (acoustic and thermal profile).	Evaluation on ex vivo porcine eyes confirmed the safety with respect to corneal endothelium.
   Successful performance of anterior capsulotomy, with successful intraocular lens placement.	Anterior capsulotomy was successfully performed in eyes using the LensAR Laser, with intraocular lenses successfully placed. Postoperatively, the course of follow-up through 3 months was unremarkable. The intraocular lens was centered in all study eyes. All capsulotomies were judged well-centered by visual inspection.
   Ease of removal of capsules comparable to or better than Continuous Curvilinear Capsulorhexis (CCC).	The ease of removal scores were 5 or better (on a scale of 1 to 10, where 1 = CCC/manual removal, 10 = easiest), with the most common score being 10.
   Anterior capsules from laser-treated eyes should be equivalent or better with respect to dimension and conformance to circularity than those done manually.	The removed anterior capsules from the laser-treated eyes were demonstrated to be equivalent or better with respect to dimension and conformance to circularity than those done manually.
   No significant difference in clinical outcomes from the sequelae of cataract surgery between treatment and conventional cataract surgery (CCC) populations.	No significant difference in clinical outcomes from the sequelae of cataract surgery was demonstrated between the Treatment and Treated Control populations.

2. Sample sizes used for the test set and data provenance

   • Test Set (Clinical): The study was a "prospective, single-center, multiple surgeon clinical trial." No specific sample size is provided for the number of eyes or patients in the LensAR Laser arm. The report mentions a "contralateral control population," suggesting at least some patients had one eye treated with LensAR and the other with CCC, but also states "not all fellow eyes underwent cataract surgery in the context of the clinical study."
   • Data Provenance: The clinical trial was a prospective, single-center study. The country of origin is not explicitly stated, but the submission is to the FDA in the USA.
   • Pre-Clinical Testing: Porcine eyes and plastic substrates were used for accuracy, reproducibility, acoustic, and thermal profile testing.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts

   • The document does not explicitly state the number of experts or their qualifications for establishing ground truth.
   • However, it does mention that "All capsulotomies were judged to be well centered by the surgeon using visual inspection in the operating microscope," indicating that the treating surgeons provided some form of assessment.

4. Adjudication method for the test set

   • The document does not describe a formal adjudication method (like 2+1 or 3+1). The assessment of capsulotomy centering was done by the operating surgeon via visual inspection.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical laser system, not an AI-assisted diagnostic or imaging device used by human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

   • Yes, the device's performance was evaluated in a standalone manner. The LensAR Laser System performs the anterior capsulotomy itself, and its performance characteristics (accuracy, reproducibility, safety, quality of cut) were assessed pre-clinically and clinically. The laser is a computer-controlled system for creating the cut.

7. The type of ground truth used

   • Clinical Ground Truth: Surgical success (successful capsulotomy and IOL placement, unremarkable postoperative course, centered IOLs), surgeon's visual inspection for capsulotomy centering, and subjective surgeon judgment for ease of capsule removal. The removed anterior capsules were also physically analyzed for dimension and circularity.
   • Pre-Clinical Ground Truth: Measurements of capsulotomy size and depth in porcine eyes and plastic substrates, and evaluation of acoustic and thermal profiles in ex vivo porcine eyes.

8. The sample size for the training set

   • No information is provided regarding a separate "training set" for the device itself. The device is a surgical instrument with computer control, not a machine learning algorithm that requires a distinct training dataset in the same sense as an AI diagnostic tool. The development process likely involved internal testing and refinement (bench testing and ex vivo studies) that could be considered analogous to iterative development, but it's not described as a formal "training set."

9. How the ground truth for the training set was established

   • As there's no explicitly defined "training set" in the context of an AI algorithm, details on how ground truth was established for it are not applicable here. The device's design and parameters were likely optimized through engineering and bench testing, for which the "ground truth" would be objective measurements of physical parameters and cut quality against design specifications.

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The iFS Laser System is an ophthalmic surgical laser indicated for use:

• In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea
• In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea
• In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments
• In lamellar keratoplasty and corneal harvesting
• In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty and in the creation of a penetrating cut/incision for penetrating keratoplasty

The iFS Laser System is a precision ophthalmic surgical laser designed for use as an ophthalmic surgical laser indicated for use:

• In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea:
• In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea;
• In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments;
• In lamellar keratoplasty and corneal harvesting;
• In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty and in the . creation of a penetrating cut/incision for penetrating keratoplasty.
  Corneal dissection with the iFS Laser is achieved through precise individual microphotodisruptions of tissue, created by tightly focused ultrashort optical which are delivered through a disposable applanation lens assembly while fixating the eye under low vacuum.

The provided text describes a 510(k) summary for the iFS Laser System, an ophthalmic surgical laser. While it details the device, its intended use, and claims substantial equivalence to predicate devices, it does not contain the specific information required to complete the table and answer the questions related to acceptance criteria, study details, and performance metrics.

The document primarily focuses on establishing regulatory equivalence and does not elaborate on clinical studies, performance metrics, ground truth establishment, or sample sizes beyond stating that the device "perform[s] equivalently to the predicate laser and patient interface for the creation of corneal resections."

Therefore, I cannot provide the requested information from the given text.

In a real-world scenario, such information would typically be found in detailed clinical study reports, performance testing reports, or more extensive sections of a 510(k) submission that are not included in this summary.

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