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The VICTUS Femtosecond Laser Platform is indicated for use for:
· the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
• for anterior capsulotomy during cataract surgery.
· the creation of cuts / incisions in the cornea in patients undergoing cataract surgery or other ophthalmic treatment requiring cuts / incisions in the cornea.
· laser-assisted lens fragmentation of nuclear cataracts during cataract surgery, not for fragmentation of posterior subcapsular (PSC) and cortical cataracts

The VICTUS Femtosecond Laser is a precision ophthalmic surgical laser indicated for use in patients undergoing ophthalmic surgery in the anterior segment of the eye. The VICTUS Femtosecond Laser system produces scanned patterns designed to create flaps, produce corneal incisions, arcuate incisions, capsulotomy cuts, and crystalline lens fragmentation patterns for use in cataract surgery. The patient is treated while supine on a patient bed that the physician can position electromechanically via simple controls. The physician controls the VICTUS laser system itself through a touchscreen display and other user controls. Laser emission and of PI suction vacuum are actuated by the physician using separate footswitch pedals.

The mode of operation for the VICTUS Platform is using Yb:KYW Femtosecond laser to produce Laser-Induced Optical Breakdown (LIOB) of the corneal tissue. Scanned patterns of laser pulses from the VICTUS are delivered through a sterile, disposable Patient Interface (PI). The PI consists of two components: (i) a contacting lens, and (ii) a suction clip. Together, the suction clip and contacting lens connect to make a single assembly during a VICTUS procedure. The surface of the contacting lens that contacts the eye is spherically curved to match the curvature of the human eye. The suction clip assembly gently immobilizes the eye with respect to the VICTUS laser beam and optical visualization systems. The PI contacting lens and suction clip together allow for proper optical coupling of the laser and optical paths into the patient's eye and create a precise opto-mechanical reference surface for depth control of the scanning laser beam.

The provided text focuses on the 510(k) premarket notification for the VICTUS Femtosecond Laser Platform, specifically regarding modifications to its Patient Interface. It primarily discusses the technological comparison and non-clinical performance data to establish substantial equivalence to a previously cleared device. Therefore, the information regarding in-depth acceptance criteria and a standard study that proves the device meets those criteria (especially in the context of AI/ML performance) is not available in the provided document.

However, based on the non-clinical performance data section, we can infer some aspects related to acceptance criteria and the study performed, even though it's not presented in a typical AI/ML study format.

Here's an attempt to structure the answer based on the available information, noting where specific details are absent:

Acceptance Criteria and Study for VICTUS Femtosecond Laser Platform (Modified Patient Interface)

This submission describes changes to the Patient Interface (PI) of the VICTUS Femtosecond Laser Platform. The study's primary goal was to demonstrate that these modifications do not negatively impact the device's performance compared to the previously cleared version, thus establishing substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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The VICTUS Femtosecond Laser Platform is 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
• · for anterior capsulotomy during cataract surgery
• · the creation of cuts / incisions in the cornea in patients undergoing cataract surgery or other ophthalmic treatment requiring cuts / incisions in the cornea.
• · laser-assisted lens fragmentation of nuclear cataracts during cataract surgery, not for fragmentation of posterior subcapsular (PSC) and cortical cataracts

The VICTUS Femtosecond Laser Platform (VICTUS) is a precision ophthalmic surgical laser and is cleared for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea and for patients undergoing anterior capsulotomy during cataract surgery. The VICTUS has additionally been cleared for patients undergoing cataract surgery or other ophthalmic treatment requiring penetrating arcuate cuts / incisions in the cornea, primary/secondary corneal incisions, and laser-assisted lens fragmentation. This submission includes the next software iteration of version 3.3 and introduces a new S60 patient bed option for the VICTUS Platform. The v3.3 software introduces an additional pattern (grid pattern) which is a variation of currently cleared patterns and is being added to the already cleared lens fragmentation capability. In addition, the software introduces a lens apex detection feature. The previously cleared patient contacting lens and previously cleared suction clip assembly are combined in one convenient package for the user as the VERAFIT patient interface kit. With the exception of the introduction of a new S60 patient bed option, the VICTUS Platform hardware remains unchanged from that described and cleared via K151161. The mode of operation for the VICTUS Platform is using Yb:KYW Femtosecond laser to produce Laser-Induced Optical Breakdown (LIOB) of the corneal tissue. For all indications for use, 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. Surgical effects are produced by scanning thousands of individual pulses, producing continuous incisions. The location of the tissue photodisruption is controlled by a fixed laser beam focused through a scanning optic system to the desired location.

This document is a 510(k) summary for the VICTUS Femtosecond Laser Platform, Model 14000. It describes the device, its indications for use, and a comparison to a predicate device (K151161). The document's purpose is to demonstrate substantial equivalence to the predicate device, not necessarily to detail comprehensive acceptance criteria and a full study proving the device meets them in the way a medical AI/software device would.

Based on the provided text, the device is a VICTUS Femtosecond Laser Platform, Model 14000, and the submission focuses on new software (v3.3) and a new patient bed option. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" are discussed in the context of demonstrating substantial equivalence to a predicate device, rather than proving a new clinical claim with specific performance metrics against a defined standard.

Here's an attempt to answer your questions based on the provided text:

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

The document does not provide a table of clinical acceptance criteria with specific performance metrics (e.g., accuracy, sensitivity, specificity, AUC) for the software changes. Instead, it refers to pre-defined acceptance criteria for non-clinical performance data (bench testing) and compliance with safety standards.

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

• Test Set Sample Size:
  • For Non-Clinical Performance Data (Bench Testing): The document states "A variety of test procedures were conducted" and "Different materials were used for the bench performance testing including: agarose gel, polyethylene terephthalate (PETG), and polymethyl methacrylate (PMMA)." However, it does not specify sample sizes (e.g., number of tests, number of samples of each material).
  • For Clinical Studies: "There was no clinical study performed to support substantial equivalence of this premarket notification." Therefore, there is no clinical test set sample size.
• Data Provenance: Not specified for the non-clinical (bench) testing. Since no clinical studies were performed, there's no clinical data provenance.

3. 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 applicable. No clinical ground truth was established as no clinical studies were performed. The "ground truth" for the bench testing would be metrology readings against engineering specifications, not expert consensus on medical images.

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

Not applicable. No clinical ground truth or human interpretation/adjudication was performed for a test set in the context of this 510(k) submission.

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. No MRMC study was done, as this is a laser surgical device, not an AI diagnostic/interpretive tool for human readers.

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

This device is not an algorithm-only device. It's a surgical laser platform. The software (v3.3) introduces features like a new grid fragmentation pattern and an apex detection feature. The apex detection feature is described as "a user convenience and the physician must still review positioning results and confirm the treatment plan prior to initiating treatment," indicating it's a human-in-the-loop system where the software provides assistance, but the human (physician) retains ultimate control and decision-making power. Therefore, no standalone algorithm-only performance was done in the sense of a diagnostic AI.

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

For the non-clinical performance data (bench testing), the "ground truth" would be the engineering specifications and expected outcomes from the laser's interaction with the test materials (agarose gel, PETG, PMMA). This is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model in the sense that it requires a "training set" of data for learning. The software (v3.3) introduces pre-programmed patterns and detection features based on established physics and engineering, not a learned model from data.

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

Not applicable, as there is no training set for a machine learning model.

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The VICTUS Femtosecond Laser Platform is indicated for use for:

· the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

· for anterior capsulotomy during cataract surgery.

· the creation of cuts / incisions in the comea in patients undergoing cataract surgery or other ophflaalmic treatment requiring cuts / incisions in the comea.

· laser-assisted lens fragmentation of nuclear cataracts during cataract surgery, not for fragmentation of posterior subcapsular (PSC) and cortical cataracts

The VICTUS Femtosecond Laser Platform (VICTUS) is a precision ophthalmic surgical laser and is cleared for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea and for patients undergoing anterior capsulotomy during cataract surgery (via K120426). The VICTUS has additionally been cleared for patients undergoing cataract surgery or other ophthalmic treatment requiring penetrating arcuate cuts / incisions in the cornea (K122386), primary/secondary corneal incisions (K132534), and laser-assisted lens fragmentation (K140615). This submission does not add to the indications previously cleared for the VICTUS Platform. With the exception of a new patient interface suction clip, the VICTUS Platform hardware and software remain unchanged from that described and cleared via K141379.

A new patient interface suction clip for the VICTUS platform is being introduced within this premarket submission, the new suction clip is smaller in diameter and contains a colorant to aid in positioning on the cornea of the eye. For all indications for use, 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. The contact lens portion of the patient interface remains unchanged from that previously cleared. Surgical effects are produced by scanning thousands of individual pulses, producing continuous incisions. The location of the tissue photodisruption is controlled by a fixed laser beam focused through a scanning optic system to the desired location.

The fundamental scientific technology and indications for use remains the same as previously cleared for the VICTUS Femtosecond Laser Platform under K141379.

The provided text describes the Victus Femtosecond Laser Platform, which is regulated as an Ophthalmic Laser. The document is a 510(k) premarket notification summary, indicating substantial equivalence to previously cleared devices.

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly provide a table of quantitative acceptance criteria for device performance. Instead, it states that the device was found to perform "equivalently to the predicate device" and that "the acquired test data successfully verified that the various parameters meet their pre-defined acceptance criteria." This implies that specific performance metrics and their acceptance thresholds exist but are not detailed in this summary.

However, based on the non-clinical and clinical performance data, we can infer some performance aspects:

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

• Non-Clinical Test Set:

  • Sample Size: Not explicitly stated as a number of distinct "test sets" but mentions "four different materials" (porcine eyes, agarose gel, polyethylene terephthalate (PETG), and polymethyl methacrylate (PMMA)) were used for bench performance testing.
  • Data Provenance: Retrospective (bench testing/lab data). Country of origin is not specified, but the applicant is based in Germany, so it's likely European or global.

• Clinical Test Set:

  • Sample Size:
    • Flap group: 58 eyes
    • Cataract group: 113 eyes
    • Total: 171 eyes
  • Data Provenance: Prospective, single-center clinical study. The country of origin for the study is not specified but the applicant is based in Germany.

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 used to establish ground truth or their specific qualifications for either the non-clinical or clinical studies.

• Non-Clinical: Ground truth for material testing (e.g., cut quality, precision) would likely be established by engineers or scientists performing the tests, comparing measurements to specifications.
• Clinical: For biometry, the LENSTAR LS900 measurements served as a reference (ground truth proxy). For capsulotomy completion and adverse events, the operating surgeons/investigators would make those assessments, but their specific expert qualifications are not detailed beyond "multi-surgeon" and "investigators."

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set data.

• Biometry: The comparison was statistical ("correlation and agreement") between the VICTUS OCT and LENSTAR LS900.
• Capsulotomy Completion/Adverse Events: These were reported by investigators, implying direct observation and recording without a separate adjudication process mentioned.

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 involving human readers improving with AI assistance was not conducted or described. This device is an ophthalmic laser for surgical procedures, not an AI diagnostic tool primarily interpreted by human readers. The clinical study focused on the device's accuracy for biometry and its effectiveness in performing specific surgical steps like capsulotomy and lens fragmentation. The "OCT subassembly" is part of the device's guidance system, not an AI assistance for human image interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The performance of the VICTUS Femtosecond Laser Platform itself, as a device performing surgical actions (cuts, fragmentation, imaging), is inherently standalone in its operation. However, surgical procedures always involve a human surgeon in the loop for planning, supervision, and execution. The "standalone" aspect, in this context, would relate to the laser's ability to precisely execute its programmed actions and measurements.

• Non-Clinical Tests: These were standalone tests of the device's physical performance characteristics.
• Clinical Studies: The study confirmed the "intraoperative accuracy of biometry visualization performed by VICTUS optical coherence tomography (OCT)" and the laser's ability to complete capsulotomy. This can be considered evaluating the standalone performance of the device's functions, although within the context of a surgical procedure where a surgeon operates the device.

7. The Type of Ground Truth Used

• Non-Clinical: The ground truth for bench testing would typically be established through precise metrological measurements and adherence to predefined engineering specifications. For material like porcine eyes, histopathology might be used to confirm laser effects, though not explicitly stated.
• Clinical:
  • Biometry: The LENSTAR LS900 was used as the reference standard for axial optical resolution accuracy (lens thickness, anterior chamber depth, and central cornea thickness). This acts as a proxy for ground truth, assuming the LENSTAR LS900 is accepted as an accurate measurement device.
  • Capsulotomy Completion: The ground truth was observed clinical outcome, specifically whether the capsulotomy was completed fully by the laser without manual intervention.
  • Adverse Events: The absence of reported adverse events constitutes the ground truth for safety in the study.
  • Cataract Grades: Clinical assessment (implicitly by ophthalmologists) was the ground truth for cataract grading.

8. The Sample Size for the Training Set

The document does not mention any "training set." This summary pertains to the evaluation of a physical medical device (femtosecond laser) whose functionality is based on established physics and pre-programmed parameters, not a machine learning or AI algorithm that requires a training dataset in the conventional sense. The "software version 3.2" is updated device control software, not a trainable AI model in the common "training set" connotation.

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

Since no training set for an AI/ML algorithm is mentioned, this question is not applicable based on the provided text. The device's "training" in a broad sense would be its design, calibration, and validation against engineering specifications during its development.

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The VICTUS Femtosecond Laser Platform is 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

· For anterior capsulotomy during cataract surgery

• The creation of cuts / incisions in the cornea in patients undergoing cataract surgery or other ophthalmic treatment requiring cuts / incisions in the cornea.

The VICTUS Femtosecond Laser Platform (VICTUS) is a precision ophthalmic surgical laser. For all indications for use, 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. Surgical effects are produced by scanning thousands of individual pulses, producing continuous incisions. The location of the tissue photodisruption is controlled by a fixed laser beam focused through a scanning optic system to the desired location. The VICTUS Platform mode of operation delivers femtosecond pulses to produce a pattern of photodisruption to create cuts / separation in ophthalmic tissue. The VICTUS Platform uses vacuum to affix a suction ring to the corneal surface prior to use.

The device referenced in the document is the VICTUS Femtosecond Laser Platform. The document describes a 510(k) submission, which means the device is being compared to a legally marketed predicate device to establish substantial equivalence. Therefore, the "acceptance criteria" discussed here are primarily about demonstrating that the modified device performs similarly to or no worse than the predicate device.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance in a table, but it does describe the outcomes of the non-clinical and clinical studies designed to show equivalence.

2. Sample Sizes and Data Provenance

• Test Set (Clinical Study):
  • Sample Sizes:
    • Femtosecond-laser flap creation (flap group): 58 eyes
    • Femtosecond laser assisted cataract surgery (cataract group): 113 eyes
  • Data Provenance: Single-center clinical study (location not specified, but likely where Technolas Perfect Vision GmbH is active). Retrospective analysis of correlation and agreement of biometric data.

3. Number of Experts and Qualifications (for Ground Truth)

• The document does not specify the number of experts used to establish ground truth or their qualifications.
• For the clinical study, the "consistency" of VICTUS OCT measurements with LENSTAR LS900 implies that the LENSTAR LS900 measurements served as a reference or a highly accepted method. LENSTAR LS900 is a well-established biometer, and its measurements are generally accepted as a clinical standard for these parameters.

4. Adjudication Method (for Test Set)

• The document does not describe any adjudication method for the clinical study data or for establishing a ground truth based on multiple expert opinions.
• The comparison was made against LENSTAR LS900, suggesting it served as the reference standard.

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

• No MRMC comparative effectiveness study was done comparing human readers with and without AI assistance. The device is a laser platform for surgical procedures, not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only) Performance Study

• A form of standalone performance was done for the device. The non-clinical performance data involved testing the device against engineering specifications and predicate equivalence using various materials (porcine eyes, agarose gel, PETG, PMMA).
• The clinical study also evaluated the device's performance in creating capsulotomies and biometry measurements directly.

7. Type of Ground Truth Used

• Non-Clinical Performance: Engineering specifications, measurements against a predicate device, and physical properties of test materials (e.g., cut quality in various materials).
• Clinical Performance:
  • For biometry accuracy: Comparison with measurements from a commercially available and clinically accepted biometer (LENSTAR LS900). This acts as a proxy for "gold standard" or highly reliable measurement.
  • For capsulotomy completeness: Observation of the actual surgical outcome (full completion without manual intervention).
  • For adverse events: Reported clinical observations by investigators.

8. Sample Size for the Training Set

• The document does not mention a training set in the context of an algorithm or AI. This submission is for a medical device (laser platform) that performs physical procedures, not a software algorithm that learns from data in the traditional AI sense. Its "training" would be more akin to design verification and validation, and calibration.

9. How Ground Truth for Training Set was Established

• As there's no explicitly defined "training set" for an AI algorithm as per the question's premise, this question is not directly applicable. If interpreting "training set" as the data used during the device's development and design verification, the ground truth would have been established through engineering design specifications, bench testing protocols, and comparison with predicate device characteristics and safety standards.

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The VICTUS Femtosecond Laser Platform is 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
• for anterior capsulotomy during cataract surgery .
• the creation of cuts / incisions in the cornea in patients undergoing cataract surgery or . other ophthalmic treatment requiring cuts / incisions in the cornea.
• . laser-assisted lens fragmentation of nuclear cataracts during cataract surgery, not for fragmentation of posterior subcapsular (PSC) and cortical cataracts

The VICTUS Femtosecond Laser Platform (hereafter referred to as the VICTUS Platform) is a precision ophthalmic surgical laser indicated for use the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea and for anterior capsulotomy during cataract surgery (via K120426). In addition, the VICTUS has been cleared for patients undergoing cataract surgery or other ophthalmic treatment requiring penetrating arcuate cuts / incisions in the cornea (via K122386), and for corneal incisions (via K 132534). This 510(k) expands the list of indications for use to include laser-assisted lens fragmentation during cataract surgery for nuclear cataracts.

For all indications for use, 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. Surgical effects are produced by scanning thousands of individual pulses, producing continuous incisions. The location of the tissue photodisruption is controlled by a fixed laser beam focused through a scanning optic system to the desired location.

Safety margins are built into the software, including an anterior capsule safety margin of 500 um, a posterior capsule safety margin of 700 um, and a pupil safety margin of 500 um. The graphical user interface is used to mark the anatomical boundaries and the software automatically calculates the safety margins. The safety margins are not modifiable by the end user.

The fundamental scientific technology remains the same as previously cleared for the VICTUS Femtosecond Laser Platform under K122386 and K132534.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance

Study Details:

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

   • Sample Size: 136 eyes from 110 subjects (26 patients treated bilaterally). 68 eyes in the VICTUS (laser) group and 68 eyes in the standard (manual) treatment group.
   • Data Provenance: The text does not explicitly state the country of origin. It mentions "multi-center, multi-surgeon clinical study," implying various clinical sites, but no geographical location is specified. It was a prospective study.

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

   • The study design describes a "randomized, controlled, open, prospective, multi-center, multi-surgeon clinical study" comparing the VICTUS device to manual methods. The "ground truth" in this context refers to the clinical outcomes and observations recorded during the study, rather than an independent expert review of images or data to establish a reference standard. The study data (e.g., EPT, adverse events, IOP, BCVA, slit lamp findings) were collected through standard clinical procedures by the participating surgeons and study personnel. The document does not specify a number of independent experts for ground truth establishment outside of the primary treating physicians and clinical staff who recorded the outcomes.

3. Adjudication method for the test set:

   • The document does not describe a specific adjudication method (like 2+1 or 3+1) for the test set results. Clinical outcomes were collected by the participating centers. Adverse events were observed and reported, but the process of determining their relation to the intervention was clinical (e.g., "All adverse events in the laser group were determined to be related to the cataract surgery and not to the use of the VICTUS Femtosecond Laser."). This implies a clinical judgment by the investigators, not an independent adjudication committee.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study compares a surgical device (VICTUS Femtosecond Laser Platform) to a manual surgical technique, not an AI or imaging-based diagnostic tool requiring human reader interpretation. Therefore, there's no mention of human reader improvement with/without AI assistance or effect sizes related to such a comparison.

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

   • This is not applicable as the device is a surgical laser platform, not an algorithm for diagnosis or image analysis. The "standalone" performance mentioned refers to the device's ability to perform specific surgical actions (e.g., lens fragmentation) as intended, which was evaluated through the clinical study and non-clinical bench testing. The outcomes were compared to manual surgical techniques, which inherently involve human-in-the-loop performance.

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

   • The "ground truth" primarily consisted of clinical outcomes data (e.g., Effective Phacoemulsification Time (EPT), adverse event rates, intraocular pressure (IOP), best corrected visual acuity (BCVA), slit lamp examination findings, intra-operative complications) obtained directly from the patients in a prospective clinical study. Non-clinical bench testing also established a "ground truth" for the device's physical performance parameters against established acceptance criteria.

7. The sample size for the training set:

   • This device is a surgical instrument and does not rely on a "training set" in the context of machine learning. Therefore, a training set sample size is not applicable. The device's design and parameters are based on engineering principles and prior iterations (as evidenced by its substantial equivalence to previous VICTUS and predicate devices).

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

   • As explained above, there is no "training set" for this type of device. The functionality and safety were established through mechanical/bench testing and clinical trials, not through learning from a dataset with established ground truth labels.

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The VICTUS Femtosecond Laser Platform is indicated for use for:

• The creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea
• For anterior capsulotomy during cataract surgery
• The creation of cuts / incisions in the cornea in patients undergoing cataract surgery or other ophthalmic treatment requiring cuts / incisions in the cornea.

The VICTUS Femtosecond Laser Platform (VICTUS) is a precision ophthalmic surgical laser and is cleared for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea and for patients undergoing anterior capsulotomy during cataract surgery (via K120426). In addition, the VICTUS has been cleared for patients undergoing cataract surgery or other ophthalmic treatment requiring penetrating arcuate cuts / incisions in the cornea (via K122386). This 510(k) expands the arcuate corneal incision by allowing the ability for primary and secondary corneal incisions. These cuts/incisions are performed for patients undergoing cataract surgery to allow direct access into the eye. The correct position and shape of the cuts is verified by the video image. The expansion of the corneal incision indication is supported by software version 2.7 SP2. In addition, an increased diameter patient interface is being introduced (referred to as PI125). The PI125 is a universal PI that allows the use for either corneal or cataract procedures. User request for a smaller diameter patient interface that can be used for both cataract and corneal procedures resulted in the qualification of the existing cataract patient interface as a universal smaller diameter patient interface. Lastly, the bottom end of the pulse duration range has been modified to be lower than that previously cleared in K120426 and K122386. For all indications for use, 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 eve relative to the delivery of the laser beam. Surgical effects are produced by scanning thousands of individual pulses, producing continuous incisions. The location of the tissue photodisruption is controlled by a fixed laser beam focused through a scanning optic system to the desired location. The fundamental scientific technology remains the same as previously cleared for the VICTUS Femtosecond Laser Platform under K120426 and K122386.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, where available:

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

The provided text does not explicitly state quantitative acceptance criteria for device performance (e.g., a specific tolerance for depth, diameter, or angle of incisions). Instead, it describes general claims of performance.

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

• Sample Size for Test Set: Not explicitly stated. The text mentions "A variety of test procedures were conducted" and "Four different materials were used for the bench performance testing: porcine eyes, agarose gel, polyethylene terephthalate (PETG), and polymethyl methacrylate (PMMA)." It does not quantify the number of tests performed on these materials.
• Data Provenance: The study was a "Non-Clinical Performance Data" study, implying it was conducted in a laboratory setting (bench testing) using specified materials. The location of the testing is not mentioned, nor is it explicitly stated as retrospective or prospective, but given it's bench testing, it would inherently be "prospective" in the sense that the tests were designed and executed for this submission.

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

Not applicable. The study was non-clinical bench testing, not involving human subjects or expert assessment of clinical outcomes. Ground truth would be based on physical measurements of the incisions in the tested materials.

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

Not applicable. The study was non-clinical bench testing. Performance was evaluated by "comparing the mean values to the specified acceptance criteria and their 95% confidence intervals." This suggests quantitative measurement and statistical analysis rather than expert 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

No. This was a non-clinical bench study of a laser surgical device, not an AI-assisted diagnostic or imaging system.

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

This refers to a standalone performance of a device itself, which is what the bench testing aimed to assess. The device performance was evaluated independently without human intervention during the "cutting" process, as it is an automated laser system.

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

The ground truth for the non-clinical testing appears to be based on direct physical measurements of attributes like depth, diameter, and angle of incisions in the various test materials (porcine eyes, agarose gel, PETG, PMMA). This would be established using appropriate metrology tools for precision measurement.

8. The sample size for the training set

Not applicable. This is not an AI-based system that requires a "training set" in the context of machine learning. The device is a laser platform; its "training" per se would relate to its engineering and calibration.

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

Not applicable, as there is no "training set" in the machine learning sense for this device.

Ask a specific question about this device

The VICTUS Femtosecond Laser Platform is 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
• for anterior capsulotomy during cataract surgery
• the creation of penetrating arcuate cuts / incisions in the cornea in patients undergoing cataract surgery or other ophthalmic treatment requiring penetrating arcuate cuts / incisions in the cornea.

The VICTUS Femtosecond Laser Platform (hercafter referred to as the VICTUS Platform) is a precision ophthalmic surgical laser indicated for use in patients undergoing cataract surgery or other ophthalmic treatment requiring penetrating arcuate cuts / incisions in the cornea.
The VICTUS Platform is an ophthalmic surgical femtosecond laser designed for cutting a penetrating arcuate cut of pre-selected depth, radius, opening angle, and position angle. The system works by first being programmed with the depth, radius, opening angle and position angle at which the penetrating arcuate cut is desired. The surgeon then fixates the eye with a sterile disposable PMMA contact lens (hercafter referred to as the Patient Interface) that is connected to the laser via a vacuum tube. Depths of -120µm, radius of 1500 - 4750 um, opening angles of 1-360°, and position angles of 0 - 359° are available.
Laser pulses are delivered through the sterile 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. Surgical effects are produced by scanning thousands of individual pulses, producing continuous incisions. The location of the tissue photodisruption is controlled by a fixed laser beam focused through a scanning optic system to the desired location.

Here's a breakdown of the acceptance criteria and the study details for the VICTUS Femtosecond Laser Platform, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria in a table format for the arcuate cuts/incisions. However, the performance data section implies the following outcomes were evaluated and met a criteria of being "highly reproducible and accurate." The postmarket surveillance review indicates "comparability to the standard manual procedure" for clinical endpoints.

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

• Sample Size for Test Set: 49 eyes from 34 subjects.
• Data Provenance: Retrospective, single site in Europe.

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

The text states that "all surgeries were performed by the same surgeon" at the single clinical location. This surgeon's performance was compared between manual and laser-assisted procedures. While this surgeon's outcomes define the "ground truth" for the comparison within the study, the text does not specify the number of experts or their qualifications that established an independent "ground truth" for evaluating the quality of the surgical outcomes themselves. The comparison is against the surgeon's own manual technique.

4. Adjudication Method for the Test Set

The provided text does not specify an adjudication method (e.g., 2+1, 3+1). The "ground truth" appears to be the clinical outcomes as assessed by the operating surgeon and the postmarket surveillance review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study compared laser-assisted procedures to manual procedures performed by the same surgeon at a single site. The effect size of how much human readers improve with AI vs. without AI assistance is not applicable in this context as the device is a surgical laser, not an AI diagnostic tool.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was done

Yes, a standalone performance evaluation was conducted in the Non-Clinical Performance Data section. This involved bench testing using various materials (porcine eyes, agarose gel, PETG, and PMMA) and scanning electron microscopy to assess the laser's cutting accuracy and reproducibility. This evaluate the device's inherent mechanical and cutting capabilities independent of human intervention in the cutting process itself.

7. The Type of Ground Truth Used

• For Non-Clinical Performance Data: The ground truth was established through measurements (rim depth, diameter, open angle, position angle, centration) and visual assessment (scanning electron microscopy) of the cuts produced in various test materials (porcine eyes, agarose gel, PETG, PMMA).
• For Postmarket Surveillance Clinical Review: The ground truth was based on clinical outcomes data (post-surgical loss of best corrected distance visual acuity (BCDVA), post-surgical overall change in refraction, postoperative induced cylinder, adverse events, and serious adverse events) observed in patients after both laser-assisted and manual arcuate incisions, as assessed by the operating surgeon.

8. The Sample Size for the Training Set

The provided text does not mention a training set or details about its sample size. This device is a surgical laser, and the studies described are performance evaluations, not the development or training of an AI algorithm.

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

As no training set is mentioned (since this is not an AI/algorithm-driven device in the context of typical AI device submissions), this question is not applicable.

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The VICTUS Femtosecond Laser Platform is indicated for use for:

• the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
• for anterior capsulotomy during cataract surgery.

The VICTUS Femtosecond Laser Platform is a precision 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 or for patients undergoing anterior capsulotomy during cataract surgery.

The VICTUS Femtosecond Laser Platform is an ophthalmic surgical femtosecond laser designed for cutting a precise corneal flap of pre-selected thickness and diameter. The system works by first being programmed with the depth and diameter at which the flap should be made. The surgeon then fixates the eye with a PMMA contact lens (referred to hereafter as the Patient Interface) that is connected to the laser via a vacuum tube. Flap thickness of 110 to 200 microns can be achieved in diameters of 6.0 to 9.5 mm.

In addition to the above, the VICTUS Femtosecond Laser Platform allows anterior capsular dissection which is achieved through precise individual micro-photodisruption of fissue, measuring a few microns in diameter, created by tightly focusing ultrashort laser pulses into the targeted capsular tissue. Pre-programmed patterns produce capsular resections of predetermined diameter and height. Capsular cut depth of 2245 to 5000 microns below the corneal surface can be achieved in diameters of 3 to 7 mm.

For both indications for use, 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. Surgical effects are produced by scanning thousands of individual pulses, producing continuous incisions. The location of the tissue photodisruption is controlled by a fixed laser beam focused through a scanning optic system to the desired location.

The provided text describes the VICTUS Femtosecond Laser Platform and its performance data. However, it does not explicitly state "acceptance criteria" in a table format with corresponding performance metrics for all aspects of the device. Instead, it presents an overall conclusion about the device's performance compared to predicate devices and manual methods.

Here's an analysis of the acceptance criteria and study information that can be extracted or inferred from the provided text, along with where the requested information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information/Cannot Be Determined from Text:

• Explicit, quantifiably defined "acceptance criteria" for many of the qualitative performance descriptions (e.g., "highly accurate" or "good"). These are described as outcomes rather than pre-defined thresholds.

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

• Anterior Capsulotomy (Clinical Study):
  • Sample Size: 119 eyes of 118 subjects.
  • Data Provenance: Prospective, single-center, multi-surgeon clinical study. Country of origin is not explicitly stated, but the study was described as "clinical performance was evaluated in a clinical study...".
• Flap Thickness (Clinical Data):
  • Sample Size: 18 eyes.
  • Data Provenance: Collected at a "VICTUS site located outside of the USA." This indicates retrospective perhaps, or a separate smaller clinical investigation.

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

• Anterior Capsulotomy (Clinical Study):
  • Ground Truth Establishment: "visual inspection during slit lamp examination" and "visual inspection at the day of surgery" were used to assess IOL centration, capsulotomy completeness, and centration. The study involved "multi-surgeon" participation.
  • Number of Experts/Qualifications: Not explicitly stated. The "multi-surgeon" aspect implies multiple surgeons were involved in both performing the procedures and potentially in the visual inspections, but their specific qualifications (e.g., years of experience, blinded assessment) are not detailed.
• Flap Thickness (Clinical Data):
  • Ground Truth Establishment/Experts: Not explicitly stated how "achieved flap thickness" was measured or validated, nor who made those measurements or assessments.

4. Adjudication Method for the Test Set

• Anterior Capsulotomy (Clinical Study): Not explicitly stated. The reliance on "visual inspection" by multiple surgeons might imply a consensus or individual assessment, but no formal adjudication method (like 2+1 or 3+1) is described.
• Flap Thickness (Clinical Data): Not stated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance?

• Not applicable. This device is a femtosecond laser platform for surgical procedures, not an AI diagnostic or assistive device for human readers. The clinical study compares laser-assisted capsulotomy to manual capsulotomy, not human readers with and without AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done?

• Partially applicable. The "Non-clinical performance data" section describes testing "without human-in-the-loop" in a surgical context, using inanimate materials (porcine eyes, agarose gel, PETG, PMMA) and scanning electronic microscopy to assess the laser's precision in creating capsulotomies and flaps. This demonstrates the device's inherent capability (akin to a standalone algorithm) to achieve specific physical outcomes.
• However, the clinical studies do involve human surgeons operating the device (human-in-the-loop), albeit comparing the device's laser-assisted method to manual surgical techniques.

7. The Type of Ground Truth Used

• Non-Clinical Data:
  • Direct Measurement/Visual Assessment: Scanning electronic microscopy for visual assessment of laser cuts, and measurements (mean values and 95% confidence intervals) against specified acceptance criteria using various inert materials.
• Clinical Data (Anterior Capsulotomy):
  • Clinical Outcomes/Expert Visual Inspection: Comparison of adverse events, severe adverse events, post-surgical complications, IOL centration, and capsulotomy completeness/centration. The "ground truth" seems to be the collective clinical judgment and observation by surgeons and clinical staff via slit lamp examinations and visual inspection.
• Clinical Data (Flap Thickness):
  • Direct Measurement (Implied): Comparison of "intended flap thickness" to "achieved flap thickness." The method for determining "achieved flap thickness" (which would be the ground truth here) is not detailed but would typically involve direct measurement techniques.

8. The Sample Size for the Training Set

• Not applicable/Not explicitly mentioned in the context of device performance studies. This device is a surgical laser, not an AI or machine learning algorithm that requires a "training set" in the traditional sense. Its design and functional parameters are based on scientific principles and engineering, not data-driven machine learning models.

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

• Not applicable, as there is no mention of a "training set" for an AI/ML algorithm within the provided text. The device's fundamental scientific technology and algorithms for laser patterns "remain unchanged from those previously cleared" predicate systems, implying established and validated physical principles rather than learned models.

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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 Orbscan II Keratometer is intended to scan, map and display the geometry of the anterior segment of the eye.

The Orbscan II is a non-invasive, diagnostic system that measures and displays the anterior segment geometry of the eye. The system consists of an optical head, power supply and CPU. The optical head projects light through moving slit shaped apertures, The slit images are projected onto the eye at equi-distant angles from a central optical axis. A video camera placed on the optical axis records the images of the slits as they pass over the eye. The location of each slit at each position is determined during the system calibration.

During an examination, the slits are stepped across the cornea and an image of the cornea at each slit location is recorded, The CPU processes the images by using edge detection algorithms to determine the location of all of the edges the light strikes during the exam. Through direct triangulation, the elevation and curvature for the various surfaces is determined. Corneal thickness, anterior chamber depth and clevation of the iris and lens can then be determined by subtracting the surfaces.

This anterior segment information is displayed graphically to a user in the form of colored maps. These maps display variations in height and thickness numerically as well as with gradations in color. The graded colors allow for easier visualization of true measurements and how they relate to elevation and thickness of the eye geometry. The maps can be displayed individually or in several combinations. They can also be customized by the user for their specific examination needs. The Orbscan operates on a Windows™ based user interface and operating system that allows for ease of operation and system control. The CPU used with the Orbscan is a standard, high-speed PC type computer. Other peripherals may include a display monitor, a mouse pointing device and a printer for hard copies of the maps, should the user desire them.

To enhance repeatability, an optional placido pattern can be attached to the Orbscan. The placido pattern provides slope data for the anterior surface of the eye. The slope data obtained from using the placido pattern is combined with the elevation data as measured with triangulation. Tests on both test objects and human subjects have shown that the reproducibility has been enhanced from +/- . 005mm without the placido to +/-.003 mm with the placido pattern.

The device is non-invasive and only contacts the patient on his/her chin and forehead. The other concerns for safety are the light output and electrical safety. The light output is of an evesafe intensity and wavelength. Electrical safety is provided by packaging which is compliant to accepted safety standards, and mcdically safe power sources which isolate the patient from hazardous voltages and current.

The device is proven effective in incasuring the anterior geometry of the eve through internal company and independent clinical studies.

Here's an analysis of the Orbscan II Keratometer's acceptance criteria and the study reported to show it meets those criteria, based on the provided document:

Orbscan IITM Keratometer Performance Study Analysis (K984443)

1. Acceptance Criteria and Reported Device Performance

The primary performance metric highlighted and improved upon for the Orbscan II is its reproducibility.

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