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ZEPTO Precision Capsulotomy System is indicated for use in performing anterior capsulotomy during cataract surgery.

The Subject Device consists of a Power Console, Disposable Handpiece, and a disposable Fluid Isolator. The Disposable Handpiece's power cord connector is connected to the front panel of the Power Console to provide power for the capsulotomy procedure. The suction tubing from the Disposable Handpiece is connected to the Fluid Isolator. The Fluid Isolator is then connected to the Power Console's front panel to provide suction during the treatment to a suction cup containing the cutting element. The functional portion used for capsulotomy is the capsulotomy tip located at the distal end of the Disposable Handpiece, which consists of a circular, silicone suction cup, and circular cutting element. Energy pulses are delivered to the cutting element to create the capsulotomy.

Prior to conducting the capsulotomy, the Disposable Handpiece's suction line is primed Balanced Salt Solution (BSS).

The capsulotomy tip is elongate by sliding the finger slider distally, this allows it to be easy inserted into the anterior chamber through the corneal incision. Once inserted into the anterior chamber the finger slider is pulled back to return the suction cup/cutting element to their original circular shapes. After centering the cutting element at the desired location on the anterior capsule, suction is initiated on the Power Console, which provides vacuum at the capsulotomy tip to properly seat the cutting element to anterior capsule.

Once suction is achieved, enerqy is initiated on the Power Console. A series of electrical pulses lasting a total of 4 milliseconds is delivered to the cutting element causing rapid phase transition of water molecules trapped between the bottom edge of the cutting element and the anterior capsule. The rapid volume expansion results in the capsule cutting action. Suction is then vented to atmosphere. The capsulotomy is nominally 5mm.

A nurse assistant will, upon command from the physician, introduce a small amount of BSS into the suction cup to allow for a gentle release of the suction cup from the capsule, and to allow the free-floating capsule button to stay behind in the anterior chamber for manual removal with forceps. This is done by advancing the fluid displacement syringe forward. Upon completion of the capsulotomy, the capsulotomy tip is removed from the anterior chamber of the eye through the corneal incision.

The Disposable Handpiece with Fluid Isolator is packaged in a sterile barrier thermoform trav. The contents in the sterile barrier are sterile via Ethylene Oxide (EO) sterilization.

Here's a breakdown of the acceptance criteria and study information for the ZEPTO Precision Capsulotomy System, based on the provided FDA 510(k) summary:

This document primarily describes the substantial equivalence of the Subject Device (K221188) to a Predicate Device (K210827), which is also the "ZEPTO Precision Capsulotomy System." The information presented focuses on demonstrating that the new device is essentially the same as the previously cleared one. Therefore, the "reported device performance" and details about separate clinical studies for this specific 510(k) submission are limited.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a table format with corresponding "reported device performance" values for this specific 510(k) submission (K221188). Instead, it relies on demonstrating substantial equivalence to a predicate device (K210827) that presumably met those criteria previously.

The document indicates that "Results of the evaluations demonstrate that the Subject Device met the safety and performance requirements as it relates to its indication for use." This is a general statement affirming compliance, not a detailed report of specific performance metrics against pre-defined acceptance criteria.

The key performance characteristic mentioned for both the Subject and Predicate Devices is:

• Capsulotomy Size: 5.0mm (nominal)

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

The document does not provide details about a specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective) for clinical effectiveness studies. The "Summary of Testing Performed" mentions "A program of design verification and validation testing," indicating engineering and software testing. It does not refer to clinical studies with patient data to establish performance anew for this 510(k) submission.

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

This information is not provided in the document. As noted, there's no mention of a clinical test set requiring expert ground truth for this submission.

4. Adjudication Method for the Test Set

This information is not provided in the document. Without a described clinical test set, an adjudication method is not applicable.

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

This information is not provided in the document. No MRMC study is mentioned, nor is there any discussion of AI assistance or human reader improvement. The device described is a physical surgical tool, not an AI diagnostic or assistive software.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This information is not applicable to the "ZEPTO Precision Capsulotomy System," as it is an electrosurgical device for performing a physical procedure, not an algorithm.

7. Type of Ground Truth Used

Based on the nature of the device (a surgical tool), the ground truth for its performance would typically involve:

• Physical measurements: E.g., verifying the actual size and circularity of the created capsulotomy.
• Histopathology/Gross examination: Examining the cut edges for cleanliness and integrity.
• Clinical outcomes data: Assessing post-operative complications related to the capsulotomy (e.g., capsule tears, IOL decentration).

However, the provided text does not explicitly detail the type of ground truth used for this specific submission. It relies on the substantial equivalence to the predicate device, which would have established such ground truth in its own clearance process.

8. Sample Size for the Training Set

This information is not provided in the document. "Training set" is typically relevant for machine learning algorithms, which is not the nature of this device. The documentation focuses on engineering and performance validation of the physical device.

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

This information is not provided and is not applicable, as there is no mention of a "training set" in the context of the ZEPTO Precision Capsulotomy System.

In summary:

The provided 510(k) summary for the ZEPTO Precision Capsulotomy System (K221188) primarily focuses on demonstrating substantial equivalence to its predicate device (K210827). It confirms that "Results of the evaluations demonstrate that the Subject Device met the safety and performance requirements as it relates to its indication for use" through a "program of design verification and validation testing," which includes software testing. However, it does not offer detailed quantitative acceptance criteria, specific clinical study sample sizes, expert qualifications, or ground truth establishment methods for this particular submission, as these were presumably established and accepted during the clearance of the predicate device. The device itself is a physical surgical tool, not an AI-driven diagnostic or assistive system, which explains the absence of information related to AI-specific metrics (e.g., MRMC studies, training sets).

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CAPSULO is indicated for photodisruption of ocular tissue using light energy emitted by a Nd: YAG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy.

The Yttrium Aluminum Garnet (YAG) ophthalmic laser system produces short pulses of focused infrared light at a wavelength of 1.064 nm. These pulses can be precisely positioned using a slit lamp microscope and a dual-point aiming system. The energy contained in a short pulse is concentrated by focusing a very small spot (10 um) so that the formation of plasma is at the focal point. The firing causes an acoustic wave that radiates from the focal point and breaks the near tissue which is known as disruptive photo-effect. Once formed, plasma absorbs and further diffuses incident light, protecting deeper structures. Furthermore, the divergence of the beam after the focal point protects the retina from damage that could otherwise occur by the absorption of concentrated energy in the Nd: YAG treatment beam. As the treatment energy is increased, the size of the plasma formed also increases, until a larger and stronger acoustic wave is produced. For increased energy, it is necessary to focus the treatment beam further behind the ocular structure being treated. The Nd: YAG 1064 nm laser operates at a nano-second pulse rate and the laser energy is delivered to the treatment site using the integrated slit lamp.

The provided text is a 510(k) summary for the Quantel Medical CAPSULO device, which is an ophthalmic laser. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria for an AI/ML-driven device.

Therefore, the information required to answer the prompt regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, and training set information for an AI/ML device is not present in the provided document.

The document discusses the following:

• Device Type: Nd: YAG ophthalmic laser (not an AI/ML device).
• Purpose: Photodisruption of ocular tissue (posterior capsulotomy, pupillary membranectomy, iridotomy).
• Equivalence: The submission claims substantial equivalence to a predicate laser device (Quantel Medical Optimis Fusion).
• Performance Data: States non-clinical testing was performed to verify design specifications and substantial equivalence, and lists the standards adhered to (electrical safety, EMC, usability, laser safety, biocompatibility). It also mentions software verification and validation activities for a "Major level of concern," but this refers to the software controlling the laser, not a diagnostic AI algorithm.

In summary, there is no information in the provided text about acceptance criteria for an AI/ML device's performance, nor any study details that would typically be conducted for verifying an AI/ML model's diagnostic accuracy or effectiveness.

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ZEPTO Precision Capsulotomy System is indicated for use in performing anterior capsulotomy during cataract surgery.

The Subject Device consists of a Power Console. Disposable Handbiece, and a disposable Fluid Isolator. The Disposable Handpiece's power cord connector is connected to the front panel of the Power Console to provide power for the capsulotomy procedure. The suction tubing from the Disposable Handpiece is connected to the Fluid Isolator. The Fluid Isolator is then connected to the Power Console's front panel to provide suction during the treatment to a suction cup containing the cutting element. The functional portion used for capsulotomy is the capsulotomy tip located at the distal end of the Disposable Handpiece, which consists of a circular, silicone suction cup, and circular cutting element. Energy pulses are delivered to the cutting element to create the capsulotomy.

Prior to conducting the capsulotomy, the Disposable Handpiece's suction line is primed Balanced Salt Solution (BSS).

The capsulotomy tip is elongate by sliding the finger slider distally, this allows it to be easy inserted into the anterior chamber through the corneal incision. Once inserted into the anterior chamber the finger slider is pulled back to return the suction cup/cutting element to their original circular shapes. After centering the cutting element at the desired location on the anterior capsule, suction is initiated on the Power Console, which provides vacuum at the capsulotomy tip to properly seat the cutting element to anterior capsule.

Once suction is achieved, enerqy is initiated on the Power Console. A series of electrical pulses lasting a total of 4 milliseconds is delivered to the cutting element causing rapid phase transition of water molecules trapped between the bottom edge of the cutting element and the anterior capsule. The rapid volume expansion results in the capsule cutting action. Suction is then vented to atmosphere. The capsulotomy is nominally 5mm.

A nurse assistant will, upon command from the physician, introduce a small amount of BSS into the suction cup to allow for a gentle release of the suction cup from the capsule, and to allow the free-floating capsule button to stay behind in the anterior chamber for manual removal with forceps. This is done by advancing the fluid displacement syringe forward. Upon completion of the capsulotomy, the capsulotomy tip is removed from the anterior chamber of the eye through the corneal incision.

The Disposable Handpiece with Fluid Isolator is packaged in a sterile barrier thermoform trav. The contents in the sterile barrier are sterile via Ethylene Oxide (EO) sterilization.

Here's an analysis of the provided text to extract information related to acceptance criteria and the study proving the device meets them:

The provided text describes the ZEPTO Precision Capsulotomy System and its 510(k) clearance by the FDA. However, it does not explicitly detail specific acceptance criteria values or a "study" in the sense of a clinical trial with a test set, ground truth, expert adjudication, or MRMC studies. The document focuses on demonstrating substantial equivalence to a predicate device through engineering and performance testing.

Therefore, many of the requested fields cannot be filled directly from the provided text. I will indicate where information is not provided or inferred from the types of tests mentioned.

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not provided. The document mentions "Summary of Testing Performed" but does not specify sample sizes for these tests. The nature of these tests (e.g., biocompatibility) suggests in-vitro or bench testing, not a clinical "test set" in the context of AI/diagnostic device evaluation.

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

   • Not applicable/Not provided. This device is a surgical instrument, not a diagnostic AI. The "ground truth" for its performance would be engineering specifications and successful operation, not expert consensus on medical images.

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

   • Not applicable/Not provided.

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 surgical device, not an AI-assisted diagnostic tool.

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

   • No. Not an AI algorithm. Its performance is inherent to the device's mechanical and electrical design.

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

   • The "ground truth" for this device's acceptance is based on engineering specifications, regulatory standards (e.g., biocompatibility, electrical safety), and successful functional operation during various performance and simulated use tests. For capsulotomy size and shape, the ground truth would be precise measurements against design specifications.

7. The sample size for the training set:

   • Not applicable/Not provided. This is not an AI device that requires a training set.

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

   • Not applicable/Not provided. This is not an AI device.

Summary of the Study:

The "study" described is a design verification and validation testing program rather than a clinical study with a patient test set. The testing covered:

• Biocompatibility
• Sterility and EO Residual
• Packaging Integrity (Sterile Barrier)
• Transportation
• Electromagnetic Compatibility and Electrical Safety
• Stability/Shelf-Life
• Performance/Functionality/Safety
• Software
• Simulated Use (Human Factors Evaluation)

The results of these evaluations demonstrated that the Subject Device met the safety and performance requirements as it relates to its indication for use and was substantially equivalent to the predicate device. The provenance of the data is not specified but would typically be from in-house or contracted laboratory testing (bench testing, in-vitro testing).

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The Volk Single-Use Contact Laser and Diagnostic Lenses (Direct Contact) are indicated for use as diagnostic lenses for eye fundus examinations and use in the therapy of intraocular abnormalities.

The Volk Disposable Contact Laser and Diagnostic Lenses are a family of diagnostic and therapeutic contact lenses used for eye fundus examinations and therapy of intraocular abnormalities. The family consists of two (2) lenses, including the following: Iridotomy Lens and Capsulotomy Lens.

The family of Volk Disposable Contact Laser and Diagnostic Lenses are designed around the classic Volk Contact Laser and Diagnostic Lenses. Each model lens is similar in design, but provide different optical elements to provide excellent visualization of the ocular anatomical areas for the particular intended use.

The lenses are provided sterile for single use.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

This document is for the Volk Disposable Contact Laser and Diagnostic Lens, a Class II medical device. It's a 510(k) premarket notification, which means the manufacturer is claiming substantial equivalence to legally marketed predicate devices, rather than submitting a full-blown PMA (Premarket Approval) which would typically require extensive clinical trials.

The provided text focuses on demonstrating substantial equivalence, not on establishing specific performance criteria against a predefined standard for a novel device. As such, there is no detailed "acceptance criteria" table in the traditional sense of performance metrics because the device is a contact lens and its primary function is direct visualization, similar to existing devices.

However, based on the "Performance Data" section, we can infer the critical acceptance criteria and studies that were performed to support the device's safety and effectiveness for its intended use, leveraging its similarity to predicates.

1. A table of acceptance criteria and the reported device performance

Regarding the study that proves the device meets the acceptance criteria, and further details as requested:

This submission is a 510(k) for a device claiming substantial equivalence, not a de novo or PMA where extensive clinical studies proving novel performance are typically required. Therefore, the "studies" mentioned are primarily validation testing to confirm specific aspects of the device's manufacturing and stability, rather than clinical trials assessing diagnostic accuracy or treatment efficacy compared to a gold standard.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• The document does not specify the sample sizes for the sterilization validation testing or the shelf-life testing. These would typically be determined by established standards for such validation (e.g., ISO standards for sterilization, statistical sampling for shelf-life).
• The data provenance is not explicitly stated as country of origin, but it is implied to be from the manufacturer's internal testing (Volk Optical Inc. in Mentor, Ohio, USA). These would be prospective validation studies designed to test the sterility and shelf life of the newly manufactured disposable lenses.

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

• Not applicable / Not mentioned. For sterilization and shelf-life testing, "ground truth" is established by laboratory measurements against defined specifications (e.g., microbial load reduction, chemical stability) rather than expert consensus on a diagnostic outcome.
• For the optical performance, the "ground truth" and expertise would logically stem from the design and manufacturing capabilities of Volk, which has a long history in ophthalmic optics, and the clinical experience with their predicate devices. The statement "Each model lens is similar in design, but provide different optical elements to provide excellent visualization" suggests reliance on established optical design principles and potentially in-house optical testing.

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

• Not applicable / Not mentioned. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human interpretation of medical images or patient outcomes requires reconciliation among multiple experts. The studies cited are laboratory-based validation tests (sterilization, shelf life) which rely on analytical measurements and adherence to protocols, not human adjudication.

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

• Not applicable. This device is a passive optical lens, not an AI-powered diagnostic system. No MRMC study was performed or is relevant for this type of device.

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

• Not applicable. This device is a physical optical lens, not an algorithm or AI system. Its function inherently requires a human operator (the clinician) to use it for diagnosis or therapy.

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

• For sterilization validation: The ground truth is the absence of viable microorganisms to a specified sterility assurance level (SAL), measured by biological indicators and microbiological testing methods.
• For shelf-life testing: The ground truth is the stability of the device's material properties, packaging integrity, and sterility over time, measured by physical, chemical, and microbiological tests at various time points.
• For optical performance: The ground truth is (implicitly) the ability to provide "excellent visualization," which is assessed by design specifications and comparison to the known performance of predicate lenses.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

• Not applicable. As above, no training set for an AI model.

Summary of the 510(k) Approach:

The core of this 510(k) submission relies on substantial equivalence to predicate devices that have been legally marketed. The performance data provided mainly addresses the differences between the proposed device and its predicates – specifically, the fact that the new lenses are disposable and sterile. Therefore, the critical acceptance criteria and studies focus on proving the safety and efficacy of these new features (sterility and stability over a shelf life) for a device that otherwise shares fundamental design and intended use with its predicates. No complex clinical trials or AI performance evaluations are presented because they are not required for this type of device and submission pathway.

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

The LensAR Laser System is an ophthalmic surgical laser that has already been cleared for use in anterior capsulotomy in cataract surgery (K090633). It is now intended for additional use in anterior capsulotomy and laser phacofragmentation in cataract surgery, performed individually or consecutively during the same surgery.

The LensAR Laser generates ultrashort laser pulses that are scanned in a three-dimensional pattern in the eye to cut the anterior capsulotomy and to pre-cut the lens into small pieces for easy removal by conventional ultrasound phaco fragmentation. The fragmentation pattern is customized to the patient's eye based on precise measurement of the size, shape and position of the patient's lens by a built-in optical measuring system. During the measurement and subsequent application of the laser pulses, the eye is positioned and immobilized by an off-the-shelf suction ring assembly which is affixed to the eye and which is in turn docked to a refractive index matching eye docking (IMED) device mounted to the laser system.

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

No acceptance criteria or reported device performance metrics (e.g., success rates, accuracy percentages, safety endpoints with specific thresholds) are explicitly stated in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices through a clinical study rather than defining specific performance thresholds for acceptance.

However, it describes the clinical study that provided performance data to support the device's substantial equivalence.

Study that Proves the Device Meets the Acceptance Criteria (Implicitly, for Substantial Equivalence):

1. A table of acceptance criteria and the reported device performance

As mentioned above, no explicit quantitative acceptance criteria or reported device performance metrics are provided in the document. The study aimed to demonstrate the device's clinical performance in comparison to predicate devices, inferring safety and effectiveness for substantial equivalence.

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

• Sample Size (Test Set): 88 subjects (for the primary cohort, one eye per subject) and a control cohort of contralateral eyes in these subjects.
• Data Provenance: Prospective clinical study performed outside the U.S.

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 in the document. The study describes the procedures performed (laser fragmentation/capsulotomy followed by phacoemulsification if needed) and a control group receiving conventional methods. It does not detail who established a "ground truth" or what that ground truth would specifically measure beyond the procedural outcomes themselves (e.g., successful fragmentation, clear capsulotomy).

4. Adjudication method for the test set

This information is not provided in the document.

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

• MRMC Study: No, this was not an MRMC study related to human reader performance with AI. The device is a surgical laser system, not an AI-assisted diagnostic or interpretation tool.
• Effect Size: N/A, as it's not an MRMC study with AI assistance.

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

The device itself is a standalone surgical laser system (an "algorithm" in the sense of its operational program). It performs the laser treatment. The clinical study evaluated the overall surgical procedure where the laser performs its function, followed by human intervention (phacoemulsification if needed). It's not a diagnostic algorithm that assists a human reader.

7. The type of ground truth used

The clinical study evaluated the clinical performance of the surgical procedures using the LensAR Laser System. The "ground truth" implicitly refers to the successful completion and clinical outcomes of anterior capsulotomy and laser phacofragmentation during cataract surgery, as observed by ophthalmologists. The document mentions:

• "Summary of Pre-Clinical Testing": "accuracy and reproducibility of capsulotomy and laser phaco fragmentation incisions in porcine eyes and plastic substrates."
• "Summary of Clinical Studies": describes patients undergoing procedures and follow-up.
  The criteria for "success" or "performance" are not explicitly defined as a specific "ground truth" metric but rather related to the procedural outcomes and comparative performance against conventional methods.

8. The sample size for the training set

This information is not provided in the document. The document describes pre-clinical testing and a clinical study but does not detail a "training set" in the context of machine learning or AI, as this is a surgical device.

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

N/A, as no "training set" in the AI/ML sense is mentioned or relevant for this type of medical device's submission summary. The product development likely involved extensive engineering and testing against design specifications, but this is not framed as a "training set" with ground truth in this context.

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