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The LenSx Laser is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of,which may be performed either individually or consecutively during the same procedure.

The LenSx Laser is indicated for use in patients undergoing penetrating keratoplasty for full thickness corneal replacement and in patients undergoing lamellar keratoplasty for partial thickness corneal replacement. The intended use in penetrating and lamellar keratoplasty includes the creation of single plane and multi-plane arc and circular cuts/incisions in the cornea.

The LenSx Laser System uses focused femtosecond laser pulses to create incisions and separates tissue in the lens capsule, crystalline lens and cornea. Individual photodisruption locations are controlled by repeatedly repositioning the laser focus. The light pulse 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. The surgical effect is produced by scanning thousands of individual pulses per second to produce a continuous incisions or tissue separation.

The location of the tissue photodisruption is controlled by moving the focus of the laser beam to the desired surgical target location. A computer-controlled scanning system directs the laser beam throughout a three-dimensional pattern to produce an incision. The laser pulses are delivered through a sterile, disposable applanating lens and suction ring assembly that contacts the cornea and fixes the eye with respect to the delivery system.

The LenSx Laser is an ophthalmic surgical laser that has previously been cleared for use in:

• • Anterior capsulotomy (K082947), performed by delivering a cylindrical pattern of laser pulses to intersect the anterior lens capsule.
• · Phacofragmentation (K090452), performed by delivering series of laser pulses to form two intersecting ellipsoidal planes that divides the lens into quadrants.
• . Cuts/incisions for keratoplasty (K092647) which are performed by delivering a pattern of circles and arcs with programmable incision length and depth.

Here's an analysis of the provided text regarding the acceptance criteria and study for the LenSx Laser System:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the acceptance criteria for the modified LenSx Laser System were the "same parameter acceptance criteria as established for single plane cuts/incisions" for the predicate LenSx 550 Laser and modified LenSx Laser. However, the document does not provide the specific numerical values or ranges for these acceptance criteria. It only mentions what was evaluated against them.

2. Sample Size and Data Provenance for the Test Set:

• Test Set Sample Size: The document mentions "Evaluation of stepped cuts/incisions in human cadaver eyes for lamellar keratoplasty, penetrating keratoplasty and cataract surgery." However, the exact number of human cadaver eyes used for this evaluation, or any other test set, is not specified.
• Data Provenance: The only explicit mention of data provenance for testing is "human cadaver eyes." No country of origin is specified. The study is retrospective in the sense that cadaver eyes are used, not living patients.

3. Number of Experts and Qualifications for Ground Truth for the Test Set:

The provided document does not specify the number of experts used to establish ground truth for the test set, nor does it detail their qualifications.

4. Adjudication Method for the Test Set:

The document does not provide any information regarding the adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss the effect size of human readers improving with or without AI assistance. This device is a surgical laser system, not an AI diagnostic tool that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study:

The document describes the performance testing of the device itself, which is a surgical laser system. In this context, "standalone algorithm performance" is not directly applicable in the same way it would be for an AI diagnostic algorithm. The performance tests evaluate the physical capabilities of the laser system (accuracy and reproducibility of cuts), not an algorithm's diagnostic output.

7. Type of Ground Truth Used:

The ground truth for the performance evaluations appears to be based on physical measurements and observations of the cuts and incisions created by the laser system. This would infer measurement of depth, geometry, and potentially histological examination in cadaver eyes, but the document does not explicitly state "pathology" or "outcomes data." It implies objective physical assessment.

8. Sample Size for the Training Set:

The document does not specify a training set sample size. This is consistent with the nature of the device; it's a physical surgical tool, not an AI algorithm that undergoes a distinct "training phase" on labeled data in the traditional sense. Its development and refinement would involve engineering and testing, rather than algorithmic training.

9. How Ground Truth for the Training Set Was Established:

As there is no "training set" in the context of an AI algorithm, the document does not describe how ground truth for a training set was established. The development of the device would rely on engineering principles, iterative design, and performance testing, rather than labeled data for algorithm training.

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The LenSx 550 Laser System is indicated for anterior capsulotomy and laser phacofragmentation during cataract surgery. The anterior capsulotomy and phacofragmentation procedures may be performed either individually or consecutively during the same surgery.

The LenSx 550 Laser is an ophthalmic surgical laser that has previously been cleared for use in anterior capsulotomy during cataract surgery (K082947). The LenSx 550 generates femtosecond laser pulses that are scanned in a three-dimensional pattern in the eye. Localization of these laser pulses is accomplished by an aiming beam that identifies the surfaces of the lens, and an off-the-shelf, disposable contact lens and suction ring assembly that fixates the eye relative to the delivery system. As described in K082947, anterior capsulotomy is performed by delivering a cylindrical pattern of laser pulses to intersect the anterior lens capsule.

The same surgical device, with only minor software changes, is now also being proposed for use in phacofragmentation during cataract surgery. As described in this premarket notification, laser phacofragmentation divides the lens into quadrants, in the same way that division of the lens into quadrants is performed with standard ultrasound phacofragmentation in the initial step of phacoemulsification.

To perform phacofragmentation, the LenSx system delivers a series of laser pulses to form two intersecting ellipsoidal planes. Photodisruption of the lens tissue in this pattern, which appears as a cross from a surgical (top) view, segments the nucleus into four sections before the eye is physically entered by any instruments or devices.

Following entry into the eye and then into lens, the fragmented nuclear quadrants created by the LenSx 550 are further fragmented and removed using a standard phacoemulsification probe.

Here's a breakdown of the acceptance criteria and study information for the LenSx 550 Laser System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., a specific percentage reduction in ultrasound power, or a target accuracy for laser pulse placement). Instead, the performance is described in comparative and qualitative terms.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Clinical Study - Test Set): A total of 92 subjects, divided into two groups of 46 eyes each.
  • Study Group: 46 eyes
  • Control Group: 46 eyes
• Data Provenance: Prospective clinical study performed outside the U.S. (specific country not mentioned).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts or their qualifications for establishing the ground truth of the clinical outcomes or the success of phacofragmentation. The clinical study evaluated performance, and "clinical results were excellent in both groups, with no significant adverse events," implying expert assessment by the surgical team or researchers involved, but details are not provided.

4. Adjudication Method for the Test Set

The document does not describe any explicit adjudication method (e.g., 2+1, 3+1). The "clinical results were excellent" implies a direct observation and assessment by the surgical team or lead investigators, rather than a formal adjudication process post-facto by a separate panel.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in the traditional sense of evaluating multiple human readers' diagnostic performance. This was a clinical comparative effectiveness study comparing a new surgical technique (LenSx laser phacofragmentation) with a standard technique (ultrasonic phacoemulsification).

• Effect Size: The study found that the laser phacofragmentation group required "significantly less manual manipulation and ultrasound power." The document states "significantly reduced" but does not provide a specific quantitative effect size (e.g., a percentage reduction or a statistical measure like Cohen's d) for the improvement in ultrasound power or manual manipulation.

6. Standalone (Algorithm Only) Performance Study

Yes, aspects of standalone performance were evaluated through pre-clinical studies:

• Plastic substrates: Demonstrated "a high degree of accuracy and reproducibility for laser pulse placement."
• Ex vivo porcine eyes: Further confirmed "the accuracy and reproducibility of the localized laser tissue effects."

These pre-clinical studies assessed the device's inherent capability to perform the intended physical action (laser phacofragmentation) without human intervention in the fragmentation process itself (though a human would operate the device).

7. Type of Ground Truth Used

• Pre-clinical studies (plastic substrates, ex vivo porcine eyes): The ground truth was based on physical observation and measurement of laser pulse placement accuracy, reproducibility, and localized tissue effects.
• Clinical study:
  • Effectiveness of phacofragmentation: Ground truth implicitly based on surgical observation of the extent of fragmentation, and measured reduction in ultrasound power needed for subsequent phacoemulsification.
  • Safety: Ground truth based on clinical observation of adverse events.
  • Clinical outcomes: Ground truth based on overall clinical assessment by the medical professionals involved, and comparison to "advanced phacoemulsification techniques reported in previous studies."

8. Sample Size for the Training Set

The document does not specify a separate training set in the context of machine learning. The studies described are performance evaluations of the device's hardware and software logic. The device itself (LenSx 550 Laser System) was previously cleared (K082947) for anterior capsulotomy, implying its core technology was already established. The current submission focuses on a new indication (phacofragmentation) with "only minor software changes." The pre-clinical studies and clinical studies described are for validation of the new indication, not for training a specific AI model.

9. How the Ground Truth for the Training Set Was Established

As no specific AI training set or process is described, this information is not applicable based on the provided text. The device's operation appears to be based on pre-programmed patterns and optical localization rather than a continuously learning AI model that requires a ground-truthed training set for its development.

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The LenSx 550 Laser System is indicated for use in the creation of a partial thickness cut/incision for lamellar keratoplasty and in the creation of a full-thickness cut/incision for penetrating keratoplasty.

The LenSx 550 Laser is an ophthalmic surgical laser indicated for use in the creation of a penetrating cut/incision for penetrating and lamellar keratoplasty. Consistent with commercially available femtosecond lasers (Product Code GEX, 878.4810 and OOE, 886.4390) the LenSx 550 Laser creates incisions using focused femtosecond laser pulses. Individual photodisruption locations are controlled by repositioning the laser focus in the cornea. The light pulse 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. The surgical effect is produced by scanning thousands of individual pulses per second 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. The laser pulses are delivered through an off-the-shelf, disposable contact lens and suction ring assembly that contacts the cornea and fixes the eye with respect to the delivery system.

The LenSx 550 Laser System is an ophthalmic surgical laser. The provided text outlines a 510(k) summary for this device, focusing on its substantial equivalence to predicate devices for creating penetrating and lamellar keratoplasty incisions. However, it does not describe specific acceptance criteria and a study proving the device meets those criteria in the way typically expected for a detailed performance evaluation of a device like an AI algorithm.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. It lists general performance areas evaluated but not specific quantitative criteria or results.

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

This information is not provided as a test set in the context of an AI algorithm evaluation. The document refers to "nonclinical tests and results" but provides no details on sample sizes or data provenance.

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

This information is not provided. As no "test set" in the context of AI evaluation is described, there's no mention of ground truth experts.

4. Adjudication method for the test set

This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. The device is an ophthalmic surgical laser, not an AI-assisted diagnostic or interpretative tool.

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

This information is not applicable/provided. The device is a surgical laser, not a standalone algorithm.

7. The type of ground truth used

This information is not provided.

8. The sample size for the training set

This information is not provided. As the device is not an AI algorithm, there is no "training set."

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

This information is not provided.

Summary of what is stated regarding performance and evaluation from the document:

The document states that nonclinical tests were performed to support the safety and substantial equivalence of the LenSx 550 femtosecond laser system to predicate devices. These tests demonstrated the following:

• Accuracy and reproducibility of the depth and geometry of penetrating cuts/incisions: This is a key performance aspect for a surgical laser, implying that the device consistently creates cuts with the intended dimensions.
• Ability to create penetrating corneal incisions in opacified corneas: This highlights the device's efficacy across different corneal conditions.
• Limited collateral tissue effects and retained endothelial cell viability adjacent to penetrating laser corneal incisions as compared to manual trephination: This points back to safety and potentially improved outcomes compared to the traditional manual method.

In conclusion, while the document confirms that performance data was generated to support the 510(k) clearance, it does not detail specific acceptance criteria, quantitative performance metrics, or the methodologies (sample sizes, expert involvement, ground truth establishment) typically associated with evaluating AI-driven diagnostic or interpretative devices. The evaluation here is for a surgical instrument, focusing on its physical capabilities and safety profile in comparison to existing technologies.

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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

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.

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